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AMIA - American Medical Informatics Association

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What is Informatics?

Biomedical and health informatics applies principles of computer and information science to the advancement of life sciences research, health professions education, public health, and patient care. This multidisciplinary and integrative field focuses on health information technologies (HIT), and involves the computer, cognitive, and social sciences.

Informatics is the science of how to use data, information and knowledge to improve human health and the delivery of health care services. Health IT is part of informatics and an essential aspect of AMIA, but technology and technological considerations are only one component of the association's work. Health IT enables advancements in health care by providing the tools with which to set knowledge in motion. Biomedical and health informatics has developed its own areas of emphasis and approaches that sets it apart from other professions and disciplines Biomedical informatics (BMI) is the interdisciplinary, scientific field that studies and pursues the effective uses of biomedical data, information, and knowledge for scientific inquiry, problem solving and decision making, motivated by efforts to improve human health.

BMI develops, studies and applies theories, methods and processes for the generation, storage, retrieval, use, and sharing of biomedical data, information, and knowledge.

BMI builds on computing, communication and information sciences and technologies and their application in biomedicine.

BMI investigates and supports reasoning, modeling, simulation, experimentation and translation across the spectrum from molecules to populations, dealing with a variety of biological systems, bridging basic and clinical research and practice, and the healthcare enterprise.

BMI, recognizing that people are the ultimate users of biomedical information, draws upon the social and behavioral sciences to inform the design and evaluation of technical solutions and the evolution of complex economic, ethical, social, educational, and organizational systems.

The growing role of HIT has created the need to broaden and deepen the pool of workers who are able to help organizations deal effectively with their investment in information technology and, thus, enhance the prospects for major improvements in the safety, quality, effectiveness and efficiency of care. Biomedical and health informaticians understand the workflow of organizations as well as the potential and limitations of information technology. Informaticians conduct research and apply findings to improve processes and propose solutions to technical, clinical, and organizational challenges hampering successful technology implementations.
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Areas of Practice

AMIA supports the following practice areas:

Changing the Way We Approach Health and Healthcare

Through education, training, accreditation and certification, AMIA supports the current and next generation of informatics professionals by:

Providing members opportunities to grow professionally, no matter what their career level or discipline.

Fostering collaboration and networking to support members' work to improve people's lives.

Expanding members' leadership opportunities within the association and in the field.

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Methods of Information in Medicine

An International Recommendation Framework of Core Competencies in Health Informatics for Nurses

Ursula Hübner, 1, Correspondence address Toria Shaw, ² Johannes Thye, ¹ Nicole Egbert, ¹ Heimar de Fatima Marin, ³ Polun Chang, ⁴ Siobhán O'Connor, ⁵ Karen Day, ⁶ Michelle Honey, ⁷ Rachelle Blake, ⁸ Evelyn Hovenga, ⁹ Diane Skiba, ¹⁰ and Marion J. Ball ¹¹

Summary

Background: While health informatics recommendations on competencies and education serve as highly desirable corridors for designing curricula and courses, they cannot show how the content should be situated in a specific and local context. Therefore, global and local perspectives need to be reconciled in a common framework.

Objectives: The primary aim of this study is therefore to empirically define and validate a framework of globally accepted core competency areas in health informatics and to enrich this framework with exemplar information derived from local educational settings.

Methods: To this end, (i) a survey was deployed and yielded insights from 43 nursing experts from 21 countries worldwide to measure the relevance of the core competency areas, (ii) a workshop at the International Nursing Informatics Conference (NI2016) held in June 2016 to provide information about the validation and clustering of these areas and (iii) exemplar case studies were compiled to match these findings with the practice. The survey was designed based on a comprehensive compilation of competencies from the international literature in medical and health informatics.

Results: The resulting recommendation framework consists of 24 core competency areas in health informatics defined for five major nursing roles. These areas were clustered in the domains "data, information, knowledge", "information exchange and information sharing", "ethical and legal issues", "systems life cycle management", "management" and "biostatistics and medical technology", all of which showed high reliability values. The core competency areas were ranked by relevance and validated by a different group of experts. Exemplar case studies from Brazil, Germany, New Zealand, Taiwan/China, United Kingdom (Scotland) and the United States of America expanded on the competencies described in the core competency areas.

Conclusions: This international recommendation framework for competencies in health informatics directed at nurses provides a grid of knowledge for teachers and learner alike that is instantiated with knowledge about informatics competencies, professional roles, priorities and practical, local experience. It also provides a methodology for developing frameworks for other professions/disciplines. Finally, this framework lays the foundation of cross-country learning in health informatics education for nurses and other health professionals.

Keywords: Health informatics competencies, nursing, inter-professional care, education, curriculum, workforce development, recommendations, methodology

1. Introduction

1.1 Health Informatics versus Nursing Informatics?

Identifying informatics competencies in nursing has had a long history and pertinent activities have increased over the last 15 years, with peaks between 2006 and 2009, staying at a high level afterwards [ 1 ]. This continued interest in education correlates with the advancement of information technologies, their implementation to support healthcare processes and the potential to make a difference in patient outcomes, and the health IT knowledge and skills gap in nursing [2 ]. Over the years, the focus on competency recommendations has shifted to reflect changing technical and other priorities in healthcare. For example, in 2001, educators distinguished between computer and informatics skills [3 ] and focused on technologies such as relational databases [4 ]. Although these recommendations have not become obsolete, the two examples highlight the need for continuously monitoring and updating informatics competencies in order to keep pace with on-going technical developments and their use.

As observed in other clinical informatics sub-specialties, informatics competencies in nursing belong to a cohesive field of its own known as "nursing informatics". However, the notion has grown that there has to be a common foundation with input from a variety of healthcare professions [ 5 ]. In this sense, the term "health informatics" comprises informatics for different disciplines and professions and recognizes inter-professionalism as an intrinsic feature of informatics [6 ]. This view matches activities to reshape healthcare from a silo dominated field to a process and patient oriented service, which requires health information technology (IT) to support inter-professional care across the continuum, based on proper process management and inclusive of quality management [7 , 8 ].

Informatics , which focuses on data, information, knowledge, the applications and the users themselves, is to be distinguished from Information Systems which focuses on the organizational use of health IT and from Information Technology , which primarily addresses systems development and system life cycle management issues [9 ]. Due to its focus on data, information and knowledge, health informatics needs to balance requirements that are specific to professions or roles and those that are generic and applicable across the spectrum of healthcare professionals. "What health informatics competencies are relevant for a special group of health professionals (e.g. nurses) and for different professional roles?" is thus a valid question and needs to be answered for each group separately.

1.2 The Benefit of International Recommendations in Education

As health IT industry is increasingly working in a global arena, international recommendations in medical and health informatics education [ 10 , 11 ] have become more desirable. Other trends also speak in favor of a global perspective. While traditional education is always situated in a local context, new modes of teaching and learning for example, such as Massive Open Online Courses (MOOCs) [12 ], are emerging that fulfill a niche for hundreds of thousands of learners from diverging backgrounds, different settings and countries. Recommendations taking a global perspective therefore match the idea of MOOCs. Research and education form a strong alliance at all levels of the translational process to improve health practice. Research, which is defined by internationally valid standards, strongly depends on the collection, analysis and publication of electronic data, also from nursing [13 ] and from sites in different countries [14 ]. Thus, informatics competencies play an essential role in the education of health and nursing researchers in order to work successfully in an international environment.

Furthermore, international recommendations can foster harmonization of education and may increase workforce mobility across countries [ 15 ]. In this light, the European Union (EU) and the United States of America (USA), signed a Memorandum of Understanding (MoU) focused on health IT in 2010. The MoU agreed to further develop the workforce's health IT skills to fully utilize the potential of new and emerging technologies. This work took place from 2013-2015 under the direction of the EU-US Workforce Development Workgroup (WDW), which compiled the results of an analysis that mapped competencies in the form of the HITCOMP (Health IT COMPetencies) Tool and Repository [15 , 16 ].

1.3 Learning and Teaching: the Competency Based Approach

Competency based approaches have increasingly gained attention in the context of medical and nursing education over the last decades [ 17 , 18 , 19 ] to overcome the shortcomings of the pure topic related approach. In psychology, competencies are understood as "[...] a roughly specialized system of abilities, proficiencies, or skills that are necessary to reach a specific goal." [20 ]. Competencies as such embrace a set of behaviors and intent and cover cognitive, social and emotional aspects of performance [21 ]. Due to the close relationship between "demands, tasks, problems, and goals" [20 ] and respective competencies, competency based learning is always associated with a specific role, scenario or task domain. For example, there are specific competencies for the nurse leader role [22 ] or for inter-professional cooperation [23 ]. In this context, we will refer primarily to cognitive competencies, which encompass the acquisition and understanding of new knowledge through iterative mental processes of sensing, experiencing, thinking and reasoning/interpreting [21 ]. We will focus particularly on those cognitive competencies that contribute to the successful accomplishment of nursing roles within an organization. In accordance with management theory [24 ], which refers to entire organizations, we call them "core competencies" of the professional role.

There are various frameworks that breakdown and describe competencies. According to some frameworks, competencies consist of both knowledge and skills [e.g. 25, 26]. These frameworks either refer to different (academic) levels [ 10 , 27 ] or at a specific level, e.g. graduate programs [25 , 28 ]. Competencies can be graded along Bloom's modified six cognitive process dimension terms (i.e. remember, understand, apply, analyze, evaluate and created) referring to "factual knowledge", "conceptual knowledge", "procedural knowledge" and "metacognitive knowledge" [29 ] or as "prerequisite knowledge and skills", "fundamental knowledge" and "procedural knowledge and skills" [25 ].

Although health informatics knowledge is global and requires international recommendations, education is typically local and the competencies addressed in the study programs and courses have to be embedded into the environment where they will be used. These two controversial requirements have to be reconciled in order to assist teachers and learners effectively in their efforts. The primary aim of this study is to empirically define and validate a framework of globally accepted core competencies in informatics and to enrich this framework with exemplar information derived from local educational settings. The methodology for developing a framework of this type should be applicable for any kind of target group. Within this study, the framework was developed for nurses with a focus on the professional roles they typically hold. The study was performed within the TIGER ( Technology Informatics Guiding Education Reform ) Initiative that includes an international network of nursing experts and reaches out to the entire community of healthcare professionals.

2. Methods

2.1 The TIGER Approach

In response to the initial formation of the Office of the National Coordinator for Health Information Technology (ONC) in the United States of America in 2004, the TIGER Initiative was officially launched in 2006 when key nursing stakeholders convened to ensure nursing was included in the mandate for health informatics education and application.

TIGER is dedicated to enabling clinicians, particularly nurses, to better exploit the use of informatics tools, their principles and underlying theories to improve patient care [ 30 ]. In 2012, the TIGER International Committee was established to widen the reach of TIGER activities in the international scientific community. When TIGER transitioned from a standalone initiative to the Healthcare Information and Management Systems Society (HIMSS) in 2014, the scope was extended to include other clinical disciplines and to enter into an inter-professional space even beyond clinicians. Today, TIGER seeks to empower educators as change agents and learners to prepare the inter-professional, inter-disciplinary clinical workforce for the digital age [31 ]. Based on these goals, TIGER initiated the international informatics competency synthesis project, which seeks defining and validating a recommendation framework.

2.2 Overview of Methodological Steps

In order to achieve this aim, a mixed method approach was pursued that combined quantitative and qualitative methods and iteratively validated the core competency areas while enriching the framework.

Figure 1 provides an overview of the three steps used to launch and finalize this project inclusive of the methods applied and the perspective from which the information was captured.

2.3 Survey

In order to identify globally relevant core competency areas to be represented in the framework, a survey was conducted. This survey made use of an existing online questionnaire [ 32 ] that had been designed drawing upon international literature, that had been further refined in two workshops and tested in three countries [32 ]. The questionnaire was comprised of 24 core competencies areas in health informatics, which had been extracted from the international literature [10 , 11 , 18 , 25 , 33 , 34 , 35 ] and embraced 10 technological items (e.g. eHealth, telematics and telehealth), two legal and ethical items (e.g. data protection, ethics and IT), 11 IT related management items (e.g. project management, change management) and finally, biostatistics/statistics. Five professional roles of nurses were targeted in accordance with the methodology established prior to this study [32 ]: 1) clinical nursing (e.g. care planning), 2) quality management (e.g. organizational development), 3) coordination of inter-professional care (e.g. case management), 4) nursing management (e.g. ward or hospital management) and 5) IT management in nursing (e.g. introduction of new IT systems). A role-based approach was chosen because role specific training for different groups of health professionals had been identified as a highly desirable action in order to increase the health IT skills of the healthcare workforce [36 ]. The meaning of these roles was explained by examples (see ►Online Appendix A). Survey participants were asked to rate the relevance of the 24 core competency areas within the five roles on a scale from 0 to 100. In order to help survey participants to get a more detailed understanding of what these core competency areas meant, examples subsumed under these core competency listings were given (►Online Appendix A). We did not distinguish between the different cognitive process dimensions "factual knowledge", "conceptual knowledge", "procedural knowledge" and "metacognitive knowledge" or any other gradating categories because this specification would have required assumptions on the (academic) level of the learning and teaching activities. It is important to note that these level differences were out of the scope of this survey. The core competency areas were presented in alphabetical order.

A personalized link to the questionnaire was sent to 72 people from 24 countries in the Americas (6 countries), Europe (10 countries), Asia (6 countries), and Australia/Pacific (2 countries). Participants were either a member of or associated with the International TIGER Committee. As TIGER comprises primarily experts with an interest in education, the majority (46%) came from universities, 26% came from health IT industry, 14% from hospitals (including university hospitals), 13% from professional associations and 1% did not give any information about their affiliation. All survey participants are regarded as high profile experts in their countries. The survey was open from November 23, 2015 to January 18, 2016. Out of the 72 experts invited, we yielded 43 responders (response rate approximately 60%). They came from 21 countries: Americas (4 countries), Europe (10 countries), Asia (5 countries) and Australia/Pacific (2 countries) and had the following affiliation: 37% from universities, 21% from health IT industry, 35% from hospitals (including university hospitals) and 7% from professional associations.

2.4 Workshop

In order to validate the survey findings within a global expert community, a workshop was held at the 13 th International Congress on Nursing Informatics (NI2016) in Geneva on June 28, 2016 [37 ]. The aim was to find out if core competency areas were missing and how to cluster them. Twenty-eight experts from 13 countries on four continents attended the workshop (six of the experts had participated in the survey). Workshop attendees reported the following types of affiliation: 39% universities, 25% hospitals (including university hospitals), 18% health IT industry, 11% professional associations and 7% gave no information. Following an introduction to the aims and visions of the TIGER Initiative, the results of the international survey on core informatics competency areas were presented and made available to the audience as a handout. The workshop then focused on discussing informatics competency issues with workshop attendees. The discussion was stimulated with the following questions: (1) "What are the top 5 informatics competencies for nurses according to your experience?" and (2) "What is your opinion about the core competency areas just presented?". The discussion was recorded and all contributions were summarized utilizing the inductive categorization method. This work included five persons from the team of authors (UH, TS, MB, HM, PC) who additionally clustered the individual competencies making use of the greater domains also mentioned by the experts at the workshop. These domains were mapped to the 24 core competency areas by the same team members plus one other author (OS). Cronbach's alpha was computed to test the internal consistency of these domains across the five nursing roles. An alpha value of 0.70 and above was interpreted as "satisfactory" in accordance with the literature [38 ].

2.5 Case Studies

Local exemplar case studies, which were compiled for this study, should illustrate the use of the core competency areas selected to represent leading institutions of education in the field of nursing and health informatics. One case study per country was chosen covering Brazil (BR), Germany (GER), New Zealand (NZ), Taiwan/China (TW-CHN), the United Kingdom (UK) and the United States of America (USA). These countries were selected to mirror a variety of different (professional) cultures. While conducting this study, no case study from an African country was available to be included into this project. These case studies should provide background information on educational institutions, varying types of students, the academic level, teaching strategy and the educational format. They also should describe if and in which way informatics core competency areas were addressed by these courses and programs. Thus, they were meant to serve as exemplars of teaching and learning individual competencies included in the core competency areas and potentially beyond.

2.6 Ethical Considerations

The methodology of this study was presented to the Ethical Committee for Research at Hochschule Osnabrück Germany, which decided that there was not need to submit a full proposal to the Committee.

3. Results

3.1 Overview

The three-step methodology resulted in a recommendation framework that consists of globally accepted core competency areas:

1. sorted by relevance within five different professional roles in nursing based on the empirical findings of the survey,

2. clustered by coherent overarching domains identified in the workshop and verified by a reliability analysis and

3. illustrated and validated by educational programs and courses in various countries by case studies.

The framework provides recommendations for high priority core competency areas to be addressed when developing curricula for the five professional roles in nursing. It also gives advice regarding the cohesion of core competency areas. Finally, it allows insight into how these areas are broken down into individual competencies in different local settings and for different purposes. This approach resulted in very concrete recommendations but also demonstrates the feasibility of the methodological approach. Each study step is described in-depth in the following sections.

3.2 Global Relevance of Core Competency Areas for Professional Roles in Nursing

► Table 1 shows the priority list and outlines the core competencies areas per professional role. Each role was characterized by one to three lead core competency areas with (nearly) the same mean percentage of relevance (in italics ► Table 1 ) and by a specific profile of core competency areas. In this sense, the leading core competency area for clinical nursing and nursing management was nursing documentation . For the quality management role, it was quality management and for coordination of inter-professional care, it was data protection and security and information management and knowledge management in patient care . For IT management in nursing, there were three (nearly) equally important core competency areas: information systems and communication systems , principles of nursing informatics and data protection and security . There was a mixture of genuine IT competency areas (e.g. information systems and communication systems), IT related management areas (e.g. strategic management and leadership), and legal and ethical issues. Competencies in the areas of nursing documentation and information management and knowledge management in patient care could be found among the top 10 in all five roles. The same held true for competencies in the area of principles of nursing informatics . Data protection and security , process management as well as quality management were rated as highly relevant in four out of the five roles among the top 10 areas of competencies.

Table 1

Clinical Nursing (Direct Patient Care)

Core competency area

REL ± SD, n = 41

Quality Management

Coordination of Inter-professional Care

Nursing Management

IT Management in Nursing

Other core competency areas were rather distinctive, such as strategic management and leadership , which appeared among the top 10 only in nursing management, and assistive technology for ageing people , which belonged to the top 10 only in clinical nursing.

Besides these more role specific considerations, the survey results also revealed the importance and relevance of many health informatics core competency areas. Mean relevance values of core competency areas ranking at position 10 still ranged between 69.0 and 83.4 across all roles ( Table 1 ).

►Online Appendix B provides an overview of the ratings for all 24 core competency areas within the five roles.

3.3 Validation and Clustering of the Core Competency Areas

When asked about the highest priority of core competencies, workshop attendees mentioned a variety of different items and competencies including greater core competency areas. These different statements were analyzed with the aim of identifying similarities and differences with regard to the 24 core competency areas (validation) and with the aim of clustering these areas. Based on the consensus of five experts from the team of authors, four domains emerged from these statements. ► Table 2 (left column) shows the domains, the corresponding items and competencies resulting from summarizing the workshop findings and finally the associated core competency areas from the survey (right column). All statements could be matched with core competency areas.

Table 2

Domains of competency areas

Associated core competency areas (main similarities)

Data, information and knowledge (DIK) domain

1) know how to use data/information not only how to enter data

2) perform care planning and use of data

3) make use of indicators (information) for decision making

4) analyze what data are needed and are useful, link to data/information science

7) information governance

Information exchange and information sharing (IEIS) domain

1) continuity of care

2) sharing of information with the patient, work in partnership, learn to listen

4) health information exchange

Ethics and legal issues (EL) domain

1) ethics

Systems life cycle management (SLCM) domain

1) address requirements

3) design thinking

The four domains derived from the expert statements were used as an initial structure to cluster the 24 core competency areas. As there were some areas that could not be assigned to one of the four domains, two more clusters were introduced by the five experts from the team of authors, which then resulted in six final domains. Two core competency areas were assigned to two domains, i.e. assistive technology for ageing people and information and communication systems. Table 3 shows the clustering and the internal consistency values of these domains computed by Cronbach's alpha.

Table 3

Domains

Clinical nursing (n = 41)

Quality management (n = 41)

Coordination of inter-professional care (n = 41)

Nursing management (n = 43)

IT management in nursing (n = 41)

Principles of nursing informatics

Information and knowledge management in patient care

Nursing documentation (including terminologies)

Information management in research

Information management in teaching, training and education

Resource planning and logistics

Information and communication systems

Applied computer science/informatics

Strategic management and leadership

Change management and stakeholder management

Human resource management

All Cronbach's alpha values were 0.70 or larger ("satisfactory") [ 37 ] with the only exception of ethics and legal issues (EL) for nursing management, which reached a value of 0.67. In summary, the expert statements from the workshop attendees could be mapped to the 24 core competency areas of the survey (► Table 2 ) and provided a consistent structure for clustering the core competency areas (► Table 3 ).

3.4 Illustration of Core Competency Areas by Cases Studies and the Final Recommendation Framework

The selected exemplar case studies covered educational activities for nurses in six countries, including two case studies describing courses at the undergraduate level (BR, UK-SCO), two at the postgraduate level (NZ, USA) and two at the certificate level in continuing education (GER, TW-CHN). There were exemplar case studies that embraced single courses (BR, GER, NZ, TW-CHN, USA) and one that described a sequence of learning units embedded in a nursing program (UK-SCO). Similarly, four of the case studies focused on nurses (BR, GER, TW-CHN, UK-SCO), one primarily on nurses but also on informatics students (USA) and the other was entirely inter-professional (NZ). In all six cases, the courses were or are designed drawing on national recommendations [e.g. 32, 39, 40, 41] or developments (BR, GER, NZ, TW-CHN, UK-SCO, USA. The case studies are described in full length in ►Online Appendix C. Competencies tied to the core competency area in each exemplar case study are represented as building blocks. These building blocks contain competency descriptions in each area (► Figure 2 ).

Table 4 constitutes the recommendation framework consisting of the core competency areas, their mean relevance values, the associated domains and the case study building blocks referring to the core competency areas. It hereby shows the distribution of competency building blocks from individual exemplar case studies. It mirrors the breadth and depth of the courses described and the competencies associated.

Table 4

Roles

Clinical nursing (direct patient care)

Quality management

Coordination of inter-professional care

Nursing management

IT management in nursing

Core competency area

Domains

REL n = 41

Covered by case studies from

REL n = 41

Covered by case studies from

REL n = 41

Covered by case studies from

REL n = 43

Covered by case studies from

REL n = 41

Covered by case studies from

Information and knowledge management in patient care

DIK

82.2

83.2

85.4

84.0

86.1

Decision support by IT

DIK

70.2

72.7

70.0

74.7

85.4

Information management in research

DIK

51.0

72.4

60.5

63.3

71.5

Information management in teaching, training and education

DIK

61.7

67.1

66.1

70.0

74.4

Resource planning and logistics

DIK

56.6

65.4

71.7

76.0

71.7

eHealth. telematics and telehealth

IEIS

69.5

69.8

77.6

66.3

80.0

The case studies from Brazil and UK-Scotland were similar with regard to addressing undergraduate students in their role as clinical nurses, i.e. direct patient care. As these were beginner courses, they focused primarily on the informatics essentials of healthcare professionals. They differed with regard to the number of teaching hours. The Brazilian course, which was a single course, included 30 hours, whereas the Scottish course covers a set of learning units that is integrated into pre-registration nurse training. These competencies matched with the ones for clinical nursing in the top 10 priority list ( Table 1 ) closely.

The US course addressed core competency areas for graduate nurses working in different roles. As a self-paced online course, no specific information on its duration was given. It emphasized competencies associated with the selection, use and evaluation of different types of systems and the exploitation of data, information and knowledge for patient care and research. The New Zealand course covered a large range of informatics competencies for various roles, which corresponded with its design as an inter-professional series of four or eight courses towards a certificate or diploma in health informatics respectively (with 150 teaching and learning hours per course). The German continuing education course was highly specialized in nursing management and analytics while being restricted in its duration (30 hours). It embraced all core competency areas of the top 10 priority list (► Table 1 ) for the role of nursing management and included statistics. It also assumed that certain competencies were already available. The Taiwan-China course was an example how developments in one country (Taiwan) were transferred to another country (China). It spanned a large range of core competency areas that were manifested in a 7-day hands-on workshop focused on learning advanced spreadsheet management and programming.

These exemplar case studies also revealed areas only partly covered by the 24 core competency areas. The case study from the USA emphasized competencies that aim to enable health professionals to teach patient/citizen digital health literacy. This approach is closely associated with consumer health informatics. Furthermore, the Scottish case study considered health service literacy, which encompasses knowledge about the national healthcare system, its professionals, roles and processes, as informatics is embedded within this wider context which is critical to understand.

4. Discussion

4.1 Recommendation Framework

We propose a framework consisting of 24 core competency areas in health informatics and five major roles of nurses. The core competency areas were ranked by international experts in a survey, validated by a different group of experts in an international workshop and clustered into six domains. Four domains are equivalent to the domains derived from the workshop expert discussion, i.e. data, information, knowledge; ethical and legal issues; information exchange and information sharing and system life cycle management. The fifth domain summarizes the core competency area that focuses on management activities in the context of informatics. Finally, the sixth domain subsumes biomedical imaging, assistive technology for ageing people and signal processing and biostatistics/statistics . Nearly all domains have at least "satisfactory" or better values for internal consistency across all roles and can be therefore regarded as reliable. The constituents of these domains, the core competency areas, had been extracted from a comprehensive analysis of the international literature and had been validated in two workshops [32 ] prior to this study. In this study, the core competency areas were again validated in a workshop and also via the cases studies. From this multi-layered process, it can be concluded that these areas are valid.

The cells of the matrix framework contain the relevance ratings of international experts. From a global perspective, we recommend areas of core competencies with high relevance ratings in their respective role ( Table 1 ), the globally accepted core competency areas in health informatics for nurses. The interpretation of what is a "high" or a "low" relevance is not given by this framework intentionally to leave the meaning of these values open to the user. The resulting globally accepted areas are meant to function as a compass to show the direction towards areas of high relevance and/or towards domains of high internal consistency. They should help learners and teachers find their route through the large realm of information technology and its application in healthcare. These recommendations are complementary to the TIGER recommendations [35 ] focused on basic IT skills.

From a specific perspective, we recommend learning from the examples provided within the different exemplar case studies. They are detailed enough with regard to (academic) levels, cognitive process dimensions and competencies at the layer of cognitive activities [ 29 ]. They are also situated in a specific context defined by the national healthcare system, the educational system of nurses and other clinicians, status of health IT adoption and culture. The case studies, which refer to the core competency areas, demonstrate how these competencies are combined to form an entire curriculum or program. We recommend that readers construct their personalized set of objectives for learning and teaching from the core competency areas and case studies. The framework is instantiated by the case studies, which indicate the core competencies that are primarily addressed.

The exemplar case studies illustrate the need for diversity in learning and teaching. This may lead to the inclusion of some competencies outside the globally accepted informatics core competency areas, e.g. statistics in the German case study. Due to the fact that the globally accepted areas consist of many core competencies, which cannot be considered in one single course, a selection has to be made that reflects local or cultural differences. Also, the teaching and learning styles may differ. The Taiwan-Chinese course allows the nurses to dive deeply into technology; the USA course incorporates a clinical case, which acts as a red thread to exemplify the use of informatics; the Scottish program accompanies the baccalaureate nursing program in the sense of a spiral learning approach; the New Zealand course pursues a fully fledged inter-professional approach; and finally, the Brazilian course is strongly tied to the establishment of nursing education as such.

The mixed methods approach combined a survey with case studies to warrant the integration of different perspectives to build the recommendation framework.

4.2 Limitations and Strengths

We did not include the roles of nursing teachers and scientists because both roles are very much dominated by the roles they refer to when teaching nurses and clinicians and when conducting research. Thus, a nursing teacher working with students in quality management should dispose of similar competencies as quality managers themselves. Likewise, nursing scientists conducting research in clinical nursing should be familiar with competencies of nurses working at the point of care. Furthermore, information management in research is a core competency area of its own that directly addresses the needs of researchers. The role-based approach as such was neither questioned in the survey nor at the workshop. Clinical nursing [ 14 , 42 , 43 ], quality management [44 ], care coordination [45 ], nursing management, i.e. leadership [46 ] and IT management in nursing as informatics nurse specialist [47 ] or as chief nursing information officer [48 ] are roles with a high informatics affinity that are well accepted by the current literature and are generic enough to cover inpatient and outpatient settings. There are certainly more roles nurses can take on, which are not explicitly considered in this framework, for which the framework, however, could offer a rough orientation.

Although we regard communication as a highly desirable competence, particularly in the context of change management and inter-professional care, we argue that communication aligns better with social and horizontal competencies and is therefore out of the scope of the framework at this stage. Moreover, it also appears as a sub-competence in many core competency areas, particularly those that focus on innovation and change.

Our findings are corroborated by other studies. Competencies of nurse leaders [ 21 ] match - despite a different clustering - to a large extent with the core competency areas for nursing managers within our study. The same applies to other global compilations of competencies in nursing informatics [49 ] and clinical informatics [50 ].

This study does not provide a picture of competencies that distinguish health informatics in nursing from health informatics for other healthcare professionals because this study did not compile information about these other healthcare professions. Due to the role based approach it could be hypothesized that roles better define the need for a certain competency pattern than professions, e.g. the role "coordination of inter-professional care". However, a profession is constituted by its body of knowledge and methods thus the details within the domain "data, information and knowledge" should vary to some extent for different professions despite a potential similarity at the formal level.

It is very likely that new competency areas will emerge as the framework is constantly instantiated with more exemplar case studies (inclusive of African countries) and is used in real life. When the framework needs updating, formalized methodologies for the following tasks can assist with this process: a) identifying and updating core competency areas, b) measuring their relevance throughout the international community and c) adding international exemplar case studies that illustrate these core competency areas and provide insight into the competencies and local curricula.

4.3 Outlook

The procedure of conducting a survey, obtaining feedback in a workshop and including exemplar case studies provided knowledge about the validity of core competency areas and about new competencies to be included. In particular, we propose adding consumer health informatics as a core competency area due to the high importance of patient-centered healthcare and the requirement that healthcare professionals share data, information and knowledge with patients and citizens [51 ]. This addition would bundle competencies that are already included in the framework such as referred to by "telehealth" and "assistive technologies for ageing people" and would highlight this area. As not all core competency areas are yet covered by case studies, there is a need to integrate additional ones in the future.

5. Conclusions

This international recommendation framework for core competency areas in health informatics for nurses aims at providing a grid to embrace knowledge about competencies, professional roles, priorities and practical experience. The framework refers to the term health informatics in nursing to demonstrate its rooting in nursing informatics [45 , 52 ] and its openness towards other healthcare professionals and their interaction with nurses. We contend that learning and teaching on the individual level are active processes of constructing the educational space. Therefore, our recommendations should work as a framework that guides and stimulates learners and teachers alike. It should leave enough room for individual creativity, aspiration for innovation and personal fulfillment. Due to technology being a moving target, this recommendation framework should be revised and updated regularly. We propose a five-year period of validity.

Acknowledgment

We wish to thank all international experts who contributed to the survey and the workshop. We also thank Beth Elias, PhD, Term Associate Professor at Virginia Commonwealth University, Richmond, VA, USA, for her assistance in preparing this manuscript.

A preliminary version of this paper was presented at the multi-conference HEC2016 in August 2016 in Munich/Germany.

Funding Statement

Funding : This work was supported by the European Commission within Horizon 2020 grant number (Grant Agreement 727552 EUUSEHEALTHWORK), HIMSS North America, the HIMSS Foundation and the Federal Ministry of Education and Research (bmbf) Germany grant number (16OH21026).

References

15. Värri A, Blake R, Roberts J, Fenton SH, Cleary M, Zacks SFet al. Transatlantic collection of health informatics competencies FinJeHeW 201608(2-3):127-136. [ Google Scholar]

17. Fischer MR, Bauer D, Mohn K.NKLM-Projektgruppe. Finally finished! National Competence Based Catalogues of Learning Objectives for Undergraduate Medical Education (NKLM) and Dental Education (NKLZ) ready for trial. GMS Z Med Ausbild 201532(3): Doc35. [ PubMed] PMC free article] [

20. Weinert FE, Smelser NJ, Baltes B.Competencies and key competencies: Educational perspective. International Encyclopedia of the Social and Behavioral SciencesIn:editors.4th ed.Amsterdam: Elsevier; 20012433-2436. [ Google Scholar]

21. Boyatzis RE. Competencies in the 21 Manag Dev. 2008;27(01):5-12. [ Google Scholar]

24. Prahalad CK, Hamel G.The core competence of the corporation. Harvard Business Review 1990. May-June.79-90.

29. Krathwohl DR. A revision of Bloom's Taxonomy: An Overview. Theory into Practice. 2002;41(04):212-218. [ Google Scholar]

36. Li S, Bamidis PD, Konstantinidis Set al. Prioritization of actions needed to develop the IT skills competence among healthcare workforce. PeerJ PrePrints 03e1137v3.2015[cited 2018 Mar 13]. Available from: https://dx.doi.org/10.7287/peerj.preprints.1137v3

41. Chang P, Kuo MC, Ball MJ, Hannah KJ, Newbold SK.Chapter 25. Taiwan Model: Nursing Informatics Training. Nursing Informatics: Where Caring and Technologies MeetIn:et al. London: Springer; 2011411-428. [ Google Scholar]

49. Cummins MR, Gundlapalli AVI, Gundlapalli AV, Murray P, Park HA, Lehmann CU. Nursing Informatics Certification Worldwide: History, Pathway, Roles, and Motivation. Yearb Med Inform. 2016;(01):264-271. [[ PMC free article] [ PubMed] Google Scholar]

Articles from Methods of Information in Medicine are provided here courtesy of Thieme Medical Publishers

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Technology Informatics Guiding Education Reform - TIGER : An International Recommendation Framework of Core Competencies in Health Informatics for Nurses

# data[].attributes.attachment_link.description
Background: While health informatics recommendations on competencies and education serve as highly desirable corridors for designing curricula and courses, they cannot show how the content should be situated in a specific and local context. Therefore, ...

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How Big Data Could Transform The Health Care Industry

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The Centers for Medicare & Medicaid Services (CMS) EHR Incentive Program-also known as Meaningful Use or MU-initially provided incentives to accelerate the adoption of electronic health records (EHRs) to meet program requirements.

Now, physicians who fail to participate in MU will receive a penalty in the form of reduced Medicare reimbursements. Physicians must use certified electronic health records technology (CEHRT) and demonstrate meaningful use through an attestation process at the end of each MU reporting period to avoid the penalty.

The AMA is encouraging all physicians subject to the 2015 Medicare MU program to apply for a hardship exception. CMS has stated that it will broadly accept hardship exemptions because of the delayed publication of the program regulations. Applying for the hardship will not prevent a physician from earning an incentive. Applications for physicians are due July 1, 2016.

CMS developed a program that requires physicians using CEHRT to capture, exchange and report specific clinical data and quality measures. The program, which began in 2011, evolved over the course of 3 stages:

Stage 1 established the base requirements for electronic capturing of clinical data.

Stage 2 encouraged the use of EHRs for increased exchange of information and continuous quality improvement at the point of care.

Modified Stage 2, released in October 2015, consolidated Stages 1 and 2 into a new program. These are the current requirements all physicians should follow. While some changes were made to reduce the complexity of the measures, many of the objectives were carried over from Stage 2.

Summary of 2015-2017 Meaningful Use (MU) Final Rule (PDF) (members only)

The requirements for Stage 3 have been published by CMS. Starting in 2018, all eligible physicians will be required to participate in Stage 3.

Summary of the Meaningful Use Stage 3 and 2015 certification rules requirements (PDF) (members only)

MU will eventually become part of the Medicare Merit-based Incentive Program.
Understanding Medicare's Merit-based Incentive Payment System (MIPS)
Physicians participating in MU for the first time in 2016 will not qualify for any MU incentive payments but will be subject to a penalty if they do not participate.

All physicians participating in MU in 2016 must demonstrate the 10 new Modified Stage 2 requirements.

Modified Stage 2 requirements (PDF)

CMS has developed a webpage on 2016 Program Requirements with detailed and downloadable lists of each requirement.
CMS 2016 program requirements
CMS has also posted their presentations on Modified Stage 2 and Stage 3 requirements from the HIMSS 2016 Annual Conference.
CMS presentations on Modified Stage 2 and Stage 3 requirements
To help physicians meet MU requirements, the AMA compiled tip sheets on some of the more complex measures.

Patient view, download and transmittal of health information (PDF) (members only)

Transition and summary of care (PDF) (members only)

Security Risk Analysis (PDF) (members only)

Part of participating in MU involves using technology certified by the U.S. Department of Health and Human Services (HHS). Certified technology includes both complete EHR systems and individual modules. Physicians can either purchase a comprehensive certified package from a single vendor or certified components from different vendors.

Physicians should ask their vendor about certification plans if they are unclear whether their EHR technology or module(s) are certified for use in the incentive program. Physicians can verify whether the equipment is certified at the Office of the National Coordinator for Health IT's (ONC) website.
Office of the National Coordinator for Health IT's (ONC)
For additional information about 2015 EHR certification criteria see ONC's final certification rule.
2015 EHR Final Certification Rule
Together with the AMA, AmericanEHR Partners provides the ability for a physician to rate or comment on EHR systems. There are also message boards that facilitate group discussion and allow users to refine their search for product information by using criteria that are most relevant to them, such as practice size and specialty.
AmericanEHR Partners
All ratings and discussion topics come from verified members who must register with AmericanEHR Partners and are compared against a physician master file, ensuring real users are discussing and rating real products.

Usability is the capacity for an individual to learn and easily use an object. Both utility (how well a system handles the work a user must do) and ease-of-use are factors in usability.

The AMA strongly believes that EHR technology should:

Facilitate a physician's practice

Improve patient care

Enhance care coordination, practice efficiencies and processes

Support decision-making, not circumvent the need for critical thinking

To improve patient care, EHRs and other health technology must work well for the people who use them. Unfortunately, the swift implementation of EHR technology compelled physicians to purchase tools not yet optimized for patients or doctors. As a result, EHR technology can often impede efficient care by making it difficult to find or understand what clinicians need. Sometimes the technology may be challenging to use effectively, efficiently and safely.

The AMA believes that the addition of user-centered design (UCD) in the development of EHR products can improve usability and increase physician satisfaction with EHRs. This process focuses on analyzing and incorporating user requirements from the beginning of the development cycle. The AMA continues to work with key EHR-industry stakeholders and advocate that ONC include robust UCD when certifying technology.
Federal and State Correspondence Finder
However, EHR design is also heavily influenced by the federal requirements for MU and certification. While there are federal requirements on EHR usability, the design priority of EHR vendors continues to be meeting MU objectives, not the needs of physicians and patients. To help elevate this concern, the AMA worked with MedStar Health to identify issues with EHR certification and the incorporation of better UCD principles in the design of health IT products.

AMA and MedStar Health partner to drive improvements in EHR usability

As part of both HIPAA and MU requirements, physicians must conduct or review a security risk analysis at least once during each program year. A practice's size, complexity, capabilities, risk and cost are used to determine the proper methodology to meet this requirement. Conducting this analysis can provide insight into the vulnerabilities in a practice's heaIth IT. It is important to note that a health IT system is typically larger than just EHR.

The first step in protecting a practice and patients' health information from cyber attacks is evaluating a system's security. The rules for a risk analysis are not prescriptive; a number of different tactics can achieve compliance. The AMA has several free resources in the AMA Education Center for AMA PRA Category 1 Credit™ to help physicians build tailored compliance processes.

Additionally, the HHS has materials to help small-to-medium-sized practices become compliant, HHS EHR contracts: Key contract terms for users to understand. (PDF)

The AMA continues to advocate for making the MU program more workable for physicians by asking CMS to establish more reasonable reporting requirements, measurement thresholds and overall flexibility so that all physicians who want to participate are able to do so. Below are links to the most recent comments and letters to the administration and Congress.

As a result of significant AMA advocacy, CMS made several changes to the Stage 2 requirements, reducing the number of overall requirements and including exceptions to certain measures.

Following years of advocacy by the AMA, the CMS has removed the computerized physician order entry (CPOE) and clinical decision support (CDS) measures from the Medicare MU program and the ACI component of the Quality Payment Program (QPP). However, the Medicaid MU program continues to include CPOE and CDS measures.

While CPOE and CDS functionality will still be included in EHRs, CMS will no longer require a certain number of orders, that a physician enter the orders, and that physicians implement a certain number of CDS tools. This means that as of Jan. 1, 2017, physician practices are free to develop policies around CPOE and CDS in ways that blend with their workflows and improve care.

AMA letters

What to do if you are audited

The AMA has received a number of complaints and concerns associated with physicians undergoing an MU audit (currently 5 to 10% of eligible professionals) and is working to improve this process. Physicians should communicate any issues to the MU audit contractor:

Peter Figliozzi Figliozzi & Company, CPAs P.C. 585 Stewart Avenue Suite 416 Garden City, New York 11530[email protected] (516) 745-6400 ext. 302

The biggest issue physicians have faced in an audit was demonstrating the "yes/no" requirements that call for attestation proving the security risk analysis was successfully met. To help with the process, CMS posted information online and provided the following:

Related Links

CMS has an informal appeals process for those denied an EHR incentive payment, determined to be ineligible for the program, or given an unfavorable audit decision. Physicians looking to appeal an adverse decision should contact their state Medicaid Agency for information about filing an appeal. Under the CMS appeals process, physicians must file a claim and submit necessary documentation by the following deadlines:

Failed Audit Meaningful Use: 30 days from the date of the adverse audit determination letter

Failed Reporting Meaningful Use: March 31

Eligibility: March 31

All appeal decisions are final. More information on the MU appeals process can be found on the CMS website.

CMS appeals - If you have been denied an EHR incentive payment, you can appeal the decision.

The HHS Office of the Inspector General (OIG) and CMS published companion rules that allow physicians to accept donations of almost free EHR technology (must pay at least 15% of the cost of the technology) from certain health care entities without violating Stark and anti-kickback rules.

HHS Office of the Inspector General (OIG) - Exception for certain electronic health records arrangements (PDF)

CMS published companion rules - EHR safe harbor under the Anti-Kickback Statute; final rule (PDF)

The exception/safe harbor was scheduled to end on Dec. 31, 2013, but due to AMA advocacy, HHS extended the time through 2021. While the AMA pushed for a permanent exception, the extension brings welcomed relief for physicians continuing to struggle with the high cost of implementing EHR technology. The rules also made several other notable changes:

Excluded labs from the types of entities that may donate EHR technology

Updated the definition of what type of software is considered interoperable for the purposes of donations

Clarified the requirement prohibiting any action that limits or restricts the use, compatibility or interoperability of donated items or services

Removed from the exception the requirement related to electronic prescribing capability

HHS accepted the argument that labs should be removed from the types of entities permitted to donate EHRs to physicians due to concerns that the items could be used to secure inappropriate referrals. However, the AMA advocated that a preferable approach is one focused more on the need for better education around the limits of the safe harbor and exception for EHR donations.

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Meaningful Use: Electronic Health Record (EHR) incentive programs

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Get more information on the incentives Medicare and Medicaid provide for medical practices to adopt new records, billing and practice management procedures.

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HIETexas is the state-level health information network operated by the Texas Health Services Authority ("the Authority") pursuant to its mandate under Chapter 182, Texas Health and Safety Code. This network covers the entire state across the public and private sectors, and includes the Emergency Department Encounter Notification (EDEN) system, the Patient Unified Lookup System for Emergencies (PULSE), as well as the Situational Awareness for Novel Epidemic Response (SANER) Project. HIETexas dramatically increases health care providers' access to patients' health information to ensure that patients receive the right care, from the right health care providers, at the right time.

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HIETexas dramatically increases health care providers access to patients

# data[].attributes.attachment_link.description
HIETexas is the state-level health information network operated by the Texas Health Services Authority ("the Authority") pursuant to its mandate under Chapter 182, Texas Health and Safety Code. This network covers the entire state across the public and private sectors, and includes the Emergency Department Encounter Notification (EDEN) system, the Patient Unified Lookup System for Emergencies (PULSE), as well as the Situational Awareness for Novel Epidemic Response (SANER) Project.

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Meaningful Use

To qualify for incentive payments through the Centers for Medicare & Medicaid Services EHR Incentive Programs, eligible providers and hospitals must demonstrate meaningful use of an electronic health record (EHR). In other words, "meaningful use" sets the specific objectives that eligible professionals and hospitals must achieve to participate in the EHR Incentive Programs.

Stages of Meaningful Use

The meaningful use objectives will evolve in three stages:

Stage 1 (2011-2012): Data capture and sharing

Stage 2 (2014): Advanced clinical processes

Stage 3 (2016): Improved outcomes

For More Information

For more information on meaningful use and how achieving meaningful use can help you improve health care quality and patient outcomes, see the following resources.

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To qualify for incentive payments through the Centers for Medicare & Medicaid Services EHR Incentive Programs, eligible providers and hospitals must demonstrate meaningful use of an electronic health record (EHR).

# data[].attributes.attachment_link.readable_text
The Centers for Medicare & Medicaid Services (CMS) EHR Incentive Program-also known as Meaningful Use or MU-initially provided incentives to accelerate the adoption of electronic health records (EHRs) to meet program requirements.

Now, physicians who fail to participate in MU will receive a penalty in the form of reduced Medicare reimbursements. Physicians must use certified electronic health records technology (CEHRT) and demonstrate meaningful use through an attestation process at the end of each MU reporting period to avoid the penalty.

The AMA is encouraging all physicians subject to the 2015 Medicare MU program to apply for a hardship exception. CMS has stated that it will broadly accept hardship exemptions because of the delayed publication of the program regulations. Applying for the hardship will not prevent a physician from earning an incentive. Applications for physicians are due July 1, 2016.

CMS developed a program that requires physicians using CEHRT to capture, exchange and report specific clinical data and quality measures. The program, which began in 2011, evolved over the course of 3 stages:

Stage 1 established the base requirements for electronic capturing of clinical data.

Stage 2 encouraged the use of EHRs for increased exchange of information and continuous quality improvement at the point of care.

Modified Stage 2, released in October 2015, consolidated Stages 1 and 2 into a new program. These are the current requirements all physicians should follow. While some changes were made to reduce the complexity of the measures, many of the objectives were carried over from Stage 2.

Summary of 2015-2017 Meaningful Use (MU) Final Rule (PDF) (members only)

The requirements for Stage 3 have been published by CMS. Starting in 2018, all eligible physicians will be required to participate in Stage 3.

Summary of the Meaningful Use Stage 3 and 2015 certification rules requirements (PDF) (members only)

MU will eventually become part of the Medicare Merit-based Incentive Program.
Understanding Medicare's Merit-based Incentive Payment System (MIPS)
Physicians participating in MU for the first time in 2016 will not qualify for any MU incentive payments but will be subject to a penalty if they do not participate.

All physicians participating in MU in 2016 must demonstrate the 10 new Modified Stage 2 requirements.

Modified Stage 2 requirements (PDF)

CMS has developed a webpage on 2016 Program Requirements with detailed and downloadable lists of each requirement.
CMS 2016 program requirements
CMS has also posted their presentations on Modified Stage 2 and Stage 3 requirements from the HIMSS 2016 Annual Conference.
CMS presentations on Modified Stage 2 and Stage 3 requirements
To help physicians meet MU requirements, the AMA compiled tip sheets on some of the more complex measures.

Patient view, download and transmittal of health information (PDF) (members only)

Transition and summary of care (PDF) (members only)

Security Risk Analysis (PDF) (members only)

Part of participating in MU involves using technology certified by the U.S. Department of Health and Human Services (HHS). Certified technology includes both complete EHR systems and individual modules. Physicians can either purchase a comprehensive certified package from a single vendor or certified components from different vendors.

Physicians should ask their vendor about certification plans if they are unclear whether their EHR technology or module(s) are certified for use in the incentive program. Physicians can verify whether the equipment is certified at the Office of the National Coordinator for Health IT's (ONC) website.
Office of the National Coordinator for Health IT's (ONC)
For additional information about 2015 EHR certification criteria see ONC's final certification rule.
2015 EHR Final Certification Rule
Together with the AMA, AmericanEHR Partners provides the ability for a physician to rate or comment on EHR systems. There are also message boards that facilitate group discussion and allow users to refine their search for product information by using criteria that are most relevant to them, such as practice size and specialty.
AmericanEHR Partners
All ratings and discussion topics come from verified members who must register with AmericanEHR Partners and are compared against a physician master file, ensuring real users are discussing and rating real products.

Usability is the capacity for an individual to learn and easily use an object. Both utility (how well a system handles the work a user must do) and ease-of-use are factors in usability.

The AMA strongly believes that EHR technology should:

Facilitate a physician's practice

Improve patient care

Enhance care coordination, practice efficiencies and processes

Support decision-making, not circumvent the need for critical thinking

To improve patient care, EHRs and other health technology must work well for the people who use them. Unfortunately, the swift implementation of EHR technology compelled physicians to purchase tools not yet optimized for patients or doctors. As a result, EHR technology can often impede efficient care by making it difficult to find or understand what clinicians need. Sometimes the technology may be challenging to use effectively, efficiently and safely.

The AMA believes that the addition of user-centered design (UCD) in the development of EHR products can improve usability and increase physician satisfaction with EHRs. This process focuses on analyzing and incorporating user requirements from the beginning of the development cycle. The AMA continues to work with key EHR-industry stakeholders and advocate that ONC include robust UCD when certifying technology.
Federal and State Correspondence Finder
However, EHR design is also heavily influenced by the federal requirements for MU and certification. While there are federal requirements on EHR usability, the design priority of EHR vendors continues to be meeting MU objectives, not the needs of physicians and patients. To help elevate this concern, the AMA worked with MedStar Health to identify issues with EHR certification and the incorporation of better UCD principles in the design of health IT products.

AMA and MedStar Health partner to drive improvements in EHR usability

As part of both HIPAA and MU requirements, physicians must conduct or review a security risk analysis at least once during each program year. A practice's size, complexity, capabilities, risk and cost are used to determine the proper methodology to meet this requirement. Conducting this analysis can provide insight into the vulnerabilities in a practice's heaIth IT. It is important to note that a health IT system is typically larger than just EHR.

The first step in protecting a practice and patients' health information from cyber attacks is evaluating a system's security. The rules for a risk analysis are not prescriptive; a number of different tactics can achieve compliance. The AMA has several free resources in the AMA Education Center for AMA PRA Category 1 Credit™ to help physicians build tailored compliance processes.

Additionally, the HHS has materials to help small-to-medium-sized practices become compliant, HHS EHR contracts: Key contract terms for users to understand. (PDF)

The AMA continues to advocate for making the MU program more workable for physicians by asking CMS to establish more reasonable reporting requirements, measurement thresholds and overall flexibility so that all physicians who want to participate are able to do so. Below are links to the most recent comments and letters to the administration and Congress.

As a result of significant AMA advocacy, CMS made several changes to the Stage 2 requirements, reducing the number of overall requirements and including exceptions to certain measures.

Following years of advocacy by the AMA, the CMS has removed the computerized physician order entry (CPOE) and clinical decision support (CDS) measures from the Medicare MU program and the ACI component of the Quality Payment Program (QPP). However, the Medicaid MU program continues to include CPOE and CDS measures.

While CPOE and CDS functionality will still be included in EHRs, CMS will no longer require a certain number of orders, that a physician enter the orders, and that physicians implement a certain number of CDS tools. This means that as of Jan. 1, 2017, physician practices are free to develop policies around CPOE and CDS in ways that blend with their workflows and improve care.

AMA letters

What to do if you are audited

The AMA has received a number of complaints and concerns associated with physicians undergoing an MU audit (currently 5 to 10% of eligible professionals) and is working to improve this process. Physicians should communicate any issues to the MU audit contractor:

Peter Figliozzi Figliozzi & Company, CPAs P.C. 585 Stewart Avenue Suite 416 Garden City, New York 11530[email protected] (516) 745-6400 ext. 302

The biggest issue physicians have faced in an audit was demonstrating the "yes/no" requirements that call for attestation proving the security risk analysis was successfully met. To help with the process, CMS posted information online and provided the following:

Related Links

CMS has an informal appeals process for those denied an EHR incentive payment, determined to be ineligible for the program, or given an unfavorable audit decision. Physicians looking to appeal an adverse decision should contact their state Medicaid Agency for information about filing an appeal. Under the CMS appeals process, physicians must file a claim and submit necessary documentation by the following deadlines:

Failed Audit Meaningful Use: 30 days from the date of the adverse audit determination letter

Failed Reporting Meaningful Use: March 31

Eligibility: March 31

All appeal decisions are final. More information on the MU appeals process can be found on the CMS website.

CMS appeals - If you have been denied an EHR incentive payment, you can appeal the decision.

The HHS Office of the Inspector General (OIG) and CMS published companion rules that allow physicians to accept donations of almost free EHR technology (must pay at least 15% of the cost of the technology) from certain health care entities without violating Stark and anti-kickback rules.

HHS Office of the Inspector General (OIG) - Exception for certain electronic health records arrangements (PDF)

CMS published companion rules - EHR safe harbor under the Anti-Kickback Statute; final rule (PDF)

The exception/safe harbor was scheduled to end on Dec. 31, 2013, but due to AMA advocacy, HHS extended the time through 2021. While the AMA pushed for a permanent exception, the extension brings welcomed relief for physicians continuing to struggle with the high cost of implementing EHR technology. The rules also made several other notable changes:

Excluded labs from the types of entities that may donate EHR technology

Updated the definition of what type of software is considered interoperable for the purposes of donations

Clarified the requirement prohibiting any action that limits or restricts the use, compatibility or interoperability of donated items or services

Removed from the exception the requirement related to electronic prescribing capability

HHS accepted the argument that labs should be removed from the types of entities permitted to donate EHRs to physicians due to concerns that the items could be used to secure inappropriate referrals. However, the AMA advocated that a preferable approach is one focused more on the need for better education around the limits of the safe harbor and exception for EHR donations.

# data[].attributes.attachment_link.title
Meaningful Use: Electronic Health Record (EHR) incentive programs

# data[].attributes.attachment_link.description
Get more information on the incentives Medicare and Medicaid provide for medical practices to adopt new records, billing and practice management procedures.

# data[].attributes.attachment_link.readable_text
The electronic health record (EHR) has catalyzed change for clinicians by making available vast amounts of patient data and other information that can be used for clinical decision support (CDS).

Legislation in the US has created financial incentives to adopt an EHR and, more importantly, to derive meaningful use from the EHR. Although adoption of the EHR has been brisk in the US, its ultimate impact on patient care is unclear and will continue to evolve for many years as new uses and problems are discovered.

The sheer amount of patient information available in a single, often digitally searchable, electronic location rather than in volumes of paper can assist clinical decision making, even if the EHR serves as nothing more than a repository of information and images that can be searched, reviewed, and compared.

Following are some potential benefits of the EHR:

Clinical parameters (eg, vital signs, test results) contained within the EHR can be used to create alerts that notify the clinician or even trigger predetermined orders or order sets, diagnostic and therapeutic bundles, or clinical pathways. As an example, in a recent study, pediatric patients between the ages of 10 and 17 were randomized to usual care or care bolstered by EHR-linked clinical decision support (CDS) during visits where blood pressure was measured at each encounter. The CDS tool displayed blood pressures and percentiles, identified incident hypertension, and offered tailored order sets. Hypertension was identified in 1.7% of 31,579 patients over a 2-year period. When CDS was available, 17.1% of hypertensive patients were referred for weight loss and exercise counseling; 9.4% had additional testing for hypertension. However, when usual care was provided, only 3.9% of hypertensive patients were referred for counseling and 4.2% had additional testing. The authors conclude that EHR-linked clinical decision support had a significant and beneficial effect on the recognition of pediatric hypertension ( 1 References The electronic health record (EHR) has catalyzed change for clinicians by making available vast amounts of patient data and other information that can be used for clinical decision support ... read more ).

Providing EHR-linked CDS at the time of diagnostic test ordering may decrease the use of low yield or inappropriate diagnostic testing. In a recent study, clinicians who, at the time of order entry, were presented with appropriateness criteria for imaging studies promulgated by the American College of Radiology (ACR) ordered fewer low utility MRI, CT, nuclear medicine, PET, and ultrasound studies. Clinicians were prompted to select a structured indication for the desired test. The selected indication was mapped by a commercially available CDS tool (ACR Select) to the ACR criteria which characterized the test selected as: low utility or usually not appropriate, marginal or intermediate utility, and well indicated or usually appropriate. This CDS support reduced the frequency of low utility tests from 11% to 5.4% and increased the frequency of high utility tests from 64.5% to 84%. Improvement was seen among attending physicians, resident physicians, and advanced practice providers (nurse practitioners and physician assistants) and was most pronounced in resident physicians ( 2 References The electronic health record (EHR) has catalyzed change for clinicians by making available vast amounts of patient data and other information that can be used for clinical decision support ... read more ).

In general, these measures aim to reduce variation in clinical practice by guiding clinicians to what is considered best practice as determined by expert panels, professional associations, insurance providers, or healthcare institutions. Because the EHR records when such triggers or prompts are provided to clinicians, adherence to protocols or guidelines can be measured. These examples illustrate the yet-to-be realized potential of the EHR in CDS. Maturing EHR systems and refined EHR-CDS will augment traditional medical decision making in the future.

On the other hand, potential detrimental effects of the EHR have also been noted:

NOTE: This is the Professional Version. CONSUMERS: Click here for the Consumer Version

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Electronic Health Records (EHR) and Clinical Decision Support - Special Subjects - Merck Manuals Professional Edition

# data[].attributes.attachment_link.description
The electronic health record (EHR) has catalyzed change for clinicians by making available vast amounts of patient data and other information that can be used for clinical decision support (CDS). Legislation in the US has created financial incentives to adopt an EHR and, more importantly, to derive meaningful use from the EHR.

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Health Information Exchange | HealthIT.gov

# data[].attributes.attachment_link.description
The demand for electronic health information exchange among care professionals is growing along with nationwide efforts to improve the quality, safety, and efficiency of health care delivery. Meaningful use requirements, new payment approaches that stress care coordination, and federal financial inc…

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Patients and Providers can get the latest information about how and when to use telehealth, policy and billing updates, best practices for telemedicine integration, and more.

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The Rural Health Information Hub is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under Grant Number U56RH05539 (Rural Assistance Center for Federal Office of Rural Health Policy Cooperative Agreement). Any information, content, or conclusions on this website are those of the authors and should not be construed as the official position or policy of, nor should any endorsements be inferred by HRSA, HHS or the U.S. Government.

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The Rural Health Information Hub is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under Grant Number U56RH05539 (Rural Assistance Center for Federal Office of Rural Health Policy Cooperative Agreement).

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The definition of telehealth, as well as its four key components: Live video, store-and-forward, remote patient monitoring, and mHealth.

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Original Paper

¹ College of Nursing, University of Florida, Gainesville, FL, United States

² School of Nursing, Columbia University, New York, NY, United States

Corresponding Author:

Rebecca Schnall, PhD, MPH

School of Nursing

Columbia University

560 West 168th Street

New York, NY, 10032

United States

Phone: 1 2123426886

Email: rb897@columbia.edu

Background: Mobile health (mHealth) apps have the potential to be effective tools for encouraging patients with chronic diseases to self-manage their health. The success of mHealth apps is related to technology acceptance and its subsequent use by intended consumers. Therefore, it is essential to gain insights from consumers' perspectives about their use of mHealth apps in daily life.

Objective: The purpose of this work was to understand consumers' perspectives on use of a self-management app following completion of a clinical trial that tested the efficacy of the app for improving health outcomes.

Methods: We conducted five focus groups with paricipants of a clinical trial (NCT03182738) who were randomized to use the video information provider (VIP) for HIV-associated nonAIDS (HANA) conditions app (VIP-HANA) or an attention control app. Thematic analysis was conducted, and the themes were organized according to the two key constructs of the technology acceptance model framework: perceived usefulness and perceived ease of use.

Results: Thirty-nine people living with HIV (20 from the intervention group and 19 from the control group) participated in the focus group sessions. Of the eight themes identified from focus group data, the five themes related to perceived usefulness were: (1) self-monitoring HIV-related symptoms of HANA conditions, (2) enhanced relationship with clinical providers, (3) improvement in physical and emotional health, (4) long-term impact of self-care strategies on improvement in symptoms of HANA conditions, and (5) inspired lifestyle changes to manage symptoms. The three themes related to perceived ease of use were: (1) easy to navigate, (2) avatar personalization, and (3) privacy/confidentiality maintained even when changing the location of app use.

Conclusions: Perceived ease of use was similar in both study groups but perceived usefulness differed between study groups. Participants in both study groups found the VIP-HANA app to be useful in monitoring their symptoms and enhancing communication with their clinical care providers. However, only intervention group participants perceived the app to be useful in improving overall health and long-term symptom management. Findings from this study highlight factors that are essential to ensure the usefulness of self-management apps and facilitate sustained use of mHealth apps for people living with chronic illnesses.

J Med Internet Res 2020;22(6):e17708

doi:10.2196/17708

Keywords

With the widespread proliferation of smartphones, the use of mobile technology has rapidly increased in health care [,]. Consumer health informatics tools such as mobile health (mHealth) apps have the potential to be effective tools to encourage patients with chronic diseases to self-manage their health [-]. The video information provider (VIP) for HIV-associated nonAIDS (HANA) conditions app (VIP-HANA) is an mHealth app that was developed to help people living with HIV self-manage their symptoms by providing self-care strategies []. Development of the VIP-HANA app is described elsewhere []. In short, the VIP-HANA app is comprised of 728 self-care strategies for the following 28 HANA condition-related symptoms: fatigue, depression, muscle aches, difficulty falling asleep, anxiety, difficulty staying asleep, difficulty remembering, neuropathy, difficulty concentrating, decreased sex drive, diarrhea, maintaining an erection, shortness of breath, constipation, dry mouth, clumsiness, weight loss, dizziness, heartburn, dry eyes, changes in appetite, ringing in ear, cough, nausea/vomiting, fever, difficulty with urination, speech difficulties, and pain during sex []. The 728 self-care strategies were tailored based on the symptom, gender, race/ethnicity, and HANA condition of each user. An avatar guides users through the app. Patients then receive self-care strategies with animated videos for ameliorating their symptoms. Users review their symptom experience over time with symptom reports, set a weekly email reminder to complete sessions in the app, and email/download the history of their reported symptoms and suggested self-care strategies [].

Two versions of the app were created to assess the efficacy of the VIP-HANA app in improving the symptom burden in a 6-month randomized controlled trial (RCT) (NCT03182738) that included 100 people living with HIV with HANA conditions (50 randomly assigned to the intervention group, 50 assigned to the control group). All participants were asked to log in at least once per week. Both study groups received weekly symptom assessment questions through the VIP-HANA app, yet only the intervention group participants were provided with the self-care strategies. presents a comparison of the two versions of the VIP-HANA app features. Participants in both groups were given US $5 per week for their time and data costs associated with completing the weekly symptom assessments.

According to a recent US national survey of mHealth app use, approximately half (46%) of the respondents reported downloading a health app but were no longer using it or had uninstalled it []. Given that the success of mHealth apps is related to the acceptance of technology and its subsequent use by intended consumers, there is a need to gain in-depth insights from consumers' perspectives about use of mHealth apps in their daily life. Accordingly, the purpose of this study was to understand consumers' perspectives on mHealth use (VIP-HANA app) following an RCT of an HIV symptom self-management intervention for people living with HANA conditions.

Sampling and Recruitment

Procedures

The Institutional Review Board of Columbia University Medical Center reviewed and approved all research activities. We conducted three focus group sessions with intervention group participants (N=20) and two focus groups sessions with control group participants (N=19). Prior to the focus group sessions, all participants were provided an explanation of the study procedures and completed a signed consent form. Using open-ended questions via a semistructured focus group guide designed based on the app's features/functionality (), a moderator (a faculty member at Columbia University School of Nursing) facilitated the focus group sessions, and participants were encouraged to discuss issues regarding their perceptions related to use of the VIP-HANA app (intervention/control group versions). All focus group sessions were audio-recorded. Data collection continued until saturation of themes was reached. Participants were compensated with US $30 for their time.

Focus group guide based on 6-month experience of using the video information provider for HIV-associated nonAIDS conditions (VIP-HANA) app.
Experience Using VIP-HANA

Please describe your experience using the VIP-HANA app in social settings.
Probe: where and when did you use it most (house/workplace/clinic/café; after breakfast/when commuting, etc) and why?

How did this fit into your lifestyle and schedule?

Please describe your experience navigating the app pages.
Probe: basic structure of the app

After your first app use, how easy/difficult was it for you in follow-up uses?

What are your thoughts about the design of the VIP-HANA app?
Probe: main logo/avatars; font/color; progress bar; Remember Me (save ID/password); Log-In Help; Continue/Skip button

Please describe your experience with any technical issues.
Probe: Log-In, crash, Back button, Continue/Skip button, How Our App Works, reminder/email, error message

(Intervention group only)

What are your thoughts about the videos displayed in the VIP-HANA app?
Probe: watching videos vs reading the content; videos with sounds, the type of sounds; effect of data plan on watching the videos

What was your experience using the app to review your symptoms and self-care strategies (=Your History)?

Impact of VIP-HANA

How did this app help you gain information about relieving your symptoms?

How do you think that your symptoms changed after using the VIP-HANA app for 6 months?

How confident are you in your ability to self-manage your symptoms?

What are some of the ways that your health might benefit through the use of VIP-HANA?
Probe: changes of current personal, professional, or health care provider relationships

Please describe how the app did/can change your quality of life.

Textbox 1. Focus group guide based on 6-month experience of using the video information provider for HIV-associated nonAIDS conditions (VIP-HANA) app.

Data Analysis

‎
Figure 1. Technology acceptance model (TAM).
View this figure

Audio recordings from the focus groups were transcribed. Thematic analysis was used to explore significant themes with similar patterns across focus group sessions. Research team members (HC, TP, and GF) independently reviewed the transcripts at least twice, and two research team members (TP and GF) generated a set of codes through a combination of inductive and deductive content analysis [-]. A codebook was developed using a Microsoft Excel spreadsheet, and free text excerpted from the transcripts was entered into the codebook followed by each of the themes. Coding discordance between TP and GF was reconciled by a third researcher (HC). Guided by the TAM framework () [], each theme in the codebook was categorized into the two constructs of perceived usefulness and perceived ease of use.

Sample

A total of 39 people who completed the 6-month trial participated in the five focus group sessions. The mean age of the study participants was 55 years (SD 10.70). Additional characteristics of the study sample are presented in .

Table 1. Characteristics of the study participants (N=39).

Characteristic

All participants (N=39)

Intervention (N=20)

Control (N=19)

Hispanic/Latino ethnicity, n (%)

13 (33)

6 (30)

7 (37)

Other (eg, ADAP a, Veteran's Association, multiple)

6 (15)

3 (15)

3 (16)

a ADAP: AIDS drug assistance program.

Main Themes

A total of eight themes related to use of the VIP-HANA app were identified. The themes were organized by the two key constructs of the TAM framework [], including five themes related to perceived usefulness and three themes related to perceived ease of use. Two themes to enhance the acceptance of the app were additionally identified.

Perceived Usefulness

The five themes related to perceived usefulness were: (1) self-monitoring HIV-related symptoms of HANA conditions, (2) enhanced relationship with clinical providers, (3) improvement in physical and emotional health, (4) long-term impact of self-care strategies on improvement in symptoms of HANA conditions, and (5) inspired lifestyle changes to manage symptoms.

Self-Monitoring HIV-Related Symptoms of HANA Conditions

Participants in both the intervention and control groups felt that the app was helpful for improving self-monitoring of their symptoms. A control group participant expressed that the app helped them realize the frequency of certain symptoms they were having, by stating:

I found that it really kept me in touch with my symptoms. And a lot of things were happening that I really didn't realize until I started using the app.
[FG2]

An intervention group participant mentioned:

The app shows you certain things that you can have, and what you can do. And you work with that. And it's been great for me. I was getting more confident with tracking and managing my symptoms.
[FG3]

Moreover, intervention group participants described enjoyment in tracking their HANA conditions:

So for those of us that do have secondary illnesses such as diabetes, asthma, high blood pressure, and so forth and so on, the app was a great thing, and not just helping us navigate the system and our bodies as far as HIV is concerned, but helped us in those other issues as well.
[FG1]

And she said the app is wonderful... for diabetes, hepatitis C, and for the different harm reduction. We know what symptoms I have.
[FG3]

Enhanced Relationship With Clinical Providers

Participants in both the intervention and control groups stated that they showed the app to their doctors/clinical therapists to guide their conversations and share their symptom reports, which empowered them to better communicate with their clinical providers and enrich their relationship. An intervention group participant described:

The changes that I made were, the app was very useful in that, in conjunction with my doctor. Because I also showed this to my doctor... And they all agreed that it's a wonderful thing.
[FG1]

A control group participant stated:

I liked the app because it was times I wanted to ask my doctor questions, but I didn't. But by doing this here app, it made me take a pen and paper and write down what I want to say to her next time I see her.
[FG2]

Improvement in Physical and Emotional Health

Participants in the intervention group noted improvements in their health as a result of app use. Participants commented that the app helped them work through their emotional issues. An intervention group participant stated:

It is not just HIV health. It is diabetes, asthma, high blood pressure... and so on... Not just your physical and your medications and stuff like that. But things that you can do to make yourself happier, better, more social.
[FG1]

Long-Term Impact of Self-Care Strategies on Improvement in Symptoms of HANA Conditions

Intervention group participants stated that they continued to use the self-care strategies for their symptoms even after the study was over. They considered that the self-care strategies resulted in a lasting improvement of their symptoms and therefore they continued to use them. An intervention group participant mentioned:

When I go through stress, I get those migraine headaches. In the app, it tells you to relax, turn off the TV. Turn off everything and just be calm in a dark room. And that still helps me. I am still doing that.
[FG1]

Inspired Lifestyle Changes to Manage Symptoms

Participants in the control group noted that the symptom questions on the VIP-HANA app helped them to think about their recent symptoms and inspired lifestyle changes. For example, some control group participants stated:

I remember one time, I was really depressed that week. And I put down real severe depression. And it made me think... So I'm trying to figure out why am I depressed? What made me depressed this week? What should I do? What changes?
[FG2]

But when you're looking at, when you're pressing this button several times every, several times a month, with the same thing, it reminds you. You need to really get serious about what you've been thinking about all this time.
[FG2]

Perceived Ease of Use

The three major themes related to perceived ease of use were: (1) easy to navigate, (2) avatar personalization, and (3) privacy/confidentiality maintained even when changing the location of app use.

Easy to Navigate

Participants in both the intervention and control groups found that the VIP-HANA app was easy to navigate, and they were able to use the app without assistance and did not experience technical issues. An intervention group participant stated:

Nothing hard at all. I am not very good to the tech... but this app, easy to get to start... easy to go to the next... very easy to move forward.
[FG3]

A control group participant described:

Yeah. The app I thought was pretty easy to navigate through. And the questions were basically always the same. I didn't need any help although I am not good at technology.
[FG2]

Avatar Personalization

Participants in the intervention and control groups noted the usefulness of an avatar to guide them through the VIP-HANA app and help them navigate through the app. They also noted that the avatar promoted their engagement with the app. Some participants in the intervention group mentioned:

I feel like I connected to it more by choosing the one that best looked like me or was fitted to me.
[FG1]

When you see it in the app, where you're actually seeing the cartoon character [avatar], get up and going. It encourages you that you can get up and go. I think it was very practical.
[FG5]

Some participants in the control group stated:

I think when you look at it [avatar], it's more personal. It's about you. And I think that it's good for your psyche to realize that you've got to really take care of yourself.
[FG2]

The app I thought was pretty easy to navigate through because of the avatar. The avatar looks like me... myself!
[FG4]

I was going to mention that the whole thing is laid out pretty attractively. The little avatar made it, to me, it made it almost like a game.
[FG2]

Privacy/Confidentiality Maintained Even When Changing Location of App Use

Participants in both the intervention and control groups felt comfortable using the app in a variety of locations ranging from their home to doctor's offices and in public spaces (ie, everywhere). They thought that the app was very discrete and did not disclose their HIV status to others if they could see the app on the screen. Several participants in the intervention group described this aspect:

To me, I feel like it was enough discretion in the app that if I wanted to explain it to somebody, because I was okay pulling out anywhere... everywhere...
[FG1]

I feel that that was really good, in the sense of you can do it really anywhere.
[FG5]

Some participants in the control group stated:

One of the good things about the program, it doesn't mention anything related to HIV. The reason... If someone want to get into your phone, nobody can access personal information related to the app.
[FG2]

I was happy because I can use it anytime and anywhere; at work, on the train.
[FG4]

Additional Comments to Enhance App Acceptance

Need for Updates of Self-Care Strategies and Videos

Participants in the intervention group expressed their desire for the app to include more self-care strategies and realistic videos. Participants felt that the app questions (symptoms) and suggestions (self-care strategies) were particularly useful for people living with HIV who were newly diagnosed with HIV/AIDS. They thought that the animated videos showing the suggestions were too simple or not serious enough in some cases. Some participants in the intervention group described:

When I look at the study you have to say that it's really geared more to like an HIV 101 plan where it's just basic stuff... For a person that's newly diagnosed and don't know a lot of things about HIV, I think it's the best thing for them.
[FG1]

Some of it [animated videos] was unrealistic. If you don't have the HIV or the pain or things that we actually experience as patients, you really couldn't understand how serious sometimes it is. It felt to me like they downplayed our experiences with those videos.
[FG3]

Request for Additional Functionality of Symptom Reports

Participants in the control group wanted the app to have an additional functionality to track their symptom reports so that they do not have to remember their weekly answers to the symptom questions (eg, what symptoms they had), as the app feature of symptom reports was limited for the intervention group participants only in this study. For example, a control group participant stated:

I don't remember there being an ability to be able to say, to run a report, so to speak, and say; between January and March, I had dry eyes this many times during the month... if I can print something out or if I can open it on the phone and show it to the doctor like that, that would be a nice addition to what you already have.
[FG2]

Principal Findings

With the exponential increase of mobile technology use in health care, mHealth apps can be a promising consumer health informatics tool for health behavior change and self-management. Although existing evidence supports the use of mHealth apps to improve health outcomes in people with chronic diseases [-], there has been limited assessment of consumers' experience following their use of these apps during a clinical trial. Given the current landscape of discontinuation of mHealth apps use [], it is imperative to understand how consumers are interacting with the apps in their daily life in an effort to accelerate acceptance of the apps by the consumers as well as ensure their subsequent use. To better understand consumers' use of a self-management app, we included both intervention and control group participants following completion of an RCT that tested the efficacy of the app for improving health outcomes. We captured valuable perspectives of both study group participants on their app use using focus groups guided by a theory-driven framework. This approach facilitated gaining an in-depth understanding of the key factors that would have a critical influence on adoption of the app [], which is a significant strength of our study.

mHealth apps should be visually appealing to consumers [], but more fundamentally should contain evidence-based health information that consumers can use to improve their health. Participants considered that the app could help improve their health and manage symptoms through the use of self-care strategies. The VIP-HANA app was developed by employing evidence from patient-centered outcomes research studies [], and the HIV symptom self-care strategies provided within the app were tailored based on symptoms, gender, race/ethnicity, and HANA condition [,]. To our knowledge, no mHealth intervention offers health information on how to ameliorate HIV symptoms specifically for people living with HIV with HANA conditions; the VIP-HANA app therefore represents a first step in the development and dissemination of a consumer health informatics tool that incorporates evidence-based self-care strategies.

Limitations

There are some limitations to the generalizability of our results. Study participants who participated in the focus groups might have been those who were most likely to be engaged with and used the app who had been retained in the 6-month trial. More than half of our study participants were men, African American/Black, those who had completed some high school or less, and those who reported an annual income of less than US $20,000. Therefore, the Hawthorne effect might influence the study findings of focus groups []. We designed the semistructured focus group guide based on our app's features and functionality, and used open-ended questions to minimize/eliminate concern about the Hawthorne effect.

Conclusions

Understanding factors influencing the use of patient-centered tools is critical. This study highlights participants' experiences, attitudes, and perceptions of their use of a behavioral intervention evaluated in a clinical trial. Participants were able to integrate the app into their daily routine, and used the app to support, track, monitor, and self-manage HIV symptoms related to HANA conditions. Although perceived ease of use was similar in both study groups, perceived usefulness differed between the groups. Participants in both groups found the VIP-HANA app to be useful in monitoring their symptoms of HANA conditions and enhancing communication with their clinical providers over time, but only the intervention group participants perceived the app to be useful for improving overall health and long-term symptom management in the HIV care continuum. Findings from this study highlight factors that are essential to ensure the usefulness of self-management apps to promote sustained use of the apps for people living with chronic illnesses.

Acknowledgments

This research was supported by the National Institute of Nursing Research, National Institutes of Health under award number R01 NR015737 (principal investigator RS) and through award K24NR018621 (principal investigator RS). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Nursing Research, National Institutes of Health. We are grateful to Dr. Suzanne Bakken for leading the focus group sessions.

Conflicts of Interest

None declared.
‎

Multimedia Appendix 1

Comparison of the VIP-HANA app features in the intervention and control group versions.
DOCX File , 459 KB

‎

HANA: HIV-associated nonAIDS

mHealth: mobile health

RCT: randomized controlled trial

TAM: technology acceptance model

VIP-HANA: video information provider for HIV-associated nonAIDS conditions

Edited by G Eysenbach; submitted 07.01.20; peer-reviewed by YC Kato-Lin, V Strotbaum; comments to author 10.03.20; revised version received 07.04.20; accepted 21.04.20; published 15.06.20

©Hwayoung Cho, Tiffany Porras, Gabriella Flynn, Rebecca Schnall. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 15.06.2020.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.

Background: Mobile health (mHealth) apps have the potential to be effective tools for encouraging patients with chronic diseases to self-manage their health. The success of mHealth apps is related to technology acceptance and its subsequent use by intended consumers. Therefore, it is essential to gain insights from consumers' perspectives about their use of mHealth apps in daily life.

Objective: The purpose of this work was to understand consumers' perspectives on use of a self-management app following completion of a clinical trial that tested the efficacy of the app for improving health outcomes.

Methods: We conducted five focus groups with paricipants of a clinical trial (NCT03182738) who were randomized to use the video information provider (VIP) for HIV-associated nonAIDS (HANA) conditions app (VIP-HANA) or an attention control app. Thematic analysis was conducted, and the themes were organized according to the two key constructs of the technology acceptance model framework: perceived usefulness and perceived ease of use.

Results: Thirty-nine people living with HIV (20 from the intervention group and 19 from the control group) participated in the focus group sessions. Of the eight themes identified from focus group data, the five themes related to perceived usefulness were: (1) self-monitoring HIV-related symptoms of HANA conditions, (2) enhanced relationship with clinical providers, (3) improvement in physical and emotional health, (4) long-term impact of self-care strategies on improvement in symptoms of HANA conditions, and (5) inspired lifestyle changes to manage symptoms. The three themes related to perceived ease of use were: (1) easy to navigate, (2) avatar personalization, and (3) privacy/confidentiality maintained even when changing the location of app use.

Conclusions: Perceived ease of use was similar in both study groups but perceived usefulness differed between study groups. Participants in both study groups found the VIP-HANA app to be useful in monitoring their symptoms and enhancing communication with their clinical care providers. However, only intervention group participants perceived the app to be useful in improving overall health and long-term symptom management. Findings from this study highlight factors that are essential to ensure the usefulness of self-management apps and facilitate sustained use of mHealth apps for people living with chronic illnesses.

J Med Internet Res 2020;22(6):e17708

doi:10.2196/17708

Keywords

With the widespread proliferation of smartphones, the use of mobile technology has rapidly increased in health care [,]. Consumer health informatics tools such as mobile health (mHealth) apps have the potential to be effective tools to encourage patients with chronic diseases to self-manage their health [-]. The video information provider (VIP) for HIV-associated nonAIDS (HANA) conditions app (VIP-HANA) is an mHealth app that was developed to help people living with HIV self-manage their symptoms by providing self-care strategies []. Development of the VIP-HANA app is described elsewhere []. In short, the VIP-HANA app is comprised of 728 self-care strategies for the following 28 HANA condition-related symptoms: fatigue, depression, muscle aches, difficulty falling asleep, anxiety, difficulty staying asleep, difficulty remembering, neuropathy, difficulty concentrating, decreased sex drive, diarrhea, maintaining an erection, shortness of breath, constipation, dry mouth, clumsiness, weight loss, dizziness, heartburn, dry eyes, changes in appetite, ringing in ear, cough, nausea/vomiting, fever, difficulty with urination, speech difficulties, and pain during sex []. The 728 self-care strategies were tailored based on the symptom, gender, race/ethnicity, and HANA condition of each user. An avatar guides users through the app. Patients then receive self-care strategies with animated videos for ameliorating their symptoms. Users review their symptom experience over time with symptom reports, set a weekly email reminder to complete sessions in the app, and email/download the history of their reported symptoms and suggested self-care strategies [].

Two versions of the app were created to assess the efficacy of the VIP-HANA app in improving the symptom burden in a 6-month randomized controlled trial (RCT) (NCT03182738) that included 100 people living with HIV with HANA conditions (50 randomly assigned to the intervention group, 50 assigned to the control group). All participants were asked to log in at least once per week. Both study groups received weekly symptom assessment questions through the VIP-HANA app, yet only the intervention group participants were provided with the self-care strategies. presents a comparison of the two versions of the VIP-HANA app features. Participants in both groups were given US $5 per week for their time and data costs associated with completing the weekly symptom assessments.

According to a recent US national survey of mHealth app use, approximately half (46%) of the respondents reported downloading a health app but were no longer using it or had uninstalled it []. Given that the success of mHealth apps is related to the acceptance of technology and its subsequent use by intended consumers, there is a need to gain in-depth insights from consumers' perspectives about use of mHealth apps in their daily life. Accordingly, the purpose of this study was to understand consumers' perspectives on mHealth use (VIP-HANA app) following an RCT of an HIV symptom self-management intervention for people living with HANA conditions.

Sampling and Recruitment

Procedures

The Institutional Review Board of Columbia University Medical Center reviewed and approved all research activities. We conducted three focus group sessions with intervention group participants (N=20) and two focus groups sessions with control group participants (N=19). Prior to the focus group sessions, all participants were provided an explanation of the study procedures and completed a signed consent form. Using open-ended questions via a semistructured focus group guide designed based on the app's features/functionality (), a moderator (a faculty member at Columbia University School of Nursing) facilitated the focus group sessions, and participants were encouraged to discuss issues regarding their perceptions related to use of the VIP-HANA app (intervention/control group versions). All focus group sessions were audio-recorded. Data collection continued until saturation of themes was reached. Participants were compensated with US $30 for their time.

Focus group guide based on 6-month experience of using the video information provider for HIV-associated nonAIDS conditions (VIP-HANA) app.
Experience Using VIP-HANA

Please describe your experience using the VIP-HANA app in social settings.
Probe: where and when did you use it most (house/workplace/clinic/café; after breakfast/when commuting, etc) and why?

How did this fit into your lifestyle and schedule?

Please describe your experience navigating the app pages.
Probe: basic structure of the app

After your first app use, how easy/difficult was it for you in follow-up uses?

What are your thoughts about the design of the VIP-HANA app?
Probe: main logo/avatars; font/color; progress bar; Remember Me (save ID/password); Log-In Help; Continue/Skip button

Please describe your experience with any technical issues.
Probe: Log-In, crash, Back button, Continue/Skip button, How Our App Works, reminder/email, error message

(Intervention group only)

What are your thoughts about the videos displayed in the VIP-HANA app?
Probe: watching videos vs reading the content; videos with sounds, the type of sounds; effect of data plan on watching the videos

What was your experience using the app to review your symptoms and self-care strategies (=Your History)?

Impact of VIP-HANA

How did this app help you gain information about relieving your symptoms?

How do you think that your symptoms changed after using the VIP-HANA app for 6 months?

How confident are you in your ability to self-manage your symptoms?

What are some of the ways that your health might benefit through the use of VIP-HANA?
Probe: changes of current personal, professional, or health care provider relationships

Please describe how the app did/can change your quality of life.

Textbox 1. Focus group guide based on 6-month experience of using the video information provider for HIV-associated nonAIDS conditions (VIP-HANA) app.

Data Analysis

‎
Figure 1. Technology acceptance model (TAM).
View this figure

Audio recordings from the focus groups were transcribed. Thematic analysis was used to explore significant themes with similar patterns across focus group sessions. Research team members (HC, TP, and GF) independently reviewed the transcripts at least twice, and two research team members (TP and GF) generated a set of codes through a combination of inductive and deductive content analysis [-]. A codebook was developed using a Microsoft Excel spreadsheet, and free text excerpted from the transcripts was entered into the codebook followed by each of the themes. Coding discordance between TP and GF was reconciled by a third researcher (HC). Guided by the TAM framework () [], each theme in the codebook was categorized into the two constructs of perceived usefulness and perceived ease of use.

Sample

A total of 39 people who completed the 6-month trial participated in the five focus group sessions. The mean age of the study participants was 55 years (SD 10.70). Additional characteristics of the study sample are presented in .

Table 1. Characteristics of the study participants (N=39).

Characteristic

All participants (N=39)

Intervention (N=20)

Control (N=19)

Hispanic/Latino ethnicity, n (%)

13 (33)

6 (30)

7 (37)

Other (eg, ADAP a, Veteran's Association, multiple)

6 (15)

3 (15)

3 (16)

a ADAP: AIDS drug assistance program.

Main Themes

A total of eight themes related to use of the VIP-HANA app were identified. The themes were organized by the two key constructs of the TAM framework [], including five themes related to perceived usefulness and three themes related to perceived ease of use. Two themes to enhance the acceptance of the app were additionally identified.

Perceived Usefulness

The five themes related to perceived usefulness were: (1) self-monitoring HIV-related symptoms of HANA conditions, (2) enhanced relationship with clinical providers, (3) improvement in physical and emotional health, (4) long-term impact of self-care strategies on improvement in symptoms of HANA conditions, and (5) inspired lifestyle changes to manage symptoms.

Self-Monitoring HIV-Related Symptoms of HANA Conditions

Participants in both the intervention and control groups felt that the app was helpful for improving self-monitoring of their symptoms. A control group participant expressed that the app helped them realize the frequency of certain symptoms they were having, by stating:

I found that it really kept me in touch with my symptoms. And a lot of things were happening that I really didn't realize until I started using the app.
[FG2]

An intervention group participant mentioned:

The app shows you certain things that you can have, and what you can do. And you work with that. And it's been great for me. I was getting more confident with tracking and managing my symptoms.
[FG3]

Moreover, intervention group participants described enjoyment in tracking their HANA conditions:

So for those of us that do have secondary illnesses such as diabetes, asthma, high blood pressure, and so forth and so on, the app was a great thing, and not just helping us navigate the system and our bodies as far as HIV is concerned, but helped us in those other issues as well.
[FG1]

And she said the app is wonderful... for diabetes, hepatitis C, and for the different harm reduction. We know what symptoms I have.
[FG3]

Enhanced Relationship With Clinical Providers

Participants in both the intervention and control groups stated that they showed the app to their doctors/clinical therapists to guide their conversations and share their symptom reports, which empowered them to better communicate with their clinical providers and enrich their relationship. An intervention group participant described:

The changes that I made were, the app was very useful in that, in conjunction with my doctor. Because I also showed this to my doctor... And they all agreed that it's a wonderful thing.
[FG1]

A control group participant stated:

I liked the app because it was times I wanted to ask my doctor questions, but I didn't. But by doing this here app, it made me take a pen and paper and write down what I want to say to her next time I see her.
[FG2]

Improvement in Physical and Emotional Health

Participants in the intervention group noted improvements in their health as a result of app use. Participants commented that the app helped them work through their emotional issues. An intervention group participant stated:

It is not just HIV health. It is diabetes, asthma, high blood pressure... and so on... Not just your physical and your medications and stuff like that. But things that you can do to make yourself happier, better, more social.
[FG1]

Long-Term Impact of Self-Care Strategies on Improvement in Symptoms of HANA Conditions

Intervention group participants stated that they continued to use the self-care strategies for their symptoms even after the study was over. They considered that the self-care strategies resulted in a lasting improvement of their symptoms and therefore they continued to use them. An intervention group participant mentioned:

When I go through stress, I get those migraine headaches. In the app, it tells you to relax, turn off the TV. Turn off everything and just be calm in a dark room. And that still helps me. I am still doing that.
[FG1]

Inspired Lifestyle Changes to Manage Symptoms

Participants in the control group noted that the symptom questions on the VIP-HANA app helped them to think about their recent symptoms and inspired lifestyle changes. For example, some control group participants stated:

I remember one time, I was really depressed that week. And I put down real severe depression. And it made me think... So I'm trying to figure out why am I depressed? What made me depressed this week? What should I do? What changes?
[FG2]

But when you're looking at, when you're pressing this button several times every, several times a month, with the same thing, it reminds you. You need to really get serious about what you've been thinking about all this time.
[FG2]

Perceived Ease of Use

The three major themes related to perceived ease of use were: (1) easy to navigate, (2) avatar personalization, and (3) privacy/confidentiality maintained even when changing the location of app use.

Easy to Navigate

Participants in both the intervention and control groups found that the VIP-HANA app was easy to navigate, and they were able to use the app without assistance and did not experience technical issues. An intervention group participant stated:

Nothing hard at all. I am not very good to the tech... but this app, easy to get to start... easy to go to the next... very easy to move forward.
[FG3]

A control group participant described:

Yeah. The app I thought was pretty easy to navigate through. And the questions were basically always the same. I didn't need any help although I am not good at technology.
[FG2]

Avatar Personalization

Participants in the intervention and control groups noted the usefulness of an avatar to guide them through the VIP-HANA app and help them navigate through the app. They also noted that the avatar promoted their engagement with the app. Some participants in the intervention group mentioned:

I feel like I connected to it more by choosing the one that best looked like me or was fitted to me.
[FG1]

When you see it in the app, where you're actually seeing the cartoon character [avatar], get up and going. It encourages you that you can get up and go. I think it was very practical.
[FG5]

Some participants in the control group stated:

I think when you look at it [avatar], it's more personal. It's about you. And I think that it's good for your psyche to realize that you've got to really take care of yourself.
[FG2]

The app I thought was pretty easy to navigate through because of the avatar. The avatar looks like me... myself!
[FG4]

I was going to mention that the whole thing is laid out pretty attractively. The little avatar made it, to me, it made it almost like a game.
[FG2]

Privacy/Confidentiality Maintained Even When Changing Location of App Use

Participants in both the intervention and control groups felt comfortable using the app in a variety of locations ranging from their home to doctor's offices and in public spaces (ie, everywhere). They thought that the app was very discrete and did not disclose their HIV status to others if they could see the app on the screen. Several participants in the intervention group described this aspect:

To me, I feel like it was enough discretion in the app that if I wanted to explain it to somebody, because I was okay pulling out anywhere... everywhere...
[FG1]

I feel that that was really good, in the sense of you can do it really anywhere.
[FG5]

Some participants in the control group stated:

One of the good things about the program, it doesn't mention anything related to HIV. The reason... If someone want to get into your phone, nobody can access personal information related to the app.
[FG2]

I was happy because I can use it anytime and anywhere; at work, on the train.
[FG4]

Additional Comments to Enhance App Acceptance

Need for Updates of Self-Care Strategies and Videos

Participants in the intervention group expressed their desire for the app to include more self-care strategies and realistic videos. Participants felt that the app questions (symptoms) and suggestions (self-care strategies) were particularly useful for people living with HIV who were newly diagnosed with HIV/AIDS. They thought that the animated videos showing the suggestions were too simple or not serious enough in some cases. Some participants in the intervention group described:

When I look at the study you have to say that it's really geared more to like an HIV 101 plan where it's just basic stuff... For a person that's newly diagnosed and don't know a lot of things about HIV, I think it's the best thing for them.
[FG1]

Some of it [animated videos] was unrealistic. If you don't have the HIV or the pain or things that we actually experience as patients, you really couldn't understand how serious sometimes it is. It felt to me like they downplayed our experiences with those videos.
[FG3]

Request for Additional Functionality of Symptom Reports

Participants in the control group wanted the app to have an additional functionality to track their symptom reports so that they do not have to remember their weekly answers to the symptom questions (eg, what symptoms they had), as the app feature of symptom reports was limited for the intervention group participants only in this study. For example, a control group participant stated:

I don't remember there being an ability to be able to say, to run a report, so to speak, and say; between January and March, I had dry eyes this many times during the month... if I can print something out or if I can open it on the phone and show it to the doctor like that, that would be a nice addition to what you already have.
[FG2]

Principal Findings

With the exponential increase of mobile technology use in health care, mHealth apps can be a promising consumer health informatics tool for health behavior change and self-management. Although existing evidence supports the use of mHealth apps to improve health outcomes in people with chronic diseases [-], there has been limited assessment of consumers' experience following their use of these apps during a clinical trial. Given the current landscape of discontinuation of mHealth apps use [], it is imperative to understand how consumers are interacting with the apps in their daily life in an effort to accelerate acceptance of the apps by the consumers as well as ensure their subsequent use. To better understand consumers' use of a self-management app, we included both intervention and control group participants following completion of an RCT that tested the efficacy of the app for improving health outcomes. We captured valuable perspectives of both study group participants on their app use using focus groups guided by a theory-driven framework. This approach facilitated gaining an in-depth understanding of the key factors that would have a critical influence on adoption of the app [], which is a significant strength of our study.

mHealth apps should be visually appealing to consumers [], but more fundamentally should contain evidence-based health information that consumers can use to improve their health. Participants considered that the app could help improve their health and manage symptoms through the use of self-care strategies. The VIP-HANA app was developed by employing evidence from patient-centered outcomes research studies [], and the HIV symptom self-care strategies provided within the app were tailored based on symptoms, gender, race/ethnicity, and HANA condition [,]. To our knowledge, no mHealth intervention offers health information on how to ameliorate HIV symptoms specifically for people living with HIV with HANA conditions; the VIP-HANA app therefore represents a first step in the development and dissemination of a consumer health informatics tool that incorporates evidence-based self-care strategies.

Limitations

There are some limitations to the generalizability of our results. Study participants who participated in the focus groups might have been those who were most likely to be engaged with and used the app who had been retained in the 6-month trial. More than half of our study participants were men, African American/Black, those who had completed some high school or less, and those who reported an annual income of less than US $20,000. Therefore, the Hawthorne effect might influence the study findings of focus groups []. We designed the semistructured focus group guide based on our app's features and functionality, and used open-ended questions to minimize/eliminate concern about the Hawthorne effect.

Conclusions

Understanding factors influencing the use of patient-centered tools is critical. This study highlights participants' experiences, attitudes, and perceptions of their use of a behavioral intervention evaluated in a clinical trial. Participants were able to integrate the app into their daily routine, and used the app to support, track, monitor, and self-manage HIV symptoms related to HANA conditions. Although perceived ease of use was similar in both study groups, perceived usefulness differed between the groups. Participants in both groups found the VIP-HANA app to be useful in monitoring their symptoms of HANA conditions and enhancing communication with their clinical providers over time, but only the intervention group participants perceived the app to be useful for improving overall health and long-term symptom management in the HIV care continuum. Findings from this study highlight factors that are essential to ensure the usefulness of self-management apps to promote sustained use of the apps for people living with chronic illnesses.

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Usability of a Consumer Health Informatics Tool Following Completion of a Clinical Trial: Focus Group Study

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Background: Mobile health (mHealth) apps have the potential to be effective tools for encouraging patients with chronic diseases to self-manage their health. The success of mHealth apps is related to technology acceptance and its subsequent use by intended consumers. Therefore, it is essential to gain insights from consumers' perspectives about their use of mHealth apps in daily life.

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What is UNINTENDED CONSEQUENCE? What does UNINTENDED CONSEQUENCE mean?

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What is the HIPAA notice I receive from my doctor and health plan?

Your health care provider and health plan must give you a notice that tells you how they may use and share your health information. It must also include your health privacy rights. In most cases, you should receive the notice on your first visit to a provider or in the mail from your health plan. You can also ask for a copy at any time.

Why do I have to sign a form?

The law requires your doctor, hospital, or other health care provider to ask you to state in writing that you received the notice.

The law does not require you to sign the "acknowledgement of receipt of the notice."

Signing does not mean that you have agreed to any special uses or disclosures (sharing) of your health records.

Refusing to sign the acknowledgement does not prevent a provider or plan from using or disclosing health information as HIPAA permits.

If you refuse to sign the acknowledgement, the provider must keep a record of this fact.

What is in the Notice?

The notice must describe:

How the Privacy Rule allows provider to use and disclose protected health information. It must also explain that your permission (authorization) is necessary before your health records are shared for any other reason

The organization's duties to protect health information privacy

Your privacy rights, including the right to complain to HHS and to the organization if you believe your privacy rights have been violated

How to contact the organization for more information and to make a complaint

When and how can I receive a Notice of Privacy Practices?

You'll usually receive notice at your first appointment. In an emergency, you should receive notice as soon as possible after the emergency.

The notice must also be posted in a clear and easy to find location where patients are able to see it, and a copy must be provided to anyone who asks for one.

If an organization has a website, it must post the notice there.

A health plan must give its notice to you at enrollment. It must also send a reminder at least once every three years that you can ask for the notice at any time.

A health plan can give the notice to the "named insured" (subscriber for coverage). It does not also have to give separate notices to spouses and dependents.

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Your health care provider and health plan must give you a notice that tells you how they may use and share your health information. It must also include your health privacy rights. In most cases, you should receive the notice on your first visit to a provider or in the mail from your health plan.

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The information ecosystem is growing at unprecedented speed, and technologies with advanced capabilities to track and assess that information are multiplying. Smartphones. Wearables. Connected medical devices. All of these innovations harness the power to transform health outcomes; all require constant data collection and submission to do so.

Welcome to the world of big data.

Breaking Down Big Data in Healthcare

In a report on big data in healthcare from Healthbox, experts shared their insights on how to break through the noise in a health ecosystem swelling with more data than ever before. The report noted that the term 'big data' was originally coined in the 1990s to describe data sets too large or complex for traditional databases to handle.
Webinar: Harnessing Big Data in Healthcare
According to James Gaston, the senior director of maturity models at HIMSS, "[Our cultural definition] is moving away from a brick-and-mortar centric event to a broader, patient-centric continuum encompassing lifestyle, geography, social determinants of health and fitness data in addition to traditional healthcare episodic data." The industry is on the cusp of learning just how powerful big data in healthcare is, he noted.

"The sheer volume, velocity and variety of data being collected poses challenges for harnessing and ensuring its validity to benefit both the macro, population-level health and the micro, evidence-based precision medicine," the report stated. In other words, finding meaning within mountains of data is a massive undertaking for any individual in any role across the health system.

This is where the power of innovations such as artificial intelligence (AI) come into play. Lily Peng, MD, PhD, product manager in the Google Brain AI Research Group, explained that while human intelligence is best suited for integrating small numbers of very large effect factors, AI is particularly adept at combing through and identifying patterns in vast numbers of very small effect, or obscure factors.

The report also emphasized an important point about AI: human and artificial intelligences each have their own unique variances which will inevitably influence how to best apply each and embed them into workflows.

How Big Data and AI Can Collaborate for Improved Decision-Making

In a world awash with data, people can rest assured that though AI and big data in healthcare hold immense potential, there are still limitations that prevent them from being a substitute to universal decision-making. No single innovation should exist as the single solution.

Incorporating a complementary approach to care with big data can help catalyze actionable health insights rather than adding a new layer of complexity to clinical workflows. This, however, will require careful consideration into evolving models of care provision and decision-making, the report notes. The result could very well be the evolution of enhanced clinical decision-making and more personalized care delivery than ever available before.

Pairing the power of machine learning and human intelligence to obtain valuable insights from large data sets will require focus on four different areas, as shared in the report.

1. Removing Bias in Data Collection

"The lens that each investigator brings to big data creates inherent biases," the report noted. This can include everything from categorization of evaluated data, how that data was collected, etc. "It is assumed that the power of high-dimensional data resides in the absence of hidden confounders that remain undisclosed in the data. Unfortunately, this assumption is far from being a forgone conclusion and poses a threat to the validity of conclusions derived from big data by AI techniques."

2. Acknowledging the Inherent Conflict Between Anonymity and Specificity

"Due precaution must be taken to structure analyses such that reverse engineering of patient identities does not occur; however, it is worth noting that the benefit of shared open data exceeds the adverse potential for re-identification of the individual."

"Society will have to come to grips with weighing the ethical trade-offs between the benefits of shared open access to data and the finite, but real, possibility for re-identification of individual people by reverse engineering of the segmented data. Human intelligence, not artificial intelligence, will be required to grapple with these questions."

3. Meaningful Validation and Measurable Impact of Collected Data

Use of big data in healthcare can pave the way to provide patients with more detailed, comprehensible guidance for on how to manage chronic diseases and other major health conditions. But will the increased access to this information directly lead to improved outcomes, satisfaction, and consumer experience as a whole?

"The integration of data, AI-derived knowledge, and informed clinical decisions must be adopted by and tightly interwoven into clinical processes and workflow to drive potential benefit in the care of patients. Appropriately structured clinical trials are needed to demonstrate that the incremental benefits of a data-driven care process justify any costs (and complications) incurred by these decisions."

4. Understanding Underlying Cause and Effect Relationships

Healthbox emphasized the fact that in data analysis, it's important to keep in mind the age-old rule that correlation does not imply causation. It's also important to "ensure that the data subjected to analysis does not suffer from the omission of confounders that may be causally related to the measured outcomes."

"Domain expertise and human intuition will always be required to work in tandem with artificial intelligence to confirm the absence of hidden confounders... The use of machines can help humans reveal these undiscovered or unanticipated variables."

With these insights in mind, it is clear that through a collaborative approach, we can better strategize for success with big data in healthcare, which will get us further on our way to harnessing the ultimate powers of health innovation. The ongoing advent of AI technologies will amplify the value of big data, paving the way for a more collaborative, human-centered approach that is helped, not hindered, by new technologies in health and care.
August 9 Get an insider advantage Originally published 6 March 2019; updated 14 July 2020

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Big Data in Healthcare: Breaking Through the Noise

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The information ecosystem is growing at unprecedented speed, and technologies with advanced capabilities to track and assess that information are multiplying. Smartphones. Wearables. Connected medical devices. All of these innovations harness the power to transform health outcomes; all require constant data collection and submission to do so.

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Roberta Pastorino, 1, ⁴ Corrado De Vito, ² Giuseppe Migliara, ² Katrin Glocker, ³ Ilona Binenbaum, 3, ⁴ Walter Ricciardi, 1, ⁵ and Stefania Boccia 1, ⁵

Abstract

Healthcare systems around the world are facing incredible challenges due to the ageing population and the related disability, and the increasing use of technologies and citizen's expectations. Improving health outcomes while containing costs acts as a stumbling block. In this context, Big Data can help healthcare providers meet these goals in unprecedented ways. The potential of Big Data in healthcare relies on the ability to detect patterns and to turn high volumes of data into actionable knowledge for precision medicine and decision makers. In several contexts, the use of Big Data in healthcare is already offering solutions for the improvement of patient care and the generation of value in healthcare organizations. This approach requires, however, that all the relevant stakeholders collaborate and adapt the design and performance of their systems. They must build the technological infrastructure to house and converge the massive volume of healthcare data, and to invest in the human capital to guide citizens into this new frontier of human health and well-being. The present work reports an overview of best practice initiatives in Europe related to Big Data analytics in public health and oncology sectors, aimed to generate new knowledge, improve clinical care and streamline public health surveillance.

Introduction

Data have become an omnipresent concept in our daily lives with the routine collection, storage, processing and analysis of immense amount of data. This characteristic is cross-sectorial, ranging from the domain of machine learning and engineering, to economics and medicine.

Over the last decades, there has been growing enthusiasm of the potential usefulness of these massive quantities of data, called Big Data, in transforming personal care, clinical care and public health.1

An overview of Big Data definitions

Despite the term Big Data having become ubiquitous, there is no universal definition until now on the use of this term. According to McKinsey the term Big Data refers to datasets whose size is beyond the ability of typical database software tools to capture, store, manage, and analyse.2 Gartner proposed the popular definition of Big Data with the '3V': Big Data is volume, high-velocity and high-variety information assets that demand cost-effective, innovative forms of information processing for enhanced insight and decision making.3 According to other definitions, instead, Big Data is also characterized by a fourth dimension: Veracity, concerning the quality, authenticity, 'trustworthiness' of data. 4

Furthermore, there is an emergent discussion that 'Big' is no longer the defining parameter, but rather how 'smart' the data are, focusing on the insights that the volume of data can reasonably provide.5 This aspect is fundamental in the health sector. The potential of Big Data in improving health is enormous. However, its potential value is unlocked only when leveraged to drive decision making and, to enable such evidence-based decision making, it is necessary to have efficient processes to analyse and turn high volumes of data into meaningful insights.

A specific definition of what Big Data means for health research was proposed by the Health Directorate of the Directorate-General for Research and Innovation of the European Commission: Big Data in health encompasses high volume, high diversity biological, clinical, environmental, and lifestyle information collected from single individuals to large cohorts, in relation to their health and wellness status, at one or several time points.6

Big Data analytics for health systems

The complexity of Big Data analysis arises from combining different types of information, which are electronically captured. The last years have seen an explosion of new platforms, tools and methodologies in storing, and structuring such data, followed by a growth of publications on Big Data and Health ( figure 1 ). To date, we can collect data from electronic healthcare records, social media, patient summaries, genomic and pharmaceutical data, clinical trials, telemedicine, mobile apps, sensors and information on well-being, behaviour and socio-economic indicators.

Healthcare professionals can, therefore, benefit from an incredibly large amount of data. Recent reports suggest that US healthcare system alone stored around a total of 150 exabytes of data in 2011 with the perspective to reach the yottabyte.7

Starting with the collection of individual data elements and moving to the fusion of heterogeneous data coming from different sources, can reveal entirely new approaches to improve health by providing insights into the causes and outcomes of disease, better drug targets for precision medicine, and enhanced disease prediction and prevention.

In light of this, opportunities and potential are enormous for the benefit of patients and, in general, of the healthcare system.

The potential benefits of Big Data for healthcare in the European Union

Big Data is a sensitive issue for European Union (EU) institutions: the availability of health-related Big Data can have a positive impact on medical and healthcare functions. EU is faced with several changes that may affect the sustainability of its healthcare system. By 2025 life expectancy is expected to further increase, and this may result in more people living longer, but not necessarily in a healthy and active condition. This will put further pressure on Europe's healthcare costs and economic productivity.

In this context, the data sharing approach can improve outcomes for patients and evidence-based healthcare decision making as reported during the workshop on 'Digitalisation and Big Data: implications for the health sector', held on 19 June 2018 at the European Parliament.8

The use of Big Data in healthcare, in fact, can contribute at different levels as reported by the Study on Big Data in Public Health, Telemedicine and Healthcare of the European Commission:9 (i) increasing earlier diagnosis and the effectiveness and quality of treatments by the discovery of early signals and disease intervention, reduced probability of adverse reactions, etc. (sector 1); (ii) widening possibilities for prevention of diseases by identification of risk factors for disease (sector 2); (iii) improvement of pharmacovigilance and patient safety through the ability to make more informed medical decisions based on directly delivered information to the patients (sector 3); (iv) prediction of outcomes (sector 4).

In the next paragraphs, examples of EU initiatives in the four macro sectors are listed.

Big Data have the potential to yield new insights into risk factors that lead to disease. There is the possibility to engage with the individual patient more closely and import data from mobile health applications or connected devices. These data have the potential to be analysed and used in real-time to prompt changes in behaviours that can reduce health risks, reduce harmful environmental exposures or optimize health outcomes.

Finally, Big Data can help identify and promptly intervene on high-risk and high-cost patients.10 Effective ways of managing these data can therefore facilitate precision medicine by enabling detection of heterogeneity in patient responses to treatments and tailoring of healthcare to the specific needs of individuals.11 All these aspects should eventually lead to a reduction in inefficiency and improvement in cost containment for the healthcare system.

Examples of Big Data analytics for new knowledge generation, improved clinical care and streamlined public health surveillance are already available. Below we report a selection of best practices in Europe in the public health and oncology fields.

Big Data in public health

Efforts to improve the availability and accessibility of data in the EU appear to be driven mainly by socio-economic purposes. However, great importance is placed on the need of using data and new information and communication technology (ICT) in public health to improve quality of prevention and care.

In the next years, European health systems must respond more efficiently to the exponential increase of chronic patients identifying the most efficient interventions and releasing the full potential of ICT. The e-health platforms that many European governments are trying to implement can be effective in improving the management of chronic patients in the community setting by interfacing between different health professionals and specialists and with the patients. Furthermore, a large part of EU citizens uses the internet looking for information on health and access to health services.

Moreover, Big Data and predictive analytics can contribute to precision public health by improving public health surveillance and assessment, therefore, in a public health perspective, the gathering of a very large amount of data, constitute an inestimable resource to be used in epidemiological research, analysis of the health needs of the population, evaluation of population-based intervention and informed policy making.9

Many projects across the EU are exploring the potential of available Big Data in a wide range of fields. A systematic review published in 2016 from the European Commission identified at that time 10 priority projects on Big Data implemented in Europe that fall in the four macro sectors described above and are aimed to support the sustainability of health systems by addressing the improvement of the quality and effectiveness of treatment, fighting chronic disease and supporting healthy lifestyles.9 Some of these projects focussed on gathering a very wide range of data types, from GP records, hospitalizations, drug prescription and laboratory and radiology analyses in order to create comprehensive national data warehouses. Among them, the 'Decision Support for Health Policy and Planning: Methods, Models and Technologies based on Existing Health Care Data' (DEXHELPP), the eHealth project in Estonia, the ARNO observatory in Italy and the Hospital Episode Statistics in the United Kingdom. The DEXHELPP project (mainly regarding sectors 1 and 4) used routinely collected health data sources to analyse the performance of the health system, to forecast future changes and to simulate the application of policy and interventions. The Estonian eHealth project (mainly regarding sectors 1, 2 and 3) was more oriented toward the improvement of the quality and efficiency of health services, aiming to digitalize all the information and prescription of each patient. Furthermore, in order to facilitate data collection, they provide an environment called X-Road to which all healthcare providers can link while using their own ICT solutions. The ARNO project (mainly regarding sector 4), was committed to epidemiological research, giving the possibility of deep stratification of the general population. The Hospital Episode Statistics (mainly regarding sector 4) was in charge of the Secondary Uses Service that publishes reports and analyses to support the National Health Service in the delivery of healthcare services.

Beside these projects characterized by a comprehensive approach, other initiatives focused on specific conditions (e.g. chronic conditions, rare diseases and psychiatric disorders) are also available in the EU.9 Among them, the PASSI surveillance project (mainly regarding sectors 1 and 2) in Italy provides large amount of information on the life style of almost the 90% of the population, enabling to individuate specific targets to implement and assess public health actions. The Shared Care Platform (mainly regarding sectors 1 and 3) in Denmark is focused on chronic patients, aiming to harmonize the course of treatment among health and social care providers. The Spanish Rare Diseases Registries Research Network (SpainRDR) (mainly regarding sector 1) focuses on the development of clinical research on rare diseases, providing the harmonization and unification into one comprehensive platform of pre-existing databases and registries of rare diseases. CEPHOS-LINK (mainly regarding sectors 1, 2 and 4), is a platform dedicated to mental health that involves six EU countries. It is committed to collect data on psychiatric hospital admissions and re-admissions, with the aim of finding determinants of re-admissions and to harmonize the psychiatric care pathways across the EU.

In addition to the projects reported above, the EU's framework programmes for research and innovation funded a large number of initiatives on Big Data in public health. In table 1 , we list 11 projects funded from the EU between 2012 and 2018 with a contribution over €499.999 that are captured from the Cordis website (source: cordis.europa.eu).

Table 1

Project acronym

Full title

Coordinator country

Start date

End date

Big Data in oncology

Cancer is one of the major health problems affecting our society, a situation that is set to deteriorate globally as the population grows and ages. According to the State of Health in the EU reports, cancer is recognized as one of the major contributors to premature deaths in the EU. It also has an impact on the economy in terms of lower labour market participation and productivity. Advances in Big Data analytics are given cancer researchers powerful new ways to extract value from diverse sources of data.

These diverse sources include a huge amount of data for one patient. As cancer is a molecularly highly complex disease with an enormous intra- and intertumoral heterogeneity among different cancer types and even patients, the collection of various different types of omics data can provide a unique molecular profile for each patient and significantly aid oncologists in their effort for personalized therapy approaches.12

The approach of combining these sources of data is implemented in Comprehensive Cancer Centres (CCCs).13 One of 13 CCCs in Germany is the National Center of Tumor Diseases, where the Molecularly Aided Stratification for Tumor Eradication Research (MASTER) trial is conducted (mainly regarding sector 1, 2 and 3). In a recent review article,14 this trial was illustrated as an example of a highly successful programme addressing the molecular profiling in cancer patients. Within the MASTER trial data relevant to diagnostic information of young patients with advanced-stage cancer diseases is collected by performance of whole exome or whole genome sequencing and RNA sequencing, analysed and discussed.

Another example for a success story given in the review is the INdividualized therapy FOr Relapsed Malignancies in children (INFORM) (mainly regarding sector 1, 2 and 3) registry which aims to address relapses of high-risk tumours in paediatric patients. Data from whole-exome, low-coverage whole-genome, RNA sequencing and microarray-based DNA methylation profiling are utilized to identify patient-specific therapeutic targets. The INFORM registry started as a national effort in Germany and has been extended with the participation of eight European countries, as well as Australia.

Next to the described projects there are many other initiatives which focus on the value of Big Data in oncology, the EU alone funds more than 90 projects working on this topic (projects with a funding over €499.999 are listed in table 2 ). A potential umbrella for bringing together national efforts such as those mentioned above at the European level is Cancer Core Europe.15

Table 2

Project acronym

Full title

Coordinator country

Start date

End date

Collaborations are of extremely high importance especially in the case of paediatric or other rare types of cancer, where the data collected for one patient is indeed enormous, however the number of patients a single centre can have access to is too low to obtain statistical power high enough to reach meaningful results. One of the main challenges of these collaborations is the access to the data as well as the opportunity to analyse the huge amount of data in an efficient way. Physicians, researchers and informatics experts can only benefit from collected data and expert knowledge when they get easy and intuitive access to own data or data of partners. For example, at the German Cancer Research Center, tools are developed to grant ways to access and analyse own data together with data from partners.

Additionally, international exemplary approaches of sharing data among partners or the public are done by The Cancer Genome Atlas (TCGA) and the International Cancer Genome Consortium (ICGC) which provide researchers with access to thousands of sequenced patients with different types of cancer. The availability of these data jointly with data by other partners has enabled large meta-analyses and machine learning algorithms, integrating different types of cancer that led to the identification of novel cancer driver genes that belong to specific pathways and can be possible therapy targets. Furthermore, there are a number of public databases that provide access to catalogues of mutations found to be involved in cancer, such as the Catalogue of Somatic Mutations in Cancer (COSMIC).

All these multiple sources of information combined and the establishment and support of CCCs across Europe offer the potential to increase the number of patients that can be offered molecular profiling and individualized treatment based on Big Data analysis.

Ethical and legal issues for the effective use of Big Data in healthcare

The use of Big Data in healthcare poses new ethical and legal challenges because of the personal nature of the information enclosed.

Ethical and legal challenges include the risk to compromise privacy, personal autonomy, as well as effects on public demand for transparency, trust and fairness while using Big Data.16

Data heterogeneity, data protection, analytical flows in analysing data and the lack of appropriate infrastructures for data storage emerged as critical technical and infrastructural issues that might endanger a Big-Data-driven healthcare.

Recently, Skovgaard et al.17 explored attitudes among people living in the EU toward the reuse of health data. The review indicates that the use of health data for purposes other than treatment enjoys support among people, as long as the data are expected to further the common good. In this context, the recent call reported in Science from a number of eminent scientists worldwide, for the unrestricted use of public genomic data, finds a fertile ground from the public.18 Concerns evolve around the commercialization of data, data security and the use of data against the interests of the people providing the data.

The recent EU Data Protection Regulation (GDPR) tries to balance patients' privacy while ensuring patient's data can be shared for healthcare and research purposes.

On 23 January 2017 the Consultative Committee of the Council of Europe's data protection convention adopted 'Guidelines on the protection of individuals with regard to the processing of personal data in a world of Big Data',19 the first document on privacy and Big Data which provides suggested measures for preventing any possible negative effects of the use of Big Data on human rights and freedoms.

Therefore, any government that uses Big Data in the health sector needs to establish affirmative policies to protect the health data of individuals, in terms of confidentiality, privacy and security, while ensuring that advancements in science can take advantage from the open use of data for the community well-being.

Conclusions

Big Data is beginning to revolutionize healthcare in Europe as it offers paths and solutions to improve health of individual persons as well as to improve the performance and outcomes of healthcare systems.

The implementation of precision medicine remains contingent on significant data acquisition and timely analysis to determine the most appropriate basis on which to tailor health optimization for individual prevention, diagnosis and disease treatment. Achieving effective and proportionate governance of health-related data will be essential for the future healthcare systems, and it requires that stakeholders collaborate and adapt the design and performance of their systems to reach the maximum innovative potential of information and innovation technology on health in the EU.

In this context, EU Member States should agree on international technical standards, taking also into account openness that is considered as the basic paradigm for digital transformation. Additionally, new approaches must be found for translating the vast amount of data into meaningful information that healthcare professionals can use. Further efforts must be made to make information for doctors and health professionals more accessible and understandable.

To achieve this, existing training and education programmes for healthcare professionals should integrate the issues of data handling in the curricula to ensure the development of the necessary skills and competencies. This is one of the objectives of the 'European network staff eXchange for integrAting precision health in the health Care sysTems' consortium (ExACT)20 project that aims to integrate precision health in European health systems by training a new generation of healthcare professionals across and outside of the EU.

In conclusion, we are living in fast-moving times, not least in terms of healthcare innovation. Whilst there are pressing needs for more personalized and sustainable health services, science and technology are offering a host of potentially invaluable new tools to deliver them. A cooperation at the EU level is needed to facilitate investments both in new technology and in the human capital, in order to guide citizens into this new frontier of human health and well-being where data are becoming a significant corporate asset, a vital economic input and the foundation of new business models.

Conflicts of interest: None declared.

References

2. Manyika J, Chui M, Brown B, et al. Big data: The next frontier for innovation, competition, and productivity. 2011. www.mckinsey.com/mgi (12 September 2019, date last accessed).

3. Beyer M, Laney D The Importance of 'Big Data': A Definition. Gartner report. 2012, 1-9.

5. George G, Haas MR, Pentland A. Big Data and management. AMJ 2014;57:321-6. [ Google Scholar]

11. Hopp WJ, Li J, Wang G. Big Data and the precision medicine revolution. Prod Oper Manag 2018;27:1647-64. [ Google Scholar]

15. Eggermont AMM, Apolone G, Baumann M, et al. Cancer core Europe: a translational research infrastructure for a European mission on cancer. [[ Mol Oncol2019;13:521-7. PMC free article] [ PubMed] Google Scholar]

19. Guidelines on the protection of individuals with regard to the processing of personal data in a world of Big Data Consultative Committee of the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (T-PD) Guidelines 1 on the Protection of Individuals with Regard to the Processing of Personal Data in a World of Big Data 2 Directorate General of Human Rights and Rule of Law. www.coe.int/data-protection (12 September 2019, date last accessed).

20. Boccia S, Pastorino R, Mariani M, Ricciardi W. The European network staff eXchange for integrAting precision health in the health Care sysTems (ExACT): a Marie Curie Research and Innovation Staff Exchange (RISE) project. Epidemiol Biostat Public Heal 2019;16. doi: 10.2427/13122. [ Google Scholar]

Articles from The European Journal of Public Health are provided here courtesy of Oxford University Press

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Benefits and challenges of Big Data in healthcare: an overview of the European initiatives

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Healthcare systems around the world are facing incredible challenges due to the ageing population and the related disability, and the increasing use of technologies and citizen's expectations. Improving health outcomes while containing costs acts ...

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AHRQ's interactive data visualization tools allow researchers, policymakers, healthcare leaders, and others to view visual depictions of healthcare trends. Content drawn from AHRQ's data resources address various topics, such as COVID-19 hospitalizations, health insurance coverage, and emergency department visits. Users may customize visualizations according to geographic location, age, income, and other categories. AHRQ also offers data infographics to showcase its research findings.

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AHRQ's interactive data visualization tools allow researchers, policymakers, healthcare leaders, and others to view visual depictions of healthcare trends. Content drawn from AHRQ's data resources address various topics, such as COVID-19 hospitalizations, health insurance coverage, and emergency department visits. Users may customize visualizations according to geographic location, age, income, and other categories.

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Using graph and timeline visualization to improve healthcare

The healthcare data visualization challenge

The healthcare industry is inherently complicated.

It involves a lot of people, stakeholders, processes and procedures. It's tightly regulated and deals with the highest possible stakes: peoples' health and well-being.

Increasingly, healthcare providers are turning to graph technology and data visualization to understand the complex networks of data at their disposal. Powerful healthcare data visualization tools transform that complex data into valuable, useful insight.

Data visualization, especially graph visualization and timeline visualization, helps healthcare providers and professionals to join the dots in data.

Let's see how it helps them improve services, drive efficiencies and deliver better patient outcomes.

Healthcare data visualization: knowledge graphs

Modern healthcare generates a lot of data. Patient records, admissions data, electronic health records, billing data, insurance policies and claims: every interaction leaves a complex digital footprint.

These footprints are often scattered between systems, limiting the ability to understand the full picture and make the best decisions. Using graph visualization tools, it's possible to collate all of this data into a single unified view, allowing systems users - clinicians, data analysts or non-specialist staff - to piece everything together and get a complete overview of the patient's situation.

These tools - often called customer 360 or patient 360 - are powerful knowledge graphs that answer many different questions.

What is this patient's medical history? What is their next best treatment?

Have other patients suffered these symptoms before? What were their diagnoses, prognoses and treatments?

Which institutions and clinicians have spare capacity?

Which clinicians have the most complaints? Who is complaining, and about what?

Interactive graph visualization allows users to query, explore and understand complex data, creating insightful and intuitive knowledge graphs.

Pulling data from multiple siloed systems, knowledge graphs give a single, unified view of a situation, allowing them to make better decisions, faster.

Healthcare data visualization: fraud detection

Billions of dollars are lost every year to healthcare fraud. According to the US Government Accountability Office, 74% of the $1.3 trillion lost to improper payments since 2003 was lost through healthcare-related programs.

Detecting fraud in programs as vast as Medicare and Medicaid might seem like an impossible task. Incorporating graph visualization into fraud detection tools, it's possible to spot patterns and anomalies, and uncover incidences of fraud.

To detect healthcare fraud, you need to see connections. Between patients, providers, clinicians, insurance policies and claims. Graph visualization makes it easy to see those connections, so we can recognise normal patterns and anomalies that might indicate fraud.

Healthcare data visualization: regulatory compliance

Healthcare is one of the most tightly-regulated industries. Ranging from data protection to HIPAA compliance, from anti-bribery rules to regulations controlling the prescription of opioids. Healthcare organizations and providers need effective processes and total visibility of their data to maintain a robust compliance regime, while still delivering the the best possible care.

Graph visualization is the ideal tool for managing regulatory compliance. This example of trust-hub's privacy data compliance platform examines an organization's data assets, and the people, processes, systems and places associated with them.

Custom healthcare data visualization

We work with healthcare-related businesses worldwide, helping them to make sense of big data.

Using our graph visualization and timeline visualization technologies, they build interactive applications that join the dots and reveal the insight they need to understand.

Want to try it for yourself?

Start a KeyLines trial

Start a ReGraph trial

Start a KronoGraph trial

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Healthcare data visualization: revealing insight in complex healthcare data

# data[].attributes.attachment_link.description
Using graph and timeline visualization to improve healthcare The healthcare industry is inherently complicated. It involves a lot of people, stakeholders, processes and procedures. It's tightly regulated and deals with the highest possible stakes: peoples' health and well-being. Increasingly, healthcare providers are turning to graph technology and data visualization to understand the complex networks of data at their disposal.

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January 01, 2022

Lisa A. Lucido , Hall Render Killian Heath & Lyman PC

Benjamin C. Fee , Hall Render Killian Heath & Lyman PC

Lisl Dunlop , Axinn Veltrop & Harkrider LLP

Jody Rudman , Husch Blackwell LLP

Shalyn Smith McKitt , Balch & Bingham LLP

Nathan A. Kottkamp , Williams Mullen

Tiffany Buckley-Norwood , Trinity Health

Michael Herald , Guardian Healthcare

Sarah Swank , Nixon Peabody LLP

Purvi Maniar , Norton Rose Fulbright US LLP

Tiana Korley , University of Michigan Office of the General Counsel

Robin Locke Nagele , Post & Schell PC

1. Full Disclosure—Surprise Billing and Hospital Price Transparency in 2022

Lisa A. Lucido and Benjamin C. Fee, Hall Render Killian Heath & Lyman PC

+Listen to Episode 1

In an effort to promote greater transparency for consumers in health care, Congress, the Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), and several states have implemented laws and regulations related to price transparency and surprise billing.

Surprise Billing. After years of debating a federal solution to end surprise medical bills, on December 22, 2020, Congress passed the No Surprises Act (Act). At a high level, the Act prohibits balance billing for: (1) emergency services provided by an out-of-network provider; (2) non-emergency services provided by an out-of-network provider at an in-network facility; and (3) air ambulance services. The requirements under the Act were effective January 1, 2022.

HHS, the Department of Labor, the Department of Treasury, and the Office of Personnel Management (collectively, Departments) issued two interim final rules (IFRs) on July 13, 2021 and September 30, 2021, respectively, to implement certain provisions of the Act. The first round of rulemaking addressed: (1) the scope of the surprise billing prohibition; (2) the process by which patient cost-sharing and the provider out-of-network rate is calculated; (3) the notice and consent process in cases where patients can waive their balance-billing protections under the Act; and (4) a complaint process for any potential violations. The second IFR addressed (in relevant part): (1) the independent dispute resolution process; (2) the good faith estimate requirements for uninsured/self-pay patients; and (3) the patient-provider dispute resolution process.

Looking to the Future—Implementation, Enforcement, Future Rulemaking, and Legal Challenges. Implementation of the Act requires substantial changes in how providers, facilities, and health plans operate. Internal workflows, technology, and communication processes with patients will need to be revamped to comply with the requirements under the Act. While HHS has deferred enforcement of some of the Act’s requirements including: (1) the requirement for providers/facilities to provide a good faith estimate for insured patients; and (2) the requirement the good faith estimate include expected charges from co-providers and co-facilities, it is not known whether HHS will exercise its enforcement discretion elsewhere. Additionally, several other key provisions of the Act are still subject to future rulemaking, including: (1) implementation of plan and issuer drug price reporting; and (2) implementation of the good faith estimate process and advanced explanation of benefits (EOB) for insured individuals. Only time will tell whether HHS will respond to stakeholder concerns through further rulemaking, sub-regulatory guidance, or additional enforcement delays. On December 9, 2021, the American Hospital Association and the American Medical Association along with two health systems and two physician groups filed a lawsuit challenging a part of the September 30 IFR that establishes a presumption in favor of the median in-network rate during disputes between providers and health insurers. Providers should closely monitor the challenge and its impact on the Departments’ regulations as the litigation moves forward.

Hospital Price Transparency Enforcement Ramps-Up. The federal regulation requiring hospitals to publicly disclose the prices they charge for items and services, including negotiated reimbursement rates with third-party payers, was effective January 1, 2021. The rule survived multiple legal challenges and the change in administrations following the 2020 presidential election. In fact, the Biden administration has only reinforced the federal government’s commitment to ensuring consumers have access to health care pricing information.

As evidence of that commitment, CMS audited hospital compliance with the price transparency rule throughout 2021. Those audits resulted in hundreds of hospitals receiving warning letters for noncompliance, usually with a 90-day period to resolve the cited deficiencies. Although there were no public reports of CMS penalizing a hospital for noncompliance as of this writing, such occurrences appear inevitable given the administration’s commitment to enforcement.

CMS also finalized increases in the financial penalties for noncompliance. The original rule capped the financial penalty at $300 per day per hospital, a relatively insignificant amount that likely contributed to hospital noncompliance. As a result, CMS raised the financial penalties to $10 per day per bed for most hospitals. Hospitals with 30 beds or fewer are still subject to a minimum penalty of $300 per day and hospitals over 550 beds a maximum penalty of $5,500 per day. The change increases the potential penalties for a year of noncompliance for hospitals over 550 beds from $109,500 to a maximum of $2,007,500. The increased penalties apply to noncompliance beginning January 1, 2022.

Good Faith Estimates. Along with the increased enforcement of the hospital price transparency rules, HHS finalized rulemaking implementing a provision in the Act that requires providers to communicate a “good faith estimate” (GFE) of expected charges to uninsured (including self-pay) patients upon their request and at the time of scheduling the health care item or service. That requirement begins January 1, 2022. Future rulemaking will implement a similar requirement for providers to provide payers a GFE of expected charges for insured patients. These new requirements only reaffirm the ongoing commitment from the federal government to price transparency in health care.

2. Provider M&A Faces New Antitrust Headwinds

Lisl Dunlop, Axinn Veltrop & Harkrider LLP

+Listen to Episode 2

The change in administration has brought a more aggressive approach to antitrust enforcement with a sharp focus on the health care industry. In July 2021, President Biden issued a sweeping Executive Order on Promoting Competition in the American Economy reasserting the administration’s policy to vigorously enforce the antitrust laws through a whole-of-government approach.1 The Biden Executive Order pointed out that past health care mergers had led to a situation where the ten largest health care systems now control a quarter of the market, and hospital consolidation has left many geographic areas, especially rural communities, without good options for convenient and affordable health care. The Biden Executive Order exhorted the Federal Trade Commission (FTC) and Department of Justice (DOJ) Antitrust Division to step up their enforcement activities to address these problems.

While the antitrust agencies have had a successful program of enforcement against health care mergers throughout the Trump administration and earlier Democratic administrations—including bringing several successful court challenges—the Biden Executive Order, as well as recent agency statements and actions, signal a major shift in the way that the agencies (in particular the FTC) will approach provider mergers going into 2022 and beyond.

Investigations with Broader Scope. FTC Chair Khan’s October 2021 memo to staff on the Commission’s priorities identified the need to use a broader frame of reference to assess the effects of transactions on competition. In contrast to the traditional approach of analyzing provider transactions primarily in terms of their impact on prices paid by commercial insurers, Khan has directed staff to consider a wider range of effects, such as impacts on workers and small businesses and effects on marginalized communities. Providers with deals before the Commission are already seeing a significantly wider range of questions from the FTC around the possible effects of the deal on medical professionals and other staff, including the existence of non-compete agreements and other aspects of competition relating to employment. The socioeconomic impacts of transactions also are likely to become an area of interest; although transactions can lead to increased investment in health care assets in marginalized communities, demonstrating such procompetitive impact can be challenging.

New Guidelines and Changing Approaches. Consistent with the Biden Executive Order and the FTC’s new “holistic” approach, both antitrust agencies have announced a review of the current horizontal merger guidelines, suggesting that the current version (introduced in 2010) may be “overly permissive.” The FTC has already taken a more dramatic step in repealing vertical merger guidelines that were introduced only last year, with the Democratic Commissioners expressing doubts as to the basis for arguments that vertical integration can have procompetitive effects. It is also likely that the 25-year-old joint agency Statements of Antitrust Enforcement Policy in Health Care—which extend far beyond mergers—also will be reconsidered. The underlying presumption for these developments is that the existing agency guidelines under which health care transactions have been judged in the past have contributed to the current “rampant consolidation and dominance” and need to be changed. Until new guidance issues, however, there will be more uncertainty about how the agencies will approach health care deals.

More Investigations of Consummated Transactions. The Biden Executive Order encouraged the FTC and DOJ to “challenge prior bad mergers that past Administrations did not previously challenge.”2 In addition, ostensibly due to workload constraints, the FTC has taken the approach of sending merging parties a letter after the expiration of the Hart-Scott-Rodino (HSR) premerger notification waiting period indicating that the investigation is ongoing and that they complete their deal at their own risk. While post-consummation challenges were not unknown before now, they have been relatively rare, particularly when a transaction had been through the HSR review process. Organizations that have previously completed significant transactions should anticipate new and ongoing inquiries from the FTC, which may lead to enforcement action.

Increased Attention to Non-Hospital Provider Mergers. Early in 2021, the FTC initiated a study of the impacts of non-hospital provider mergers—including combinations of physician groups, hospital acquisitions of physician practices, and mergers of non-hospital outpatient facilities—examining both price effects and non-price factors, such as health care outcomes. While the FTC has in the past investigated and challenged physician group mergers, such as Sanford Health’s acquisition of Mid-Dakota Clinic in 2017, parties are likely to see more investigations of transactions involving providers and potentially more enforcement activity, including challenges to consummated deals, as the results of the FTC’s study become available.

3. Pandemic-Related Enforcement and Oversight

Jody Rudman, Husch Blackwell LLP

+Listen to Episode 3

The COVID-19 pandemic ushered in an unprecedented array of measures to provide relief, assistance, and monetary protections for Americans, businesses, and health care systems and providers, among others. The Coronavirus, Aid, Relief, and Economic Security Act (CARES Act), signed into law on March 27, 2020, served as the initial major relief package. The CARES Act alone made available $2.2 trillion in relief funds through a number of programs.3 These include the Paycheck Protection Program (PPP) and Provider Relief Fund.4

With any funding mechanism of such a substantial size, post-hoc enforcement is inevitable. Indeed, DOJ quickly proclaimed its intention to investigate misconduct associated with CARES Act and COVID-19.5 Hotlines were established for reporting fraud and U.S. Attorneys’ Offices were encouraged to maintain prosecution resources dedicated to COVID-19-related fraud cases.6 While the rollout of the CARES Act and other pandemic relief programs was extremely quick, many investigations, audits, and enforcement activities—particularly with regard to the Provider Relief Fund—will likely take years.

Early enforcement efforts of misused CARES Act funds are already well under way. Less than a year after the pandemic began, DOJ announced scores of criminal fraud cases, at least 11 civil fraud actions to enjoin fraudulent coronavirus-related schemes, and more than 50 PPP cases involving over $225 million in intended loss. 7 Loan applicants who lied on their applications about their businesses or who claimed entitlement to funds not borne out by actual fact have already been the target of investigation and prosecution. Similarly, federal prosecutors and investigating agencies have uncovered and pursued the misuse of PPP funds for luxury purchases, the payment of personal debt, stock market investments, and the like.8 These types of enforcement efforts are ongoing and can be expected to continue steadily for some time.

More complex investigations and more complicated fraud schemes or False Claims Act cases will likely follow audits under the CARES Act’s Provider Relief Fund. Recipients of CARES Act funding have found themselves navigating through complex and changing terms and conditions of participation in the program. The first tranche of funding simply arrived in providers’ bank accounts, with an after-the-fact attestation or presumed attestation of entitlement to the funds if they were not returned. Guidance governing entitlement and reporting has shifted over time. Recipients are bound to spend the funds within the boundaries of the program, but that guidance has been similarly uneven. The program itself entails mandatory reporting, self-auditing, audits by HHS, and claw-backs of funds improvidently granted or improperly spent. This is a recipe ripe for years of enforcement efforts.

Enforcement activity may come from any number of sources, some established within the CARES Act itself, and others that already exist in the law. These include the Office of Inspector General for Pandemic Recovery, which exists within the Department of the Treasury and oversees the PPP, among other programs; and the Pandemic Response Accountability Committee, which consists of 20 Inspectors General of various Departments and is tasked with conducting, coordinating, and supporting them in their oversight of CARES Act funds. Enforcement mechanisms also include the existing federal False Claims Act9 and a number of criminal laws that are used to prosecute and punish fraud schemes.

Contemporaneous documentation will be key as the audits and investigations unfold. Keeping guidance documents, even as they shifted, that bore upon decision making will prove a helpful tool for proving good faith. Internal audits, including responsiveness to employee or whistleblower concerns, should help mitigate future problems. Targets of enforcement activities would be wise to have a response plan and to maintain important communications. Such efforts may help minimize the risk of a negative post-hoc audit for providers.

4. Health Care Workforce Employment Law Issues to Watch in 2022

Shalyn Smith McKitt, Balch & Bingham LLP

+Listen to Episode 4

We thought 2020 was unprecedented, but health care employers were faced with new challenges in employment law as the world adapted to COVID-19 in 2021. And 2022 won’t be any different. The introduction of vaccines in 2021 led to workforce dilemmas and the shift to the new “normal” called for regulation of the industry regarding the safety and welfare of health care employees. In 2022, four issues for health care employers to watch are discussed below.

Vaccine Mandates. As 2021 came to a close, the issue of requiring employees to be vaccinated became even more contentious than before. As a result, health care employers will most likely find themselves torn between implementing vaccination policies and foregoing them in 2022. In September 2021, President Biden ordered vaccination mandates for the federal workforce, federal contractors, and private sector businesses with more than 100 employees. The administration also announced that it would require COVID-19 vaccinations for health care workers in hospitals and other facilities and settings that participate in Medicare and Medicaid. This order came shortly after litigation in multiple states where hospital employees refused to follow hospital policy requiring COVID-19 vaccination. Under an interim final rule issued in November 2021, CMS required health care providers to establish policies to ensure all eligible staff get vaccinated by January 4, 2022. However, federal courts in Missouri and Louisiana granted preliminary injunctions blocking the administration from enforcing the vaccination requirement for health care workers nationwide after finding the states challeging the IFR were likely to succeed on their claim that CMS exceeded its statutory authority. The Fifth Circuit later narrowed the scope of the injunction so that the administration is now enjoined from enforcing the mandate in 24 states. As of this writing, the administration had asked the Supreme Court to allow the vaccination mandate for health care workers to go into effect in those states while appeals proceed in the two challenges. In 2022, health care employers will have to monitor how these challenges play out in court or decide to move forward with vaccination requirements on their own.

COVID-19 Exposure Liability. 2021 marked the beginning of lawsuits from family members of health care workers who contracted COVID-19 when at work. Cases in New Jersey and Illinois demonstrate just how unexpected these lawsuits were, and likely will be in the coming year. Essentially, most workforce members are usually prohibited from bringing suit against their employers for contracting a disease at work under workers’ compensation laws. But, when a family member is exposed due to an employer’s negligent management of the disease in the workplace, the employer is exposed to liability. Employers will need to ensure they follow government guidelines and manage the spread of COVID-19 to avoid these lawsuits.

Staffing Shortages. In 2022, the health care workforce shortage will probably continue its spiral, and health care providers will be faced with more challenges than ever before. It is currently estimated that by 2030 there will be a global shortfall of more than 10 million nurses, for example. Research shows that COVID-19 has impacted the health care workforce both physically and mentally. Employees are not only more susceptible to contracting COVID-19, but they are also prone to increased stress and mental health issues. Health care providers have to take time in 2022 to focus on retaining and growing their workforces before it is too late. Organizations like the World Health Organization and the American Hospital Association have published widely on this topic and can be great resources for health care employers.

Whistleblower Cases on the Rise. States are reacting to the rise of whistleblower claims related to COVID-19, and 2022 will likely signal a new era for these claims for health care providers. Generally, under federal law and most state laws, employers cannot retaliate against an employee who reports a practice that threatens public health and safety. However, in 2020 and 2021 these complaints skyrocketed due to employees with concerns regarding the availability of personal protective equipment (PPE), the implementation of facemask policies, or lack of COVID-19-related training. Cases in California, Texas, and Illinois included employees who raised these kinds of concerns and were ultimately terminated. New York has already started to react to this phenomenon by updating its labor laws in 2020, but other states are sure to follow.

5. Beware, Ransomware: Considerations When System Access Exceeds the Value of the (Digital) Assets

Nathan A. Kottkamp, Williams Mullen

+Listen to Episode 5

Ransomware is a current darling of cybercriminals for a broad array of industries, and for good reason: the return on investment from extortion can be extraordinary. The health care industry is particularly vulnerable because the value and importance of having access to data are separate from, and often greater than, the inherent value of the data itself.

As a general matter, cybercrime is pervasive because nearly all important information in today’s world is digital. Recall the famous quote from Willie Sutton on why he robbed banks: “Because that’s where the money is.” Today, the value of so many things is in bits and bytes. And, unfortunately, cybercriminals have learned that breaking into “secure” systems is actually not overly difficult.

Once the criminals compromise a system, the next question is what to do. The most obvious options include (1) stealing and selling data, (2) using the data to establish financial fraud schemes, and (3) holding the entity hostage. Since the first two options often require considerable follow-up work and leave more detailed cyber footprints, the returns on “investment” make them less attractive for many cybercriminals. By contrast, holding an entity hostage with an encryption program is comparatively simple, and the payout (where the attack actually yields a ransom) is nearly immediate. Furthermore, the rise of cryptocurrency has made the receipt of ransom funds substantially easier and swifter than traditional methods of exchanging and/or laundering large amounts of money and/or trying to sell health information on the “dark web.” Finally, with respect to scale, the effort to breach security may not differ all that much based on the entity’s size. As a result, cybercriminals have an incentive to go big.

As frustrating as it may be, at this point in the evolution of our digital lives, the risk of ransomware should not be considered a surprise for any entity. Therefore, all entities should have a response plan, with at least three core components:

Preventive: keep educating employees about the fundamental ways in which digital systems become compromised, particularly how the vast majority of compromises involve basic gullibility and human error.

Operational: by maintaining a robust system of backups, redundancies, and data segmentation, entities can substantially reduce the impact on their systems.

Strategic: to pay or not to pay, that is the question. If the entity anticipates a willingness to pay, it should consider such variables as its payout limit, how it will assemble the funds, and whether anyone in the organization has cryptocurrency experience. If the entity plans not to pay, it should consider its strategies and alternatives to operating without the original data, what kind of messaging it will provide to patients and business partners while its systems are compromised, and its public image management if the ransomware attack blows up in the traditional or social media.

Beyond the above, all entities should have robust cyberinsurance to help mitigate the costs of managing an attack.10

It would be helpful if there were straightforward and consistent guidance on what to do in response to an attack. Unfortunately, recommendations and actual experiences vary. Remarkably, even the Federal Bureau of Investigation (FBI) does not take a strong position; instead, it offers only that “The FBI does not encourage paying a ransom to criminal actors.”11 Furthermore, it is likely (but not entirely clear) that paying a ransom is de facto illegal under certain current laws. There also are various proposed laws floating around state legislatures that would directly and expressly address the legality of such payments. Of course, punishing the victims of an attack may not reduce the number of attacks or the number of payments. Reporting matters to law enforcement is sensible, but it may not help a current victim. Finally, despite the encouraging news that DOJ was able to recover a significant portion of the Colonial Pipeline ransom, it is unlikely that law enforcement would devote similar recoupment efforts to small medical practices or facilities. As a result, health care entities may be left with little practical guidance and few supports in the event of an attack.

In the context above, response strategies have become even more complicated by questionable reliability of the criminals to do as they say. Specifically, there is a significant risk that the criminals will take a victim’s money but then not actually return/release the ransomed data. Another risk is that paying a ransom in the first place may increase the likelihood of being a repeat victim based on the presumption that payment once signals willingness to pay again. For what it is worth, game theory probably has a lot to say about ransomware for both the bad actors and the victims. Specifically, if too many criminals fail to restore encrypted data, then victims will be much less likely to pay. If victims uniformly refuse to pay, then ransomware may be worthless. Of course, with so many actors, the range of responses is all but certain to keep ransomware around for a while.

While the discussion above primarily focuses on money and logistics, it is important not to lose sight of why health care entities (and those with which they contract) are particularly vulnerable: lives depend on data. Significantly, a case that is currently working through the courts expressly poses the question about causation between a ransomware attack and a baby’s death. Specifically, according to the lawsuit, a multi-day ransomware attack on Springhill Medical Center compromised a wide array of the hospital’s systems, including its fetal monitors, which led to the failure to detect complications with one of the hospital’s pregnant patients and which then was a material cause of the baby’s death nine months after birth.12 Regardless of the outcome of this particular case, there will undoubtedly be subsequent lawsuits, presumably with much tighter facts and easier causation arguments.

Finally, as if the above issues with ransomware were not enough for providers, the Office for Civil Rights (OCR) has taken the position that all ransomware incidents must be considered under the Health Insurance Portability and Accountability Act (HIPAA) Breach Notification Rule.13 Significantly, because there are no bright line standards in the Breach Risk Assessment requirements,14 entities may be forced to make the difficult choice of providing expensive and potentially image-damaging notice about an event that actually may not have compromised patient information in the first place or, in the alternative, risk a significant enforcement penalty if the OCR learns about the incident and then disagrees with the entity’s breach risk assessment conclusions.

Unfortunately, the risks of ransomware are not limited to organizations. The stakes are growing at the personal level as “connected” devices and the “internet of things” put more and more health information in internet-accessible form. Imagine a person with a connected pacemaker who receives an email saying: “I’ve hacked your heart, now pay up in bitcoin,” or consider a diabetic individual who gets a text along these lines: “Do you know what your blood sugar is right now? I do. To unlock your monitor, send $100 to [anonymous account].” With these types of situations, game theory, once again, comes into play, where the scope, amount of ransom, and ease of payment may enable criminals to make a fortune from a large-scale attack with relatively small ransoms that are very likely to be paid because the risks of non-payment are potentially fatal. It is for these circumstances, that anyone developing a health care app or a connected device should incorporate robust security features at the absolute outset of the design process (i.e., “security by design”). Similarly, providers, insurers, or others who recommend or reimburse for the use of connected devices should be mindful of the security features built into the systems, lest they find themselves indirectly liable for individual device attacks.

As long as information is digital, it will be vulnerable. And, it is foolish to assume that the cybersecurity industry will actually stay ahead of cybercriminals. Of course, this does not mean ignoring technical features to minimize the risk of a successful attack or structural/operational features to reduce the impact of a successful attack. But reliance on these measures is not enough; workforce education is also essential.

Until cybercriminals move on to a new favorite method of attack, entities should assume that a ransomware attack could happen at any moment. As a result, it is essential to have a logistical plan for either restoring the entity’s relevant data or operating without such data, and it is equally important to have a strategy regarding whether to pay. With any luck, a victim entity will merely have to deal with the significant challenges of implementing its plan rather than the even greater challenge of figuring out its plan and rolling it out at the same time. #forewarnedisforearmed

6. The Health Care Workforce IDEA (Inclusion, Diversity, Equity & Accessibility)

Tiffany Buckley-Norwood, Trinity Health

+Listen to Episode 6

Diversity and inclusion in the health care workplace carries several benefits, such as higher employee morale, better recruitment and retention, more creative problem solving through varied perspectives, and better care for the community.15 The following are three areas to watch.

Defining Diversity. As health care employers continue to create and implement diversity initiatives, it is important to define diversity. That definition may continue to change in 2022, just as it has in the past. Early civil rights laws, such as the Equal Pay Act of 1963, Title VII of the Civil Rights Act of 1964, and the Age Discrimination in Employment Act (1967), in addition to early Presidential Executive Orders, reflect that the conversation about diversity began with overt characteristics, such as race, gender, religion, and national origin. Next the diversity discussion continued to expand to protections for medical condition such as disability, pregnancy, and genetic information. This is seen in the passage of the Pregnancy Discrimination Act (1978), Americans with Disabilities Act of 1990, Family Medical Leave Act (1993), and Genetic Information Nondiscrimination Act (2008). Then, the diversity conversation expanded again to include more discussions around equity, accessibility, and sexual orientation. This is seen in the passage of the Lilly Ledbetter Fair Pay Act (2009), the accessibility and breast milk expression provisions of the Affordable Care Act (2010), and changes to existing laws to include gender identity and sexual orientation as forms of sex discrimination.16 It is also seen in the passage of numerous state laws related to pay equity and paid family and medical leave. The definition of diversity will likely continue to expand into 2022 to involve more lifestyle topics. During the pandemic, employees spent more time with their families and working from home, which has prompted them to reevaluate how work impacts their life.

As the definition of diversity continues to expand, employers will need to be able to clearly articulate what “diversity” means for their organization. A starting foundation should be state and federal civil rights laws to avoid creating unlawful policies. But the culture of a health care workplace should also dictate other specifics of the diversity definition for the organization.

Unconscious Bias and Microaggressions. Just as the definition of diversity has expanded, the definition of inequality has as well. In 2020 and 2021, the terms “unconscious bias” and “microaggressions” became more prominent in the national dialogue around diversity and inclusion. Specific to the health care industry, there was a focus on health care inequalities (particularly related to the pandemic), potential causes for those inequalities, and laws that could be enacted to remediate those causes. For example, on June 1, 2021, Michigan’s Department of Licensing and Regulatory Affairs (LARA) adopted new administrative rules mandating implicit bias training as part of the knowledge and skills necessary for obtaining and maintaining a health care license in Michigan.17 More states may make unconscious bias training mandatory for health care workers. Additionally, more health care employers may voluntarily decide to include an unconscious bias segment in their training. In doing so, however, it is important to be aware of any laws or regulations that dictate or restrict the content of that training. For example, now-revoked federal Executive Order 13950 prohibited federal contractors from using certain types of diversity and unconscious bias training.

Use of Statistics in Diversity Initiatives. Under the federal Executive Order 11246, the Rehabilitation Act, and Vietnam Era Veterans Act, many health care employers who are federal contractors are already required to utilize statistics to create diversity goals as part of a formal affirmative action plan. But other employers are starting to see the benefit of using statistics to be more efficient in creating and tracking their strategic diversity initiatives. While such statistics can be a benefit, there are certain pitfalls that should be avoided. For example, public pronouncements that involve statistics should be carefully worded to minimize claims of intentional discrimination or disparate impact discrimination, in violation of state and federal civil rights laws. Likewise, while it is permissible to create goals based on diversity analytics, creating quotas may lead to claims of discrimination. Thus, it is important to have an employment attorney familiar with the pitfalls of such statistical analysis review any strategic plan based on diversity analytics for appropriate wording.

In conclusion, the conversation around what constitutes diversity and how to achieve it will continue to evolve in 2022. It is important to remain up to date on the laws regulating this area to avoid pitfalls.

7. Securing the Supply Chain for Health Care Providers

Michael Herald, Guardian Healthcare, and Sarah Swank, Nixon Peabody LLP

+Listen to Episode 7

In the early days of the pandemic, many health care providers, their workers, and patients experienced first-hand the impact of supply chain disruption. Supplies such as masks, gloves, and gowns used to keep workers safe were in limited supply. In some parts of the country, supply chain issues left surging hospitals without enough PPE or ventilators to care for those infected with COVID-19.

Today, challenges with the supply chain persist. While the global marketplace has slowly reopened and manufacturing has resumed, we are still competing for scarce resources with other countries. The United States also has experienced an inability to manage the uptick in imports at major shipping ports due largely to a lack of drivers for the trucks that play an important role in carrying goods out of ports for delivery. Critical medical supplies and equipment remain in short supply, potentially jeopardizing patient care or worker safety.

FDA Guidance and Waivers. During the initial weeks of the pandemic, the Food and Drug Administration (FDA) in conjunction with the Centers for Disease Control and Prevention (CDC) provided guidance regarding alternatives to PPE such as cloth masks and actions to take when medical supplies were low. In October 2021, the FDA published a notice announcing the process for making COVID-19 guidance available to the public, including periodic publication of consolidated notices describing all COVID-19-related guidance issued during a relevant period.18 The FDA said the new process will help the agency to more rapidly disseminate and implement recommendations and policies related to COVID-19. Earlier in the year, the FDA published updated information on exercising enforcement discretion for importing certain medical devices during the pandemic. Providers should look to prior guidance on single use and infection control processes with concerns of medical supply shortages.

OSHA Enforcement. Procuring PPE like N95 respirators has always been important for health care providers. The Occupational Safety and Health Administration’s (OSHA’s) respiratory protection program standard requires employers to provide appropriate protection for employees from a known hazard, like COVID-19, in the workplace.19 OSHA and many state agencies are updating guidance for employers as the pandemic continues. Providers must ensure they secure adequate supplies of PPE for health care workers to avoid fines and penalties from OSHA or state agencies.

Defense Production Act. During the initial phase of the pandemic, it quickly became apparent that the national stockpile did not contain sufficient supplies to support the increased demand across the country as individual health care providers experienced shortfalls in their own inventory. Eventually, the Federal Emergency Management Agency (FEMA) and HHS moved to increase supply and domestic production of medical supplies and equipment under the Defense Production Act. FEMA and Customs and Border Protection also continue to work to prevent domestic brokers, distributors, and others from diverting critical medical resources overseas.

Role of States. Individual health care providers and states were also competing for the same limited resources. State governors prepared executive orders to address supply shortages especially in surge areas. For example, in New York, a ventilator shortage during the initial surges of the pandemic prompted the governor to issue an executive order allowing supplies, equipment, and staff to be redistributed across the state to hard hit areas, as well as acknowledging that ventilators intended for one patient were now being used for two patients.

Supply Chain Fraud. The supply shortage also opened the door to fraudulent activity. On April 2, 2020, DOJ released an alert regarding enforcement by the FBI and DOJ against those hoarding scarce medical supplies like PPE and hand sanitizer and then selling them at excessive prices.20 Other health care providers experienced fraud when they ordered and paid for critical supplies that never arrived. The FBI issued releases to look out for suspicious activity related to fraudulent sales, including warning signs such as unusual payment terms, last-minute excuses for delays in shipment, and last-minute changes in payment terms.

Crisis Standard of Care. COVID-19 pandemic surges have impacted health care system capacity including space, staff, and supplies. A crisis standard of care describes the plan for managing patient services and allocating scarce resources. A crisis standard is defined as a substantial change in usual health care operations and the level of care it is possible to deliver during a pervasive or catastrophic disaster. Reviewing and planning for a crisis standard of care prior to a surge helps ensure health care providers have critical guidance in place before facing a need to ration or allocate scarce resources.

It Is Not Over. As the pandemic continues, the idea of a well-managed supply chain is being redefined. Supply chain models used to reward those who kept a limited supply of what they needed on hand with close review of expiration dates to eliminate waste. As we look to 2022 and beyond, the global pandemic may have a lasting impact on how the medical supply chain affects the delivery of health care.

8. Behavioral Health Transactions Outlook for 2022

Purvi Maniar, Norton Rose Fulbright US LLP

+Listen to Episode 8

A Pandemic Within a Pandemic. Already one of the most active sectors in health care mergers and acquisitions for a number of years, behavioral health was propelled to the forefront by the challenge to our collective mental health and wellbeing posed by COVID-19. During the pandemic, about four in ten adults nationwide have reported symptoms of anxiety or depressive disorder—a four-fold increase from pre-pandemic levels.21 While rates of childhood mental health concerns and suicide have been rising steadily since 2010, the pandemic also intensified this crisis. Following dramatic increases across the country in emergency department visits for pediatric mental health emergencies, including suicide attempts, the American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and the Children’s Hospital Association recently jointly declared a National State of Emergency in Children’s Mental Health, issuing a call to action to policy makers.22

Increased Market Activity. The increase in demand led to several significant behavioral health transactions in 2021. For example, Lyra Health, which provides comprehensive mental health services through employee assistance programs, raised $200 million in its latest funding round (bringing its valuation to over $2 billion) in order to accelerate delivery of mental health benefits for companies with employees around the world.23 In June 2021, global investment giant, KKR announced the launch of Geode Health, which intends to build a new platform to offer in-person and virtual outpatient mental health across the United States. Overall, by the second quarter of 2021, there were already 119 behavioral health transactions, on track to more than double the 179 transactions completed in all of 2020.

Regulatory Advances. On the regulatory side, the federal Consolidated Appropriations Act, 2021 (CAA) amended the federal Mental Health Parity and Addiction Equity Act, including new reporting and oversight requirements focused on strengthening mental health parity requirements applicable to group health plans. The CAA as well as the American Rescue Plan Act of 2021 continued and expanded telehealth funding and reimbursement due to the COVID-19 public health emergency.24 These funding and reimbursement expansions, as well as regulatory flexibility implemented in 2020 related to physician state licensure, prescribing controlled substances, and HIPAA compliance related to the provision of telehealth (including telebehavioral health) services, are limited to the duration of the public health emergency at the time of this writing. However, they have helped prove the effectiveness of health care services via telemedicine, particularly in behavioral health. Given the national shortage in behavioral health providers, as well as the fact that, because a physical exam is usually not required, behavioral health services can generally be provided remotely much more often than general telemedicine services, key stakeholder groups are pushing to make these changes permanent. In light of the growing pediatric mental health crisis, several bills have been introduced in Congress that are intended to improve students’ access to mental health services and provide funding for suicide awareness and prevention.25 The outlook for additional helpful legislative changes is bright given the broad bipartisan support for improving behavioral health in the country.

Current Market and Consolidation. Despite the increase in behavioral health transactions, the behavioral health market remains highly fragmented. Aside from a handful of established players, most behavioral health providers are small or solo practices or operators of one to two facilities. The behavioral health market is now more ripe for consolidation than ever before driven by the wider awareness and increased prevalence of mental health and substance use disorders during the pandemic, awareness of the significant improvement in outcomes and overall cost savings that can be achieved through better integration of behavioral health care with physical health care in primary care, inpatient settings and emergency room visits, increasing progress towards overall parity of reimbursement for behavioral health services, and the relaxation of regulations related to telebehavioral health.

Consolidation of health practices and facilities by private equity and traditional health care players (such as large nonprofit behavioral health providers and hospitals and health systems) will permit consistent implementation of best practices and professional management across this sector. This consolidation will also accelerate the movement towards better integration of behavioral health with traditional health care, including collaborations and joint ventures between behavioral health providers and hospitals and health systems. Further, the increased market power brought about through the consolidation, combined with increasing awareness and demand will likely lead to higher reimbursement rates. Although the behavioral health provider shortage will remain a challenge in the near term, these market forces will attract more talent to the profession in the longer term to help bridge the gap.

Heightened Scrutiny. While generally good news, the expansion of reimbursement will like bring greater regulatory scrutiny and enforcement. Smaller behavioral health facilities and providers, many of which were largely dependent on self-pay, often flew below the radar, but large, private equity-backed players and other deep-pocketed consolidators that receive significant governmental and commercial reimbursement will become attractive targets for federal enforcement of the False Claims Act (FCA). Since 2013, at least 25 private equity-backed health care companies have paid settlements in excess of $570 million for allegedly violations of the FCA. Behavioral health companies may be at greater risk for enforcement (compared to other health care services companies) given the availability of legislative tools specific to behavioral health, such as EKRA, the Eliminating Kickbacks in Recovery Act of 2018. However, larger players in behavioral health, which have both the resources and incentives to invest in appropriate pre-acquisition diligence and maintain sound compliance programs and practices post-acquisition, have the opportunity to raise the bar for quality across the behavioral health industry as a whole.

Silver Linings. These recent market and regulatory advances in behavioral health represent significant overall progress towards closing the gap in an area of health care that has been historically misunderstood and neglected. Improving behavioral health through greater access and closer integration with physical health care represents a significant opportunity to improve health care outcomes, patient satisfaction and achieving efficiencies that will improve the bottom line. Much like the overall acceleration in telemedicine trends that resulted from the pandemic, the progress we have recently seen in behavioral health, including increased access to telebehavioral health and early attention to pediatric mental health, and will continue to see in 2022 and beyond represent some of the silver linings of a tumultuous period for health care in the United States.

9. Towards A Common Definition for Value-Based Arrangements

Tiana Korley, University of Michigan Office of the General Counsel

+Listen to Episode 9

A survey of the general public revealed that among the small number of respondents who had heard of the phrase “value-based care,” there were widespread differences in their understanding of the phrase’s meaning.26 Many health care industry stakeholders likely find this result unsurprising. Providers traditionally have used the phrase in so many ways that it has lost some meaning.

At the end of 2020, the HHS Office of Inspector General (OIG) and CMS released companion final rules that provided a construct of “value-based care” by which we can understand what regulators and enforcement agencies believe this phrase means. With the creation of new safe harbors under the Anti-Kickback Statute (AKS) and new exceptions under the Stark Law designed to facilitate value-based arrangements, CMS and OIG have established a common paradigm under which providers and regulators can operate.27

Health care industry stakeholders have entirely new terminology, such as “value-based enterprises,” “target patient populations,” and “patient engagement tools and supports.” It is fair to say that with the deregulatory companion rules came numerous regulatory terms for industry stakeholders to understand and apply.

There has been some criticism from the provider community that the new regulatory flexibility did not go far enough. Some providers were unhappy that the safe harbor for care coordination arrangements includes a contribution requirement. Others wanted higher thresholds for the patient engagement tools and supports safe harbor to allow for even more expansive efforts to address social determinants of health. Furthermore, OIG declined to establish safe harbors in some areas, such as for broad waivers of cost-sharing obligations. Providers will have to continue to rely upon the advisory opinion process.

Though the final rules did not provide exhaustive relief, the latitude that providers now have to compensate physicians differently under the Stark Law, and to partner with physicians and other health care organizations under new AKS safe harbors is unprecedented. Many health care leaders have been asking for flexibility to partner in new ways around caring for patients. Such innovation can result in lower health care costs for all involved—federal health care programs (and thus taxpayers) as well as beneficiaries.

Organizations that make strategic use of this flexibility may be able to move more expeditiously out of fee-for-service and into risk-based models of care. CMS recently announced that it hopes to drive accountable care in a more meaningful way such that all Medicare beneficiaries with Parts A and B will be in a care relationship with accountability for quality and total cost of care by 2030.28 This has heightened the urgency for providers to move towards more efficient, cost-effective models of health care delivery.

Innovative leaders will leverage this regulatory flexibility to care for patients in new ways. Hospitals can now partner with each other to take care of patients with a particular medical diagnosis and more easily provide in-kind exchanges of remuneration, such as staff. As participants in value-based enterprises, hospitals can assure patients can access remote patient monitoring tools and other modalities to improve their health in alternate care settings. Hospitals can compensate physicians involved in such care coordination arrangements in a more flexible manner. This is a big win for hospitals attempting to partner with physicians—and each other—in innovative ways.

Looking to the Future. In 2022, we may see further clarity regarding how OIG and CMS interpret the new regulations. The ambiguity and newness of value-based arrangements will eventually be a target for whistleblowers. It will be interesting to see whether good faith participation in value-based enterprises negates bad intent in causes of action involving the AKS. We also may see the first advisory opinions that provide additional insight as to how OIG applies the regulations to specific arrangements.

The Medicare Trust Fund faces insolvency in 2026.29 With recent pronouncements from CMS as to the agency’s vision for federal health care programs, the question is whether in 2022 and beyond, hospitals and other health care providers successfully leverage new flexibilities to take better care of patients at a lower cost and improve health care quality for the communities that they serve.

10. COVID Is a Catalyst for APP Expansion

Robin Locke Nagele, Post & Schell PC

+Listen to Episode 10

In the coming year, we expect that Advance Practice Professionals (APPs) will continue to see significant opportunity for expansion as to their scope of their services and their level of independence in the clinical and the business end of providing services. COVID has taught that “the assumption that a task is automatically safer when it is performed by the highest trained practitioners” is faulty and “actually risks a more hazardous care environment” by placing onerous responsibility on the physician, instead of using skilled non-physicians to relieve some of that burden.30 During COVID, APPs, facilitated by the COVID waivers, have demonstrated their value in ensuring access and continuity of care.31 However, they also face considerable uncertainty about their status as the waivers expire.

Historical Barriers to Practice Autonomy. APPs, including Physician Assistants (PAs), Certified Registered Nurse Practitioners (CRNPs), Certified Nurse Midwives (CNMs), and Certified Nurse Specialists (CNSs), have long advocated for greater autonomy in the provision of health care services. Strides have been made in many states, but restrictions remain. As of the beginning of the pandemic, only 22 states provided “Full Practice Authority” to NPs—allowing them to diagnose and treat patients and prescribe medications without a supervising or collaborating physician.32 Beyond the licensure restrictions, APPs are challenged by restrictive insurance and reimbursement policies, CMS regulations, and institutional and organizational policies related to credentialing as providers. The cost of mandated collaborative or supervisory services is unregulated and can be cost-prohibitive.33

Impact of COVID. During COVID, the federal emergency declaration and state waivers of licensure, practice, and telehealth restrictions radically shifted the practice landscape for APPs. APPs have been able to practice across state lines, beyond their usual scope of practice limitations, and via telehealth.34 The impacts on APP practices included an increased ability to practice independently and without delays resulting from the need for physician chart review, approval of orders, and the ability to follow patients through home health and direct care. And the dramatic increase in the use of telehealth has enabled APPs to treat patients in wide variety of practice settings.35 The pandemic response has provided evidence that some of the restrictive rules surrounding APP practice are unnecessary and can even impede the delivery of quality health care.36

At the federal level, CMS has begun to relax some of the more onerous requirements for APPs. Effective January 1, 2020, CMS removed its own supervision requirements for PAs, and instead now simply requires that they meet applicable state law licensure and scope of practice requirements.37 Effective January 1, 2021, CMS now allows a wide range of APPs—PAs, NPs, CNSs, CNMs, and CRNAs—to review and verify (sign/date) documentation in the medical record without have to re-document notes already in the record, for purposes of Part B Billing.38

The Post-Pandemic Future. Notwithstanding these important gains, APPs face an uncertain future in the immediate term. Many states have completely lifted their emergency waiver provisions, suddenly returning APPs to the licensure and scope of practice restrictions that existed pre-COVID.39 Some forward-looking states—including Colorado, New Hampshire, and Virginia—have replaced the emergency waivers with permanent legislative practice expansions—particularly in the area of telehealth.40 For example, New Hampshire passed permanent telehealth legislation that, among other things, expanded the list of providers able to provide telehealth to include PAs and APRNs, among others.41

APPs still face significant barriers to achieving the level of independent practice that they seek. State-specific barriers to owning their own practices, to practicing without supervision or collaboration, to performing services that are within their training but not permitted scope of practice continue to exist and will require legislative initiatives to effectuate change. But there are signs that APPs are increasingly being recognized and deployed in appropriate settings as good quality, cost-effective alternatives to physicians.42 And many in the industry hope that the data and knowledge generated during the pandemic regarding the valuable skillsets that APPs can offer in a wide range of practice settings will provide powerful arguments for continuing their march towards greater independence and self-determination.

Lisa Lucido is an attorney with Hall Render where she concentrates her practice in the areas of regulatory compliance, reimbursement, billing, and payment practices. Lisa provides counsel to a wide variety of health care entities in developing strategies and policies to ensure compliance with the Medicare and Medicaid programs, including the evaluation of provider-based issues, conditions of payment, disclosure, and compliance matters. Additionally, Lisa advises providers in the negotiation and administration of managed care contracts and works closely with clients to address regulatory and compliance issues related to participation in Medicare Advantage.

Ben Fee is an attorney with Hall Render where he practices exclusively in the area of health law advising health systems and hospitals on a variety of regulatory, compliance, and corporate transactional matters. He regularly advises clients on reimbursement and financial strategies; government reimbursement and payment matters; corporate structure and reorganization; the 340B drug discount program; and corporate compliance issues.

Lisl Dunlop is a Partner at Axinn Veltrop & Harkrider LLP. Lisl has more than 25 years of experience guiding leading U.S. and multinational companies through the antitrust-related aspects of mergers and acquisitions, joint ventures, and other combinations. For her health care clients, Lisl provides antitrust and strategic advice in evaluating value-based payment initiatives, the establishment and operation of ACOs and independent physician networks, financial and clinical integration issues, and other transactions and collaborations.

Jody L. Rudman is a Partner at Husch Blackwell LLP in the Austin, TX office. Jody is a litigator with well over two decades’ experience in jury trials, bench trials, contested hearings and oral arguments in federal and state courtrooms. Jody focuses primarily on government investigations, both civil and criminal, in the health care space. A former Assistant United States Attorney for the Northern District of Texas, she handles all aspects of government investigations, trials, sentencings, and appeals.  Her work is largely white collar criminal and False Claims Act matters, representing clients during investigations, negotiations, and litigation. She is a frequent speaker and published author in health care matters, antitrust matters, and litigation issues.

Shalyn Smith McKitt is a Litigation Associate at Balch & Bingham LLP in the Birmingham, Alabama office. She earned her BA from Stillman College and her JD and MA in Health Studies from the University of Alabama. Shalyn started her practice as a litigator in the Ohio Attorney General’s Office Health and Human Services section where she represented the Department of Developmental Disabilities, the Department of Mental Health and Addiction Services, the Department of Medicaid, and the Chemical Dependency Professionals Board. She then joined the Dallas office for the U.S. Department of Health and Human Services Office of the General Counsel as Assistant Regional Counsel. There she primarily represented CMS and OCR in matters relating to Medicare and Medicaid billing and overpayments, facility compliance, HIPAA, and Civil Rights. Shalyn then served as Senior Legal Counsel at SS&C Health, a Healthcare Technology company. There she drafted and negotiated multi-million dollar contracts for health and pharmacy solutions and was essential in analyzing company HIPAA compliance. She then came to Balch where she works on a variety of litigation matters including those related to health care providers and suppliers, health systems, and HIPAA compliance.

Nathan A. Kottkamp is a Partner in the Healthcare Department of Williams Mullen, in Richmond, Virginia. Nathan’s practice focuses on a broad array of operational and regulatory issues, including HIPAA, licensure/accreditation/professional board matters, and ethics. Nathan is also the Founder of National Healthcare Decisions Day (www.nhdd.org), in which AHLA has been a participant since its inception in 2008.

Tiffany Buckley-Norwood is the Vice Chair of Publishing for AHLA’s Labor and Employment Practice Group. As of November 1, 2021, she is also an Associate Counsel, Employment for Trinity Health. Prior to that, she was the Healthcare Industry Group Co-Lead and a Principal at Jackson Lewis PC. Any statements in this article are Tiffany’s opinion and do not necessarily represent the views of Trinity Health.

Michael Herald is the Chief Administrative Officer & General Counsel at Guardian Healthcare. He is responsible for managing the legal affairs and leading the human resources, IT, shared services, and loss prevention teams for the post-acute care enterprise. In addition, Michael serves as an adjunct faculty member for Penn State University’s Nursing Home Administrator training program, a member of the Board of Visitors for the Health Care Administration and Management Program at Slippery Rock University, and is a member of the Board of Directors at Global Links.

Sarah Swank is a health care attorney in Nixon Peabody LLP’s Washington, DC office, with more than 20 years of experience as senior in-house counsel for two of the largest national health care systems and as a thought leader and advisor in two nationally recognized, top-rated law firms. Sarah supports clients navigating a complex and changing regulatory landscape to promote innovation and thoughtful growth by providing strategic and practical advice on CMMI programs, ACOs, telehealth, AI, health equity, and clinical research and where they intersection with operations, compliance, the Stark Law, Anti-Kickback Statute, HIPAA, OCR civil rights, and other health care regulatory issues. She is a nationally recognized speaker and author, a Vice Chair on the Publications Board of ABA Health Section and the Vice Chair of Education for AHLA’s In-House Counsel Practice Group.

Purvi Maniar is a member of Norton Rose Fulbright’s health care transactions team and is a partner based in the firm’s St. Louis and New York offices. She is a health care business lawyer who focuses on bringing together hospitals, health systems, medical group practices, behavioral health organizations, private equity clients, and emerging health care companies in mergers, acquisitions, joint ventures, and other strategic business arrangements. Purvi focuses on both domestic and international health care transactions and helped lead the expansion of the global law firm’s high caliber domestic health system practice to include international health care transactions. Purvi is passionate about improving access to and quality of behavioral health. She represents private equity companies and prominent nonprofit behavioral health providers in connection with their mergers, acquisitions, strategic partnerships, and clinically integrated networks. She also advises hospitals in connection with restructuring their inpatient behavioral health programs, as well as tele-behavioral health providers and other clients focused on the behavioral health space. She is the Chair of AHLA’s Behavioral Health Practice Group.

Tiana Korley is an Associate General Counsel for the University of Michigan Office of the Vice President and General Counsel.  In this role, she provides advice on regulatory compliance matters, including interpretation and guidance related to the fraud and abuse laws. Tiana also provides guidance on delivery system reform efforts, including alternative payment models. Prior to joining the University of Michigan, Tiana worked in several other capacities in the health care arena, including as a health care consultant, congressional staffer, and as a senior staffer for the Centers for Medicare and Medicaid Services.

Robin Locke Nagele is Co-Chair of the Health Care Practice Group of Post & Schell in Philadelphia. She has a national health care litigation and consulting practice in which she counsels and represents hospitals, health systems, and other health care provider entities in complex medical staff matters, including peer review proceedings, summary suspensions, corrective action, fair hearing processes, and associated litigation.  She also counsels and represents federally listed Patient Safety Organizations (PSOs) and Participating Providers with regard to legal compliance and privilege protection under the federal Patient Safety Quality Improvement Act, and litigates PSQIA privilege disputes. She is a former Chair of AHLA’s Medical Staff, Credentialing, and Peer Review Practice Group, and has written and spoken extensively on medical staff issues.

ARTICLE TAGS

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AHLA - Top Ten Issues in Health Law 2022

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Lisa A. Lucido and Benjamin C. Fee, Hall Render Killian Heath & Lyman PC

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Introduction

According to the non-maleficence principle of medical ethics, ensuring patients' safety and preventing any injury or damage to them is a major priority for healthcare providers ( 1). Thus, it has been the most emphasized component of the quality of health care services all around the world. The Institute of Medicine (IOM) released a report in 1999 entitled "Man is fallible: create a safe health system" in relation to the incidence of medical errors in United States, and consequently, initiated widespread international change in the field of patient safety ( 2). Correspondingly, the Iranian health care system implemented special plans purposed to deliver standard health care services and prevent any mistakes and an organized approach to risk management, systematic deficiency, and patient safety improvement ( 3). One of these programs is clinical governance which was introduced by the Ministry of Health and Medical Education (MOHME) and initiated since November 2009. Although great emphasis has been placed on the importance of clinical governance by the MOHME, there are some challenges in achieving the desired outcomes ( 4). This could be the result of healthcare providers' inadequate understanding about the importance of clinical governance and lack of organizational safety culture ( 5, 6).

Studies showed that a non-negligible percentage of patients are exposed to health care-related injuries. Based on World Health Organization (WHO) report, the possibility of harming patients in the process of providing health care services is 1 out of 300, whereas the possibility of aviation accidents is 1 out of 100,000. Since 2004, with the beginning of the patient safety project, so far 140 countries have attempted to improve their patients' safety plans in their own health system ( 7). The most common cause of injury is medication errors and falling. Although falling includes 21% of total incidents, only 4% of them are serious. Meanwhile the neonatal falling statistics in the USA is 1.6-4.4 in 10,000 live births, an estimated 600-1600 falling incidents in a year. These cases are often the result of shortcomings in systems and processes, organizational complexity and ambiguity, and poor communication ( 8, 9).

Despite various patient safety guidelines and standards, less attention is paid to the ethical and legal aspects of this issue. From a moral perspective, the main goal of patient safety in the health system can be studied from two aspects. It can be studied as a practical value, in the sense that the main focus is its positive outcomes and benefits. It can also be studied as a moral value by focusing on the protection and promotion of humanity and human dignity. It should be emphasized that both aspects are important in the health system. From a professional point of view, moral values in patient safety are not separated from basic medical obligations, but are so central that they may be the source of other moral values emphasized in medicine. This means that patient safety is closely related to the concept of human dignity and all patient safety measures taken must insure the protection of human's dignity ( 10). In other words, the responsibility of the health care staff and professional commitment, in general, are closely related to human dignity ( 11).

This case was raised in the monthly ethics round in the Children's Medical Center of Tehran University of Medical Sciences, Iran, and ethical dimensions of patient safety were discussed by experts in various fields. The opinions expressed in this article are a summary of the views of experts in various fields including neonatology, medical law, ethics, and nursing.

It is worth mentioning that the ethics round has been held every month for more than 5 years in the Children's Medical Center. A complicated case is discussed in each session with the presence of different relevant experts.

The clinical case

A 12-day old newborn infant was hospitalized in the neonatal intensive care unit (NICU) because of multiple seizures. He was the first child of the family. The mother's and family history was negative for seizures or any other disease. Seizures were controlled by medications, and diagnostic assessments including electroencephalography (EEG) were ordered. As the infant was stable and had tolerated breast feeding, it was planned to transfer him to the level II NICU, but it was postponed due to lack of available beds.

On the evening shift of the third day of admission, his nurse heard a sudden noise and noticed that the incubator door was open and the baby was on the floor. The in-charge nurse immediately announced the incident to the on-call physician. The newborn was examined thoroughly and no physical injuries were found. Moreover, the incident was reported to the chief physician of the department and the record of this incident was immediately sent to the hospital officials. Later, all other incubators were inspected to make sure they were secure enough.

When the staff informed the newborn's father of the falling, he accused the mother of neglecting the child, although she had said that she was resting at the time of the incident.

The questions raised in the meeting were as follows:

What are the factors leading to this incident? How could this incident been prevented? What is the responsibility of the staff in dealing with this incident? Based on professional commitments, what is the duty of medical and nursing staff in such events? What are the ethical issues of patient safety in this case? What are the legal obligations and consequences of this case?

Discussion

Root cause analysis and risk management

Searching for the causes and finding the right solution, in other words, the basic analysis of the incident is one of the initial and essential measures taken to decrease the incidence of patient injuries. It should be noted that the mentioned process must be free of any bias and should focus on finding the main cause and resolving it instead of identifying the responsible person. One way of preventing such events is to have a special guideline for reporting the event in a suitable organized ethical atmosphere without accusing anyone. Indeed, fear of blame, penalties, limited organizational support, inadequate feedback, and lack of knowledge about the associated factors are some of the barriers to reporting medical errors in hospitals ( 12).

Assessment and reduction of patients' risk of injury, or risk management in the clinical setting is influenced by several factors. One way is the establishment of an organizational culture based on mutual trust and effective communication in all hospital levels ( 13, 14).

From an ethical perspective, the value of trustworthiness is a prerequisite of successful risk management. This value is connected to safety culture since it refers to physical safety, psychological safety, and cultural safety. Thus, the managers' responsibility is to create mental and physical safety settings based on openness in order to promote patient safety and care quality. Furthermore, it is important for the managers to encourage multidisciplinary collaboration to facilitate transparent reporting ( 10).

In this case, the apparent reason was that the incubator door was left open by someone or was not correctly closed. Questions raised in this context include the following: Was the nurse occupied with other emergency and essential actions? Was the incubator door latch broken? Why would the nurse forget to accurately examine the door? Is it possible that lack of guidelines for patient safety led to this incident?

The most important step to reduce the possibility of such events in clinical settings is to establish policies and procedures that work best for each ward. Furthermore, the continuous training of the personnel in patient safety, steady supervision, and controlling the efficacy level of the performed actions are some other steps that can be taken in this regard. For instance, in this case, frequent checking of the incubator door, the use of two locks, and explanation of safety tips regarding the incubator to the staff are also important. Furthermore, evaluation and constant controlling of compliance with patient safety rules, and feedback are also necessary.

The role of human resources

The quantity of human resources is also noteworthy in the field of patient safety. In other words, quality assurance depends on the quantity of manpower. Therefore, in order to prevent similar incidents, providing an adequate number of staff at the bedside is essential ( 12).

The role of professionalism

Professional ethics and patient safety are intertwined fundamental concepts in medicine. Patient safety is grounded in ethical principles which are considered as care quality indicators ( 15). The realization of patient safety requires the provision and implementation of a professional code of ethics. Based on the Iranian healthcare professional code of conduct, it is expected that all patients be treated with dignity and be protected from any possible harm ( 16). Accordingly, adherence to ethical principles requires healthcare providers to identify potential safety failures to prevent falling incidents ( 15).

The establishment of patient safety has different individual, professional, and organizational aspects with a special focus on ethics. Professional and organizational commitment leads to detecting and reporting of both one's own and others' errors ( 10).

From an ethical view, the following actions are recommended:

Following professional and institutional guidelines (if any exist) related to falling incidents; Taking basic actions to assess the patient's physical health and rescue his/her life; Informing the in-charge staff; Punctual assessment of the situation, and complete documentation and reporting of the event (important data such as the time of the incident, the infant's position, level of consciousness, vital signs, those present at the scene, actions taken in the process, and etc.) should be documented; Informing the parents and providing them with emotional support.

Informing parents (Disclosure of medical errors)

It seems in case of any error made by the care team, the event must be announced to the parents honestly without blaming the care providers. Moreover, irritating phrases such as "It happens" and "Nothing has happened though" should not be used.

Under circumstances in which errors were caused by inappropriate pattern of providing hospital services, parents should be reassured that all services will be paid for by the hospital. It would be better if the parents were informed by the chief physician or the head nurse and given enough time to express their concern or anger.

Although anger under such circumstances is a natural reaction, we cannot hide medical errors because of fear of parents' reaction. Moreover, parents' anger would be more severe if they found out that the hospital personnel have concealed the truth.

It should be considered that knowing the truth is one of the basic rights of patients and their family members. According to similar studies, explaining the error to the patients could be a stressful situation combined with intense emotional reactions from patient/family members or the care team. Generally, the person who committed the error has a sense of guilt or fear of punishment, and patient/family members experience feelings such as anger and anxiety. Furthermore, it should be noticed that primary conversations usually take place when there is not accurate and comprehensive information about the event, so recognizing, understanding, and explaining all the details in complicated clinical situations is not possible. Thus, it is suggested that in such situations, information be given in several stages and by providing psychological support for the patient. Furthermore, while they may need supportive interventions, the patient's family can be considered as an important source of information in the process of root cause analysis (RCA) of similar incidents ( 17- 20). Since creating ethical patient safety is a multidimensional accomplishment, it should be considered that actively partnering with the patient's family may be a high-yield approach to detecting and preventing medical errors ( 10).

In addition, regarding the presented case, the father should be ensured that hospitalizing the newborn was necessary and the mother should not be blamed. In fact, he should be ensured that the incident was entirely due to system error and not by the mother. Basically, maintaining the integrity of the family is essential and medical staff must consider family support at all stages, especially in such circumstances.

Indeed, an important ethical point in this case is the necessity of offering an honest apology. It is not always as simple as saying: "We are sorry". The way of informing the parents is a sensitive issue and there is an urgent need for training healthcare providers in sensitive interpersonal relationships and related skills to facilitate honest and proper communication with the patient's family ( 20).

Forensic medicine aspect

Laws and regulations related to patient safety, which may vary based on the legislation system of each country, should encourage the disclosure of medical errors while supporting the implementation of the ethical imperatives of patient safety. In general, based on the medical law, the patient who is a victim of negligence is supposed to be fairly compensated. In addition, these rules provide possibilities for promotion of transparency and open communications in all levels. Reaching this goal requires regarding all stakeholders in the healthcare system ( 21).

In the mentioned case, some questions could be raised. Either the falling was in the presence of the mother or not. If it was in her presence, the hypothesis is that she dropped the baby intentionally. However, if there is no sign of any apparent trauma, it seems there was no specific hurtful force or he fell from his mother's arms, and it shows the mother's lack of experience.

Accordingly, it should be considered that maternal postpartum sleepiness is one of the major risk factors for falling of newborns. Half of all newborn falling incidents in hospitals have occurred while the mother was holding the infant in a hospital bed. Therefore, recognizing the risks of neonatal falling during mother-baby care situations and teaching the mothers is a major nursing responsibility ( 22).

If the mother is incapable of taking care of the hospitalized baby, she should be under supervision of the care team and should be educated. Furthermore, notifying the father is an appropriate act if the complaint was raised by the father.

The main task of the physician or nurse after a detailed examination and treatment is the detailed registration and description of all events without any assumptions. If the examinations found evidence of neglect, it would be a completely different discussion and calling the social services would be absolutely necessary.

The question might also be raised that "if nothing happened to the child and we did all the assessments to insure his health, are we obligated to inform the parents?"

There is an obligation to inform the patient or the family about every unwanted event in healthcare settings. The idea that there is no need to disclose errors which did not affect the patient is based on the traditional stance of the law. Furthermore, today, it is well known that such disclosures will enhance patients' trust to healthcare professionals while making them aware of that which is going on around them. In addition, through this approach, healthcare professionals can respect the patients' autonomy and dignity ( 21, 23).

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Ethical and legal aspects of patient's safety: a clinical case report

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Since patient safety is multidimensional and grounded in ethical and legal imperatives, both ethical and legal challenges should be taken into account. In this regard, a falling incident case of a 12-day-old newborn was raised in the monthly ethics round ...