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We're often asked to explain what nursing informatics is. While it's difficult to quickly summarize this complex field, at its core, it takes the clinical and the technical languages of health and translates them into one. It also promotes meaningful, user-friendly and patient-centric innovation while driving improved outcomes for patients and enhanced clinical workflows for healthcare staff.

What is Nursing Informatics Definition?

The definition provided by the American Nurses Association (ANA) and recommended by HIMSS has become widely referenced in response to the question, "What is nursing informatics?"

Nursing informatics "is the specialty that integrates nursing science with multiple information and analytical sciences to identify, define, manage and communicate data, information, knowledge and wisdom in nursing practice."

As a global advisor and thought leader in healthcare information and technology, HIMSS has focused on this professional field for decades. Understanding the integral role this specialty plays today in the healthcare workforce, we've worked to amplify awareness by convening the experts and conducting extensive research on the topic.

What Are Nursing Informatics Roles and Requirements?

If you're looking to venture into this field of informatics, there are a variety of different skills and qualifications that can help ensure your success:

A bachelor's degree in nursing (BSN), at minimum

A master's degree and certifications, particularly for executive roles (chief nursing informatics officer)

Experience and/or strong understanding of working in a clinical setting

Strong technical skills; ability to quickly adapt to emerging technologies and innovation

Strong project management skills

An affinity for obtaining, analyzing and strategizing about data

Understanding of medical economics

Strong interpersonal skills

Leadership experience

Here are a few of the many job titles in use today:

Nurse informaticist

Nursing informatics specialist

Nursing informatics clinician

Clinical nurse informatics specialist

Chief nursing informatics officer

Perioperative informatics nurse

The field of nursing informatics has helped drive healthcare's application of technologies such as EMRs and computerized provider order entry. Nursing informatics professionals work with a diverse group of stakeholders across the care continuum, ultimately helping to bridge the gap between clinical and technical perspectives. Their number one priority is maintaining focus on patient safety.

This role was included in the top 15 highest paying nursing professions in the U.S. The HIMSS Nursing Informatics Workforce Survey, led by the HIMSS Nursing Informatics Committee, unveiled a multitude of findings about the profession:

Over two-thirds (68%) of the 1,359 survey respondents work for a hospital or multifacility health system

Ambulatory nurse informaticists are on the rise, with 6% of respondents reporting the ambulatory environment as their primary work place

The percentage of respondents (66%) who have a master's degree in nursing (24%), nursing informatics (27%), or some other field (11%) has gone up

The role of chief nursing informatics officer/senior nursing informatics officer continues to be on the rise with 41% of respondents reporting that their organization had the formal role

Overall, the results of the survey indicated that most professionals are burning bright with potential. After all, these findings confirm that many make higher wages than the average nursing professional, they enjoy the work they do, and many of them plan to keep doing it in the future.

What is Nursing Informatics Value?

" Nursing informatics specialists are the translators that have evolved into health tech innovators who establish businesses, manage medical economics, create technology and amplify the voice of end-user clinicians," said Danielle Siarri, MSN, RN, a HIMSS member and social media ambassador, global nursing expert and the lead publisher at InnoNurse. "Healthcare and technology were separate entities that have now fused into one language which evolves daily."

Nursing informatics professionals are unique, hybrid heroes of healthcare. As advocates for impactful innovation, their work keeps patients safe and at the center. Through their contributions and guidance, workflows are improved for healthcare staff and best practices followed in the effective management of information structures, processes and technology.

Through consistent leadership and hard work, the dynamic language and energy of health information and technology continues to grow and evolve along with the nursing informatics profession.

Empowering Nursing Informatics Professionals
National Nurses Week
HIMSS joins the American Nurses Association and the Alliance for Nursing Informatics and numerous other partners in celebrating National Nurses Week each May. The purpose of this week-long celebration is to raise awareness of the value of nursing and help educate the public about the role nurses play in meeting the healthcare needs of Americans. Join us in celebrating the nurses of our nation, who are at the forefront of improving patient care and transforming healthcare.
Online Journal of Nursing Informatics (OJNI)
Powered by the HIMSS Foundation and the HIMSS Nursing Informatics Community, the OJNI is a free, international, peer-reviewed publication that is published three times a year and supports all functional areas of the field. The journal was launched in 1996, with readership spanning over 49 countries.
Alliance for Nursing Informatics (ANI)
ANI represents thousands of nurses and brings together nursing informatics groups that function separately at local, regional, national and international levels. ANI is a collaboration of organizations that represent a unified voice for nursing informatics and provides the synergy and structure needed to advance the efforts of nursing informatics professionals in improving the delivery of patient care.
Identifying for a Unique Nurse Identifier
While nurses are making a difference in patients' health outcomes, without a nurse identifier, which is a unique numeric identifier automatically generated for each RN at the time of their state board exam, health systems have no way of demonstrating the full value of nursing.

It is a free, unique identifier, publicly available, that is automatically generated for each RN and LPN at the time of their NCLEX exam. No additional action is needed. The workgroup recommends that the NCSBN ID should be used by key stakeholders as the unique nurse identifier to enable identification and demonstration of the value of nurses through documentation in the EHR and other health IT systems.
Change Management Infographic
Formed within the HIMSS CNO-CNIO Vendor Roundtable, the infographic was created with a purpose to realize the value of the health IT investment, achieve benefits and sustainable transformation required for an organizational change management approach, as well as ongoing organization/vendor relationships for continued innovation for leaders across the healthcare spectrum.
CNIO Job Description
As the Chief Nursing Informatics Officer (CNIO) role varies within healthcare organizations, it is essential to have a standardized job description that can be referenced for needed competencies regardless of specific job title. This document provides recommendations for a C-Suite level CNIO job description including qualifications and Experience, Key Responsibilities, and Reporting Structure.
The TIGER Initiative
TIGER (Technology Informatics Guiding Education Reform) is a grassroots initiative focused on education reform, fostering interprofessional community development and global workforce development. The spirit of TIGER is to maximize the integration of technology and informatics into seamless practice, education and research resource development.
Register now Originally published May 14, 2019, updated February 27, 2023

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You asked, "What is nursing informatics?" And we answered. Explore the profession and how it is a driving force behind improved outcomes for patients and enhanced workflows for healthcare staff.

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Kenrick D. Cato, PhD, RN, CPHIMS, FAAN, assistant professor, Kathleen McGrow, DNP, MS, RN, PMP, chief nursing information officer, and Sarah Collins Rossetti, RN, PhD, FACMI, FAMIA, assistant professor

Artificial intelligence (AI) is part computer science and part cognitive science, encompassing the phenomena of computers performing tasks that require human intelligence.1 Current interest in AI is motivated, in part, by recent developments in machine learning, in which algorithms learn from data without human direction.2 Machine learning is a group of different mathematical methods to build AI rules. Each of these methods has its strengths and weaknesses based on the types of data being analyzed. Some machine learning approaches, such as speech recognition when talking into the speaker of a smart phone or smart home device, are now mainstream.

Although we've been on a journey for decades to augment human capabilities, recently there's been a dramatic rise in AI research in healthcare. AI has been brought to the forefront due to multiple factors, including the tremendous amounts of data that are captured and stored through electronic health records (EHRs), more availability of computer power, and significant innovations in AI tools and algorithms. The increase in AI availability and use in healthcare makes it imperative that both nurse leaders and nurses have a fundamental understanding of AI when used in conjunction with clinical models, critical-thinking skills, and evidence-based practice.

Graves and Corcoran identified the conceptual model that's pivotal to nursing informatics known as the data, information, knowledge, wisdom (DIKW) framework.3 This framework has subsequently been used to define how nursing informatics impacts nursing practice and care delivery, and it aligns well with the American Nurses Association Nursing Informatics: Scope and Standards of Practice, which identifies nursing informaticists as assisting in the development of wisdom for all nurses.4 In addition to the use of knowledge, wisdom includes decision-making and applying nursing actions through the applicable use of data, information, and knowledge.5,6 In the healthcare setting, AI is often paired with a clinical decision support (CDS) application to move from knowledge to wisdom, which involves exercising judgment.7 The ability to use AI-assisted wisdom to solve problems and identify solutions is key for nurses to enable the delivery of nursing care that's more precise and efficient, benefiting both nurses and patients.8

In this article, we explain the DIKW framework, review key concepts of AI and CDS, offer examples of real-world AI/CDS applications within the DIKW framework and how they can be used, and identify relevant questions to ask when investigating AI for use in clinical and operational scenarios.

DIKW, AI, and CDS

The DIKW framework explains that data leads to information, information to knowledge, and knowledge to wisdom.9 This framework is particularly relevant when designing CDS tools to advance nursing practice to top of licensure for improved nurse decision-making. The DIKW framework can be used to categorize CDS tools, including those that are driven by AI. This framework is pyramidal, which implies that data are profuse and wisdom is rare. As defined in previous publications discussing this framework, data have little or no meaning in isolation, information is data plus meaning, knowledge is derived by discovering patterns and relationships between types of information, and wisdom is understanding and internalization of knowledge patterns and relationships. (See Table 1 .)10 The DIKW framework isn't just a way to understand how information can be processed; it's also a means by which nurse leaders can strategically evaluate the relationship between AI and CDS.

Table 1.

Concept

Definition

Wisdom

Understanding and internalization

Knowledge

Derived by discovering patterns and relationships between types of information

Information

Data plus meaning

Data

Little or no meaning in isolation

AI generally refers to "machines that respond to stimulation consistent with traditional responses from humans, given the human capacity for contemplation, judgment, and intention...[these machines] make decisions which normally require human level of expertise."11 West and Allen describe three characteristics of these systems, which "operate in an intentional, intelligent, and adaptive manner."12 Intentionality is defined as algorithms designed to make decisions, typically using real-time data.12 Intelligent systems use underlying trends or patterns to inform decision-making.12 And an adaptive manner includes the ability to learn and improve decisions based on new information or pattern recognition.12 In the healthcare setting, AI is used with analytics to support CDS, improve operational efficiency, and for general cost effectiveness.13

CDS and AI aren't one in the same. CDS provides clinicians with computer-generated clinical knowledge and patient-related information that's intelligently filtered and presented at appropriate times to enhance patient care.14 In other words, AI can be thought of as a fuel to power more intelligent CDS. For example, imagine having a CDS alert for nurses to help them manage a patient with diabetes based on information from tens of thousands of patients and other nurses in a similar situation. Even though CDS interventions can be used to implement AI at the point of care, they don't always leverage AI. In fact, a 2017 integrative review identified that only 25% of CDS targeting nurses uses real-time EHR data.15

An analysis of requests for development of CDS targeted at nurses identified that the majority of requests were information and knowledge related when plotted along the DIKW framework.16 There's untapped potential for use of AI within CDS interventions that target risk assessment/risk reduction activities within the nursing process.16 These areas include AI-based CDS interventions that align with the wisdom concept from the DIKW framework and use, for example, predictive analytics, personalization of information presentation, patient preferences, and social and behavioral determinants of health to guide nurses' understanding and internalization of knowledge patterns and relationships.16

Targeted CDS nursing interventions shouldn't stop at the planning stage of the nursing process as many do currently.16 To impart wisdom--understanding and internalization of knowledge patterns and relationships--AI designed for nurses should be intentionally designed to use real-time data to recommend decisions, have intelligent recognition of patterns within nursing and patient care workflows and processes, and be adaptive by aligning with the cyclical nature of workflow activities in the nursing process.

In healthcare, there's been an increase in AI/CDS-based tools. Some of these offerings don't solve critical nursing decision support needs. However, there are AI/CDS tools that nurse leaders can benefit from; for example, tools that provide predictive analytics for staffing and bed management, to name a few. The DIKW model can help leaders understand which of these AI/CDS tools will be useful in their organization. Figure 1 illustrates the hierarchical nature of AI/CDS applications in which there are data capture, data processing to meet information needs, clinical knowledge-based rules to guide decision-making, and exposed analytics in the form of wisdom to augment nurse decision-making.16

From a clinical user perspective, the bottom three levels of the application usually aren't visible. The user often sees the top, fourth level in the form of an alert, dashboard, risk score, app, or other interface. However, when investigating AI/CDS applications, it's essential to understand how all of the levels were developed and validated.

Real-world examples

There are numerous examples of AI/CDS applications for nurses, such as the AI-based sepsis CDS alerts used in many EHRs today.17-22 There are also newer AI/CDS tools, such as the Communicating Narrative Concerns Entered by RNs (CONCERN) CDS system. CONCERN is an AI/CDS tool that predicts a patient's risk of clinical deterioration, which is currently being used at Partners Health System, with a planned rolled out at NewYork-Presbyterian Hospital later this year.23 Both the sepsis CDS tool and the CONCERN CDS system illustrate how the DIKW approach can be used by nurse leaders to determine if these technologies make sense in their clinical setting.

A number of different types of AI rules have been built to trigger sepsis CDS alerts.24 The data that most of these sepsis alerts use are vital signs and lab results. Machine learning is then used to build AI-based rules to predict patients who are at risk for sepsis. The information generated is the meaning of different types of lab results and vital signs, and the knowledge is the predicted increased risk. The current sepsis CDS alerts don't reach the wisdom level for two reasons. First, because the sepsis alerts are delivered by the EHR, there's a false alarm or fatigue alert issue. This situation happens because no AI is perfect; many patients receive the sepsis alert, disrupting the nurse's regular workflow when the patient clearly isn't at risk for sepsis. Eventually, nurses get tired or fatigued by these alert-based disruptions and ignore the CDS altogether. Second, most sepsis alerts trigger 4 hours before it's clinically clear that the patient is significantly deteriorating.24 This doesn't allow clinicians much time to intervene and effectively treat the patient.

The CONCERN CDS identifies nursing documentation patterns that are a proxy of a nurse's concern for patient deterioration and generates a predictive early warning score. The CONCERN CDS consists of two main components: the decision engine, which uses AI models to analyze the content and patterns of nursing EHR data (such as flowsheet entries and nursing notes), and front-end interfaces that display the predicted CONCERN levels (green, yellow, red), with red indicating that a patient is at the highest risk for deterioration. A web application provides tracking of the CONCERN level over time and facilitates transparency of the AI models by displaying what factors contributed most to the current calculation.

The result of more than 8 years of qualitative and quantitative research involving clinician input at every stage, the CONCERN CDS is built with the DIKW framework in mind. Data capture is automatic from the EHR, with the AI model using data entered during the normal nursing workflow. The nursing data used include patterns and content of nursing notes, medications administration record information, and flowsheet entries. The system continuously monitors data inputs from patterns in nursing documentation and flowsheets to model performance. Alerting tools let the programmers who maintain the system know when expected data feeds are missing or the model output is different than expected.

Information generation is based on focus group and simulation testing with nurses and physicians. An example of knowledge representation is the green, yellow, red scoring system that indicates the patient's risk of deterioration. When the CONCERN CDS was being developed, nurses and physicians indicated in focus group and simulation testing that colored levels for risk of deterioration would be the most clinically meaningful. Also, the setting-specific (acute care versus ICU) CONCERN AI models are optimized to identify patients who score in the yellow category. Clinicians reported that patients at the lowest and highest risk for deterioration are much easier to identify. Patients at the yellow level are at increased risk for clinical deterioration but haven't started showing signs yet. Figure 2 shows a sample patient list in which users can quickly see a patient's CONCERN level in their workflow.

The CONCERN CDS is designed to augment clinical expertise instead of replacing it. Figure 3 shows the main CONCERN web application, which opens when a clinician clicks on a CONCERN level in the patient list. The main decision support part of the CONCERN CDS system is focused on visualizing trends in patient risk. The factors portion of the CONCERN CDS provides AI transparency, explaining what elements of the patient record contributed to the risk calculation. Additionally, a major goal of CONCERN CDS system is to support interdisciplinary communication by providing the relevant information (notes, medications administered, flowsheet entries) for patients at increased risk for deterioration in a centralized, accessible location many hours before the patient crashes. The CONCERN score has been shown to trigger up to 24 hours before a clear deterioration event.

Questions for nurse leaders to ask

With the abundance of data inside and outside of the EHR, AI/CDS applications are being used more frequently by nurses to provide care for patients.25 However, research indicates that the success of new AI/CDS systems requires careful planning, evaluation, and decision-making.15,26-28 AI/CDS applications are often presented as solutions to pressing clinical problems. The DIKW framework can help nurse leaders organize strategic planning and prioritization of potential AI/CDS applications, helping connect clinical practice with informatics solutions and revealing potential nursing practice or informatics gaps for proposed CDS.16 Table 2 describes a number of questions based on the DIKW levels that nurse leaders should ask about AI/CDS systems.

Table 2.

DIKW level

Question

Explanation

Data
What data is used in the AI/CDS tool?

It is important to understand the required datasources. Also, what types of transformations that are done on the data that might change it's clinical meaning. For example, what are the cutoffs for how results are categorized?

How is it captured? Does this data capture fit into the existing clinical workflow?

It is important to know if data capture will add any additional burden to clinicians. Also, will clinicians workflow be impacted by required data capture?

Is there an appropriate life cycle plan for the CDS?

Data capture is dynamic, with continuous changes in the configuration. For example, forms in the EHR will be updated, created, or retired. Is there a similar life cycle plan for the CDS.18 How will the CDS handle EHR changes? Is there de-implementation planning?

Information
Does the AI/CDS information take into account the clinical context?

The CDS should be agile enough to adapt to changes in clinical settings. For example, the same models should not be applied across settings where workflow and policies are different, for example acute care versus intensive care settings.

Does the information produced make clinical sense and have clinical relevance?

You should ensure that clinicians review the decision support and validate the clinical appropriateness and relevance of the CDS recommendations.

Knowledge
Does the AI/CDS help to solve a clinical problem. What were the examples that were used to teach the model?

For, AI/CDS, the products of the model are only as good as the data and information that helped create it. 22

Does the clinical decision support fit nursing processes?

Effective CDS should adhere to nursing science and processes.

Wisdom
Is the AI/CDS augmenting or taking over decision making?

The goal of effective AI/CDS should be to aid in decision making not replace the clinician particiapation.23

Is the AI explainable to the clinician?

AI/CDS will not be effective if clinicians don't understand how the recommendation are produced.24

Is the required short-term and long-term training in place?

Continuous and effective training is required to be confident that AI/CDS users know what recommendations represent and how to use them in their clinical practice?25-27

Strategic implementation

AI-powered CDS tools offer great promise in helping nurses to provide higher quality, safer, and more efficient care. It's imperative that nurse leaders understand the key concepts of AI and CDS. The DIKW framework and relevant questions support nurse leaders in thinking strategically about current and future implementation of AI/CDS applications.

​

There are a number of exciting examples of these new AI/CDS applications, among them is the Communicating Narrative Concerns Entered by RNs clinical decision support CONCERN CDS system. The CONCERN CDS is an AI/CDS that uses technology that has identified nursing documentation patterns that are a proxy of a nurses concern for deterioration and includes these proxies as features in a predictive early warning score. The CONCERN CDS is consists of two main components. First, the decision engine that uses AI models to analyze the content and patterns of nursing EHR data (e.g. flowsheet entries and nursing notes ). Second, front-end interfaces display the predicted CONCERN levels (green, yellow, red), with red indicating a patient is at highest risk for deterioration. A web application provides tracking of the CONERN level over time and facilitates transparency of the AI models by displaying which factors contributed most to the current calculation.

Acknowledgments

This study was funded by NINR 1R01NR016941-01, Communicating Narrative Concerns Entered by RNs (CONCERN): Clinical Decision Support Communication for Risky Patient States. The content is solely the responsibility of the authors and does not necessarily represent the official views of NIH. The authors have disclosed no financial relationships related to this article.

Contributor Information

Kenrick D. Cato, Columbia University School of Nursing in New York, NY.

Kathleen McGrow, Microsoft Corporation in Redmond, Wash.

Sarah Collins Rossetti, biomedical informatics and nursing at Columbia University in New York, NY.

REFERENCES

4. American Nurses Association. Nursing Informatics: Scope and Standards of Practice. 2nd ed. Silver Spring, MD: American Nurses Association; 2015. [ Google Scholar]

23. Rossetti SC, Knaplund C, Albers D, et al. Leveraging clinical expertise as a feature--not an outcome--of predictive models: evaluation of an early warning system use case. AMIA Annu Symp Proc. 2020;2019:323-332. [[ PubMed] PMC free article] [ Google Scholar]

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Kenrick D. Cato, PhD, RN, CPHIMS, FAAN, assistant professor, Kathleen McGrow, DNP, MS, RN, PMP, chief nursing information officer, and Sarah Collins Rossetti, RN, PhD, FACMI, FAMIA, assistant professor Artificial intelligence (AI) is part computer science and part cognitive science, encompassing the phenomena of computers performing tasks that require human intelligence.1 Current interest in AI is motivated, in part, by recent developments in machine learning, in which algorithms learn from data without human direction.2 Machine learning is a group of different mathematical methods to build AI rules.

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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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This guidance remains in effect only to the extent that it is consistent with the court's order in Ciox Health, LLC v. Azar, No. 18-cv-0040 (D.D.C. January 23, 2020), which may be found at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2018cv0040-51. More information about the order is available at https://www.hhs.gov/hipaa/court-order-right-of-access/index.html. Any provision within this guidance that has been vacated by the Ciox Health decision is rescinded.
Most of us believe that our medical and other health information is private and should be protected, and we want to know who has this information. The Privacy Rule, a Federal law, gives you rights over your health information and sets rules and limits on who can look at and receive your health information. The Privacy Rule applies to all forms of individuals' protected health information, whether electronic, written, or oral. The Security Rule is a Federal law that requires security for health information in electronic form.

HIPAA Right of Access Videos

OCR has teamed up with the HHS Office of the National Coordinator for Health IT to create Your Health Information, Your Rights!, a series of three short, educational videos (in English and option for Spanish captions) to help you understand your right under HIPAA to access and receive a copy of your health information.

HIPAA Right of Access Infographic

OCR has teamed up with the HHS Office of the National Coordinator for Health IT to create this one-page fact sheet, with illustrations, that provides an overall summary of your rights under HIPAA:

HIPAA General Fact Sheets

Who Must Follow These Laws

We call the entities that must follow the HIPAA regulations "covered entities."

Covered entities include:

Health Plans, including health insurance companies, HMOs, company health plans, and certain government programs that pay for health care, such as Medicare and Medicaid.

Most Health Care Providers-those that conduct certain business electronically, such as electronically billing your health insurance-including most doctors, clinics, hospitals, psychologists, chiropractors, nursing homes, pharmacies, and dentists.

Health Care Clearinghouses-entities that process nonstandard health information they receive from another entity into a standard (i.e., standard electronic format or data content), or vice versa.

In addition, business associates of covered entities must follow parts of the HIPAA regulations.

Often, contractors, subcontractors, and other outside persons and companies that are not employees of a covered entity will need to have access to your health information when providing services to the covered entity. We call these entities "business associates." Examples of business associates include:

Companies that help your doctors get paid for providing health care, including billing companies and companies that process your health care claims

Companies that help administer health plans

People like outside lawyers, accountants, and IT specialists

Companies that store or destroy medical records

Covered entities must have contracts in place with their business associates, ensuring that they use and disclose your health information properly and safeguard it appropriately. Business associates must also have similar contracts with subcontractors. Business associates (including subcontractors) must follow the use and disclosure provisions of their contracts and the Privacy Rule, and the safeguard requirements of the Security Rule.

Who Is Not Required to Follow These Laws

Many organizations that have health information about you do not have to follow these laws.

Examples of organizations that do not have to follow the Privacy and Security Rules include:

Life insurers

Workers compensation carriers

Most schools and school districts

Many state agencies like child protective service agencies

Most law enforcement agencies

Many municipal offices

What Information Is Protected

Information your doctors, nurses, and other health care providers put in your medical record

Conversations your doctor has about your care or treatment with nurses and others

Information about you in your health insurer's computer system

Billing information about you at your clinic

Most other health information about you held by those who must follow these laws

How This Information Is Protected

Covered entities must put in place safeguards to protect your health information and ensure they do not use or disclose your health information improperly.

Covered entities must reasonably limit uses and disclosures to the minimum necessary to accomplish their intended purpose.

Covered entities must have procedures in place to limit who can view and access your health information as well as implement training programs for employees about how to protect your health information.

Business associates also must put in place safeguards to protect your health information and ensure they do not use or disclose your health information improperly.

What Rights Does the Privacy Rule Give Me over My Health Information?

Health insurers and providers who are covered entities must comply with your right to:

Ask to see and get a copy of your health records

Have corrections added to your health information

Receive a notice that tells you how your health information may be used and shared

Decide if you want to give your permission before your health information can be used or shared for certain purposes, such as for marketing

Request that a covered entity restrict how it uses or discloses your health information

Get a report on when and why your health information was shared for certain purposes

If you believe your rights are being denied or your health information isn't being protected, you can

You should get to know these important rights, which help you protect your health information.

You can ask your provider or health insurer questions about your rights.

Learn more about your health information privacy rights.

Who Can Look at and Receive Your Health Information

The Privacy Rule sets rules and limits on who can look at and receive your health information

To make sure that your health information is protected in a way that does not interfere with your health care, your information can be used and shared:

For your treatment and care coordination

To pay doctors and hospitals for your health care and to help run their businesses

With your family, relatives, friends, or others you identify who are involved with your health care or your health care bills, unless you object

To make sure doctors give good care and nursing homes are clean and safe

To protect the public's health, such as by reporting when the flu is in your area

To make required reports to the police, such as reporting gunshot wounds

Your health information cannot be used or shared without your written permission unless this law allows it. For example, without your authorization, your provider generally cannot:

Give your information to your employer

Use or share your information for marketing or advertising purposes or sell your information

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This guidance remains in effect only to the extent that it is consistent with the court's order in Ciox Health, LLC v. Azar, No. 18-cv-0040 (D.D.C. January 23, 2020), which may be found at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2018cv0040-51 . More information about the order is available at https://www.hhs.gov/hipaa/court-order-right-of-access/index.html .

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Mary A. Dolansky, PhD, RN
Shirley M. Moore, PhD, RN, FAAN

Over a decade has passed since the Institute of Medicine's reports on the need to improve the American healthcare system, and yet only slight improvement in quality and safety has been reported. The Quality and Safety Education for Nurses (QSEN) initiative was developed to integrate quality and safety competencies into nursing education. The current challenge is for nurses to move beyond the application of QSEN competencies to individual patients and families and incorporate systems thinking in quality and safety education and healthcare delivery. This article provides a history of QSEN and proposes a framework in which systems thinking is a critical aspect in the application of the QSEN competencies. We provide examples of how using this framework expands nursing focus from individual care to care of the system and propose ways to teach and measure systems thinking. The conclusion calls for movement from personal effort and individual care to a focus on care of the system that will accelerate improvement of healthcare quality and safety.

Citation: Dolansky, M.A., Moore, S.M., (September 30, 2013) "Quality and Safety Education for Nurses (QSEN): The Key is Systems Thinking" OJIN: The Online Journal of Issues in Nursing Vol. 18, No. 3, Manuscript 1.

DOI: 10.3912/OJIN.Vol18No03Man01
https://doi.org/10.3912/OJIN.Vol18No03Man01

Key words: QSEN, quality, safety, systems, QSEN competencies, education, measurement

...national healthcare quality organizations, such as the Leapfrog Group, report that the majority of hospitals have demonstrated little progress in improving quality and safety. Over a decade has passed since the Institute of Medicine (IOM) report, To Err Is Human: Building a Safer Health System, and the follow-up report, Crossing the Quality Chasm, which turned healthcare professionals' attention to the importance of improving healthcare outcomes ( IOM, 2000; Committee on the Quality, 2001). These reports highlighted the need to redesign systems of care to better serve patients in the complex healthcare environment. During the last decade, national initiatives to improve quality and safety have been implemented, such as the Institute for Healthcare Improvement's (IHI) Transforming Care at the Bedside, 5 Million Lives Campaign, and the Triple Aim ( IHI, 2013a; IHI, 2013b; IHI, 2013c). To accelerate change, regulatory agencies have implemented National Patient Safety Goals, Core Measures, ( Joint Commission, 2013a; 2013b; 2013c), and Hospital Acquired Conditions (HAC) Never Events ( Kuhn, 2008). Yet national healthcare quality organizations, such as the Leapfrog Group, report that the majority of hospitals have demonstrated little progress in improving quality and safety. For example, although we know that zero central line infections should be a reality in hospitals, thousands of infections are still reported each year ( Clark, 2013).

QSEN is a national movement that guides nurses to redesign the 'what and how' they deliver nursing care so that they can ensure high-quality, safe care. In 2005, nursing leaders responded to the IOM call to improve the quality of healthcare by forming the Quality and Safety Education for Nurses (QSEN) initiative funded by the Robert Wood Johnson Foundation. The QSEN initiative consisted of the development of quality and safety competencies that serve as a resource for nursing faculty to integrate contemporary quality and safety content into nursing education ( QSEN Institute, 2013). The focus of QSEN, now the QSEN Institute, has expanded from undergraduate nursing students' education to include quality and safety education for all nurses. The mission of QSEN is to address the challenge of assuring that nurses have the knowledge, skills, and attitudes (KSA) necessary to continuously improve the quality and safety of the healthcare systems in which they work. QSEN is a national movement that guides nurses to redesign the 'what and how' they deliver nursing care so that they can ensure high-quality, safe care. Linda Cronenwett, PhD, RN, FAAN, the founder of QSEN, often states that QSEN helps nurses to identify and bridge the gaps between what is and what should be and helps nurses focus their work from the lens of quality and safety (Personal Communication, 2013).

Viewing nurses' work through the lens of quality and safety requires a contemporary approach that incorporates systems thinking. A crucial skill, systems thinking helps nurses to meet the challenge of improving healthcare as they move beyond the application of the QSEN competencies from individual patients and families to accelerate the overall improvement of healthcare quality and safety. In this article, we review the history of QSEN and propose a framework that expands nursing focus from individual care based on personal effort and care of the individual to systems thinking and care of the system. Examples are provided to demonstrate how to integrate systems thinking in the application of QSEN competencies and how systems thinking can be taught and measured.

Although QSEN competencies have spurred quality and safety in nursing education, it is now time to accelerate their use and impact. In response to calls for improved quality and safety, leaders from schools of nursing across the country joined forces to create the Quality and Safety Education for Nurses (QSEN) initiative. The Robert Wood Johnson Foundation in 2005 funded QSEN Phase 1 and three subsequent phases followed ( Table 1). The major QSEN contribution to healthcare education was the creation of six QSEN competencies (modeled after the IOM reports) and the pre-licensure and graduate-level knowledge, skills, and attitude (KSA) statements for each competency ( Cronenwett et al., 2007). The competency statements provide a tool for faculty and staff development educators to identify gaps in curriculum so that changes to incorporate quality and safety education can be made ( Barnsteiner et al., 2013). The QSEN website serves as a national educational resource and a repository for nurses to publish contemporary teaching strategies focused on the six competencies: patient-centered care, teamwork and collaboration, evidenced-based practice, quality improvement, and informatics. Currently, there are over 100 teaching strategies posted.

QSEN competencies and their requisite KSAs

QSEN.org website

qsen.org/competencies/pre-licensure-ksas/
Cronenwett et al., 2007

Funded 15 pilot schools to use the IHI Learning Collaborative method to develop, test, and disseminate teaching strategies

Peer reviewed teaching strategies on the website

qsen.org/about-qsen/pilot-schools-june-2007-november-2008/

http://qsen.org/teaching-strategies/

November 2008-February 2012

National forums to educate nursing faculty

Incorporation of nurses into the Veterans Affairs (VA)

Quality Scholars program (VAQS- 2 year pre or post-doctoral fellowships in quality and safety)

Faculty modules to the QSEN website

8 regional Faculty Development workshops (train the trainer) were coordinated by the AACN

http://qsen.org/conferences/
http://qsen.org/faculty-resources/learning-modules/
Barnsteiner et al., 2013
http://qsen.org/faculty-resources/aacn-workshop-modules/

American Association of Colleges of Nursing (AACN) funded to further develop graduate competencies and coordinate 5 graduate level faculty development conferences

www.aacn.nche.edu/faculty/qsen/competencies.pdf

www.aacn.nche.edu/qsen/faculty-development

San Francisco Bay Area (SFBA) QSEN Faculty

Development Institute b

2009-2013

AACN implementation and evaluation of impact of incorporating the QSEN content into 22 schools of nursing in the San Francisco Bay area. Funding for a series of workshops for faculty and clinical leaders

Disch et al., 2013

apps.aacn.nche.edu/qsenec/GBMFoverview.html

Academic/Clinical Partnership and collaboration in QSEN

Lourdes University and ProMedica c

Innovative educational model for undergraduate education that includes a clinical integration partner to assist with the QSEN-based clinical education model

Didion, Kozy, Koffel, Oneail, 2013 www.rwjf.org/en/research-publications/find-rwjf-research/2013/04/academic-clinical-partnership-and-collaboration-in-quality-and-s.html

QSEN Institute

July 2012 to present

The Frances Payne Bolton School of Nursing at Case Western Reserve University continues to host the website and the National QSEN forum

aRobert Wood Johnson Foundation funding
bGordon and Betty Moore Foundation funding
c Bureau of Health Professions, Health Resource and Services Administration, Department of Health and Human Services Nurse Education Practice, Quality and Retention

QSEN competencies have been used by national nursing organizations and are the central focus of the National Council of State Boards of Nursing (n.d.) Nurse Residency program, the foundational concepts in the Massachusetts Future of Nursing Framework ( Massachusetts Department of Higher Education, 2010), and the Ohio Hospital Association ( Ohio Organization of Nurse Executives, 2013). The QSEN competencies also have been incorporated into nursing textbooks such as the medical-surgical text by Ignatavicious and Workman ( 2013), and other books, such as Quality and Safety in Nursing: A Competency Approach to Improving Outcomes ( Sherwood & Barnsteiner, 2012), Second Generation QSEN, a special issue of the Nursing Clinics of North America ( Barnsteiner & Disch, 2012) and Quality and Safety for Transformational Leadership ( Amer, 2012).

Although QSEN competencies have spurred quality and safety in nursing education, it is now time to accelerate their use and impact. The full effect of the QSEN competencies to improve the quality and safety of care can only be realized when nurses apply them at both the individual and system levels of care. Many nurse educators report that the QSEN competencies are already integrated into their curriculum, but in our practice, we have noted that often this integration is at the individual level of care, rather than at the level of the system of care. The full effect of the QSEN competencies to improve the quality and safety of care can only be realized when nurses apply them at both the individual and system levels of care. Figure 1 provides a display of how the six QSEN domains are linked to optimal patient care through both vigilant individual care and vigilant systems of care. Traditionally, nurses have focused primarily on vigilant individual care; less attention has been given to assisting nurses to provide vigilant systems of care. We propose that in addition to the emphasis on teaching critical thinking skills ( Simpson & Courtney, 2002), nurses also need to be taught the knowledge and skills associated with systems thinking. In their day-to-day work, nurses' abilities to engage in better problem-solving, priority setting, delegation, interactions and collaborations, decision making, and action-taking are greatly influenced by their ability to view how any one component of their work system is related to other components and to the whole.

Figure 1 Source: Authors

Systems thinking is the ability to recognize, understand, and synthesize the interactions and interdependencies in a set of components designed for a specific purpose. This strategy includes the ability to recognize patterns and repetitions in interactions and an understanding of how actions and components can reinforce or counteract each other. These relationships and patterns occur at different dimensions: temporal, spatial, social, technical or cultural ( Oshry, 2007). Systems thinking links a person's environment to his/her behavior. In the delivery of nursing care, this involves the nurse's understanding and valuing how components of a complex healthcare system influence care of an individual patient. Systems thinking can be viewed as a continuum, ranging from the individual to the larger internal and external environmental components. Figure 2 shows examples of care approaches that represent increasing levels of systems thinking.

Figure 2 Source: Authors

Systems thinking links a person's environment to his/her behavior. How nurses view both themselves as nurses, and their work, is shaped by the structures and processes of the systems in which they work. Most nurses provide care in healthcare organizations that are characterized as complex, multilevel, and multifunctional. Greater knowledge and application of systems thinking skills by nurses have the potential to mitigate errors in practice, improve nurse priority setting and delegation, enhance problem solving and decision-making, improve timing and quality of interactions with other professionals and patients, and enhance workplace quality improvement initiatives. The ability to engage in systems thinking has been viewed as a key component in the successful delivery of safe and high quality care ( Bataldan & Mohr, 1997; Bataldan & Leach, 2009; Batalden & Stoltz, 1993; Senge, 2006). Systems thinking is required to redesign healthcare to improve the quality and safety of care.

The importance of systems thinking in quality improvement (QI) initiatives was identified in early literature on application of QI techniques to healthcare ( Batalden & Stoltz, 1993; Deeming & Appleby, 2000) and, more recently, was highlighted in reports from the Institute of Medicine ( IOM, 2003), the Accreditation Council for Graduate Medical Education ( Varkey, Karlapudi, Rose, Nelson, & Warner, 2009), and the article, "Quality and Safety Education for Nurses" ( Cronenwett, Sherwood & Barnsteiner, 2007). Given the hypothesized importance of systems thinking in the success of quality and safety in healthcare, it is probable that if nurses engage in better systems thinking, greater improvements in outcomes will be achieved. Knowledge and skills associated with systems thinking, however, are seldom addressed in basic or continuing nursing education. The next sections describe strategies for teaching and learning systems thinking, especially as related to QSEN competencies, and a newly developed tool for measurement of systems thinking.
Teaching and Learning Systems Thinking
Systems thinking is an essential skill for nurses. Yet, there has been little knowledge disseminated about how to assist nurses to better engage in this type of thought process, despite their key roles in planning, delivering, and improving patient care in complex organizations. To teach systems thinking it is important to enhance the learner's awareness of the interdependencies in people, processes, and services and to view problems as occurring as part of a chain of events of a larger system, rather than as independent events.

The clinical environment is an ideal place to teach systems thinking in undergraduate, graduate, and staff development education. During the clinical experience, the faculty preceptor can broaden the learner's problem identification from a focus on personal effort in a single situation to a focus on sequences of events with possible multiple causes for both individuals and populations. Table 2 provides examples of this continuum of systems thinking using the QSEN competencies. An example of a teaching technique for systems thinking is to have learners create grids such as those presented in Table 2 to expand their scope of thinking from the individual to the system level of care. Students might obtain outcome data from their unit and identify reasons for variation across time. Enhancing systems thinking skills also can be done by having learners complete an assessment of their unit or microsystem.

Assessment tools are available from the Clinical Microsystem ( 2013) Green Books for inpatient, emergency room, long-term care, and outpatient groups. These free workbooks from the Dartmouth Institute have been developed to help individuals assess the complexity of the system in which they work. Another approach to expand learners' scope of thinking to a systems level is to have them connect nursing skills and clinical issues to national quality and safety initiatives ( Armstrong & Barton, 2013). For example, urinary care is connected to the National Quality Forum ( 2012) Catheter Associated Urinary Tract Infection (CAUTI) prevention and the Joint Commission's ( 2013c) National Patient Safety Goal Number 7.

Nurses can also learn systems thinking by creating flowcharts or process diagrams that elicit the steps of a care process and the multitude of healthcare workers involved in that process. This mapping technique is one of the first steps of a quality improvement project. For example, to improve the care coordination of preparing hospitalized patients for discharge, teams of healthcare professionals could map steps in the course of a patient's stay leading to discharge. This exercise has been shown to increase knowledge about system factors and enhance awareness of the importance of interprofessional collaboration ( Brennen, Olds, Dolansky, Estrada, & Patrician, in press).

Another approach to teach systems thinking is to have learners conduct a root cause analysis ( Lambton & Mahlmeister, 2010; Tschannen & Aebersold, 2010). Root cause analysis (RCA) is a widely used technique to assist people to move beyond blame of an individual for errors made in the workplace to understanding the system factors that may have contributed to errors. Healthcare organizations routinely perform RCA after an event so that appropriate changes can be made in the system to prevent future errors. This technique could be used to understand system factors even when events "almost happen." Having nursing students participate in RCAs during their undergraduate education has been shown to be beneficial ( Dolansky, Druschel, Helba, & Courtney, 2013). For example, having students conduct an RCA for addressing a medication error may lend a new perspective to how system level factors interact with individual level factors in the creation of that error.

In the classroom setting, systems thinking also can be enhanced by using case studies. The book Set Phasers to Stun ( Casey, 1998) includes stories of design, technology, and human error that can be discussed in class. These stories identify the close connection between technology and humans. Another book, Systems Concepts in Action ( Williams & Hummelbrunner, 2011), is a practitioner's toolkit to teach the principles of systems thinking, such as system dynamics, outcome mapping, and social network analysis. Highly effective and very interactive, the game Friday Night in the ER ( 2009) guarantees learning and fun. The game is played by four people and simulates the challenge of managing a hospital during a 24-hour period. Each player is in charge of a unit. The demands of the game demonstrate that systems thinking is the key to success.

Lastly, teaching systems thinking requires guided reflection. Faculty need to assist learners to look for and recognize patterns in systems of care by standing back, reflecting on data, and considering the system as a whole. Too often in healthcare we make quick judgments that are based on limited information and preconceived ideas. Teaching nurses to step back and consider the dependencies and interconnectedness of system components will lead to a broader understanding of the healthcare system and the quality of care that results from that system.
Measurement of Systems Thinking
To improve systems thinking, we need to be able to measure it. A valid and reliable measure of systems thinking is now available. The Systems Thinking Scale (STS) is an instrument that measures healthcare professionals' systems thinking specifically related to system interdependencies. The 20-item STS has good reliability as demonstrated by a test-retest reliability assessment (N=36; correlation of .74) and internal consistency testing (N=342) using Cronbach's alpha (.89) ( Case Western Reserve University, 2013b).

...systems thinking can be taught and learned and an individual's level of systems thinking can be changed. Data from recent studies indicated that systems thinking can be taught and learned and an individual's level of systems thinking can be changed ( Abourmatar et al., 2012; Moore, Dolansky, Palmieri, Singh, & Alemi, 2010). Moore and colleagues tested three groups of healthcare professions students (n= 102) who received high, low, or no dose levels of systems thinking education. There were no differences in STS mean scores at pretest. At posttest, the high-dose systems thinking education group scored significantly higher on the STS than both the low and no-dose groups (p=.05 and .01, respectively). The STS is now publicly available for use and a website has been established to provide information on its use ( Case Western Reserve University, 2013a).

Almost 10 years have passed since the QSEN competencies were developed, and the field of quality and safety is rapidly advancing. The time has come to consider what new competencies should be added. We propose that the current QSEN competencies and knowledge, skills, and attitudes (KSAs) be reviewed and evaluated. Do the KSAs need to be updated, reclassified, or expanded? Should a systems perspective be made more prominent in the QSEN model? The QSEN competencies were developed to be a tool to promote better education for nurses in healthcare quality and safety. We need to update the QSEN competencies to be as useful as possible to prepare all nurses to ensure the highest level of care possible.

... a safe and high quality system of care requires that all healthcare professionals take responsibility to learn and apply skills associated with improving the wider system of care. Throughout QSEN history, reports from nurses and nurse faculty are that they already integrate the QSEN competencies into education and practice. However, we have observed that, despite the fact that contemporary approaches to quality and safety emphasize a systems view, much of the nursing education approach to teaching quality and safety (including application of the QSEN competencies) emphasizes personal effort at the individual level of care. Although we believe that personal expertise of the nurse with individual patients is necessary, a safe and high quality system of care requires that all healthcare professionals take responsibility to learn and apply skills associated with improving the wider system of care. We argue, therefore, that the QSEN competencies should be integrated into nursing curriculum and practice with a strong systems-perspective emphasis. Nurse faculty and staff development educators must critically evaluate the extent to which they apply QSEN competencies and at what levels.

Mary A. Dolansky, PhD, RN
Email: mad15@case.edu

Mary A. Dolansky is an Associate Professor at the Frances Payne Bolton School of Nursing, Case Western Reserve University in Cleveland, OH. Dr. Dolansky is Director of the QSEN Institute (Quality and Safety Education for Nurses) and Senior Fellow in the VA Quality Scholars program, mentoring pre- and post-doctoral students in quality and safety science. She has co-published two books on quality improvement, co-authored several book chapters and articles, and was guest editor on a special quality improvement education issue in the Journal of Quality Management in Health Care. She has taught the interdisciplinary course, "Continual Improvement in Health Care," at CWRU for the past 8 years and was chair of the quality and safety task force at the School of Nursing that integrated quality and safety into the undergraduate and graduate curriculum.

Shirley M. Moore, PhD, RN, FAAN
Email: smm8@case.edu

Shirley M. Moore is the Edward J. and Louise Mellon Professor of Nursing and Associate Dean for Research, Case Western Reserve University in Cleveland, OH. She is a past President of the Academy for Healthcare Improvement and is on the leadership team of the national Quality and Safety Education for Nurses (QSEN) project. She is currently leading the integration of nurse scholars in the VA Quality Scholars Program. She also is conducting NIH-funded studies testing a process improvement approach to health behavior change with patients.

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© 2013 OJIN: The Online Journal of Issues in Nursing
Article published September 30, 2013

# data[].attributes.attachment_link.keywords[]
healthcare and quality: perspectives from nursing

# data[].attributes.attachment_link.title
Quality and Safety Education for Nurses (QSEN): The Key is Systems Thinking

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Mary A. Dolansky, PhD, RN Shirley M. Moore, PhD, RN, FAAN Over a decade has passed since the Institute of Medicine's reports on the need to improve the American healthcare system, and yet only slight improvement in quality and safety has been reported.

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*Three major initiatives: QSEN, AACN, and the TIGER initiatives.
*QSEN's 6 Competencies: patient-centered care, teamwork and collaboration, evidence-based practice, quality improvement, and informatics
*ACCN: Provides accreditation for nursing programs and standards for delivery of nursing education
*TIGER Initiative: Main goal is to encourage healthcare providers to use technology and informatics to improve the delivery of patient care.

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What is Interoperability?

It is the ability of different information systems, devices and applications (systems) to access, exchange, integrate and cooperatively use data in a coordinated manner, within and across organizational, regional and national boundaries, to provide timely and seamless portability of information and optimize the health of individuals and populations globally.

Health data exchange architectures, application interfaces and standards enable data to be accessed and shared appropriately and securely across the complete spectrum of care, within all applicable settings and with relevant stakeholders, including the individual.

Four Levels of Interoperability

Foundational (Level 1): Establishes the inter-connectivity requirements needed for one system or application to securely communicate data to and receive data from another

Structural (Level 2): Defines the format, syntax and organization of data exchange including at the data field level for interpretation

Semantic (Level 3): Provides for common underlying models and codification of the data including the use of data elements with standardized definitions from publicly available value sets and coding vocabularies, providing shared understanding and meaning to the user

Organizational (Level 4): Includes governance, policy, social, legal and organizational considerations to facilitate the secure, seamless and timely communication and use of data both within and between organizations, entities and individuals. These components enable shared consent, trust and integrated end-user processes and workflows

What is Health Information Exchange and Data Sharing?

Health information exchange, or HIE, provides the capability to electronically move clinical information among disparate healthcare information systems and maintain the meaning of the information being exchanged. The goal of health information exchange is to facilitate access to and retrieval of clinical data to provide safe, timely, efficient, effective and equitable patient-centered care. HIE can also be used by public health authorities to assist in the analysis of the health of populations.

The term HIE is generally used as either a verb or a noun.

Verb: The electronic sharing of health-related data between two or more organizations facilitated by applied standards for use by a variety of stakeholders to inform health and care.

Noun: Organizations within the United States that provide health information exchange technology and services at a state, regional or national level and often work directly with communities to promote secure sharing of health data.

In the European Union, the act of information exchange is often referred to as data sharing. The European Commission's Support Centre for Data Sharing uses the term to refer to the collection of practices, technologies, cultural elements and legal frameworks that are relevant to transactions in any kind of information digitally, between different kinds of organizations. This term is more broadly applied to all types of data sharing, but can also be specifically used for health-related data.

Interoperability Standards

Standards provide a common language and a common set of expectations that enable interoperability between systems and/or devices. In order to seamlessly digest information about an individual and improve the overall coordination and delivery of healthcare, standards permit clinicians, labs, hospitals, pharmacies and patients to share data regardless of application or market supplier.

Standards Development

A standards organization, standards body, standards development organization (SDO) or standards setting organization is focused on developing, coordinating, promulgating, revising, amending, reissuing, interpreting, or otherwise producing standards that are intended to address the needs of some relatively wide base of affected adopters.

In order to be recognized as an SDO, an organization may be accredited by the American National Standards Institute (ANSI) or the International Organization for Standardization (ISO). Standards are also developed by other groups such as trade unions or associations. The development and adoption of open, consensus-based standards can be a complex process involving many different stakeholders and subject matter experts.

There are over 40 different SDOs in the health IT arena. Some entities create standards, such as Health Level Seven (HL7), Systematized Nomenclature of Medicine (SNOMED) International, and the Clinical Data Interchange Standards Consortium (CDISC). Others, like Integrating the Healthcare Enterprise (IHE), do not develop new standards, but rather bundle complementary base standards into IHE profiles that are used to define a specific function or use case, and then are balloted. This creates a scenario that helps drive adoption of the base standards by providing implementation guidance that describes how multiple standards can be used together to support interoperable health information exchange.

The different SDOs and profiling organizations have varying compositions and processes, but generally follow shared principles based on developing standards through a multi-stakeholder, consensus-based process to respond to specific industry or market needs.

Types of Standards

In order to understand the types of health data standards available for use, informatics professionals organize these standards into the following specific categories: vocabulary/terminology, content, transport, privacy and security, and identifiers.

Vocabulary/Terminology Standards

Vocabulary/terminology standards address the ability to represent concepts in an unambiguous manner between a sender and receiver of information, a fundamental requirement for effective communication. Health information systems that communicate with each other rely on structured vocabularies, terminologies, code sets and classification systems to represent health concepts. Some common vocabulary standards currently used in the marketplace include:

Current Procedural Terminology (CPT®): A code set, maintained by the American Medical Association (AMA), used to bill outpatient and office procedures.

Healthcare Common Procedure Coding System: A set of healthcare procedure codes based on CPT that is used for Medicare reimbursement.

ICD-10 and ICD-11: The International Statistical Classification of Diseases and Related Health Problems (ICD) is a medical classification list by the World Health Organization (WHO). It contains codes for diseases, signs and symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or diseases. The 11th revision will replace the ICD-10 in January 2022.

Logical Observation Identifiers Names and Codes (LOINC®): A universal code system for identifying health measurements, observations and documents. These codes represent the "question" for a test or measurement. LOINC codes can be grouped into laboratory and clinical tests, measurements and observations.

National Drug Code (NDC): Maintained by the U.S. Food and Drug Administration, NDC provides a list of all drugs manufactured, prepared, propagated, compounded or processed for commercial distribution.

RadLex: A unified language of radiology terms for standardized indexing and retrieval of radiology information resources, managed by the Radiological Society of North America. It unifies and supplements other lexicons and standards, such as SNOMED-Clinical Terms and DICOM.

RxNorm: A terminology used to normalize names for clinical drugs and links its names to many of the drug vocabularies commonly used in pharmacy management and drug interaction software. By providing links between these vocabularies, RxNorm can mediate messages between systems not using the same software and vocabulary.

Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT): A comprehensive clinical health terminology product. It enables the consistent, processable representation of clinical content in electronic health records (EHRs). These codes often represent the "answer" for a test or measurement to the LOINC "question" code.

The Centers for Disease Control and Prevention (CDC) provide a number of code sets for vaccines (Vaccines Administered (CVX)) and manufacturers (Manufacturers of Vaccines (MVX)). These codes can be used in immunization messages.

The Unified Code for Units of Measure: A code system intended to include all units of measures used in international science, engineering and business to facilitate unambiguous electronic communication of quantities together with their units.

Content Standards

Content standards relate to the data content within exchanges of information. They define the structure and organization of the electronic message or document's content. This standard category also includes the definition of common sets of data for specific message types.

Consolidated CDA (C-CDA): A library of CDA templates, incorporating and harmonizing previous efforts from HL7, IHE, and Health Information Technology Standards Panel (HITSP). It represents harmonization of the HL7 Health Story guides, HITSP C32, related components of IHE Patient Care Coordination and Continuity of Care Documents, or CCD.

HL7's Version 2.x (V2): A widely implemented messaging standard that allows the exchange of clinical data between systems. It is designed to support a central patient care system as well as a more distributed environment where data resides in departmental systems.

HL7 Version 3 Clinical Document Architecture (CDA®): An XML-based document markup standard that specifies the structure and semantics of "clinical documents" for the purpose of exchange between healthcare providers and patients. It defines a clinical document as having the following six characteristics: persistence, stewardship, potential for authentication, context, wholeness and human readability.

Transport Standards

Transport standards address the format of messages exchanged between computer systems, document architecture, clinical templates, user interface and patient data linkage. Standards center on "push" and "pull" methods for exchanging health information.

Digital Imaging and Communications in Medicine (DICOM): The standard for the communication and management of medical imaging information and related data. DICOM enables the transfer of medical images across systems and facilitates the development and expansion of picture archiving and communication systems.

Direct StandardTM: Defines a set of standards and protocols to allow participants to send authenticated, encrypted health information directly to known, trusted recipients over the internet. Two primary specifications are the Applicability Statement for Secure Health Transport v1.2 and the XDR and XDM for Direct Messaging.

Fast Healthcare Interoperability Resources (FHIR®): An HL7 standard for exchanging healthcare information electronically. The basic building blocks of FHIR are "resources," which describe exchangeable health data formats and elements. FHIR also provides standardization for application programming interfaces (APIs). FHIR provides a number of benefits and improvements as a modern healthcare standard including facilitating interoperable exchange with legacy standards, lower overhead, shorter learning curve, an ability to transmit only the necessary pieces of information, potential for patient mediated data, and an energized community of supporters and implementers.

IHE provides a number of specifications that can be used in the exchange of health information.

PCHAlliance co-sponsors the Personal Health Device (PHD) efforts within the IHE Devices Domain, which are focused on developing IHE profiles that leverage and build upon the Continua Design Guidelines and are also updated to support FHIR. These profiles provide guidance to implement globally recognized, consensus-based approaches to connect and test both personal and clinical devices and integrate them into health information systems. The specifications being developed support both medical devices and mainstream consumer facing apps to enable scalable interoperability of the rapidly expanding connected health ecosystem.

Privacy and Security Standards

Privacy standards aim to protect an individual's (or organization's) right to determine whether, what, when, by whom and for what purpose their personal health information is collected, accessed, used or disclosed. Security standards define a set of administrative, physical and technical actions to protect the confidentiality, availability and integrity of health information.

In the U.S., the Health Insurance Portability and Accountability Act (HIPAA) outlines standards that safeguard the privacy and security of protected health information.

HIPAA Privacy Rule: Establishes national standards to protect individuals' medical records and other personal health information. It applies to health plans, healthcare clearinghouses, and healthcare providers that conduct certain healthcare transactions electrically. The rule applies safeguards to protect the privacy of personal health information, and sets limits and conditions on the uses and disclosures of such information without patient authorization. The rule also gives patients rights over their own health information, including the right to examine and obtain a copy of their records, and to request corrections.

HIPAA Security Rule: Sets national standards for protecting the confidentiality, integrity, and availability of electronically protected health information. Compliance with the Security Rule was required as of April 20, 2005 (April 20, 2006 for small health plans). The rule addresses the technical and non-technical safeguards that "covered entities" must have in place to secure an individual's electronic protected health information. Prior to HIPAA, there were no generally accepted requirements or security standards for protecting health information.

In Europe, the General Data Protection Regulation (GDPR) outlines privacy and security regulations for all processing and storage of data relating to data subjects-or people-in the European Union (EU). This regulation extends to health information and any organization that may process or store data on these subjects, meaning it has extensive reach to many organizations worldwide and related to the sharing of data across organizations.

Identifier Standards

Entities use identifier standards to uniquely identify patients or providers.

Enterprise Master Patient Index (EMPI): A data registry used across a healthcare organization to maintain consistent and accurate data on the patients treated and managed within its departments.

Medical Record Number (MRN): An organization specific code used as a systematic documentation of a patient's history and care during a hospital stay.

National Council of State Boards of Nursing ID (NCSBN ID): A unique identifier automatically generated for each registered nurse and licensed practical/vocational nurse, freely available via the Nursys database and maintained by NCSBN.

National Provider ID (NPI): A unique 10-digit number for a healthcare provider to create a standard identification. These NPIs are included in the free NPI Registry.

Object ID (OID): A globally unique ISO identifier and a preferred scheme for unique identifiers in HL7.

Standards, Implementation Guides and Profiles

Standards on their own are helpful because they describe and constrain what data moves.

Implementation guides describe how to implement these standards for a specific use case. An implementation guide is a companion to a standard that describes how to use a standard to satisfy a specific healthcare use case. It should specify which way a standard is to be applied in a particular use case-how to structure the data consistently and what vocabulary to use. While you can implement a standard in a number of different ways, when using an implementation guide to integrate a standard into a health IT system, the guide directs one way to constrain the standard for a particular situation, removing ambiguity and achieving consistency.

A benefit to the use of implementation guides like IHE Profiles is that they provide a common language for purchasers and market suppliers to discuss the integration needs of healthcare sites and the integration capabilities of health IT products. They provide precise definitions of how to implement standards to meet specific clinical needs. They offer developers a clear implementation path for standards that has been carefully documented, reviewed and tested as well as supported by industry partners. They give purchasers a tool that reduces the complexity, cost and anxiety of implementing interoperable systems. IHE profiles, in particular, organize and leverage the integration capabilities that can be achieved by coordinated implementation of communication standards, such as DICOM, HL7 W3C and security standards.

Testing and Conformance Efforts

The adoption and implementation of standards involves a testing ecosystem that spans standards development, implementation and feedback from real-world testing into the development process to support continuous improvement. There are various different testing and compliance efforts that support advancing health IT interoperability, including:

Conformity Assessment: IHE International administers the IHE Conformity Assessment Scheme, which forms the basis for IHE Conformity Assessment Programs and any official certification of conformance to IHE Profiles associated with such testing programs. IHE International authorizes designated test laboratories accredited under this standard to assess the conformity of products with selected IHE profiles.

eHealth Exchange Testing Program: The program was developed to test compliance for HIE standards as required by the eHealth Exchange Coordinating Committee for onboarding to the eHealth Exchange network. Its purpose is to enable organizations that wish to participate in the exchange to validate the compliance of their health IT with the eHealth Exchange Performance and service specifications.

HL7 FHIR® Connectathons: These events provide hands-on FHIR development and testing opportunities held in conjunction with working group meetings. Participants engage in development and testing, working directly with other FHIR developers and senior members of the FHIR standards development team.

IHE Connectathons: A cross-vendor, supervised and structured testing event where the industry tests implementation of IHE Profiles and other standards to successful standards implementation and use. All tests are evaluated on interoperability and conformance to IHE Profiles found in IHE's technical frameworks. The test floor is overseen by IHE's technical project managers, providing a safe, neutral test environment and an opportunity for industry collaboration and problem resolution.

Office of the National Coordinator for Health IT Health IT Certification Program: A voluntary certification program established by the Office of the National Coordinator for Health IT (ONC) to provide for the certification of health IT. Requirements for certification are established by standards, implementation specifications and certification criteria adopted by the ONC secretary. The program supports the availability of certified health IT for its encouraged and required use under other federal, state and private programs. The program is run as a third-party product conformity assessment scheme for health IT based on the principles of the ISO and International Electrotechnical Commission framework.

Organizations like the Global Consortium for eHealth Interoperability, which was co-founded by HIMSS, IHE International and HL7 International, work to amplify and align the work of organizations like IHE and HL7 to increase adoption of emerging and mature health IT standards. The primary goal of the consortium is to coordinate work with governments and national ministries of health to further align existing and emerging standards and implementation guidance with strategic healthcare policy goals to achieve improved health outcomes for people everywhere.

The Interoperability Ecosystem

The health interoperability ecosystem comprises individuals, systems and processes that want to share, exchange and access all forms of health information, including discrete, narrative and multimedia. Individuals, patients, providers, hospitals/health systems, researchers, payers, suppliers and systems are potential stakeholders within this ecosystem. Each is involved in the creation, exchange and use of health information and/or data.

An efficient interoperability ecosystem provides an information infrastructure that uses technical standards, policies and protocols to enable seamless and secure capture, discovery, exchange and utilization of health information.

Exchange Partners and Data Sources

Historically, the focus was on the exchange of clinical information between providers and hospitals. As the technology has progressed, these exchange partners have broadened to include individuals, such as patients and caregivers, and organizations, such as long-term care, public health departments, community-based organizations and payers. With this expansion, along with the shift to value-based care, has also come a broader range of data types that are available to inform health and care, including device data, patient-generated data and data pertaining to the social determinants of health. Social determinants of health can include data points such as an individual's housing status, access to reliable transportation and level of food security.

Network Architectures

There are three primary types of exchange network architecture used to coordinate the exchange of health information across entities.

Centralized: Patient data are collected and stored in a centralized repository, data warehouse or other databases. The exchange organization has full control over the data, including the ability to authenticate, authorize and record transactions among participants.

Federated (Decentralized): Interconnected but independent databases allow for data sharing and exchange, and grant users access to the information only when needed.

Hybrid: Incorporates variations of federated and centralized architectures to harness the advantages of both. These are becoming common as various combinations of available services are implemented.

An important technical development that has expanded exchange partners and data sources is the emergence of healthcare APIs. APIs outline a set of clearly defined specifications to allow for one software application to build on the data and functionality of another application, without needing to understand its system design. APIs are already ubiquitous in today's web economy, and will play an essential role with respect to fueling healthcare interoperability for person centered care.

Types of HIE Organizations

An HIE organization oversees and governs the exchange of health-related information among organizations according to nationally recognized standards. The purpose of a health information exchange organization is to perform oversight and governance functions for information exchange. There are several different types of HIEs currently operating across the U.S. and its territories:

1. Hybrid HIEs are often collaborations between organizations, such as an ACO and a vendor network, within a state or region. The Kentucky Health Information Exchange is an example of a hybrid model.

2. Private/Proprietary HIEs concentrate on a single community or network, often based within a single organization, and include overall management, finance and governance. Examples may include hospital/integrated delivery system networks, payer-based HIEs and disease-specific HIEs. Some software vendors have also established an HIE network for their clients across the U.S. Additionally, the industry may see other evolving entities such as Accountable Care Organizations (ACOs) supporting information exchange.

3. Regional/Community HIEs are inter-organizational and depend on a variety of funding sources. Most are not-for-profit. Indiana Health Information Exchange and Chesapeake Regional Information System for Our Patients are examples of a regional HIEs.

4. State-wide HIEs are run by the governments of their respective states or maybe the state's designated entity. Some state-wide (and regional) HIEs use an umbrella approach and serve as the aggregator for disparate private health information exchanges. Statewide Health Information Network for New York and Arizona's Health Current are examples of a state-wide HIEs.

U.S. Exchange Initiatives: An Environmental Scan

Many organizations are actively working to achieve ubiquitous exchange. This environmental scan provides a curated review of the current landscape of the U.S.-based networks and frameworks which enable interoperable, nationwide health information exchange via a variety of methods and collaborations.

International Networks Enabling Exchange

Beyond the examples outlined above, various exchange networks and infrastructure have been established globally.

The eHealth Digital Service Infrastructure (EHDSI) facilitates the two primary building blocks of cross-border digital health services in Europe: ePrescription and Patient Summary. ePrescription (and eDispensation) allows EU citizens to obtain their medication in a pharmacy located in another EU country. Patient Summary provides information on important health related aspects such as allergies, current medication, previous illness, surgeries, etc. The digital Patient Summary is meant to provide doctors with essential information in their own language concerning the patient, when the patient comes from another EU country and there may be a linguistic barrier.

An important precursor of major exchange initiatives in Europe have been the European Reference Networks. These are virtual networks involving healthcare providers across Europe. They aim to facilitate discussion on complex diseases and conditions that require highly specialized treatment, providing concentrated knowledge and resources. Coordinators convene virtual advisory panels of medical specialists across different disciplines, using a dedicated IT platform and telemedicine tools.

Argentina's National Interoperability Network uses standards to enable communication between participating health information systems, providing a bridge for identity management across systems, sharing documents and patient summaries, managing ePrescriptions and supporting national registries.

Australia's My Health Record is an opt-out, CDA-based document repository used to store shared health summaries, eReferrals, specialist letters, discharge summaries, event summaries, prescription records, diagnostic imaging and pathology reports. Once patients have their record, they are able to manage access and permissions.

Canada's Health Infoway manages an ePrescribing service, PrescribeIT, electronically shares prescription information from clinicians with pharmacies for dispensing. Another Infoway initiative, ACCESS Health, aims to accelerate citizen access to personal health information and digital health services. The exchange initiative is expected to use a cloud-based infrastructure, a FHIR-based API service and a blockchain-enabled consent service.

Hong Kong's Electronic Health Record Sharing System is the country's equivalent to a regional HIE, managing patient data on care episodes, lab results, radiology studies and drug items. The Hong Kong Hospital Authority launched eHRSS to public and private health sectors using an opt-in patient consent model.

Uses of Information Exchange
Watch the HIMSS TV deep-dive on interoperability.
Ultimately, the goal is to be able to share and access information that informs an individual's full, longitudinal health story. By having and understanding the complete and accurate picture of an individual's health-including their preferences and other determinants of health-includes a number of benefits. Clinicians can better inform care and decision making, patients can become active participants in their care plans, and health IT developers and implementers can leverage evidence to create and adopt systems that support clinical processes and improve care delivery.

A number of benefits can be realized for exchange stakeholders, including:

1. Care coordination: Care coordination often involves a variety of stakeholders, including patients, caregivers and care teams across settings in the management of a patient's health. This is a dynamic process that requires data movement across platforms and among service providers in real time to successfully manage care.

2. Improving business and administrative processes: Having access to health information can eliminate time-consuming tasks within a health system, including processing of intake information, coordination across care teams and reporting needs associated with various regulatory requirements.

3. Increased patient safety and satisfaction: Having a full picture of a patient's health through access to disparate data can better inform clinicians on the patient's medical history, preferences and past encounters. This can help avoid duplicate testing, reduce adverse events, inform care decisions and conduct appropriate follow-up to ensure adherence with care management.

4. Value-based care: Population-level data analysis is an essential component of health systems managing high-risk patient populations, public health systems and other stakeholders working to coordinate care needs for a community. Understanding population data can enable better risk analysis and more cost-effective care. At an individual level, having access to longitudinal health data on a patient can reduce duplicative testing and close gaps in information. A key consideration in the shift to value-based care is the incorporation of non-traditional health data, such as an individual's social determinants of health data (e.g. food security status, housing stability and access to reliable transportation) into patient records. This data can be leveraged by health systems to proactively identify a health risk within a target population and intervene to work toward positive outcomes.

With these benefits in mind, taking a use-case driven approach can frame how information sharing may inform care or business practices and can help frame the potential benefits and drive interoperability forward. The following examples provide a snapshot at how interoperable exchange may occur.

Care delivery data: A physician can query a network or external health system for the appropriate patient data from other sources, such as other clinicians and hospitals. The physician can then select certain patient documents or resources (such as medication lists and reconciliations, allergy lists or lab reports) that they want to access during a patient visit.

Consent management: Where consent is not governed by other laws or regulations, a centralized consent management process can enable consensus among the community's stakeholders for a patient consent model, and provide awareness of a patient's willingness to participate in data sharing activities.

Lab results: HIE services provide physicians with the ability to get results directly via their exchange networks.

Medication reconciliation: Having a longitudinal view of all of a patient's encounters can raise awareness of the potential medications a patient was previously or is currently using. This can allow for appropriate follow up with the patient to reconcile differences in records to produce an accurate picture of their medication lists for future encounters.

Patient intake: Using a query and response process, the patient's health record can be acquired ahead of an appointment for clinician review.

Patient preferences: Exchange networks can enable access to information about a patient's care preferences, such as advance directives, empowering patients to make decisions in their care.

Provider alerts: HIE organizations are able to provide alerts to a clinician on their patients when one presents to the emergency department or is admitted to or discharged from a hospital, to ensure appropriate follow-up can be conducted.

Query services: Physicians may want to obtain more information about a patient that is referred to their office. They can query an exchange network which can in turn query other networks or health systems to assemble a complete, longitudinal health record.

Record locator services/master patient indexes: Many exchange networks enable creation of one continuous community record or search capabilities for patient records, facilitating patient identification across multiple provider settings.

Referrals: Organizations have the ability to send referrals directly through HIE services, along with all appropriate documentation.

Secure messaging: Many use cases require the exchange of patient records or related health information between clinicians in different healthcare settings with different EHRs or IT systems. For instance, providers needing to send referrals can electronically share data, eliminating paper documents and expediting the patient's treatment.

Transitions of care: As patients make the transition from one care setting to another (such as from hospital to a primary care provider or skilled nursing facility), interoperable exchange of relevant documentation from one care setting can be easily accessed at the next.

Workflow Considerations and Guidance

As the HIMSS definition suggests, interoperability goes beyond its technical requirements. Often there are policy changes influencing the value proposition and therefore willingness to exchange. Organizational considerations must align with external organizations and work toward achieving trust across stakeholders to enable meaningful data sharing. The following outlines some of these considerations and the approaches that may be leveraged.

Obtaining Patient Consent

Ensuring and communicating patient consent for data sharing activities is critical to abide by regulatory requirements and maintain the trust of the patient. There are several consent models used in information exchange, dependent on regulatory requirements within a jurisdiction.

No consent: Patient health information at a participating healthcare organization is automatically included in and available for exchange.

Opt-in: No patient data sets are made available for electronic exchange until patients actively express whether they would like to make all, or a pre-defined set, of their information available.

Opt-in with restrictions: No patient data sets are made available for electronic exchange until patients actively give their consent to participate. Patients have the option to:

Allow information to flow only to specific providers/li>

Include only specific categories of data or data elements

Make all of their information available for exchange

Opt-out: All or some predefined data sets are qualified to be included and available for exchange, after patients are given the opportunity to opt out in full.

Opt-out with exceptions: All or some predefined data sets are qualified to be included and available for exchange after patients are given the opportunity to:

Allow the exchange of their information only for specific purposes

Limit exchange of their information only for specific purposes

Limit exchange of their information to specific providers or provider organizations

Opt out in full

Selectively exclude categories of data or specific data elements from the exchange

Regardless of the model leveraged, a patient has the right to revoke their consent at any time, and processes to ensure that preference is communicated and enforced is important for data sharing processes.

Ensuring Privacy and Security

Regulations such as GDPR in the EU, HIPAA in the U.S., and various other national and state laws and regulations set forth privacy and security requirements to safeguard health information when it is created, received, transmitted, or maintained by health systems and other organizations. Privacy and security considerations may include the following:

Executing and implementing data use and reciprocal support agreements (DURSA)-also known as trust agreements-with the health systems and other stakeholders. These agreements set forth who may access and exchange the data. Additionally, such agreements set forth standard privacy and security policies and procedures that govern data protection and use. Further, data is typically encrypted when data is exchanged from one organization to another.

While specific security requirements may differ depending upon the DURSA, a typical DURSA may call for each participant to maintain appropriate administrative, physical and technical safeguards to ensure the confidentiality, integrity and availability of the data, aligned with the HIPAA requirements and any other applicable laws and/or regulations.

Producing High-Quality Data

In order to ensure that the information received from disparate sources can be trusted that it is accurate and complete, there needs to be efforts by organizations to maintain high-quality data. This can be achieved by ensuring that:

1. Data are structured and coded with standardized terminology and styles where possible to be leveraged in a machine-readable format for analysis and interpretation

2. Documentation is robust and complete to communicate the full patient story in a way that provides meaning to the human end user of the information.

Public Policy and Government Efforts

Achieving interoperability to date has required government involvement, guidance and regulation. Public policy efforts have the potential to drive forward frameworks for trusted exchange, align and educate stakeholders on existing and emerging standards and broaden stakeholder participation to ensure an inclusive exchange ecosystem for care coordination and continuity. The following outlines examples of how governments have worked to facilitate exchange both within the U.S. and in countries around the world.

United States Policies and Initiatives

With the goal of achieving ubiquitous, interoperable, nationwide exchange, the U.S. Department of Health and Human Services (HHS) has enacted and implemented a variety of legislation, regulations and guidance to further the adoption of standards-based approaches to interoperability.

21st Century Cures: Key Provisions

Among the health IT provisions outlined in 21st Century Cures, many sections provide directives to the ONC, Centers for Medicare and Medicaid Services (CMS) and other agencies related to improving interoperability.

The draft Trusted Exchange Framework and Common Agreement includes the policies, procedures and technical standards that build from existing health information network capabilities and enables them to work together to provide that single on-ramp to electronic health information regardless of the developer, health information exchange, or where a patient's records are located.

The U.S. Core Data for Interoperability is a "standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange." A "Data Class" is an "aggregation of various Data Elements by a common theme or use case."

The ONC Interoperability and Information Blocking Final Regulation implements key provisions of the 21st Century Cures Act focused on advancing interoperable exchange; supporting the access, exchange and use of electronic health information; and addressing occurrences of information blocking. The rule calls for accelerated use of healthcare APIs. ONC Certified Health IT must have standardized APIs for patient and population services, and meet specific requirements called out in the API Conditions and Maintenance of Certification. Most importantly, the regulation requires that United States Core Data for Interoperability is available for healthcare providers and patients "without special effort."

The Cures Act tasks ONC with the creation of an EHR Reporting Program as a condition of their certification and maintenance of certification. ONC has a process to solicit feedback from the industry on what criteria and methods of collection should be explored for this program. The program's reporting criteria aims to address the following five categories: security, interoperability, usability and user-centered design, conformance to certification testing, and other categories as appropriate to measure the performance of certified EHR technology.

In parallel with the release of the ONC Interoperability and Information Blocking Final Regulation, CMS also outlined an Interoperability and Patient Access Final Regulation, as part of their MyHealthEData Initiative, focused on driving exchange of and patient access to health information by liberating patient data using CMS authority to regulate Medicare Advantage, Medicaid, Children's Health Insurance Plan, and Qualified Health Plan issuers on the federally facilitated exchanges.

Interoperability Standards Advisory

The Interoperability Standards Advisory (ISA) process represents a single, public list of standards and implementation specifications published by ONC. ONC coordinates the identification, assessment and determination of these recommended standards and implementation specifications for industry use to fulfill specific clinical health IT interoperability needs. Stakeholders are encouraged to implement and use these recommended standards as applicable to their needs.

The ISA is organized into sections with related interoperability needs, each including one or more standards or implementation specifications to accomplish the listed need. Additional characteristics on these standards and implementation specifications are listed to inform stakeholders on maturity and adoption. These include:

1. Adoption Level: Approximate, average adoption level for that specific use case in healthcare within the United States.

2. Cost: Conveys whether a fee is involved to purchase, license, or obtain membership for access or use of the recommended standard or implementation specification.

3. Federally Required Status: Conveys whether a standard or implementation specification has been adopted in regulation, referenced as a federal program requirement, or referenced in a federal procurement (i.e., contract or grant).

4. Implementation Maturity: Conveys maturity based upon its implementation state.

5. Standards Process Maturity: Conveys maturity in terms of its stage within a particular organization's approval/voting process.

6. Test Tool Availability: Conveys whether a test tool is available to evaluate health IT's conformance to the standard or implementation specification.

Advancing Standards for Precision Medicine

This ONC project aims to standardize data found outside of traditional care delivery settings. As part of the precision medicine initiative, it focuses on standards in two areas:

1. Mobile health, sensor and wearable data

2. Social determinants of health data

Interoperability Proving Ground

ONC hosts an open, community platform where individuals and organizations can share and learn from projects occurring in the United States and internationally.

Data: Elemental to Health Campaign

HIMSS and PCHAlliance strongly urge prioritization of necessary funding and technical assistance to implement modern health information and technology strategies to ensure timely interoperability and sharing of public health surveillance data. An important component is the work in partnership with the Association of Public Health Laboratories, Council of State and Territorial Epidemiologists and the National Association for Public Health Statistics and Information Systems that support this multi-year effort to modernize public health data systems, surveillance and analytics at the CDC, and state, local and tribal health departments. Funding included in the Fiscal Year 2020 Appropriations Package and the Coronavirus Aid, Relief and Economic Security (CARES) Act, will help address some of the challenges, but in the long term, we need a predictable and sustained funding source to fully tackle this issue.

State-Level Interoperability Initiatives

In the U.S., state public health agencies manage and track information for immunizations, infectious diseases and vital statistics, however, they often lack adequate funding to ensure their information systems are updated and conform to national standards and profiles. Health information exchanges -which are public or private entities, depending on the state and region-aim to ensure there is robust and standardized data exchange between and among public health entities and state and local health departments.

Global Governmental Policies and Initiatives

At an international level, there are a variety of initiatives being led by health ministries and governments to further country-level and cross-border interoperability efforts.

The Global Digital Health Partnership (GDHP) is a collaboration of over 40 governments and territories, government agencies and the World Health Organization, formed to support the effective implementation of digital health services. Interoperability is one of the various work streams explored by GDHP. The proposed work stream activities focus on the evolving challenges of sharing patient data between care providers, organizations, caregivers and patients. These challenges are partly a technical problem for health systems, clinicians and patients, however they also pose significant risks for patient safety, and detract from high-quality coordinated care and the efficient delivery of services. A GDHP report outlines a variety of government efforts from 15 participating countries.

In Europe, the EU EHR Exchange Format developed the EU's eHealth Network to support the digital transformation of health and care in the EU by seeking to unlock the flow of health data across borders, and support implementation of the Cross-Border Health Care Directive. The recommendation seeks to facilitate the cross-border exchange of EHRs in the EU by supporting member states in their efforts to ensure that citizens can securely access and exchange their health data wherever they are in the EU. It will help citizens to quickly access and share their health data with healthcare professionals, for example, when consulting a specialist or receiving emergency treatment in another EU country.

The backbone infrastructure for the EHR exchange is the EHDSI. The EHDSI consists of services and infrastructure that use information and communication technologies to enable cross-border healthcare services. Initial focus is on enabling the exchange of baseline health information, including:

ePatient Summary to provide access to verified key health data of a patient during an unplanned care encounter while abroad

ePrescriptions to enables patients to receive equivalent medication treatment while abroad to what they would receive in their home country

A number of EU countries are already exchanging the ePatient summaries and ePrescriptions. As part of the EHDSI, Finland and Estonia were among the first to implement infrastructures to support the exchange of patient summaries, leveraging the X-Road platform, a free and open-source data exchange layer solution that enables organizations to exchange information securely over the internet. Future phases will include lab results, medical imaging and reports, and hospital discharge letters.

The European Commission also outlined priorities for 2019-2024 EU Digital Strategy, which included the creation of a European Health Data Space (EHDS) to foster the exchange and sharing of different kinds of health data (electronic health records, genomics, registries, etc.) in Europe. It aims to not only support exchange for the delivery of primary care, as well as, the development of new treatments, medicines, medical devices and services. Beyond the citizens, this would help meet the needs of different users and actors in the health system, while simultaneously protecting citizens' data. The commission is currently working with the member states and stakeholders to define the best governance structure and set up the appropriate infrastructure for the EHDS. Additionally, some existing regulatory gaps regarding member states implementation of the GDPR for the secondary use of data are being addressed.

The European Interoperability Framework (EIF) gives specific guidance on how to set up interoperable digital public services. It offers public administrations 47 concrete recommendations on how to improve governance of their interoperability activities, establish cross-organizational relationships, streamline processes supporting end-to-end digital services, and ensure that both existing and new legislation do not compromise efforts.

In an effort to ensure secure and federated access to genomic data, the European 1+ Million Genomes Initiative aims to create a technical infrastructure to improve disease prevention, allow for more personalized treatments and provide a sufficient scale for new clinically impactful research. In addition to the technical foundation for this effort, the signatory countries will also assess ethical and legal implications of genomics, and data storage, security and ethical uses.

Beyond these broader initiatives occurring across Europe, many countries are also leading specific regional and national efforts to expand exchange abilities./p>

The Nordic Interoperability Project is a consolidated grassroots effort to demonstrate the value for the patient from a seamless cross-border exchange of health data. The consortium includes organizations from all five Nordic countries-Denmark, Finland, Iceland, Norway, Sweden-and works to enable patients to live and act in an open, seamless, cross-border healthcare ecosystem, by showcasing and implementing solutions and innovations from the Nordics. The goal is to enable the Nordics by 2030 to be the most sustainable and integrated health region in the world, providing personalized healthcare for all its citizens.

In Portugal, the Shared Services of the Ministry of Health (SPMS) is a state-owned enterprise that manages the Portuguese Health Ministry Central Purchasing and serves as the national IT authority and the Portuguese representative for eHealth cross-border affairs. SPMS provides shared services in the areas of purchasing and logistics, financial services, human resources, and information and communication technologies to health and care entities to centralize and optimize the procurement of goods and services within the Portuguese National Health System.

In Asia and the South Pacific, many governments are also adopting digital health strategies to encourage interoperable exchange. For example, India's The Ministry of Health and Family Welfare (MoHFW) publishes EHR standards and created a Centre for Health Informatics under the eHealth Division of MoHFW as part of their Digital Health Strategy to initiate several digital health initiatives in the country, and started the National Health Portal as a citizen portal with the objective of improving the health literacy of the masses in India. New Zealand's health agencies, organizations and individuals signed a Commitment to New Zealand Health Interoperability to outline principles to drive the adoption of exchange infrastructures and processes in their health sector.

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Discover key insights about interoperability and better understand how data sharing can make a difference in healthcare.

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Developing Understanding using the DIKW Pyramid

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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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Improved Diagnostics and Outcomes with EHRs

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Improved Diagnostics and Outcomes with EHRs

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Improved Diagnostics & Patient Outcomes | HealthIT.gov

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When health care providers have access to complete and accurate information, patients receive better medical care. Electronic health records (EHRs) can improve the ability to diagnose diseases and reduce—even prevent—medical errors, improving patient outcomes.

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Future of Electronic Health Records: Supporting Clinicians and Patients

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At CORHIO (a Contexture organization), we connect the digital health record systems for healthcare providers so that regardless of where a patient goes for care, their medical history is accessible to the physicians and healthcare professionals who need it.

Health information exchange, or HIE, is the technology that supports the flow of health information between physician practices, hospitals, long-term care, labs, radiology centers, and other healthcare organizations. HIE allows delivery of the right health information to the right place at the right time, providing safer, more timely and efficient patient-centered care.
Watch Webinar on CORHIO Health Information Exchange
HIE Services From CORHIO

CORHIO offers a broad array of health information exchange services to meet the needs of different healthcare organizations.

HIE Connects You With Other Healthcare Providers Throughout Colorado

CORHIO makes it easy to securely exchange information with healthcare providers in your local community and statewide. Participation in the CORHIO HIE network gives you immediate access to send and/or receive data from other providers who participate in the CORHIO HIE network. Healthcare providers and organizations served by CORHIO:

Physicians and mid-level practitioners

Hospitals

Safety net clinics

Behavioral and mental health centers

Public health departments

Long-term care

Skilled nursing

Home health

Hospice

Labs

Imaging centers

Urgent care clinics

Emergency medical services

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Health Information Exchange Making a Difference

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Health Information Exchange Making a Difference

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Office of the National Coordinator for Health IT

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Health Information Exchange: Making a Difference

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The Importance of Telehealth During and Beyond Covid

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The Importance of Telehealth During and Beyond Covid

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The Importance of Telehealth During and Beyond COVID-19

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Telemedicine and its Role in Revolutionizing Healthcare

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Telemedicine and its Role in Revolutionizing Healthcare

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The use of telemedicine has been shown to allow for better long-term care management and patient satisfaction; it also offers a new means to locate health information and communicate with practitioners (eg, via e-mail and interactive chats or videoconferences), thereby increasing convenience for the patient and reducing the amount of potential travel required for both physician and patient. Web-based disease management programs encourage clients to assume greater responsibility for their own care, help healthcare providers to treat clients earlier (when they are not as ill), provide local and less expensive services, extend scarce healthcare resources, enhance follow-up care, improve client access to services, and increase the accuracy and quality of patients' medical records. ¹

Telemedicine connects the convenience, low cost, and ready accessibility of health-related information and communication using the Internet and associated technologies. Beginning with the use of telephone consults, telemedicine has become more sophisticated with each advance in technology, and now involves telecommunication and computers to provide healthcare information and services to clients at multiple locations. The application of this tool covers a wide and diverse scope, including: a) online databases and tools to ensure standards of care, b) critical pathways and patient outcomes, c) computer-assisted diagnosis, d) effective drug information and electronic prescription filling, and e) enhanced availability of research data. Through that information to healthcare professionals and consumers alike. Clinicians are able to handle more patients than traditional care models would typically allow, and with increased access and a more connected level of care, physicians and patients can work together to achieve their therapeutic goals, particularly in the home and hospice care environments. 2,3

This paper presents a critical review of the prevailing literature on telemedicine.
METHODS
A literature review was established by utilizing databases accessible through the Health Professions Divisions Library at Nova Southeastern University. The following databases were used to search for the sources for this project and identify current research on telemedicine: Citations and Abstracts for Literature of Nursing and Allied Health (CINHAL) plus full text, Cochrane Library, EBSCO host, and OVID. Key search phrases used in the scan included "telemedicine" and "telehealth," which produced 6563 and 4482 results, respectively. To narrow study selection, Boolean strings were considered for the literature search, with "AND" used with the advanced search pairings, such as "telemedicine AND nursing" and "telehealth AND nursing." Sources from the last 10 years were considered for inclusion in the review of literature. The subsequent search generated 119 and 272 results, respectively. The abstracts were reviewed and 18 articles were chosen based on their consistencies surrounding the investigation of telemedicine.
RESULTS Clinical Applications of Telemedicine
There are 4 clinical applications of telemedicine: 1) real-time interactive mode, 2) store-and-forward mode, 3) remote monitoring, and 4) communication via telephone. ⁴ Telephone communication the most basic type of telemedicine that provides communication and remote care delivery. In real-time telemedicine, a link between the involved individuals allows a real-time interaction to take place, but requires sending patient data from one site to a remote location, with an expert available to evaluate the data. These real-time encounters use a specially equipped personal computer with a telephone line hook-up to allow people to meet face-to-face and/or view papers and images simultaneously, even though they are not in the same location. Videoconferencing is one example of this type of application. ⁴ Store and forward ensures that all information, including digital images, video, audio, and data, is captured, stored, and sent electronically to a specialist or clinician at another facility for interpretation and feedback. ⁴ In remote monitoring, devices intelligently acknowledge the patient, record any abnormalities, and transmit data. For example, a cardiac event monitoring device allows patients to record arrhythmia whenever they experience dyspnea, angina, palpitations, or unexplained syncope. They can transmit the data over the phone and the ordering physician is notified immediately in the event of an abnormal rhythm. The benefits of this type of technology allow clinicians to cut travel time without decreasing client contact. In addition, telemedicine services eliminate the need for visas for international patients. ¹
Benefits of Telemedicine
Using telemedicine technology to remotely monitor health, such as through the use of smart surveillance cameras and analytical software, can be used with elderly clients to notify their caregivers of changes in activity, falls, or lack of movement. This type of care can reduce costs, potentially keep these older individuals in their own homes longer, and help physicians to more easily tailor treatment according to a patient's choices and availability of services. ⁵ This is particularly important as the 65-years-and-older population explodes without a concomitant increase in funds for healthcare services. It is estimated that by 2030, individuals 65 years or older will represent 20% of the US population. Therefore, Medicare and Social Security programs will face financial challenges as the ratio of individuals paying taxes to retirees receiving benefits will drastically diminish. ³

Use of telemedicine also has the potential to help patients become more involved in their healthcare plan and increase their autonomy. ³ Patients who require wound care are another population that can be managed well at home through telemedicine applications. For instance, telemedicine facilitates communication among: a) a tissue viability nurse at a patient's home who evaluates the patient's condition via wound description and photographs that are entered into the database, b) another tissue viability nurse working in an outpatient clinic at a different hospital, and c) a physician who is highly interested in wound care working in a different healthcare facility. ⁶

A Web-based solution for care coordination can integrate information from biometric measures and diagnostic tests and automatically alert clinician of panic values. As an example, "Health Buddy," an in-home communication device, can be used to provide heart failure disease management, ⁷ with biometric measurements (eg, heart rate and pattern, blood pressure, respiratory rate, fetal heart rate) able to be monitored at another site. Women with high-risk pregnancies, individuals with diabetes, and cardiac and postoperative patients can also be monitored at home. The device prompts the appropriate patients to take their medicine and keep their legs elevated when sitting and monitors subjective reports of difficulty breathing or increased edema. On the other end of the connection, nurses receive alerts when problems are indicated.
Legal and Privacy Issues/Resolutions
Telemedicine is plagued by a number of liability concerns. ⁸ First, there is the possibility that a patient may perceive it as inferior because the consulting professional does not perform a hands-on examination. Therefore, the distant provider, who has not personally examined the patient and may be relying on another presenter, might not be able to render a fully informed opinion or could end up with results that are inaccurate, incomplete, or misleading. Major issues include questions of liability when information provided over the telephone is misinterpreted. ¹
Reimbursement and Licensure
These 2 items represent major barriers to the growth and practice of telemedicine and need to be addressed in the context of technology-enhanced interventions. ⁹ There have been incidents in which practitioners were eligible for reimbursement of the costs associated with telemedicine services and problems with how they are paid. Further, although healthcare professionals are only licensed to practice within certain jurisdictions, telemedicine requires multiprovince licensure, both for their primary province and for the jurisdiction in which services are rendered. Applications for licensure in different provinces can be lengthy and expensive, with the ultimate result being restricting access to services. There are different practice provisions across the country, and the uncertainties related to licensure may be subject to malpractice lawsuits and questions about how that liability might be distributed, which will continue to hamper access to telemedicine. ¹
Privacy and Confidentiality
Telemedicine should not create greater concerns about or risks to medical record privacy than any other form of consultations-in the United States, it is subject to Health Insurance Portability and Accountability Act (HIPAA) regulations. ¹ Although patients require continuous support and education, the privacy, security, and confidentiality of their data must be maintained at all times. Only authorized users-those who are directly involved in the ongoing care and treatment of a patient-and those having a legal right and clear need to approach the systems where the information resides have access to this information. This restricted access increases patient safety and reduces anxiety regarding misuse and availability of personal information. Maintaining the privacy and confidentiality of telemedicine services is crucial to acceptance by consumers and healthcare professionals; these providers must adhere to all data privacy and confidentiality guidelines. ⁴ Nurses and other healthcare professionals need to be mindful of these issues, especially when technicians not bound by professional codes of ethics are present at telemedicine sessions. ¹

Protection of information and computer systems should receive top priority. Security mechanisms use a combination of logical and physical restrictions to provide a greater level of protection, including firewalls and antivirus and other software that detects malicious programs and spyware. An example of a logical restriction is automatic sign-off; the operating system should lock down after a specified period of inactivity. ¹ In addition, the constant creation of new viruses makes it necessary to update antivirus software often. These measures should be reevaluated periodically to determine what modifications need to be made.

Information security training and education are important components in fostering proper system use. Most problems with information system security are primarily related to the human factor rather than the technical one. Support staff should be capable, flexible, and experienced. Technical support staff who are present during the exchange of client information need to be aware of institutional policies, procedures, and laws (such as HIPAA) that are designed to protect client privacy. These individuals should sign the same sort of statement that clinical personnel sign on when receiving their information system access code. In the case of home monitoring, support is crucial to help participants feel comfortable with the technology, particularly when using the internet and Web applications. ¹⁰

Additionally, secure modems and encryption are particularly useful in conjunction with remote access. System security involves protection against deliberate attacks, errors, omissions, and disasters. Good system management is a key component of a strong security framework because it encompasses monitoring, maintenance, operations, traffic management, supervision, and risk management. Greater awareness, sufficient resources, and an organization-wide commitment to information security are needed. ¹

Speed and access to information at any time, from any place, are essential to maintaining a high quality of service; slowdowns or outages in service are not acceptable. ¹ Descriptions of some telemedicine applications describe inadequate funding to establish and maintain the technological infrastructure needed. ¹¹ In certain cases, nurses are responsible for the set-up and basic support of telemedicine devices. Although the wisdom of this approach may be questioned in light of the limited availability of nurses, it can be used as an opportunity to establish rapport and comfort with the technology. ¹² Equipment capable of transmitting and receiving diagnostic-grade images can be cost-prohibitive-although costs are declining-but it is significantly less costly than that of an inpatient admission.

There are 2 other major issues surrounding the quality of telemedicine services. The first is that services must be at least of the same quality as traditional services, particularly for reimbursement services. The second is the paradox that geographically isolated populations stand to derive the largest benefits from telemedicine although they have limited access to traditional healthcare services and often have the poorest infrastructure, resources, and capability to support telemedicine. ¹³ Telemedicine visits can require extra time for equipment management and transmittal of prescriptions. ¹⁴ There is also a need for extensive research to establish effectiveness and cost and quality relationships. ¹⁵
Other Barriers to Telemedicine
Despite its advocates, many healthcare professionals have been slow to accept the application of telemedicine. ¹⁶ Some are simply resistant to change unless they see the potential benefits, while other reasons include the perception that telemedicine applications are not indicative of "real" nursing-this may stem from liability concerns and discomfort over not seeing a client face-to-face-and that telemedicine applications will eventually reduce the number of healthcare professionals needed and they fear job loss as more clients can be treated at home.

There are threats to patient safety when telemedicine applications fail to render the same level of care as hands-on care or when problems occur with the use of electrical devices. ¹ There is also lack of acceptance by users that may arise from discomfort with technology, the relationship with the provider, and concerns over security of information and confidentiality. It is essential to educate the clients and increase public awareness. Healthcare professionals need to hold free information sessions for patients who are interested in more comprehensive information to aid them in making an informed decision and to promote a better understanding of such technology.

Most discussions of telemedicine include the electronic health record as the primary means to make client data readily available and store diagnostic images. Picture Archiving Communications Systems (PACS) permit remote access to diagnostic images at times that are convenient to physicians. Health personnel need to shape the development of technological standards by determining the adequate image quality for diagnosis. Unfortunately, there has been insufficient funding for further development of PACS technology. ¹⁷
Strategies to Establish a Telemedicine Plan
Successful establishment and implementation of a telemedicine plan requires strategic planning and consideration of: a) necessary infrastructure, b) costs and reimbursement, c) human factors, and d) equipment and technology issues. In terms of infrastructure, it is essential to address how telecommunication breakdowns will be handled: will backup be provided? What happens when a power outage in the home severs a link? Technical support must be available to resolve any problems that might arise. ¹ Additionally, the individuals who will use the system should be involved in its design from the beginning to ensure its effectiveness and uptake. Specific competencies that must be addressed include training time to develop the technical skills needed to set up and use equipment, professional knowledge, interpersonal skills, documentation, professional development, resource management, practice and administrative issues, and security of healthcare information. ¹ Time is needed for healthcare providers to get accustomed to telemedicine practices; an example of this may be seen in teleradiology, where radiologists must learn how to interpret images using a monitor. ¹⁷
Future Directions
Converged devices, such as smartphones, combine the utility of cell phones and personal digital assistants, allowing users to monitor telemetry patients while performing other tasks. These devices provide the potential to increase patient safety, facilitate communication among healthcare professionals, and reduce liability (because orders can be clearly viewed), thus eliminating the errors associated with poor handwriting or verbal instructions. ¹⁸

The model of "connected health"-a new paradigm of care-promises to reduce costs and improve quality by working with clients proactively. Individuals monitor their own health, which results in fewer visits to physicians and inpatient hospital stays. ¹⁹ The demand for telemedicine services is expected to grow exponentially as baby boomers age, and home-based care will likely continue its exponential growth as a means to help keep older patients in their own homes and better manage their conditions. Demands for quality, patient safety, and more options will help change the reimbursement picture and open the door for more telemedicine applications, new technologies will emerge to meet this need, and the use of existing measures, such as biometric authentication, will become more common.
DISCUSSION
Telemedicine significantly contributes to the provision of healthcare in underserved areas through services such as telestroke, telecardiology, teledermatology, telepediatrics, telepsychiatry, and teleneonatology care. This tool aims to improve access to care for anyone regardless of their location ²⁰ and has the potential to reduce the number of face-to-face visits. Additionally, it can help improve the organization of the health record with automatic collection of data and better coordination of care among clinicians in various locations.

In telecardiology-the transmission of cardiac diagnostic tests in conjunction with electronic stethoscope examinations for second opinions by cardiologists at another site-there may be a reduction in the need for a patient to travel by allowing the specialist to perform an assessment remotely using a digital Bluetooth stethoscope and existing telemedicine equipment. Another example is telestroke, which enhances on-demand emergency acute stroke care by using videoconferencing to connect neurologists with emergency departments at facilities without neurologists on site. With telestroke, neurologists can communicate directly with the patient and family during assessment, discuss the treatment plan with all involved, and provide comprehensive and coordinated acute stroke care. Reducing the time to receive treatment is critical in improving patient recovery.

During the telemedicine implementation phase, providing support to facilitate transition and communicate accuracy and availability of the electronic system is very important. There is a need to provide continuing education and develop a communication plan, with useful tools like newsletters and posters, to increase awareness of telemedicine and later expand its capability. To promote adoption, a change management plan must be structured in conjunction with the telemedicine implementation design. It is essential to incorporate change agents into the program that will help implementers and users to effectively and meaningfully communicate with each other in order to address any gaps that may exist. The change agents provide education sessions related to the importance of change that are key to having healthcare providers open their minds to change and adapt the system to existing practices.

Change management provides invaluable assistance to healthcare organizations to better manage their resources and improve productivity through the use of continuous positive reinforcement and involvement of supporting resources. They will be able to troubleshoot, and their inputs for change will act as catalysts to get their active involvement in setting up new environment. Timely and ongoing training will allow healthcare educators, providers, and agencies to examine information trends and react to changes proactively. As new rules emerge and technology changes, all organizational members need to participate in the use of telemedicine to ensure wide acceptance. 2,4
CONCLUSIONS
Among other benefits, the use of telemedicine improves follow-up care, ensures patient access to services, and allows providers to treat patients at home and in remote areas. Some telemedicine applications include diagnostic evaluation, decision making, storage and dissemination of records, and education of healthcare professionals. Several factors are essential to establishing and using a telemedicine link: implementers should develop a plan that addresses areas such as compliance with standards, technical requirements, reimbursement, human factor considerations, and strategies to handle telecommunication breakdowns and how to deal with equipment malfunctions.
Acknowledgments
This paper was also submitted toward a partial completion of Doctor of Health Science at Nova Southeastern University.

Author Affiliations: Department of Health Science, Nova Southeastern University, Fort Lauderdale, FL.

Source of Funding: None.

Author Disclosures: Dr Alvandi reports no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article. She affirms that her academic institution has no financial interest or conflicts.

Authorship Information: Concept and design; acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content.

Send Correspondence to: Maryam Alvandi, DHS, Nova Southeastern University, Fort Lauderdale, FL 33329. E-mail: malvandi@yahoo.com. REFERENCES

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Telemedicine and its Role in Revolutionizing Healthcare Delivery

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The use of telemedicine has been shown to allow for better long-term care management and patient satisfaction; it also offers a new means to locate health information and communicate with practitioners (eg, via e-mail and interactive chats or videoconferences), thereby increasing convenience for the patient and reducing the amount of potential travel required for both physician and patient.

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'Alpha Beats Cancer' is a Children's Game Demystifying the Illness

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'Alpha Beats Cancer' is a Children's Game Demystifying the Illness

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Alpha Beats Cancer - ‘Alpha Beat Cancer’ is a delightful point and click game designed to teach young kids about cancer. Developed by Mukutu Games and Beaba...

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Could Video Games Help Kids Recover from Cancer?

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Could Video Games Help Kids Recover from Cancer?

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Cancer treatment aims to eradicate disease from the body, but the chemotherapy-related effects can be challenging. The medical community focuses on recovering physical strength, flexibility, and endurance during and after the treatment. A team of researchers at University of Utah Health have developed EmpowerStars!, a mobile video game to help pediatric cancer patients as they progress through and complete cancer therapy. The results are published in the April issue of Frontiers in Pediatrics.

Previous studies have shown that digital technologies, such as mobile apps and games, offer an effective tool to improve a patient's understanding of health, disease, and treatment. Today, FDA-approved mobile technologies are helping patients manage diabetes and recover from stroke and traumatic brain injury.

With this in mind, the team developed EmpowerStars!, a proof of concept prototype mobile video game aiming to improve physical and mental condition in children with cancer. The game is anchored in imaginative stories and graphics. After customizing an avatar, the child grasps the handles on the case enclosing the tablet. Using a series of actions, like balancing, stirring, sawing, and pumping, the player obtains the stars needed to power the first mission. In addition to this physical activity, the game aims to help children gain strength and confidence while overcoming the fear and anxiety associated with the cancer diagnosis and the subsequent treatments.

In this study, ten children, aged 7 to 14 who were undergoing chemotherapy, received the one-day video game treatment, which consisted of 20-minutes of physical activity during the 30-minute gaming session. One parent of each child also reviewed the game, along with 12 pediatric health care providers, including nurses, child life specialists, social workers, and physicians. All three groups responded positively to the prototype but stressed the need to improve the instructions and overall objective of the game.

"I really enjoyed being so involved in the clinical usability evaluation," said Carol Bruggers, MD, professor of pediatrics at U of U Health, first author on the paper, and principal investigator on this study. "Being able to experience first-hand the excitement, laughter, and enjoyment of children who played the prototype game re-enforced that creating an exercise and educational empowerment-centered, mobile, cancer-related game was right on track."

The game was developed in conjunction with Spy Hop, a Utah-based program aimed at empowering young people by developing their skills in the digital media arts. In addition to creating and coding the graphics, storylines, activities and music in the game, the high school students were challenged to link the tablet's internal sensors to respond to the patient's physical movements during each activity.

The current game prototype was designed as a mission to one planet with diverse challenges and exercise components, but the number of planets in this universe can be expanded to incorporate more teaching and exercise opportunities. The next version of the game will include a multi-day delivery of exercise and empowerment interventions to tackle chemotherapy-related fatigue. The long-term benefits of this prototype game remain unclear. Future work will need to evaluate the clinical benefits of the game in children during and after chemotherapy treatment.

"We are still at the beginning of this process," said Grzegorz Bulaj, PhD, associate professor of medicinal chemistry and co-author on this paper. "Digital medicine technologies can improve therapy outcomes by modulating a patient's behavior".

The researchers believe that this concept can be expanded to deliver treatment for other chronic childhood diseases, including obesity, asthma, cystic fibrosis, diabetes, and juvenile idiopathic arthritis.

# data[].attributes.attachment_link.title
Could Video Games Help Kids Recover from Cancer?

# data[].attributes.attachment_link.description
Cancer treatment aims to eradicate disease from the body, but the chemotherapy-related effects can be challenging. The medical community focuses on recovering physical strength, flexibility, and endurance during and after the treatment. A team of researchers at University of Utah Health have developed EmpowerStars!, a mobile video game to help pediatric cancer patients as they progress through and complete cancer therapy.

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The Impact of Digital Patient Portal on Health Outcomes

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The Impact of Digital Patient Portal on Health Outcomes

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The Impact of Digital Patient Portals on Health Outcomes, System Efficiency, and Patient Attitudes: Updated Systematic Literature Review - PubMed

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Evidence regarding health outcomes is generally favorable, and patient portals have the potential to enhance the doctor-patient relationship, improve health status awareness, and increase adherence to therapy. It is still unclear whether the use of patient portals improves health service utilization …

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Office of the National Coordinator for Health IT

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What is HIPAA LAW? What does HIPAA LAW mean? HIPAA LAW meaning, definition & explanation

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Healthcare analytics is the analysis of data to create data-driven, actionable insights that is used to inform and improve critical healthcare decisions.

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Using Big Data to Improve Healthcare Services | Tiranee Achalakul | TEDxChiangMai

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Susan McBride, PhD, RN-BC, CPHIMS, FAAN
Mari Tietze, PhD, RN-BC, FHIMSS
Catherine Robichaux, PhD, RN, CNS, Alumnus CCRN
Liz Stokes, JD, MA, RN
Eileen Weber, DNP, JD, BSN, RN, PHN

With the passage of the Health Information Technology for Economic and Clinical Health Act in 2009, the United States, as of 2017, has achieved 95% saturation with electronic health records as a means to document healthcare delivery in acute care hospitals and guide clinical decision making. Evidence is mounting that EHRs are resulting in unintended consequences with patient safety implications. Clinical teams confront usability challenges that can present ethical issues requiring ethical decision-making models to support clinicians in appropriate action on behalf of safe, effective clinical care. The purpose of this article is to identify and address ethical issues raised by nurses in use of electronic health records. We provide a case scenario with application of the Four Component Model and describe a study of nurse experiences with the EHR. The nursing Code of Ethics, Nursing Scope and Standards, and Legal Implications are reviewed, and we conclude with recommendations and a call to action.

Citation: McBride, S., Tietze, M., Robichaux, C., Stokes, L., Weber, E., (January 31, 2018) "Identifying and Addressing Ethical Issues with Use of Electronic Health Records" OJIN: The Online Journal of Issues in Nursing Vol. 23, No. 1, Manuscript 5.

Key Words: electronic health records, ethics, ethical decision making, moral distress, usability, unintended consequences, patient safety, quality, Health Information Technology, Rest Four Component Model

Healthcare delivery in the United States (U.S.) is changing at a rapid pace to keep up with the ever-growing population health needs and for management of chronic diseases ( Healthy Aging Team, 2017). With the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009 ( U.S. Department of Health and Human Services, 2012), the United States, as of 2017, has achieved a 95% saturation with electronic health records (EHRs) as a means to document healthcare delivery in acute care hospitals and guide healthcare delivery clinical decision making ( Office of National Coordinator for Health Information Technology, 2017). Approximately 60% of U.S. office-based physicians have an EHR implemented and in use.

...in many respects, care has improved with use of technologies... Collectively, these trends impact nurses nationwide across all care settings. Studies have indicated that, in many respects, care has improved with use of technologies and, when meaningful use of EHRs is fully achieved and experienced by nurses, they are much more likely to be satisfied with the EHR ( McBride, Tietze, Hanley, & Thomas, 2017). Evidence is mounting that these same systems are also resulting in unintended consequences with patient safety implications, potentially contributing to provider moral distress ( Henry, Pylypchuk, Searcy, & Patel, 2016). Clinical teams often confront usability challenges that present ethical issues and require ethical decision-making models to support clinicians with appropriate action on behalf of safe and effective clinical care.

Clinical teams often confront usability challenges that present ethical issues... The purpose of this article is to identify and address ethical issues raised by nurses in use of EHRs. We provide a case scenario with application of the Four Component Model (FCM) ( Rest, 1986). To do this, a clinical case study will be presented, along with discussion of nurse experiences using the EHRs in a recent study ( McBride, Tietze, Hanley, & Thomas, 2015). Then, recommendations and a call to action are made based on the FCM in light of nursing practice standards, ethical issues, and where applicable legal issues.

...formulaic alerts can present challenges to clinical decision making... One strength associated with certified EHRs under the HITECH Act of 2009 for supporting patient safety and quality is that evidenced-based protocols can be reinforced by using clinical decision support (CDS). CDS is designed to trigger, or alert, the clinical team with the right information, through the right channels, to the right person, at the right time, for the right patient, via the correct route of the EHR or supporting technologies ( Osheroff et al., 2012). These same formulaic alerts can present challenges to clinical decision making for clinical teams working with an actual patient, raising practical and ethical considerations.

When examining ethical issues and applying frameworks to analyze a situation, clinical scenarios often help to ground discussions of problems in the day-to-day clinical care that commonly occur in healthcare delivery. The following case presents a scenario for applying a framework to address ethical concerns that nurses have raised regarding the function of some EHRs.

She suspects that the afebrile patient does not have sepsis, but instead has an exacerbation of HF with possible pulmonary edema... Nancy has worked in a busy community hospital emergency department (ED) for over ten years. She is caring for a patient that presents to the ED with the following:

sepsis suspected due to possible pneumonia

oxygen saturation 88% on 4 liters of O2 via nasal cannula

respiratory rate of 30

heart rate of 110

These symptoms trigger the EHR CDS alert for sepsis because the patient scored high on the hospital sepsis screening tool built within the EHR. The CDS fires alerts that prompt the ordering physician to fluid resuscitate the patient according to the Center for Disease Control guidelines for suspected sepsis. Nancy recognizes that not only does this patient have symptoms that could be evolving sepsis, but the EHR indicates the patient has previously been admitted for fluid overload from heart failure (HF). She suspects that the afebrile patient does not have sepsis, but instead has an exacerbation of HF with possible pulmonary edema because the patient also exhibits 2+ pitting edema and crackles in both lung bases.

The ED physician follows the CDS sepsis alerts that call for fluid resuscitation. The ED physician follows the CDS sepsis alerts that call for fluid resuscitation. Nancy questions the doctor order for aggressive fluid bolus and relates her concern that the patient is not septic. She points out the history of HF, which creates a risk for fluid overload with the bolus. The physician agrees with the nurse but states, "just drip it in slow, otherwise if we don't follow protocol we may fall out of the sepsis quality metric for the hospital. I don't want to send this patient to the ICU and have it later determined to be a sepsis case that we didn't follow protocol on!"

[Nancy] feels very distressed but hopes for the best outcome for this patient. No order for a slow drip was noted in the EHR, with only a verbal instruction on a busy ED shift for a patient ready for transfer to the ICU. Nancy questions the appropriateness of the physician orders, but follows physician instructions. She feels very distressed but hopes for the best outcome for this patient. She subsequently reports the request by the physician to drip slowly in a verbal handoff to the ICU nurse who receives the patient. The ICU nurse, recognizing that the drip does not follow the EHR recorded order, opens up the drip according to the computer provider order entry (CPOE). The patient has respiratory arrest. The patient requires intubation due to flash pulmonary edema with a subsequent diagnosis of acute onset of exacerbated fluid overload, secondary to rapid administration of intravenous (IV) fluid bolus and complication of HF. The attending intensivist on duty determines that the patient does not have sepsis.

This case presents a scenario happening across the nation in terms of EHR triggered protocols that capture electronic quality measures, often tied to value-based purchasing payer models upon which the organization will be penalized in the event measures are not met. This case study illustrates evolving guidelines that require clinical teams to use critical thinking skills when presented with CDS or information within the EHR that is not aligned with the clinical judgment of the entire clinical team. Further, this case offers several ethical considerations for examination. The scenario also reinforces nurses' statements as reported in 2015 via the Texas Nurses Association-Texas Organization of Nurse Executives (TNA-TONE) statewide study on EHRs ( McBride et al., 2015). For example, the following was one of 352 statements by nurses about EHR experiences:

Yes, the documentation of "quality standards" has greatly improved, but patient care and patient safety has not. In fact nurses have to enter false information sometimes and work around the system (I use vendor X, Y and Z) and all have similar issues. I know first-hand of 2 sentinel events caused by the systems (X and Y). Also systems audits are being used to evaluate and discipline nurses; this is a big ethical issue as nurses are charting stuff for the wrong reasons/........creating a conflict of interest.

This case scenario can be examined in terms of the overall context of ethical implications in use of the EHR. We can also consider the distress that can occur when protocols/guidelines; clinical decision support systems; nurse-patient relationship; and clinical communications between and among teams conflict with a nurse's code of ethics.

As a result of the HITECH Act in 2009, the TNA Board of Directors formed a Health Information Technology advisory committee. This committee was to evaluate the changing health technology environment and make recommendations to the TNA Board regarding steps needed to prepare Texas nurses for the rapid uptake of technology in healthcare settings required by this legislation. The TNA Board joined with the Texas Organization of Nurse Executives (TONE) to create a statewide partnership with nursing leaders to address the impact of health information technology (HIT) on nursing in the state of Texas.

The TNA-TONE HIT committee was charged with examining how Texas nurses were impacted by newly implemented EHRs across the state and to establish baseline measures of nurse satisfaction to inform evidence-based improvement strategies. A statewide study was initiated to evaluate nurse perceptions about clinical information systems such as EHRs.

... analysis of text comments found patterns and trends that reflected distress related to moral issues and ethical dilemmas... Quantitative results from the statewide study indicated that nurses were 84% more likely to be satisfied when they reported high scores related to a meaningful use maturity sensitivity index (MUMSI). The MUMSI allowed for analysis that addressed differing levels of functional status, or maturity of the given EHR using the meaningful use (MU) measures as a proxy for maturity ( McBride et al., 2017). However, analysis of text comments found patterns and trends that reflected distress related to moral issues and ethical dilemmas (please note that we are using the terms "moral" and "ethical" interchangeably in accordance with the current literature). We believe the ethical issues, in particular, warrant further exploration and require models of decision making to support clinical interprofessional teams in appropriate decision-making and subsequent action.

In the Texas-based statewide study ( McBride et al., 2015), researchers elicited additional information to learn about experiences of nurses using EHRs with this open-ended statement: "We are interested in your feedback and anything we might not have covered, please provide any additional information you care to provide." Just over 30% (352 of 1,157 participants) provided written comments about their experiences.

A thematic content analysis of the narrative responses to the open text question was used to analyze the data. Texts were organized in a spreadsheet and reviewed systematically by two qualitative researchers from the TNA/TONE committee research subgroup to identify key concepts. The text narrative responses were then reorganized according to concepts and summarized into categorical statements. Further immersion and analysis of the categories by two researchers with informatics expertise resulted in a synthesis of comments within the categories that revealed several primary themes. These are noted in Figure 1.

A conceptual model that reflects the overall common concepts detected in the thematic analysis was developed by the research group and is also noted in Figure 1. Note that "Patient Safety and Quality" is a major theme, with a minor theme "documentation/legality." This suggested that practice challenges associated with patient safety and quality were experienced. We learned that these were reflected, among other ways, in the EHR-based documentation that varied from established interprofessional practice standards. Although the case study and the Texas nurses' comments reflected ethical issues raised by nurses, there are significant implications for the entire care team given the EHR is the primary means of interprofessional communication.
Figure 1. Major and minor themes related to qualitative study comments.
[ View full size]

A sampling of these comments is provided by categories in Table 1. They are grouped by category of content.
Table 1. Comments by Nurses about their EHR Experience

I have almost no training on the "System." I have to fumble around to do anything on this "System" and it is purely an accident when I do find what I need.

System was not designed by the people who would use it. It does not capture the data required by the state to successfully use it. We are unable to see any notes/assessments that we did not personally input. Very frustrating because we constantly have to do double work. Sometimes the canned responses to questions do not have the appropriate answer listed as an option, and the only way to complete the documentation is to go to another menu and enter a nurse's note. Our preop department uses entries in both the nursing module and the OR module, which necessitates constantly switching from one menu to another - time consuming and inefficient. The "copy/paste" function has made it easier for providers to not write new original assessments. Because most of the notes are copy and pasted, there are many discrepancies (on one line, the patient is intubated; on the next line of the same patient, the patient is on nasal cannula). It's made the notes semi-worthless. This system has quadrupled our workload. It is not accurate and orders tend to disappear. The pharmacy part allows expired orders to carry on and continue to be active even after stop dates which lead to medication errors. This system is difficult to view orders and communicate with others. Things do not work well. It takes several hours to get thru discharges due to links that do not work. With the ER after two weeks on the program, it developed an application error that would not let nurses go back to add information while the patient is still active and document is active.

Our computers at times freeze inside the room. During am med pass, it is so stressful finding a good computer that does not freeze. Sometimes I have to go through 3-5 computers before finding one that works.

Sometimes I feel that the barcode scanning system for medication administration hinders critical thinking and prevents truly looking at what you are giving the patient.

The FCM describes the deliberative thought processes that occur from initial recognition of a situation with ethical content to implementation of a justifiable action... The case scenario above provides an opportunity to explore a holistic framework, the Four Component Model ( Rest, 1986), to identify and address ethical issues in nursing practice. The FCM describes the deliberative thought processes that occur from initial recognition of a situation with ethical content to implementation of a justifiable action: sensitivity, judgment, motivation, and action ( Rest, 1986; Robichaux, 2012; Robichaux, 2017; Rushton & Penticuff, 2007).

Ethical Sensitivity
Ethical sensitivity is described as our ability to recognize an ethical problem, the moral implications of our decisions, and how our actions affect other people ( Milliken, 2016). Its development depends on an understanding of the ethical nature of the role as an obligation of the nursing profession ( Milliken & Grace, 2017). In the case scenario, Nancy recognized that adhering to the EHR-triggered CDS guideline might result in a poor outcome. She may have also been aware of her accountability in the situation as stated in the ANA Code of Ethics for Nurses with Interpretive Statements, "Systems and technologies that assist in clinical practice are adjunct to, not replacements for, the nurse's knowledge and skill" ( American Nurses Association [ANA], 2015, p.16; hereafter referred to as Code of Ethics). Having practiced in the ED for ten years, Nancy may be respected by her nursing peers and physician colleagues and may question how her actions could potentially affect those professional relationships.

Ethical Judgment
Not all issues will require an in-depth consideration of all elements in a specific model, and the goal is to reach a prudent choice, not certainty. The second component of the FCM is ethical judgment or decision-making, a deliberative process reflecting knowledge of ethical principles, theories, and codes. There are several models (see Table 2); most have elements that outline an approach to reaching a decision through identifying facts and considering specific questions related to ethical principles and/or virtue ethics and care ethics. Not all issues will require an in-depth consideration of all elements in a specific model, and the goal is to reach a prudent choice, not certainty ( Grace, 2014; Milliken & Grace, 2017; Robichaux, 2017). Recognizing the potential harm of following the sepsis guidelines in a patient with suspected pulmonary edema, Nancy decides to share her concerns with the physician.
Table 2. Ethical Judgment/Decision-making Models
Ethical Motivation
All nurses want to be ethical and live in a manner consistent with their personal and professional values. Although they may recognize an ethical issue and be aware of their role-associated obligations, personal and/or institutional barriers may impede their motivation to act. The third component in the FCM, ethical motivation is the bridge between decision-making and action ( Robichaux, 2017).

Competing personal values... can impede motivation and action. Competing personal values such as protecting one's position or reputation can impede motivation and action. "Persevering to do the right thing" ( Grace, Robinson, Jurchak, Zollfrank, & Lee, 2014, p. 14) can also be hampered by institutional barriers. Lack of supervisory support, fear of reprisal, and hierarchal decision-making may silence nurses' moral voices ( Pavlish, Hellyer, Brown-Saltzman, Miers, & Squire, 2013). These obstacles may characterize a unit ethical climate that does not promote patient/family advocacy and nurse moral agency. Wolf et al. ( 2016) described the moral distress of ED nurses who are unable to meet their role obligations to provide safe and effective patient care in such environments.

The stress felt by Nancy in the presented ED case scenario is an example of this type of moral distress. Specific themes reflected in the case scenario and noted by Wolf and colleagues' ( 2016) qualitative investigation relate to moral distress due to overemphasis on documentation, tasks, and metrics at the expense of patient care, as well as role conflicts resulting from hierarchical decision making. These same issues are reflected in a number of comments in Table 1 (e.g., overemphasis on documentation and measurement creating inefficiencies and a distraction to patient care).

Ethical Action
Nancy questions the physician's decision to follow the sepsis quality metric and not write an order in the EHR for slow intravenous fluid administration. She verbally reports this information to the receiving ICU nurse and hopes "for the best outcome" for the patient. Could additional actions have been taken? Developing moral courage may assist in overcoming personal and institutional barriers to further nurse advocacy. Individuals with moral courage have developed skills of effective engagement and "willingness to speak out and do what is right in the face of forces that would lead a person to act in some other way" ( Lachman, 2007, p. 131). Moral courage can also be "learned, practiced, and mentored" ( Hawkins & Morse, 2014, p. 268). When moral courage and ethical action are thwarted by constraints outside the nurse's control, moral distress can result.

Nurses experience moral distress, a concept first highlighted by Andrew Jameton in 1984, when they "know the right thing to do while being in a situation in which it is nearly impossible to do it." ( Jameton, 2017, p. 617). Jameton described three components that can apply to the pain expressed by the nurses that contributed to the Texas study: knowing what is right, being in a situation that constrains acting on that knowledge, and the psychological distress resulting from that inability to do the right thing ( Jameton, 2017).

It may be challenging to remember what actions to take when encountering a situation that requires moral courage. It may be challenging to remember what actions to take when encountering a situation that requires moral courage ( Lachman, 2010; Lachman, Murray, Iseminger, & Ganske, 2012) Lachman et al. ( 2012) have developed a useful mnemonic, CODE ( Courage; Obligations to honor; Danger management; Expression), that reminds nurses of their ethical obligations and actions as detailed in the nursing Code of Ethics ( ANA, 2015). The CODE mnemonic strategy helps nurses to recall these actions and includes ways to overcome fear and reluctance to speak up including reflection, reframing, and assertiveness skills.

The accelerated growth and adoption of the EHR has produced a situation that repeatedly occurs in the history of technology and parallels the rise of bioethics. The Code of Ethics states, "Patients' rights are the primary factor in any decisions regarding personal information, whether from or about the patient. These rights of privacy and confidentiality pertain to all information in any manner that is communicated or transmitted" ( ANA, 2015, p. 10). While nurses are aware of this ethical obligation in relation to the EHR, they may be less familiar with additional ethical issues inherent in its use and development. The accelerated growth and adoption of the EHR has produced a situation that repeatedly occurs in the history of technology and parallels the rise of bioethics. From cardiopulmonary resuscitation (CPR) to genetic engineering, the creation and use of an innovative tool may surpass the knowledge and resources required to ensure an ethical and appropriate use ( Goodman, 2015).

The current and potential positive impact of the EHR on quality care is not disputed. However, ethical issues surrounding dominance of institutional priorities over autonomous patient-centered practice and care driven by application of decision-support, templates, and/or clinical practice guidelines (CPGs) have been documented ( Lown & Rodriguez, 2012; McBride, Tietze, Hanley, & Thomas, 2015; Sulmasy, López, & Horwitch, 2017). Perhaps the most troubling ethical issue noted is the potential erosion of the patient-nurse relationship ( de Ruiter, Liaschenko, & Angus, 2016; Rathert, Mittler, Banerjee, & McDaniel, 2016).

The centrality of the patient-nurse relationship to the nursing discipline is reflected in the interpretive statement, "The nurse's primary commitment is to the recipients of nursing and health care services" ( ANA, 2015, p. 5). Effective communication is vital to this relationship, and the EHR may have a negative effect. Research suggests that it can become a "third party "in the process, potentially reshaping the interaction, changing the patient narrative, and diverting nurse attention away from the patient ( Rathert et al., 2016).

Perhaps the most troubling ethical issue noted is the potential erosion of the patient-nurse relationship. The use of computers and communication technologies will impact more lives in the 21st century than any other technology, including stem cells, transplants, and nanomedicine ( Goodman, 2015). As the largest group of healthcare professionals who document, more than any other discipline in acute care organizations, ( OʼBrien, Weaver, Settergren, Hook, & Ivory, 2015) nurses are at the forefront to ensure that the EHR is patient-centered and contributes to safe, ethical practice.

As indicated in the case scenario and the study findings, the use of the EHR can result in a unique set of ethical and legal challenges. Nurses must be prepared to face these challenges and recognize the requirements of state and federal law, workplace policies, and obligations of the profession. A study in 2006 revealed that nurses spent a majority of indirect nursing time documenting in the EHR, demonstrating the critical necessity of proper usage to satisfy quality of patient care ( Kim, 2006). The Scope and Standards of Nursing Practice ( ANA, 2015) establishes the standard of practice for registered nurses in the United States, noting "Nurses must document relevant data accurately and in a manner accessible to the interprofessional team" ( ANA, 2015, p. 54). Documentation in the nursing record must follow principles of "factuality, accuracy, completeness, timeliness, organization, and compliance" ( ANA, 2015, p. 270). Documentation must be clear and accurate to provide a basis for the contribution of nurses to patient outcomes and the viability of healthcare organizations ( ANA, 2015).

Documentation that fails to meet these principles can result in undesirable outcomes for the nurse, patients and families, or for the healthcare organization ( ANA, 2015). Nursing documentation, electronic or handwritten, are legal documents that can, under some circumstances, be used in legal proceedings. Nurses maintain competence regarding the legal significance of documentation and therefore must demonstrate legible and comprehensive reporting ( Larsen, 2012). Some EHR systems are designed as templates or 'fill-in' instruments, which allow for auto-population of lab results or other critical information ( Sittig & Singh, 2011). The auto-fill function can result in unintentional documentation of a clinical finding that may not be within a nurse's clinical purview ( Sittig & Singh, 2011). Once documentation has been electronically recorded and signed by the nurse, the liability of that acknowledgement is not clear.

A number of healthcare organizations have implemented 'copy and paste' policies for documenting in the EHR. The copy and paste functionality includes copying, pasting, cloning, auto-filling, carrying forward, replicating data and reusing content from one section to another within the EHR ( Scruth, 2014). The copy and paste phenomenon has caused significant debate from those who argue its necessity for time efficiency weighed against the significant risk of inaccuracy and patient safety errors ( Harrington, 2017). Copy and paste functionalities can result in unintentional reliance on outdated or inaccurate clinically relevant information, such as treatment plan; distracted notes; diagnostic biases; incorrect information for a specific patient visit; and expired patient symptoms and assessments ( Scruth, 2014; Weis & Levy, 2014). These practices can result in timeliness issues or time-related accuracy of documentation in any EHR.

... healthcare providers have experienced notable challenges to balance necessary time for patient care with computer entry. EHRs are designed to facilitate easier provider order entry and have been shown to reduce prescription errors ( Scruth, 2014). They have tremendous potential to improve efficiency of healthcare delivery and improvement of quality patient care. However, healthcare providers have experienced notable challenges to balance necessary time for patient care with computer entry ( McBride et al., 2017; Wolf et al., 2016). In the early 1990s 'charting by exception' was an acceptable method to decrease charting in nursing ( de Ruiter et al., 2016). Historically, it was assumed that all standards of care were met unless documented otherwise. However, with the introduction of the EHR, complete documentation requires charting of all clinical assessments, care plans, interventions, and outcomes requiring more time for documentation ( de Ruiter et al., 2016).

As a result of time constraints and usability issues, nurses have reportedly been intentionally entering false information to bypass or 'work-around' EHR systems ( McBride & Tietze, 2017). Although privacy, security, and confidentiality have been identified as three main areas of concern when using EHRs, little attention has focused on false entries, work-arounds, or system bypasses ( Ayatollahi, Mirani, & Haghani, 2014; CMPA, 2015).

...a false entry into an EHR can follow a patient for years. Additionally, alert fatigue and clinical information overrides must be addressed within the organization. Legal concerns over notification of federally regulated drug interactions, through pop-ups or alerts, can be overwhelming or desensitizing to the nurse ( Sittig & Singh, 2011). Overriding content in what is often an undesirable system design can result in misinformation in charting that can have detrimental effects on the nurse, patient, and healthcare organization. For example, a false entry into an EHR can follow a patient for years. The patient is likely unaware of the false entry, but subsequently applies for health or life insurance. The patient may be denied insurance coverage based on a one-time false entry that was replicated over time.

We conclude with a call to action for interprofessional teams, associations, industry, and others to collaboratively address these issues on behalf of the health and safety of the nation, and equally as important, the health and well-being of the healthcare workforce. To do that, the authors suggest the following recommendations to address challenges with EHRs. These recommendations may help mitigate ethical and legal issues arising as a result of the massive uptake of technology that has resulted in the digital age of healthcare delivery.

Nurses must have a seamless mechanism for reporting EHR challenges... Nurses face time constraints, overstaffing, and unfamiliarity with EHR systems on a daily basis. Healthcare organizations must have structures in place at the unit, management, and administrative levels to facilitate effective use of EHRs in nursing practice. For example, some EHR contracts have "hold harmless clauses" which restrict nurses' ability to effectively and timely report EHR problems ( Sittig & Singh, 2011). Nurses must have a seamless mechanism for reporting EHR challenges (e.g., inappropriate or cumbersome alerts) without an arduous process or fear of reprisal. This type of support could potentially mitigate the moral distress noted in the case scenario.

Culture of Safety
Nurse managers and executives have a particular obligation to ensure that direct care nurses are empowered to identify and engage in ethical situations associated with EHRs. All nurses are "responsible for contributing to a moral environment" in healthcare ( ANA, 2015, p. 24). Nurse managers and executives have a particular obligation to ensure that direct care nurses are empowered to identify and engage in ethical situations associated with EHRs. The ANA Scope and Standards of Practice for Nursing Administration (2009) cites the obligation of nurse administrators to advocate for practice that reflects the Code of Ethics ( ANA, 2015). It specifies duties that nurses in leadership and managerial roles have, particularly in transformational and servant leadership frameworks, to open communication and to act "entirely on the behalf of those led" ( ANA, 2009, p. 8) to identify problems and integrate ethical provisions in all areas of practice. Nurses in administrative roles should promote a culture of safety in their settings that include reducing the risk of harm arising from inadequate EHR design, and usability ( ANA, 2009).

Studies have shown that nurses with one year or less in practice demonstrate almost 70% more timely charting than nurses with more years of experience ( Ahn, Choi, & Kim, 2016). This emphasizes the need for continuing education for novice and expert nurses in EHR management and documentation. Informatics specialty nurses and advanced practice nurses can serve as leaders to assess and research documentation for timeliness and accuracy, along with providing continuing education on a frequent basis ( Scruth, 2014). Education about principles of documentation and competence in specific EHR system usage is needed to foster nurse mastery and development to successfully improve health outcomes ( Goodman, 2015).

Awareness of Support of Interprofessional Imperatives
Guidelines and best practices, such as the American College of Physicians position paper on clinical documentation ( Kuhn, Basch, Barr, & Yackel, 2015), ANA ( 2015) position statement on Privacy and Confidentiality,and American Nursing Informatics Association ( 2015) position statement on Addressing the Safety of Electronic Health Records are critical to ensuring that nurses are able to efficiently and appropriately meet principles of documentation. The American Health Information Management Association ( AHIMA, 2011) Code of Ethics has 11 principles with interpretive statements, referred to as guidelines, that seem to underscore the importance of practices that stand in stark contrast to the experiences of nurse participants in the Texas nursing research ( McBride et al., 2015). The AHIMA principles cite the primacy of accuracy, avoidance of conflicts of interest, and similar to the ANA code, "respect [for] the inherent dignity and worth of every person" ( AHIMA, 2011, 11). Under this AHIMA principle, the noteworthy guideline to "ensure all voices are listened to and respected" ( AHIMA, 2011, 11.4) demands that health information managers not only welcome input from nurses who find the technological determinism of EHRs violates ethical practice and clinical judgment, but also seek out that input.

... the patient's story of his/her illness may be lost to the goal of generating standard data points that, in turn, trigger algorithms and practice recommendations. For care characterized by "screen-driven information gathering" ( Lown & Rodriguez, 2012, p. 393) the patient's story of his/her illness may be lost to the goal of generating standard data points that, in turn, trigger algorithms and practice recommendations ( Brown, 2015). This computational capacity may establish EHR information as authoritative, potentially displacing work processes critical to nurse-patient interaction.

As evidenced in the study themes and the case scenario presented, critical thinking may be hindered and experiential knowledge devalued ( Campbell & Rankin, 2017). Most importantly, the EHR must not substitute for a current and accurate clinical assessment, and appropriate intervention ( Campbell & Rankin, 2017; Lown & Rodriguez, 2012; Sulmasy et al., 2017). Systems and technologies such as EHRs that assist in clinical practice are adjunct to, not replacements for, nurse knowledge and skill ( ANA, 2015).

Most importantly, the EHR must not substitute for a current and accurate clinical assessment, and appropriate intervention. Finally, as reflected in the Texas study and clinical scenario, current technology in the healthcare industry often presents challenges with usability, design, implementation, and failure to adequately support clinical teams. This results in ethical situations often associated with feelings of moral distress. Application of the FCM can assist clinical teams to explore and potentially resolve these issues. Additionally, the authors recommend further research into the moral distress noted in emerging evidence, including the TNA-TONE statewide study and the case scenario presented. As such, the healthcare industry has an imperative to identify and address ethical issues with use of EHRs.

The authors wish to acknowledge the support for the study by Texas Nurses Association (TNA) and the Texas Organization of Nurse Executive (TONE). From the beginning in 2010 when the TNA Board of Directors resolution was passed, the two organizations created the partnership that provided cumulative guidance, funding, and dissemination efforts throughout the years. Specifically, we would like to acknowledge the staff of these organizations, the dozens of volunteer committee members who have served, and the report writing sub-committee of Susan McBride, Mary Anne Hanley, Cindy Zolnierek, Laura Thomas, Mari Tietze, and Huaxin Song. Finally, we acknowledge the many subject-matter experts who, through numerous focus groups, helped yield the final surveys. Please see the TNA/TONE HIT Web site for the long list of names.

Dr. McBride is a Professor at the Texas Tech University Health Sciences Center School of Nursing whose research focus is on methods development for implementing, evaluating and utilizing health information technology to address patient safety, quality and population health. Dr. McBride was the Principal Investigator for a Texas Statewide Study of Nurses Satisfaction with their electronic health records. She is a professor with teaching responsibilities supporting graduate courses in statistics, informatics, and epidemiology. She is a Fellow in the Academy of Nursing and sits on the Information Technology and Informatics Expert Panel.

Dr. Tietze is a Professor at the Texas Woman's University (TWU) College of Nursing, teaching informatics courses focused on interprofessional collaborative practice and Director of the Graduate Certificate in Interprofessional Informatics program. Dr. Tietze is the Doswell Endowed Chair for Nursing Informatics aimed at advancing nursing informatics at TWU. Since 2010, she has been the co-chair of the Texas Nurses Association/Texas Organization of Nurse Executives Health Information Technology committee to represent nurses' experiences related to information technology use in their practice of patient care delivery. Research focus is telehealth with a telemedicine, remote management and mobile health component. Dr. Tietze has been certified since 2000 by ANA in Informatics Nursing.

Dr. Robichaux is an Adjunct Assistant Professor at University of Texas Health; San Antonio, Texas and The University of Mary in Bismarck, North Dakota. She has taught ethics at the undergraduate and graduate levels and conducted research on moral distress and ethical climate among other issues. Catherine was a member of the Steering Committee to revise the Code of Ethics and is currently a member of the ANA Ethics Advisory Board.

Ms. Stokes is the Director of the American Nurses Association Center for Ethics and Human Rights. She worked for several years as a critical care nurse and later received her law degree. She worked as a consultant for the D.C. Board of Nursing interpreting professional ethics provisions and recently completed her masters in bioethics. Her leadership is demonstrated through various charitable roles. Liz serves as an Associate Editor for the Journal of Bioethical Inquiry and is a volunteer with the D.C. Bar Association. She is currently an American Academy of Nursing Jonas Health Policy Scholar.

Dr. Weber is a nurse attorney and Clinical Assistant Professor at the University of Minnesota School of Nursing, where she teaches ethics, leadership, and public policy in the context of a continuum of interprofessional healthcare. She founded and leads the Upper Midwest Healthcare Legal Partnership Learning Collaborative. She serves on the American Nurses Association Center for Ethics and Human Rights Advisory Board and the University of Minnesota Medical Center (Fairview) ethics committee.

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© 2018 OJIN: The Online Journal of Issues in Nursing

Article published January 31, 2018

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Identifying and Addressing Ethical Issues with Use of Electronic Health Records

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Susan McBride, PhD, RN-BC, CPHIMS, FAAN Mari Tietze, PhD, RN-BC, FHIMSS Catherine Robichaux, PhD, RN, CNS, Alumnus CCRN Liz Stokes, JD, MA, RN Eileen Weber, DNP, JD, BSN, RN, PHN With the passage of the Health Information Technology for Economic and Clinical Health Act in 2009, the United States, as of 2017, has achieved 95% saturation with electronic health records as a means to document healthcare delivery in acute care hospitals and guide clinical decision making.

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23andMe: A new two-sided data-banking market model

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23andMe: A new two-sided data-banking market model

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BMC Medical Ethics 17, Article number: 19 (2016) Cite this article

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Abstract

Background

Since 2006, the genetic testing company 23andMe has collected biological samples, self-reported information, and consent documents for biobanking and research from more than 1,000,000 individuals (90 % participating in research), through a direct-to-consumer (DTC) online genetic-testing service providing a genetic ancestry report and a genetic health report. However, on November 22, 2013, the Food and Drug Administration (FDA) halted the sale of genetic health testing, on the grounds that 23andMe was not acting in accordance with federal law, by selling tests of undemonstrated reliability as predictive tests for medical risk factors. Consumers could still obtain the genetic ancestry report, but they no longer had access to the genetic health report in the United States (US). However, this did not prevent the company from continuing its health research, with previously obtained and future samples, provided that consent had been obtained from the consumers concerned, or with health reports for individuals from other countries. Furthermore, 23andMe was granted FDA authorization on February 19, 2015, first to provide reports about Bloom syndrome carrier status, and, more recently, to provide consumers with "carrier status" information for 35 genes known (with high levels of confidence) to cause disease.

Discussion

In this Debate, we highlight the likelihood that the primary objective of the company was probably two-fold: promoting itself within the market for predictive testing for human genetic diseases and ancestry at a low cost to consumers, and establishing a high-value database/biobank for research (one of the largest biobanks of human deoxyribonucleic acid (DNA) and personal information).

Summary

By dint of this marketing approach, a two-sided market has been established between the consumer and the research laboratories, involving the establishment of a database/DNA biobank for scientific and financial gain. We describe here the profound ethical issues raised by this setup.

Peer Review reports

Background

23andMe is a company based in Mountain View, California. This specialist company operates in the biotechnology sector and was founded in 2006 by Linda Avey and Anne Wojcicki. Google has been one of the principal investors in the four rounds of investment in this company (Table 1) [ 1]. 23andMe offers a direct-to-consumer (DTC) genetic testing service based on the use of single-nucleotide polymorphisms (SNPs) to determine ancestry and to identify genetic markers associated with specific diseases and conditions and a few specific causal variants that the company claimed could provide information about their clients' health and how to improve it [ 2]. The approach used can be summarized in five steps, as follows (Fig. 1): 1) online consent and ordering of the kit; 2) delivery of the kit to the client's home for the collection of a saliva sample; 3) shipping of the saliva sample to 23andMe; 4) DNA extraction and analysis on an Illumina Human Omni Express-24 chip (2 million SNPs covering the whole genome); 5) provision of the genetic results online via a personalized 23andMe web account six to eight weeks after reception of the sample by the company. However, DTC health genetic testing was being carried out in the absence of a medical prescription or information from a whole-genome analysis (WGA) based on genome-wide association (GWA) studies. The use of such an approach raised questions about the reliability of the 23andMe test in terms of the rates of true and false negatives and positives (as this test had not been validated as a health test), and of the information delivered to consumers.

Table 1 Series dates, amounts and names of the main investors in 23andMe [1]

DTC genetic testing service of 23andMe, according to its website

Beyond the legal issues, we focus here on the original nature of the service provided to consumers and its probable consequences in the near future. Indeed, given the exponential nature of the 'geneticization' of medicine and medical research [ 3] in the US and Europe over the last decade, requests for DNA and biological samples from research laboratories have greatly increased in number. The interface between patients and research remains complex and potentially conflictual, due to ethical issues relating to the ownership of the body and of any data pertaining to it, which are still under debate. In this context, a simple but innovative way of proceeding may have emerged. Given how difficult it is to obtain biological samples from a large cohort with the consent and full history of the patients in a short space of time by the standard route, the idea of creating an interface between individuals and researchers has emerged. Indeed, information about human genomes, in addition to being a personal source of useful information for treating the sick or for healthy people that might become sick, could be exploited and used as a source of profit for companies. This vision raises profound ethical issues about the way in which subjects are included in research and about how information about them is gained and used.

An analysis of the 23andMe website and the scientific literature highlights how this and other American biotech companies have specialized in medical genetics so as to become essential intermediaries between researchers and their research subjects, through the generation of DNA banks and biobanks containing hundreds of thousands of different samples provided for DTC genetic testing.

Discussion

23andMe: the two-sided market model

According to the 23andMe website, particularly the "Terms of Service" section, two types of service seem to be on offer: DTC genetic testing service and participation in "23andMe Research". The DTC genetic testing service is the service most highlighted and best understood on the website and on social networks (mostly Facebook and Twitter). As explained above, DTC genetic testing is based on the use of SNPs to identify genetic markers associated with specific diseases and conditions and a few specific causal variants. This test is a type of whole-genome analysis (WGA) carried out with a microarray, based on a technique different from whole-genome sequencing (WGS) or whole-exome sequencing (WES), in which all the nucleotide sequences of the genome (WGS) or exome (WES, the exome being the sum of all the exons present) are determined. Interestingly, 85 % of all known disease-causing mutations are in coding regions (detectable by WES) [ 4]. The genetic information obtained by testing is made available to the consumers via their own protected personal 23andMe web accounts. The company states that its consumers are protected by federal law, under the Genetic Entitled Information Non-Discrimination Act (GINA). This law, in its current state, protects Americans against discrimination on the basis of genetic information. However, according to the "Consent and Legal Agreement" (commercial contract) and the "Research Consent Document" (informed consent), consumers can agree to their genetic information, web behavior information and self-reported information (Fig. 2) being used in the 23andMe Research program, the second service on offer.

Definitions according to the "Full Privacy Statement" section of the 23andMe website

23andMe Research could be considered as a voluntary and optional service of the DTC genetic testing service. According to the "Terms of Service", this service is different from their Research and Development activity (R&D), and is designed to improve services and to offer new products or services to consumers. According to the "Full Privacy Statement" section, "23andMe Research refers to scientific research conducted by 23andMe or third parties in collaboration with 23andMe". The "third parties" are "public, private, and government partnerships to develop research and advance genetic understanding". Consumers must sign the informed consent freely available from the company's website if they wish to make use of this service. This option is associated with the notion of a "full service", because the company announces that it involves the supply of additional beneficial information not available to consumers making use of the DTC genetic testing service only and not providing informed consent. The third parties are the other side to the 23andMe Research offer. Indeed, in exchange for information about their genes, the consumers supply not only money, but also web behavior information and self-reported information. All of this information is shared with or sold to third parties for the purposes of scientific research and commercial applications, patents or operating licenses. Ethically, 23andMe seems to be at the center of a flow of information between people and research.

Can 23andMe be considered to constitute a two-sided market strategy? By definition, a two-sided market model is a market in which two different user groups interact via an intermediary economic platform, known as a "two-sided platform" [ 5- 7]. This set-up makes possible exchanges that would not otherwise have occurred, creating value for both sides. Both sides (in this case, the people seeking DNA analyses and the structures seeking to obtain information about them) can be considered to be consumers. Two-sided markets exist in many different types of industry, occupying the same economic space as traditional offers of products or services, such as those provided by Facebook, Sony or Google (Alphabet), for example. Such a market may exist in the case of 23andMe, and may, indeed, always have been planned as a business strategy. This company may effectively constitute a two-sided platform, with two kinds of consumers: people who want information about their own genes (for multiple reasons), and researchers and others who want access to genetic, web behavior and self-reported information for a large number of people (Fig. 3). The use of this strategy enables 23andMe to obtain biological samples, DNA samples and accurate self-reported information for DNA and biobanking (Fig. 2), with probable strong positive-feedback effects on their business model in the long term. The term "data-banking" does not appear in the informed consent document or in any other document on the website, including the "Privacy Highlights" and the "Terms of Service" ( www.23andme.com, US, UK, EU and Canada). The term "bio-banking" is used once, but only to describe the storage of saliva samples (Fig. 2). Three separate events have favored this approach: growing financial investment, falling prices of genetic testing and an exponential increase in the number of consumers over a very short period of time (Fig. 4) [ 1].

23andMe two-sided market model. Information flows relating to the consumer and his/her body and the database are shown in blue. Biological (saliva) sample flows and to and from the biobank are shown in green

a Increasing investment in 23andMe over time. Decrease in kit price over time. November 2010: $399 or $199 + $5 less (at least one year). March 2011: $399 or $99 + $9 per month (one year). b The almost exponential increase in the number of users coincides with the falling price of the kit to $99 in November 2012 [ 1]. c Increase in the number of users over time

DNA banking issues

In the past, biological samples were stored in a single laboratory [ 8], but large collections of DNA samples are becoming increasingly common in human genetics. With the publication of the first draft sequence of the human genome in Nature [ 9] and Science [ 10], and its completion by the Human Genome Project, the strategic importance of DNA banking and data collection has increased. Over the last 10 years or so, medicine and medical research have become increasingly "geneticized", with the general population becoming increasingly interested in genetic aspects. DNA can be obtained from a number of potential sources, including the blood, cell and tissue banks of hospital and academic research centers, and it has been estimated that there are already several hundred million biological samples stored in such repositories [ 11]. 23andMe do not state the exact number of samples to which they have access on their website or in other documentation, but it can probably be safely assumed that they have a collection of hundreds of thousands of biological and DNA samples. Indeed, their collection may be one of the largest available and it is driven not only by scientific or medical aims, but also by business imperatives [ 12]. 23andMe have established a high-value biobank and database for use by private and public research laboratories (Fig. 3).

DNA banking is becoming a business and there is a rush to acquire DNA sequencing data, which may prove to be the organic and molecular equivalent of a gold mine. With personalized medicine, biofuels and genetically modified organisms (GMOs), the potential gene market in 2030 is estimated to be worth as much as $100 billion [ 13]. In 2001, the technology used to sequence the human genome was still based on capillary electrophoresis of individual fluorescently labeled Sanger reaction products; it produced 115 thousand base pairs per day [ 14] for a total cost of almost $3 billion [ 15]. For 30 years, until the advent of next-generation sequencing (NGS) methods, "Sanger sequencing" was the only method used for DNA sequencing [ 16]. Devices for NGS first appeared in 2007 and owe their success to a synchronous sequence analysis, resulting in faster, more sensitive analyses at a lower overall cost [ 17]. Indeed, whereas Sanger's direct (or first-generation) sequencing method requires the generation of DNA strands of different lengths labeled with a fluorophore for analysis, NGS methods reconstruct previously prepared DNA strands by direct determination of the nucleic acids incorporated [ 18]. These methods, based on a sequencing-by-synthesis approach, have increased sequence output per run and read length, and have decreased costs and improved the accuracy of base-calling [ 14]. With the release of the HiSeq X Ten, the genetic sequencing company Illumina is currently attempting to solidify its domination of the market, with the possibility of sequencing an entire genome for $1,000 [ 15]. However, this offer is not yet available to everyone, as the HiSeq X Ten system is available only as a combination of at least 10 HiSeq X machines, with each machine costing around $1 million (Illumina source). This system could sequence the genomes of 18,000 humans per year. However, even if DNA sequencing costs are declining, questions still remain about the generation, storage, analysis and interpretation standards for genetic data. This issue is of particular relevance for DTC genetic testing, even if WGA by genome-wide SNP chip approaches are subsequently replaced by WGS.

For DNA sequencing, a DNA source is required, and interpretation of the genetic data generated requires information about the source, such as clinical data or private data for the patient. Obtaining more information about the source improves the quality of interpretation for genetic data and, thus, their scientific and medical value. However, these new approaches require even faster technology, as previously reported. In 2012, Oxford Nanopore Technology (ONT) introduced a new sequencing system called Minion, based on nanopores (pores with a diameter between 1 and 100 nm). This technology has two advantages: sample preparation is very simple and does not require expensive reagents and longer reads can be obtained (>1,000 bp). However, the error rate (4 %) is currently too high for most of the applications envisaged, including medical diagnostics. Nevertheless, this technology may, in the near future, provide real new opportunities for DTC testing services. Indeed, in medicine and industry, the key issue is the relationship between specific genetic sequences, not necessarily restricted to SNPs or potential causal mutations, and particular diseases, with a view to guiding treatment and developing new drugs. This relationship is the key to the financial value of DNA data and may be the premise underlying the development of two-sided platforms, such as that of 23andMe, for obtaining large numbers of samples and considerable amounts of information for research and industry through a DTC genetic testing service. These approaches are based on DNA banking, but DNA sample collections may differ considerably in several critical ways: storage, confidentiality, requests, security and quality [ 19]. These aspects and the differences in them between collections raise ethical issues.

Ethical aspects of the model

The two-sided market model of 23andMe can be considered a case study. This model raises important ethical questions about genetic testing, DNA banking and research relating to autonomy, ownership of the body, data obtained from the body, and informed consent (Fig. 5). The people sending samples are not considered to be patients. They are instead considered to be consumers, and the majority are healthy. They are given the opportunity to give informed consent for participation in scientific research, but they primarily sign a commercial contract and pay for the purchase of a service, offering genetic testing. When obtained, consent is not given during an individual medical consultation with a physician or a genetic counsellor at a hospital or in a doctor's surgery. The clients give their consent alone, via their computer, at home. This set-up raises a major ethical issue: that of the autonomy of the individual, in particular, and the right to access to his or her own genetic information [ 20]. In France, oral information explaining the goal of testing is considered necessary. According to French civil law, the individual does not own his or her body and cannot ask directly for genetic health tests to be directly. Furthermore, it remains a matter of debate whether individuals really have the right to access their own genetic information, their own DNA [ 21, 22]. Instead, a physician must prescribe the test, with the approval of the " Agence de Biomédecine" (Biomedicine Agency). Moreover, the test cannot be performed by a private company, but only by a public genetics laboratory also approved by the " Agence de Biomédecine". A medical diagnosis must be based on the sequencing of specific genes to be considered accurate. The need to protect privacy is illustrated by the family imbalances, preventive and curative surgery following diagnosis and discrimination by insurance companies that may result from poor regulation [ 23].

Ethical aspects of the 23andMe model and connections with Google. Information flows relating to the consumer and his/her body and database are shown in blue. Ethical issues are shown in red

Several studies have focused on genetic tests and raised the issue of the apparent ethical conflict between two concepts of autonomy: some specialists from different countries prefer to maximize autonomy, whereas others support the notion that autonomy is only effective if accompanied by protective measures [ 24, 25]. Some authors have suggested that one of the prerequisites for autonomous choice is that the person is able to understand the information provided and to provide a rational argument for his or her choice [ 26- 28]. The degree of autonomy of the customers of companies such as 23andMe is highly variable, depending on genetic competence [ 29]. Indeed, we can assume that the individual's knowledge of genetics, family history and the penetrance or pathogenicity of the disease will determine his or her ability to evaluate the benefits and risks of genetic testing and the consequences for members of his or her own family, to compare tests prescribed by a physician and non-prescribed tests and to compare the different DTC testing companies in terms of the quality of the services on offer.

Two major problems relating to autonomy are immediately apparent here: the problem of scientific literacy [ 30] and the lack of training of physicians in genetics [ 31, 32]. Indeed, it has been shown that more than half the individuals buying genetic tests online subsequently consult a physician to discuss the result [ 33]. It might therefore be a good idea to create a "direct-to-physician genetic reporting service", or at least an optional service of this kind, effective before and after the purchase of the kit. Such a service would ensure that physicians were better trained in the interpretation and explanation of genetic tests and would ensure better counseling and follow-up for users, while providing users with greater autonomy. It would also make it possible for the test offered by 23andMe to be considered a real medical diagnosis test rather than as simply providing information. This vision of autonomy differs from those prevailing in the UK and the US, in which all individuals wishing to have access to their genetic and medical data are free to do so, provided an agreement has been reached with the family in cases of clinical analysis, regardless of their level of genetic knowledge and the conditions of the service on offer [ 29, 34].

The press has reported incidents in which families requesting genetic tests via the Internet have learned, from the results obtained, that the presumed father was not the real biological father or in which the biological father has found that he has children that he didn't know existed [ 35, 36]. 23andMe warns its clients in advance of the possibility of such discoveries being made through its tests (see the website and blog of 23andMe) and seems to have resolved this problem. It nevertheless remains legitimate for civil society to pose the question as to whether private companies should be able to reveal such information through so-called "phylogeny" or "health report" genetic testing rather than through (official) paternity tests, particularly if they do not ensure, other than virtually, that this choice was consented to by all of the people concerned by the results and not just by the principal person concerned [ 34]. For preventive surgery, the best known case is undoubtedly that of an American actress who underwent a prophylactic double mastectomy following positive results in a genetic test for the breast cancer 1 (BRCA1) mutation [ 37]. In the wake of her decision, an increase was observed in the numbers of BRCA1 and 2 tests and of prophylactic double mastectomies carried out [ 38]. Over and above the principle of not doing harm, which is called into question by major, potentially traumatic surgery, this approach also raises questions about the principle of autonomy, because there may be a risk of abuse in the long term. Indeed, if such practices were to become systematic, insurers might have the right to oblige their clients to undergo testing if they have a family history of disease, particularly for genetic predispositions to cancer, due to the costly and debilitating nature of targeted treatments if the disease is diagnosed late.

Ethical issues also arise within the testing company. These issues include the dematerialization and digitization of data, the anonymization of genetic data, the confidentiality of self-reported information and the storage of data and samples (Fig. 5) [ 39, 40]. Indeed, when informed consent forms and the commercial contract are signed digitally, the consumers provide the company with their names, together with a set of personal information about themselves and their families relating to health and ethnicity. The company states on its website that names, addresses, e-mail addresses and bank data will not be disclosed or used. Nevertheless, such information (Fig. 2) significantly increases the medical, scientific and financial value of the data. It is therefore unsurprising that the contract stipulates that data, DNA and biological samples will be kept and may be re-used in other research if the consumer consents. With the multiplication of this transaction by hundreds of thousands of individuals, the company is well aware that its consumers have not only paid a few hundred dollars each, on average, for genetic testing services, but have actually sold their samples and information for inclusion in a major biobank and database for use by scientists and doctors. But what are the consequences for the consumer? Can separate pieces of information about an individual be brought together? Particularly as concerns the consumer's name and important items of personal information? These issues have not been sufficiently explored by the company, which seems to safeguard its own interests more strongly than those of its consumers, although 23andMe received institutional review board approval for its research protocol and a revised consent document in 2010 (23andMe blog). Indeed, Genentech has paid $60 million (in total) for the WGS data of 3,000 23andMe consumers with Parkinson's disease, with the aim of generating new therapeutic target leads [ 41]. However, despite large amounts of clear, illustrated information about the phenotypes and/or diseases revealed by their analyses, the robustness and accuracy of the chip used for testing are not perfect at individual level and not all of the mutations detected have been validated by Sanger sequencing (thereby potentially mixing false and true positives and negatives). A client may therefore unknowingly carry a deleterious mutation that may be reported in the information delivered by the company or may knowingly carry such a mutation that is not identified in the results delivered by the company. The risk of false-positive or false-negative results for these tests is the principal concern of the FDA and its approval process [ 42]. However, in the context of a study of several thousand people (carried out by GWA), missing a single SNP in an individual is not a problem because there are thousands of others. At an individual level, missing a SNP may have much greater consequences. The previous economic model was based on low prices to attract more consumers, providing more data and biological samples to be valorized and sold. The four rounds of investment in this company (Fig. 4) may have been designed to address the problem of the probable lack of benefit from this side of the market until the second market had been established (Fig. 3) [ 43]. This second market has now been established through the collaboration between 23andMe and Genentech.

According to a French Agence de Biomédecine report on genetic tests published in 2014 [ 44], there is currently no consensus definition of a genetic test and very few countries have adopted specific legislation relating to genetic testing, the principal countries to have done so being Austria, Switzerland, Germany and Portugal. In the United States, genetic tests for medical purposes are accessible without a medical prescription and are billed by the laboratories concerned. However, 24 American states have prohibited divulgation of the results of genetic tests in the absence of a physician. Nevertheless, companies selling genetic tests via the Internet, such as 23andMe, at least before they were prevented from doing so by the FDA, report the results of their tests directly to their clients. According to an Institut National de la Santé et de la Recherche Médicale (INSERM) report on genetic tests dating from 2008 [ 45], this is permitted because genetic information is not considered to be particularly sensitive in the US. Instead, it is seen as ordinary personal information, unless supplied by a genetic test governed by the FDA. Nevertheless, increasing numbers of "genetic privacy" laws have been passed in the US in recent years, by contrast to Europe, which now seems to be moving in the opposite direction [ 44]. Indeed, the European Union (EU) is increasingly moving towards the broader and freer circulation of data for research purposes [ 44]. According to the French Agence de Biomédicine report published in 2014 [ 44], the UK has recently gone further, because the Human Genetics Commission responsible for providing the British government with expert advice now considers that it would not be desirable to ban tests bought over the Internet, simply because it would be impossible to police such a ban given the freedom of access to the Internet available today. However, it did recommend the establishment of a certain number of guidelines concerning test quality, the information transmitted and the qualifications of those carrying out the test. The proof of this shift in position is that 23andMe entered the British market in December 2014, about a year after it was banned by the FDA in the US [ 41, 46]. Ireland, Denmark, Finland, the Netherlands and Sweden have all accepted the sale of the 23andMe test in their territories (23andMe Europe). It might be possible for France to follow the same course of action. Most countries are currently facing a change in the definition of health data much more complex than any previously observed, which has been neglected for far too long. It is now possible to generate health data with non-certified medical technologies as simple as a smartphone or any kind of connected object [ 47]. Is it really the fault of 23andMe for having understood this issue or that of the health authorities for not having thought sufficiently deeply about it?

The data and samples that 23andMe "lend" to different research teams also raise two other ethical problems: the inequality of access to data and samples between research teams due to differences in financial resources or nationality, as the laws of some countries are not compatible with the patentability of human genes (Fig. 5.). One direct consequence is a significant bias in the race for publication and international tenders [ 39]. The issue of the patenting of human genes is far from resolved, particularly in the US and in European countries, such as France. In the emerging world of targeted molecular therapies and genetic tests for diagnosis and prognosis, these questions will need to be addressed [ 39, 48]. There are already inequalities between research teams in terms of the production and use of scientific knowledge, through access to high-quality scientific publications or various new technologies, probably due to significant qualitative and quantitative differences in resources between countries and between research teams in the same country. Should access to and use of knowledge be based on the financial clout of a team or its scientific intuition, particularly if society hopes for new ideas to emerge from science [ 49]?

Another link that would merit closer scrutiny is that connecting 23andMe to Google. Google was one of the principal investors in all four rounds of financial investment in this company. Google may be interested in the web behavior information for its search engine activity, and in the self-reported information and genetic information, which may be of use to subsidiary companies, (e.g., X, originally Google X lab) (Fig. 5). This idea raises other ethical issues due to the transhumanist vision of Google, with its growing monopoly on the emergence of new technologies, ultimately resulting in a lack of competition and, in some instances, a possible threat to democracy. Indeed, after five years of investigation, the European Commission accused Google of abusing its dominance of the market in April 2015 [ 50]. This example illustrates the difficulties inherent to companies attempting both to provide services and to relay information. 23andMe should therefore carefully consider the risks they face, because, in this instance, the products are biological materials and health data.

Conclusion

23andMe had the brilliant and original idea of responding to the desires of the population at a large scale. In accordance with legislation, they offer consumers genetic data obtained with current technology and they aim to create a valuable biobank with data and DNA from 1,000,000 individuals. This new two-sided data-banking market is developing more rapidly than consumer protection laws. A profound ethical reflection on the practices of this new market model is therefore required, taking into account the history of 23andMe and other companies. By communicating more openly with clients and with the press about its data-banking activities, 23andMe might help the wider community to perceive the benefits of such a large-scale donation of data (genetic, medical and personal) to companies through the purchase of a kit. Greater communication would also increase transparency concerning the second market, which is essential for the development of a lucrative data-selling enterprise, as it would suspend the distrust and interrogations (some based on pure fantasy) of consumers, the scientific community and the press. As expected, following the provision of more information and tests to the FDA, 23andMe was granted FDA authorization on February 19, 2015, first to provide reports about Bloom syndrome carrier status [ 41], and, more recently, to provide consumers with "carrier status" information for 35 genes known (with high levels of confidence) to cause disease [ 51]. Further authorizations are likely to follow, because ethical reflections on testing practices are now underway.

In conclusion, full information and an open mind are essential to prevent misunderstandings. This synergy between 23andMe and its research and commercial partners may extend well beyond what the consumers initially sought, with predictions for the future in which DNA molecules are used like crystal balls. It could result in new class actions, like those already experienced by the company. We may now have no choice but to deal with a new form of two-sided market model that is likely to inspire other companies in the near future. For these reasons, it is essential to anticipate developments through the ethics reflections proposed by European and Canadian bioethicists [ 19, 22], to help these companies to grow and to allow scientific research to progress, while maintaining the best possible protection of individuals.

We think that 23andMe should provide more information about its data banking activities to its clients and the press so that society can be made more aware of the benefits of such a donation of data (genetic, medical and personal) through the sale of the kit via the Internet. We recommend greater transparency concerning the second market the sale of the data obtained. If such an approach had been employed from the outset, much suspicion and many questions (some entirely based on fantasy) from consumers, the scientific community and the press might have been avoided, together with the class action against the company. However, companies such as 23andMe are raising key questions that we need to address, concerning autonomy, ownership of the body, data relating to the body and informed consent in the new digital age. It has now become necessary to define new rules validated by all for the use of different balances between consumers and patients, the services offered and private and public healthcare, freedom and justice in a democratic, liberal and globalized background, if we wish to construct a new world in which the patient is fully respected by innovative genius, enterprise and international law.

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Abbreviations

BRCA1:

Breast cancer 1

BRCA2:

Breast cancer 2

DNA:

Deoxyribonucleic acid

DTC:

Direct-to-consumer

EU:

European Union

FDA:

Food and Drug Administration

GINA:

Genetic Entitled Information Non-Discrimination Act

GMO:

Genetically modified organism

GWA:

Genome-wide association

INSERM:

Institut National de la Santé Et de la Recherche Médicale (French National Institute of Health and Medical Research)

NGS:

Next-generation sequencing

ONT:

Oxford Nanopore Technology

R&D:

Research and Development

SNP:

Single-nucleotide polymorphism

UK:

United Kingdom

US:

United States

WES:

Whole-exome sequencing

WGA:

Whole-genome analysis

WGS:

Whole-genome sequencing

References

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Acknowledgment

We thank Charles-Henri Frouart for suggestions on the manuscript, Professor Pierre Laurent-Puig (MD-PhD) and CARPEM (CAncer Research For PErsonalized Medicine) for funding.

Funding

CARPEM (CAncer Research For PErsonalized Medicine).

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Authors and Affiliations

1. Medical Ethics and Legal Medicine Laboratory EA4569, Paris Descartes University, Centre Universitaire des Saints-Pères, Paris, France

Henri-Corto Stoeklé, Marie-France Mamzer-Bruneel, Guillaume Vogt & Christian Hervé

2. Laboratory of Human Genetics of Infectious Diseases, Necker Branch, Institut National de la Santé et de la Recherche Médicale INSERM-U1163, Paris, France

Guillaume Vogt

3. Paris Descartes University, Imagine Institute, Paris, France

Guillaume Vogt

4. Assistance Publique-Hôpitaux de Paris AP-HP, Necker-Enfants Malades Hospital, Paris, France

Marie-France Mamzer-Bruneel

5. CAncer Research For PErsonalized Medicine (CARPEM), Paris Descartes, APHP (HEGP, Cochin, Necker) INSERM, Paris, France

Henri-Corto Stoeklé, Marie-France Mamzer-Bruneel & Christian Hervé

Corresponding author

Correspondence to Guillaume Vogt.

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Competing interests

The authors declare that they have no competing interests.

Authors' contributions

CH, GV, HCS contributed to conceptualizing the paper, drafting sections and discussing how different sections should be refined and integrated. MFMB made substantial contributions to study conception and design. All the authors have seen and approved the final manuscript.

Authors' information

¹ Medical Ethics and Legal Medicine Laboratory EA4569, Paris Descartes University, Centre Universitaire des Saints-Pères, Paris, France. ² Laboratory of Human Genetics of Infectious Diseases, Necker Branch, Institut National de la Santé et de la Recherche Médicale INSERM-U1163, Paris, France. ³ Paris Descartes University, Imagine Institute, Paris, France. ⁴ Assistance Publique-Hôpitaux de Paris AP-HP, Necker-Enfants Malades Hospital, Paris, France. ⁵ Cancer Research for Personalized Medicine (Carpem), Paris Descartes, APHP (HEGP, Cochin, Necker) INSERM, Paris, France.

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Stoeklé, HC., Mamzer-Bruneel, MF., Vogt, G. et al. 23andMe: a new two-sided data-banking market model. BMC Med Ethics 17, 19 (2016). https://doi.org/10.1186/s12910-016-0101-9
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Keywords

Biobanking

Data banking

Direct-to-consumer (DTC) genetic testing

Two-sided markets

Research

Service

Ethical issues

# data[].attributes.attachment_link.title
23andMe: a new two-sided data-banking market model - BMC Medical Ethics

# data[].attributes.attachment_link.description
Background Since 2006, the genetic testing company 23andMe has collected biological samples, self-reported information, and consent documents for biobanking and research from more than 1,000,000 individuals (90 % participating in research), through a direct-to-consumer (DTC) online genetic-testing service providing a genetic ancestry report and a genetic health report.

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Deeper understanding of Ethical Issues in Health Informatics