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Whalen v. Roe

James. A. Haley VA Medical Center

Tampa General Hospital

Memorial Hospital - Hollywood

U.S. v. Ferrer

Florida Data Theft

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division of health informatics and surveillance

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Division of Health Informatics and Surveillance | DHIS | CDC

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CDC OPHSS CSELS Division of Health Informatics and Surveillance (DHIS) Home Page

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As in all other areas of healthcare, ethical issues arise in the use of information technology. Principles of privacy, the patient's right to autonomy and decision-making in the management of their personal health information, and concepts of fairness and equity in access to care and to information are just some examples of areas in which ethics can inform the provider's strategies and decisions.

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PRIVACY Concerns

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SECURITY Concerns

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Though the technology has been around for roughly 30 years, physicians making the move from paper to electronic medical records may still face some challenges - particularly when it comes to understanding the legal implications of EMRs. In Nov. 2011, the Centers for Disease Control and Prevention reported that the percentage of physicians who've adopted basic EMRs in their practice doubled from 17 to 34 percent from 2008-2011. The percent of primary care physicians using EMRs grew even more, roughly doubling from 20 to 39 percent in that same time frame.

A large portion of EMR implementation revolves around a seamless transition for physicians, nurses and other caregivers, so as to not disrupt workflow or take excessive time out of their day. These systems, however, pose certain legal risks for physicians and healthcare systems that should not go unnoticed.

1. Risk for medical malpractice claims. Although EMRs present significant opportunities for long-term gain, they are quite a thorn in physicians' side at first. Physicians undergoing EMR implementation are at increased risk for medical malpractice during the time of adoption. The risk of error increases during the "implementation schism," or the time between the health system's transition from a familiar system to a new one. While many believe EMRs improve patient safety, their impact on medical malpractice claims remains unclear. A 2010 New England Journal of Medicine report was unable to determine whether EMR-use increases or reduces malpractice liability overall - even after the implementation stage is complete.

Beyond boosting the mere risk of lawsuits, EMRs also affect the course of such litigation by increasing the availability of data and documentation that can either defend or prove a malpractice claim. Documentation in electronic form is often organized, detailed and more legible. Under federal law, EMR metadata - which consists of all electronic transactions such as time stamps of clinical activity and the input of orders - is discoverable in civil trials. This ranges on a state-by-state basis, however, and state law governs most malpractice litigation.

EMRs include more detailed patient information than what is required in traditional paper records, according to a report from the Federal Trade Commission. This can either help or hurt the physician's case against malpractice claims. For instance, the FTC report details a case in which a patient was left quadriplegic after surgery. The suit first targeted the surgeon's competence, but further review of EMR metadata revealed a date stamp that signaled suspicion over whether the anesthesiologist was present for the entire duration of the surgery. The availability of such EMR data in pre-trial discovery can heighten the likelihood of prosecutors finding some evidence of wrongdoing among an entire team of providers.

Sometimes basic human behavior, rather than egregious medical errors, is enough to trigger malpractice claims. EMRs provide physicians with clinical decision support, pop-up alerts, clinical prediction rules, or reminders for follow-up - a large variety of resources intended to improve care delivery. Still, while these EMR resources may influence a physician's clinical decision-making, any decisions related to patient care ultimately rest on the physician's shoulders.

"There's human tendency to fall to recommendations coming from literature," says Holly Carnell, JD, attorney with McGuireWoods in Chicago. "But if you read the EMR contract, there are various limitations related to the liability of the EMR vendor. If there's an error related to the accuracy of the clinical content or the manner in which the content is presented to the physician, it's difficult for the patient or hospital to hold the vendor accountable. That increases malpractice risk for the physicians," says Ms. Carnell.

EMRs also present the courts and the industry with previously unaddressed issues, for example, what constitutes the "legal medical record?" In the paper world, a medical record is a folder containing a stack of paper a physician uses as part of his or her basis for a clinical decision. However, in the electronic world, a physician is looking at certain screen shots in a particular order. "There's a big debate on what should be produced when a plaintiff requests a copy of a patient's medical record," says Ms. Carnell. Generally, the "print medical record" function in an EMR generates a report that bears no resemblance to what a physician was looking at when he or she made clinical decisions at the time of treatment.

EMRs are also regularly upgraded and hospitals aren't required to maintain a copy of the old environment, since doing so would be quite costly. Therefore, even if screen shots were produced, if the system had been upgraded between the time of treatment and the time the screen shots were captured, the screen shots may not represent what the physician relied upon to make a clinical decision. While there has not yet been a clear and concise resolution to this issue, it is certainly a matter to keep an eye on as EMRs continue to grow more sophisticated are more commonly adopted by healthcare providers.

2. Likelihood of medical errors. Given the tools available in EMR software, there's a common belief that EMRs can greatly reduce medical errors. But just as a reliance on spell check can leave an email peppered with spelling blunders, too much dependence on an EMR can result in small mistakes that can quickly turn into medical errors.

A 2005 study published in the Journal of the American Medical Association¹ found widely-used computerized physician order entry systems facilitated 22 different types of medication error risks. This included pharmacy inventory displays being mistaken for dosage guidelines, inflexible ordering formats that generated wrong orders, and CPOE display screens that prevented a coherent view of the patient's medications. Further, 75 percent of clinical staff surveyed said the encountered these error risks weekly or more often.

The New England Journal of Medicine article previously mentioned also pointed out that physicians' overreliance on a simple EMR function like copy and paste can perpetuate mistakes, leaving a long trail of errors less likely to be corrected. The copy and paste function also presents issues when it comes to authorship if a medical record is investigated for legal purposes. Aside from individual errors, EMRs also present the risk of bugs, viruses or other technological inefficiencies - crises that were never an issue with paper records.

Sometimes all it takes is a click of a mouse. Kenny Lin, MD, a family physician practicing in the Washington, D.C.-area, wrote a column in 2010 for U.S. News & World Report in which he recalled the time he nearly prescribed a patient the wrong medication for an ear infection due to an accidental click of the mouse. "I knew perfectly well that oral antibiotics - not eardrops - were the best choice and knew which one to prescribe, but had accidentally clicked on the wrong choice in my EMR system, leading to the wrong prescription being printed," Dr. Lin wrote in the column. Fortunately, Dr. Lin caught the mishap in time to still provide the patient with the correct prescription.

3. Vulnerability to fraud claims. The Obama administration's robust focus on healthcare fraud has signaled sharper focus on specific avenues for improper claims or billing, including EMRs. The Office of Inspector General's 2012 Work Plan included a focus on fraud vulnerabilities specifically presented by EMRs, making it the first work plan in which the agency explicitly named EMRs as targets for review. It also outlined plans to review Medicare and Medicaid EMR incentive payments to prevent erroneous payments to providers.

Apart from OIG scrutiny, EMRs present another risk to physicians when it comes to violations of the Stark Law and the Antikickback Statute. Under the Medicare Modernization Act of 2003, the Dept. of Health and Human Services developed safe harbors to promote physicians' adoption of HIT. Under these rules, published in 2006, healthcare systems or hospitals can pay as much as 85 percent of an EMR's cost for physicians in private practice. The physicians, in turn, must pay for hardware, installation and technical support. The safe harbor protects an exchange that would otherwise violate Stark Law - which prohibits monetary or non-monetary exchanges for referrals - and the Antikickback Statute. The rule was finalized under the rationale that the benefit of HIT adoption trumps potential risks of fraud.

Still, despite the safe harbor and exception, hospitals and physicians still risk legal repercussions if agreements are not meticulously crafted. "There are very specific requirements for the Stark Law exception and Antikickback Statute Safe Harbor," says Ms. Carnell. "There needs to be a written agreement carefully structured to avoid running afoul of these laws." A financial relationship between an entity offering designated health services and a referring physician will violate the Stark Law if it does not meet all of the requirements of a Stark Law exception. The Stark Law is strict liability and does not factor intent. "Even a so-called technical error, such as not fully executing the agreement, would be a violation," says Ms. Carnell.

The Antikickback Statute, on the other hand, is an intent-based statute with civil and criminal penalties. The government would examine the donation of EMR technology and determine whether there was intent to induce referrals to the hospital. "Full compliance with the Safe Harbor protects the donor and recipient of EMR technology from liability under the Antikickback Statute," says Ms. Carnell.

The Stark Law exception and the Antikickback Safe Harbor are substantially similar. However, because Antikickback is intent based, failure to meet all of the requirements of the Safe Harbor does not necessarily constitute a violation of the Antikickback Statute. "If the arrangement does not meet all of the elements of the Safe Harbor, and there is intent by the hospital to induce referrals though the EMR agreement, then the donor and recipient risk liability under the Antikickback Statute," says Ms. Carnell.

4. Breaches, theft and unauthorized access to protected health information. The Department of Health and Human Safety posts all data breaches affecting 500 or more individuals on a public website. Since Sept. 2009, there have been 380 incidents reported. The number of patients affected by health data breaches has been on the rise, with 5.4 million affected in 2010 compared to roughly 2.4 patients million affected in 2009. Theft was the most common cause of breaches affecting 500 or more individuals in 2010, the last year for which such data is available. Human error, loss of records and intentional unauthorized access to protected information were also general causes of breaches.

In 2011, Sacramento, Calif.-based Sutter Health was one system to experience a breach when a computer was stolen from its administrative offices and potentially exposed private information pertaining to more than four million patients. HHS and the Office for Civil Rights showed teeth in 2011 when they issued a civil money penalty of $4.3 million against Largo, Md.-based Cignet Health for a HIPAA violation. The fine, issued Feb. 22, was the first imposition of a CMP by the OCR for a HIPAA violation. A mere two days later, the agencies announced Massachusetts General Hospital in Boston had agreed to pay $1 million to settle potential HIPAA violations. A message was sent loud and clear to healthcare providers in those three days: OCR doesn't take HIPAA enforcement lightly.

"That was an interesting week," says Ms. Carnell. Prior to the HITECH Act [part of the American Recovery and Reinvestment Act of 2009], HIPAA was all bark and no bite. Enforcement efforts related to HIPAA were virtually non-existent. Now the government's ability and resources to pursue covered entities and their business associates is vastly enhanced," says Ms. Carnell. Economic factors come into play when it comes to this enforcement, as the administration has recognized HIPAA and HITECH violations as an ample avenue to recover funds and bring money back into a financially-addled government.

The most important steps hospitals can take to protect themselves in this environment of enforcement are thorough preparation and timely and appropriate response to HIPAA related incidents. For example, hospitals should have comprehensive HIPAA policies and procedures and the workforce should be appropriately trained to comply with such policies. Further, in the event of an impermissible use or disclosure of a patient's protected health information, the hospital should analyze the facts and circumstances, determine whether the use or disclosure rises to the level of a breach, take remedial measures to minimize the likelihood of the event happening again, report the incident as required under the HIPAA breach rules, and ensure accurate documentation is retained related to the incident.

"If a hospital is investigated or audited, it wants to be able to show it has taken steps to appropriately respond and remedy the incident. Fines aren't generally imposed unless it's an egregious violation or the violator has not cooperated with the government," says Ms. Carnell. "When a hospital suffers an inadvertent disclosure of health information because of a human error and immediately responds and remedies the situation, we haven't seen many fines." In general, the OCR has expressed a stronger focus on voluntary compliance rather than sanctions, according to Ms. Carnell.

5. Practical tips for healthcare leaders. Given the relative novelty of the EMR, hospital leaders may need to devote more strategy to ensure physicians are well-informed about compliance and legal risks. This starts in the EMR training process, which is not always easy for physicians. Given their traditional modus operandi, hospitals may need to develop certain initiatives in EMR education to make sure employees don't risk legality out of ignorance.

"Physicians are trained to autonomously practice medicine in the care of their patients," says Alan Cudney, RN, an executive consultant with healthcare consulting firm Beacon Partners. "Sometimes physicians and other members of the clinical team don't like to admit it when they don't know things. Sometimes, when teaching them to use new clinical software application, you may have to do so in a private environment. One-on-one training, as well as personalized "at the elbow" user support may be more effective, since physicians may feel less intimidated admitting uncertainties about using the EMR. In these one-on-one settings, physicians can more comfortably think about and discuss impacts of the software on their workflow, including real-life examples of how legal concepts affect their day-to-day routine.

Mr. Cudney also recommends hospital leaders promote cooperation between the hospital's IT department and physicians. The IT department can isolate itself from EMR-users within the hospital and lose touch of the "customer" focus. In this context, physicians are not necessarily customers, but should be treated as so with an emphasis on convenience, user input, reliable support and comprehensive training. When the IT department provides these services, physicians will be more accepting to change and more likely to embrace the new technology, according to Mr. Cudney. At the same time, this focus on the end-user must be balanced with a change control process that reviews all user requests and input against the strategic plan for the EMR and its impact on patient care workflows. Without adequate change control, the IT department could over-accommodate to the point of implementing inconsistent content or conflicting enhancements. To this point, hospital management should consistently evaluate physician-IT relations to ensure balance and cooperation.

1. Brian Abaluck, Abigail Cohen, Stephen E. Kimmel, Ross Koppel, A. Russell Localio, Joshua P. Metlay, Brian L. Strom. "Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors," Journal of the American Medical Association, March 9, 2005.
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5 Legal Issues Surrounding Electronic Medical Records

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Though the technology has been around for roughly 30 years, physicians making the move from paper to electronic medical records may still face some challenges - particularly when it comes to understanding the legal implications of EMRs. In Nov.

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One patient's blood pressure plummeted dangerously after he was allegedly discharged with the wrong medications. In another instance, a physician couldn't place a pharmacy order for a newborn to receive vitamin K, which is given to babies to prevent serious bleeding.

On several other occasions, patients weren't accurately tracked, creating potential problems getting drugs to them.

Each of these alleged mishaps occurred at PinnacleHealth, a three-hospital system based in Harrisburg, Pa. PinnacleHealth blames each of the mishaps on its electronic health records vendor, Siemens; Cerner Corp. purchased Siemens' health IT business in February 2015.

The incidents came to light as part of a breach-of-contract lawsuit Cerner filed against PinnacleHealth last year after the system, which had used Siemens as a vendor for 20 years, sharply curtailed its relationship and entered into a contract with a competing EHR vendor, Epic Systems Corp. PinnacleHealth related the incidents in its counterclaim; the counterclaim was filed in March of this year in state court in Pennsylvania, where it is seeking damages for Cerner's alleged fraud and breach of contract.

Cerner spokesman Dan Smith declined to comment on pending litigation, but did say "patient safety is of the utmost importance to us."

Some experts say the PinnacleHealth-Cerner battle is among the first of what could become an avalanche of legal battles over EHRs and patient safety. For years, many patient safety advocates have warned that EHR systems carry numerous potential risks due to their poor design and the ease with which data entry errors can lead to medical mistakes.

MH Takeaways A recently filed lawsuit alleging a faulty electronic health record system caused patient harm may be among the first in a wave of such cases, even though most experts say the latest EHR systems are better designed than older models.

Last year, 35 professional medical associations sent a letter to the Office of the National Coordinator for Health Information Technology at HHS warning that EHRs were raising serious patient safety concerns.

And now lawsuits are making hard allegations.

Some attorneys believe many more lawsuits are imminent. "It looks like it's a round of litigation that's about to happen as the inevitable human errors in dispensing healthcare are now being traced back to negligent use of the computer technology," said Robert Fuller, a partner at Nelson Hardiman and former chief operating officer at Downey (Calif.) Regional Medical Center.

Fuller said his firm has recently been involved in about a half dozen consultations over potential lawsuits.

Until now lawsuits involving patient safety and EHRs have been handled as malpractice cases, where it can be difficult to get a handle on exactly who has been named or the nature of the alleged EHR errors because most such cases settle out of court and include nondisclosure clauses that bar the plaintiffs from discussing them, said Ross Koppel, an adjunct sociology professor at the University of Pennsylvania and healthcare IT scholar.

But the number of such malpractice suits will likely continue to climb. Medical malpractice insurer the Doctors Co. closed 28 claims in 2013 involving EHRs, and nearly that many during the first two quarters of 2014. In all, the Doctors Co. closed 97 claims involving EHRs from January 2007 to June 2014.

EHR-related issues contributed to less than 1% of all claims closed by the malpractice insurer during that time. In that limited sample, 64%, involved user errors while 42% involved issues with the EHR system itself; some of those claims involved more than one contributing factor. Of those overall EHR claims, 10% involved a failure of system design, and 9% involved an electronic systems or technology failure.

Typically, those filing malpractice suits go after individual doctors or their hospitals and sometimes both. Ross Koppel, an adjunct sociology professor at the University of Pennsylvania, says contracts with EHR vendors often include hold-harmless clauses protecting vendors.

Yet another 7% were due to a lack of an EHR alert or alarm for things like obvious gender-specific entry errors, such as the case of an elderly woman who was prescribed Flomax, a drug for treating an enlarged prostate, when she should have been prescribed Flonase, a nasal spray. The woman ended up in an emergency department, complaining of dizziness.

"Anecdotally, we're thinking we're going to continue seeing more" cases involving EHRs, said Robin Diamond, a senior vice president of patient safety and risk management at the Doctors Co. She said that will be especially true as plaintiffs' attorneys become more knowledgeable about EHR systems.

EHR vendors, however, aren't often named in malpractice suits. Typically, those filing malpractice suits go after individual doctors or their hospitals and sometimes both, Koppel said. That's partly because contracts between providers and EHR vendors typically include so-called hold-harmless clauses, saying the vendor can't be held responsible for medical errors. Lawyers can sometimes find ways around those clauses, but they present significant barriers to winning malpractice lawsuits against vendors, Koppel said.

Going after an EHR vendor despite a hold harmless clause can mean added expense, time and complications for plaintiffs and their attorneys, said Dr. Scot Silverstein, an adjunct professor of healthcare informatics at Drexel University. "It's only now getting on the radar of the plaintiffs' attorneys to start to go after the actual makers of these systems," he said.

Silverstein, who serves as an independent expert witness in cases involving health IT issues, and Koppel said they know of a number of cases that name EHR vendors, but they're not at liberty to discuss them.

Re Knack, a member at law firm Ogden Murphy Wallace who represents providers, also said more claims against EHR vendors might start surfacing. She said the Cerner-PinnacleHealth lawsuit may foreshadow what's to come.

Knack said she'll be interested to learn whether PinnacleHealth's complaints are legitimate or if the system is just trying to get out of its financial obligation to Cerner. Cerner has alleged in court documents that PinnacleHealth hasn't paid it for services since February 2015 and owes it more than $20 million. Cerner has accused PinnacleHealth of violating the terms of its contract, which was supposed to run through 2020.

PinnacleHealth, however, alleged in its counterclaim that "the software solutions and related information technology services provided by Siemens to Pinnacle have been an utter failure that has jeopardized the care and safety of the patient population served by Pinnacle."

PinnacleHealth CEO Michael Young said the system isn't trying to end its contract with Cerner early, but instead wanted to negotiate with the vendor about lowering Cerner's staffing levels at the system per their contract. Cerner wouldn't discuss lowering staff levels, so the system stopped paying the vendor, he said.

Young, who took over as CEO in 2011, said PinnacleHealth wanted to have the same EHR systems for ambulatory and inpatient care, which it did not have with Siemens. Having ambulatory and inpatient care on the same EHR systems will make it easier for doctors and nurses to keep track of patients' medications, Young said.

Cerner, however, said in court documents that many of PinnacleHealth's allegations in the countersuit should be dismissed.

PinnacleHealth's counterclaim "is rife with scandalous and impertinent averments of alleged issues and problems PinnacleHealth claims it has had with Siemens going back to 1996, during PinnacleHealth's entirely voluntary two-decades-long contractual relationship with Siemens," according to Cerner.

Optimists, noting that EHR systems have improved, counter the idea that lawsuits involving EHRs will proliferate. Future versions may cause fewer patient safety problems and may actually result in fewer lawsuits, they say.

EHRs have made care safer, but they've also introduced some safety hazards, such as when a young patient was given 39 pills of an antibiotic instead of one. Dr. Robert Wachter, interim chairman of the medicine department at the University of California at San Francisco, says no legal action was taken in the case.

Dr. Sarah Corley, vice chair of the HIMSS Electronic Health Records Association, said in a statement that EHR-related safety problems-and lawsuits over them-are minimal. She pointed to another study by a malpractice insurer, in this case CRICO, that, like the Doctors Co. study, found that EHR issues were associated with less than 1% of malpractice claims.

That "is a remarkable low number given how widespread EHRs have become," she said.

Dr. Bob Wachter, who wrote the book The Digital Doctor, said EHRs have made care safer by eliminating records scrawled in physicians' handwriting, by making patient information more easily accessible and by offering built-in reminders for healthcare workers about patient care.

But he acknowledges that EHRs have also introduced some safety hazards, such as one instance he describes in his book when a young patient was given 39 pills of an antibiotic instead of one. The doctor thought she had ordered a certain amount of milligrams of medication when she had actually ordered that amount of milligrams per kilogram of the patient's weight. The doctor and pharmacist then ignored the EHR's alerts about the error, having grown accustomed to routinely getting alerts about less important matters, Wachter said.

The boy spent a week in the intensive-care unit but survived. No legal action was taken, he said.

Still, Wachter expects EHRs to improve over time.

In the future, "We'll have worked on fixing these problems," he said.

Even PinnacleHealth's Young expects that lawsuits making the kinds of safety allegations PinnacleHealth is now making against Cerner will eventually fade away.

"I think the machines are much smarter now in identifying areas of risk," he said. "The ability to really see what's going on across the whole spectrum of care will be a vast improvement."

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Lawsuit claiming patients harmed by EHR could be among the first of a wave of such cases

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A recently filed lawsuit alleging that a faulty electronic health record system caused patient harm may be among the first in a wave of such cases, even though most experts say the latest EHR systems are better designed than older models. <meta property=

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Falsification of credentials on business cards raises red flags

A reader asked about a nurse colleague who had business cards made that falsely indicated the nurse colleague had a BSN degree when she did not, nor was she enrolled in a baccalaureate nursing education program. Moreover, according to the reader, the nurse's immediate supervisor knows the nurse does not have a BSN, but has not required her to correct the fabrication. The reader was concerned about where to go with this information.

The nurse certainly could try to report her concerns to the CNO, who should appropriately intervene in the situation. Or the nurse could report the situation to her state board of nursing, which would investigate the matter and determine if disciplinary proceedings should be initiated. The bottom line is that the reader is describing an example of falsification, which is the willful perversion of facts and includes such behavior as lying, distorting and paltering.

There's no shortage of penalties for falsification

When anyone falsifies information about themselves, it is a serious matter, as it is obviously misleading, deceptive and reflects on your trustworthiness. But it is extremely serious when a nurse does this.

State boards of nursing can initiate professional disciplinary proceedings against a nurse when falsification occurs, including in cases when unprofessional conduct is likely to deceive, defraud or harm the public; using false, deceptive or fraudulent statements in any record in connection with a nurse's practice; practicing beyond the scope of one's practice; and violating state or federal laws, rules and regulations governing controlled substances. In most states, disciplinary actions include a reprimand, censure, probation, suspension or revocation of the nurse's license.

"When anyone falsifies information about themselves, it is a serious matter, as it is obviously misleading, deceptive and reflects on your trustworthiness. But it is extremely serious when a nurse does this."

Unfortunately, falsification of documents in nursing is not a new phenomenon. A 2012 article in the Journal of Nursing Regulation by Latrina Gibbs McClenton, discusses two cases of falsification of licensure applications by two separate candidates applying for RN licensure in Mississippi. McClenton identifies falsification in such instances as a result of "deception or omission" and includes failure to disclose a criminal history, listing or claiming an educational degree that the applicant does not possess, and using personal information taken from another to apply for licensure.

Falsification by nurses also occurs in other situations. The Texas Board of Nursing, in its publication "Behavior Involving Lying and Falsification," gives examples such when an individual pretends to be a nurse or when a nurse licensee may represent that he or she has a "broader scope of practice" than is actually authorized by his or her license. These individuals are viewed by the board as nurse imposters.

Perhaps the most troubling instances of falsification by nurses is when they occur in relation to patient care. I discussed one such circumstance in Brent's Law on Sept. 17, 2012, when a hospice nurse practitioner misdated her visits. Although the nurse practitioner's rationale was that she didn't remember the dates and probably "just signed the wrong day," it is difficult to accept her lack of memory of the visits when she then adds that she probably used the wrong dates. If there is no memory of the visits, no date would have been accurate, and the issue of falsification is raised as the real culprit.

"Falsification by nurses is not only unethical, it shatters legal parameters. Initially, criminal charges on the state or federal level may be brought against the nurse."

Other examples of nurse falsification with patient care matters include inaccurate entries; medications and treatments documented as being given when they are not; covering up bad outcomes; and staff simply documenting in charts "en masse," not knowing for sure whether what is being recorded is accurate ( "Falsified Patient Records Are Untold Story of California Nursing Home Care," California Advocates For Nursing Home Reform).

Falsification by nurses is not only unethical, it shatters legal parameters. Initially, criminal charges on the state or federal level may be brought against the nurse. These charges include fraud (see "Five Years In Prison For Miami VA Nurse Who Falsified Patient's Record" at: ), falsifying business records, criminal possession of a controlled substance, practicing nursing without a license, and petit larceny.

If your falsification involves a felony conviction relating to a controlled substance or a misdemeanor conviction relating to healthcare fraud, you may be excluded from working in any Medicare or Medicaid facility by the Office of Inspector General of the U.S. Department of Health and Human Services. And boards of nursing report disciplinary actions against nurses to the National Practitioner Data Bank. The data bank is used by organizations to determine licensing, credentialing, privileging or employment decisions.

Falsification can end your career or even land you in jail. Two words sum whether you should be accepting of falsification by other nurses or practice it yourself: Not ever.

Courses Related to 'Maintaining Ethical and Legal Standards as a Nurse'
60207: Texas Nursing Jurisprudence and Ethics (2 contact hrs)
The goal of this continuing education module is to provide Texas nurse licensees, and those who are interested in being licensed in Texas, with an introduction to the Texas Nursing Practice Act and Rules. In addition, ethical principles and six grounds for discipline of nurses will be discussed.
CE548: Protect Yourself (1.00 contact hr)
This module will enhance nurses' knowledge of nurse practice acts and how they define professional practice and nurses' rights and responsibilities as practitioners. It includes information on provisions included in most nurse practice acts and types of violations included and the rights afforded the nurse licensee in most nurse practice acts.

EDITOR'S NOTE:

About the author

Nancy J. Brent, MS, JD, RN, Nurse.com's legal information columnist, received her Juris Doctor from Loyola University Chicago School of Law and concentrates her solo law practice in health law and legal representation, consultation and education for healthcare professionals, school of nursing faculty and healthcare delivery facilities. Brent has conducted many seminars on legal issues in nursing and healthcare delivery across the country and has published extensively in the area of law and nursing practice. She brings more than 30 years of experience to her role of legal information columnist. To ask Nancy a question, email BrentsLaw@nurse.com.

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Falsification in nursing: It's a legal line you should not cross | Nursing News, Stories & Articles

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A reader asked about a nurse colleague who had business cards made that falsely indicated the nurse colleague had a BSN degree when she did not, nor was she enrolled in a baccalaureate nursing education program. Moreover, according to the reader, the nurse's immediate supervisor knows the nurse does not have a BSN, but has not required her to correct the fabrication.

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What health information is considered protected or private?

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What health information is considered protected or private?

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What are the penalties for breach of confidentiality under HIPAA law?

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What are the penalties for breach of confidentiality under HIPAA law?

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HIPAA Violation ClassificationsThe four categories used for the penalty structure are as follows: Category 1: A violation that the CE was unaware of and could not have realistically avoided, had a reasonable amount of care had been taken to abide by HIPAA Rules             Category 2: A violation that the CE should have been aware of but could not have avoided even with a reasonable amount of care. (but falling short of willful neglect of HIPAA Rules) Category 3: A violation suffered as a direct result of “willful neglect” of HIPAA Rules, in cases where an attempt has been made to correct the violation    Category 4: A violation of HIPAA Rules constituting willful neglect, where no attempt has been made to correct the violation

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HIPAA Violation ClassificationsThe four categories used for the penalty structure are as follows: Category 1: A violation that the CE was unaware of and could not have realistically avoided, had a reasonable amount of care had been taken to abide by HIPAA Rules             Category 2: A violation that the CE should have been aware of but could not have avoided even with a reasonable amount of care. (but falling short of willful neglect of HIPAA Rules) Category 3: A violation suffered as a direct result of “willful neglect” of HIPAA Rules, in cases where an attempt has been made to correct the violation    Category 4: A violation of HIPAA Rules constituting willful neglect, where no attempt has been made to correct the violation

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(www.hipaajournal.com, 2015)

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The general factors that can affect the level of financial penalty also include prior history, the organization’s financial condition and the level of harm caused by the violation. These factors could decrease or increase the financial penalty issued.

Category 1: Minimum fine of $100 per violation up to $50,000

Category 2: Minimum fine of $1,000 per violation up to $50,000

Category 3: Minimum fine of $10,000 per violation up to $50,000

Category 4: Minimum fine of $50,000 per violation

(www.hipaajournal.com, 2015)

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Data Breaches in Health Care Infographic

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Data Breaches in Health Care Infographic, 5 Things You Should Know. Unfortunately, healthcare data breaches are now commonplace. Traditional methods of protecting this information are not working. Implementing a comprehensive Web-use security solution plays an important role in dramatically reducing the risks of Web-borne threats that lead to personal information and medical data theft.

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Wendia Dees-Woodard
Cheryl Hall
Sheila McDaniel
Gladys Stoner
Aisha Webster

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Electronic medical records (EHRs) made available on the internet raised many legal and ethical concerns.

EHR technology advances raised many questions and challenges for the purpose to increase access, improve quality care, and decrease cost saving in healthcare for all if made available on the internet.

Healthcare professionals and the expertise of health informatics are responsible for protecting an individual personal health information (PHI) via any digital technology.

Health informatics address the challenges, barriers, and meet compliance and regulatory requirements of EHR available on the internet and creditable medical information published on the web.

Because the internet has now allowed all individuals to more involved and responsible for the management of their health.

Many laws, regulations, and standards were implemented to protect PHI that can be transmitted by EHR systems are safe (Sewell, 2016).

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Personal Health Information (PHI) Laws

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Several laws and regulations designed to protect Americans PHI

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U.S. Department of Health &
Human Services HHS.gov
HIPAA for Professional-
Compliance Enforcement-
Case Examples

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http:www.hipaajournal.com

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"Research is Creating New Knowledge"---- Neil Armstrong

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"Research is Creating New Knowledge"---- Neil Armstrong

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Health Informatics have Revolutionized Research and Development

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Health Informatics have Revolutionized Research and Development

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CER studies are less time-consuming and more cost effective but relies on data sharing which raises many ethical and legal issues in today's healthcare sector.

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Ellen-Marie Whelan discusses evidence-based healthcare and how it can improve care in this video from the Center for American Progress.

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Legal and Ethical Considerations in Research 

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Legal and Ethical Considerations in Research 

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EHR4CR - Electronic Health Records for Clinical Research

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EHR4CR - Electronic Health Records for Clinical Research (animation)

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For more information please visit http://www.ehr4cr.eu

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Information Sharing for Research Purpose

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Information Sharing for Research Purpose

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Sharing for Better Caring: Breaking Down Silos To Advance Medical Research

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Why is sharing medical data so important to curing diseases? Learn about HIPAA, Big Data, and how data sharing can help break down the barriers that are preventing medical breakthroughs.

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The Role of Health Data Warehouses in the Face of Research

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The Role of Health Data Warehouses in the Face of Research

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Using metadata to help translate clinical research into better healthcare

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Differences between Electronic Medical Records and Electronic Health Records

An EMR contains the standard medical and clinical data gathered in one provider's office. Electronic health records (EHRs) go beyond the data collected in the provider's office and include a more comprehensive patient history.

For example, EHRs are designed to contain and share information from all providers involved in a patient's care. EHR data can be created, managed, and consulted by authorized providers and staff from across more than one health care organization.

Unlike EMRs, EHRs also allow a patient's health record to move with them-to other health care providers, specialists, hospitals, nursing homes, and even across states. For more information about electronic medical records and the differences between EMR vs EHR, please visit the Health IT Buzz Blog.

An electronic medical record (EMR) is a digital version of a paper chart that contains all of a patient's medical history from one practice. An EMR is mostly used by providers for diagnosis and treatment.

Benefits of Electronic Medical Records

An EMR is more beneficial than paper records because it allows providers to:

Track data over time

Identify patients who are due for preventive visits and screenings

Monitor how patients measure up to certain parameters, such as vaccinations and blood pressure readings

Improve overall quality of care in a practice

The information stored in EMRs is not easily shared with providers outside of a practice. A patient's record might even have to be printed out and delivered by mail to specialists and other members of the care team.

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An EMR contains the standard medical and clinical data gathered in one provider's office. Electronic health records (EHRs) go beyond the data collected in the provider's office and include a more comprehensive patient history. For example, EHRs are designed to contain and share information from all providers involved in a patient's care.

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Ethical and Legal Issues | National Commission on Correctional Health Care

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National Commission on Correctional Health Care

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Legal Implications Of Informatics On Healthcare - Bing News

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News from world, national, and local news sources, organized to give you in-depth news coverage of sports, entertainment, business, politics, weather, and more.

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Leagal Issues in Health Information Exchange

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The Health Insurance Portability and Accountability Act set a national standard for the privacy of health information. With health records going electronic, privacy is a major concern for people because they consider information about their health highly sensitive, and they want strong protection from the law.

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Case Studies: Healthcare Data Breach Risks

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Nursing informatics and healthcare go hand-in-hand these days. Technology in nursing practice is not new, but the ways in which technology exists and contributes to healthcare is. One change is the use of the electronic health record (EHR). At the end of 2013, 80% of hospitals and 50% of healthcare providers implemented EHRs.1

But, the EHR is only one aspect of nursing informatics, which has become an essential aspect of nursing practice in all settings, including clinical practice (e.g., patient monitoring devices, work lists to help with planned nursing interventions), nursing administration (e.g., automated staff scheduling, quality assurance and outcomes analysis), nursing education (e.g., computerized-assisted instruction, distance learning online courses), and nursing research (e.g., computerized literature searching).2

Nursing informatics is defined as 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."3

There are many roles nurses fulfill in nursing informatics. An essential one is that of the nurse informaticist or informatics nurse specialist. In your capacity as the INS, your responsibilities include the selection of computer systems, testing computer systems, educating and training end-users of computer systems, and the identification of computer technologies that can benefit nursing and patient care.2

Inherent in these responsibilities are many legal obligations. Some include:

1. Developing sound policies and procedures for the use of the informatics system utilized in the facility;

2. Adequately training and re-training end-users of the system;

3. Requiring and strictly emphasizing patient safety as the No. 1 priority when the informatics system is used for patient care;

4. Establishing a zero tolerance for sharing passwords or codes to gain access to the informatics system, including developing codes of conduct prohibiting any unauthorized use of codes or passwords and resulting ramifications (e.g.,termination);

5. Educating all health team members to use the system as it is intended to be used (e.g., not entering information in the system or attempting to bypass it);

6. Securing the privacy and confidentiality of all information in the system, pursuant to federal and state laws regulating these rights;

7. Requiring employees to sign confidentiality and privacy agreements restricting access to identified healthcare information and restricting access to healthcare information only as part of the employee's job;

8. Requiring any printouts from the system be shredded immediately when no longer needed;

9. Emphasizing age-old and proven principles of good documentation that was used with hard copy charting; and

10. Reducing, insofar as possible, potential medical and nursing errors that may arise with the system used for patient care documentation (e.g., improper use of copy and paste features, accidental click of the mouse when using a check list for medications).5

When these, and other, legal obligations are not met, the facility and the INS may face numerous lawsuits. Potential legal court cases include data breaches; accusations of modification of EMRs; inadequate templates for diagnoses, medications and treatment plans; failure to select appropriate software for use when documenting patient care; and failure to provide ongoing evaluation of current systems.6

As an INS, keeping abreast of new developments in nursing informatics, maintaining certification, participating in continuing education, active involvement in nursing informatics professional associations, and maintaining standards of practice in nursing informatics can help avoid these potential legal pitfalls and, at the same time, establish and maintain a health information system in your facility that is useful in ensuring good patient care.7

FOOTNOTES

1. Mary Beth Mitchell (2015), "We Save Lives: An Informatics Perspective On Innovation," 45(2) Nursing 2015, 20-21. Available at: http://www.nursingcenter.com/JournalArticle?Article_ID=2706436&Journal_ID=54016&Issue_ID=2706379.

2. Katherine Bengan (2015), "Nursing Informatics: A Needed Role in Today's Health Care," Nursing Examiner, 2-6. Available at: http://www.nursingexaminer.com/nursing-careers/nursing-informatics.

3. Nursebooks.com (2014), "Nursing Informatics: Scope and Standards of Practice," 2nd Edition, 1. Available at: http://www.nursesbooks.org/Main-Menu/Standards/H-N/Nursing-Informatics-2nd-Ed.aspx.

4. Nancy J. Brent (2013), "Legal Issues Every Nurse Informatist Should Consider, 1." Available at: www.himss.org/news/NewsDetail.aspx?ItemNumber=18399.

5. Molly Gamble (2012), "5 Legal Issues Surrounding Electronic Medical Records," Becker's Hospital Review, 1-5. Available at: http://www.beckershospitalreview.com/legal-regulatory-issues/5-legal-issues-surrounding-electronic-medical-records.html.

6. Alicia Gallegos (2012), "Legal Risks of Going Paperless," American Medical News, 1-4. Available at: amednews.com.

7. Brent, supra note 4.

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Legally speaking: Nursing informatics and healthcare

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Nursing informatics and healthcare go hand-in-hand these days. Technology in nursing practice is not new, but the ways in which technology exists and contributes to healthcare is. One change is the use of the electronic health record (EHR).

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Ethical, legal, and social issues related to health information technology are emerging as central issues. All are within the purview of AMIA's Ethical, Legal and Social Issues Working Group, where a range of issues are discussed related to health information technology and systems:

Protecting private information

HIT system vendor-provider relationships

Patient safety

Ethics of good design and data displays

User involvement

System implementation

Liability

Risk assessments

Training adequacy

Biobanking

Computer decision support

Curriculum development

Ethical dilemmas created by the use of health information technologies

Secondary data use

Public health

Security

Surveillance

Research ethics

Autonomy and empowerment (especially in light of new health and telehealth technologies)

Social networking

Policy and Regulation

We actively collaborate with other AMIA working groups, and our varied backgrounds from healthcare to law to philosophy to social science make for lively and provocative discussions on our active listserve, wiki, and monthly conference calls.

Visit the online community for this group at http://connect.amia.org/ELSI-WG

To send a message to this group, please use
amia-ELSIWG@connectedcommunity.org

You must be a member of AMIA and a member of the WG in order to post.

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Ethical, legal, and social issues related to health information technology are emerging as central issues.

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Clinical Informatics is the application of informatics and information technology to deliver healthcare services. It is also referred to as applied clinical informatics and operational informatics.

AMIA considers informatics when used for healthcare delivery to be essentially the same regardless of the health professional group involved (whether dentist, pharmacist, physician, nurse, or other health professional). Clinical Informatics is concerned with information use in health care by clinicians.

Clinical informatics includes a wide range of topics ranging from clinical decision support to visual images (e.g. radiological, pathological, dermatological, ophthalmological, etc); from clinical documentation to provider order entry systems; and from system design to system implementation and adoption issues.

Informatics Certification

AMIA offers a Clinical Informatics Board Review Course to provide a comprehensive review of the core content for Clinical Informatics that will be the basis for the examination for certification. The CME eligible course is offered live and online and helps physicians identify those areas where they may need further study. Physicians in all 24 subspecialties are now eligible to become Board Certified in Clinical Informatics through an exam offered by the American Board of Preventive Medicine and the American Board of Pathology. Beginning in 2018, physicians must have completed a ACGME accredited Clinical Informatics Fellowship Program in order to sit for the board exam.

AMIA continues to pursue steps towards developing Advanced Interprofessional Informatics Certification. Recognition of the certification path for board certified physicians is one step forward for the profession. It does not represent the totality of AMIA's certification-related activities. AMIA recognizes that the opportunity for subspecialty certification is relevant to a majority of its members. An equivalent level of certification is being pursued for informaticians who have equivalent competencies.

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Clinical Informatics is the application of informatics and information technology to deliver healthcare services. It is also referred to as applied clinical informatics and operational informatics. AMIA considers informatics when used for healthcare delivery to be essentially the same regardless of the health professional group involved (whether dentist, pharmacist, physician, nurse, or other health professional).

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Legal and Ethical Implications in Informatics

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Data Collection and Use