Editor’s Note: How has health IT emerged in its first 10 years? How is it reshaping the medical and legal landscape? How are electronic health records (EHRs) transforming healthcare? Manatt Health answered these questions and more in our recent webinar for Bloomberg BNA, “The Evolution of Health IT and EHRs: Setting the Stage for Growth and Value.” The webinar detailed the emergence of health IT, focusing primarily on developments over the last decade that have accelerated the adoption and use of EHRs. The article below, which focuses on issues around EHR-related errors, safety issues and liability, is the second in a series summarizing key segments of the presentation. Click here for a hard copy of the full presentation. Or, if you missed the webinar, click here and enter LGNBBNA1 to view the program free.
While health IT presents opportunities to improve patient care and safety, it also can create potential hazards. Designed or applied inappropriately, health IT in general and EHRs in particular can lead to unintended adverse consequences including dosing errors, failures to detect illness and delays in treatment.2
Using EHRs can lead to the unintended creation of new errors or the propagation of existing ones. There are four main categories of potential errors:
- Inappropriate use of templates, default settings and copy and paste features. EHR vendors often add functionalities to assist with documentation, such as copy and paste capabilities, templates, use of standard phrases and paragraphs, and automatic object insertion (e.g., clinical values brought in from other parts of the electronic record).3 Benefits of these features include improved efficiency, timeliness, legibility, consistency and completeness of documentation.4 When used inappropriately or without proper education, however, these features can lead to inaccurate documentation and potentially result in medical errors or allegations of fraud.5 Errors related to default settings and copy/paste functionality represent two of the most common EHR risks associated with inappropriate documentation capture.6
- Alert fatigue. EHR systems often include decision support functionalities such as drug-drug interaction, drug-dose, drug-lab and contraindication alerting. Several studies have identified “alert fatigue” (choosing to ignore alerts) as a common condition among clinicians using EHRs with decision support.7
- Patient matching problems. Enabling a clinician to view a comprehensive picture of the patient requires accurately “matching” individual patients to their health records. Error rates—which average eight percent and can be as high as 20 percent—can result in sub-optimal care and medical errors.8,9 Incorrectly matching a patient to a health record may also have privacy and security implications, such as wrongful disclosure or inappropriate treatment based on another patient’s health information.10
- Poor user interface design. Poor interface design can lead to unclear information displays that contribute to clinician misinterpretations11 and negatively impact clinical workflow, leading to errors.12
Federal Efforts to Address EHR Safety
In response to growing concern about potential harm from health IT use, the Office of the National Coordinator of Health Information Technology (ONC) released the Health IT Patient Safety Action and Surveillance Plan (Health IT Safety Plan) in July 2013.13 The Health IT Safety Plan:
- Addresses the role of health IT within HHS’s commitment to patient safety.
- Highlights current and future efforts to strengthen patient safety across both government and the private sector.
- Outlines tangible actions through which stakeholders can fulfill their obligation to increase knowledge about health IT’s impact on patient safety.
Coinciding with the report’s release, ONC announced the creation of the Health IT Patient Safety Program within the Office of the Chief Medical Officer with support from the Office of Policy and Planning.14 On December 5, 2013, ONC released a patient safety guide designed to “help clinicians and other EHR users address health IT-related safety issues.”15
Through the 2014 Edition EHR Standards and Certification Criteria final rule,16 ONC incorporated two new patient safety features into the EHR Incentive Program standards and certification criteria requiring technology developers to:
- Identify publicly the method they used to incorporate user-centered design processes into the development of their EHR technology for the capabilities included in eight medication-related certification criteria.17
- Provide transparency regarding their approach to “quality management systems” in the development of their products.18
Enacted in July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA)19 also addresses health IT product safety. Section 618 of FDASIA instructs the Secretary of HHS, acting through the FDA Commissioner—in collaboration with ONC and the Federal Communications Commission—to issue a report by January 2014 on a proposed strategy and recommendations for an appropriate risk-based HIT regulatory framework that promotes innovation, protects patient safety and avoids regulatory duplication.20
To assist with developing the report, the FDA in collaboration with ONC and FCC formed a new workgroup under ONC’s HIT Policy Committee to provide input and recommendations.21 On September 4, 2013, the HITPC approved the FDASIA Workgroup’s initial health IT safety framework.22
EHR Use, Risks and Legal Liability
When properly used, EHRs can improve care quality and safety. When improper use creates or propagates errors, however, there can be legal consequences for providers.
The liability implications of EHRs are likely to vary over the adoption life cycle. Healthcare providers’ adoption of EHR systems increases liability risk in the short term but may lower it over time by improving outcomes and conforming with the evolving legal standard of care.23
During the initial transition from paper to electronic processes, providers may increase their liability risk. As with any new technology, the risk of error increases as providers move from a familiar system to a new one.
At least one case suggests that providers have a duty to minimize risks during the transition period.24 A federal court held that a hospital that switched from a paper to an electronic system for delivering test results had a duty to “implement a reasonable procedure during the transition phase” to ensure the timely delivery of test results to physicians.25
It is unclear whether the use of EHRs is likely to increase or decrease malpractice claims and liability.26 Some experts hypothesize that using EHRs will become a standard of practice and could be a factor in evaluating the propriety of clinician conduct. There are other possible scenarios where one can envision use or non-use of an EHR as part of a malpractice claim. For example, a plaintiff’s attorney stating that failure to view readily available information through an EHR itself supports a malpractice claim.
Generally, to prove medical malpractice, a plaintiff must establish the applicable standard of care and prove that the defendant caused injury by falling short of that standard. As the use of EHRs grows, it may reshape medical liability by altering how to determine the standard of care and by changing the standard of care itself.