Legislation Prohibiting FDA Regulation of EHRs 'Incomplete' Association Says
(BETHESDA, MD) — The American Medical Informatics Association (AMIA) praised the Senate Health, Education, Labor and Pensions (HELP) Committee today for passing important legislation, intended to provide regulatory stability and assurance to the growing ecosystem of health IT not considered a medical device. Now, the nation’s health informatics professionals call on officials in Washington to address the unanswered question of how to ensure the safety and effectiveness of health IT deployed across the nation’s hospitals and physician practices.
Referred to as the "Medical Electronic Data Technology Enhancement for Consumers' Health Act" (MEDTECH Act), or S. 1101, this legislation prohibits the Food and Drug Administration (FDA) from regulating several categories of software functionality, ranging from electronic health records (EHRs) to clinical decision support (CDS) software. A similar version of legislation was passed in the House as part of the 21st Century Cures Act of 2015.
"Now that both the House and the Senate have reached an agreement on the limitations of what the FDA can regulate, we must have an honest discussion about how to ensure health IT is safe and effective," said AMIA President and CEO Douglas B. Fridsma, MD, PhD. "As a way to address pre-market barriers to innovation, we agree with the approach taken by MEDTECH, but we are concerned the legislation is incomplete. The legislation is silent on how the safety and effectiveness of health IT should be managed absent regulatory oversight, despite our growing awareness of how even benign functionality can harm patients."
A host of emerging evidence suggest that everything from software design through implementation decisions can have a dramatic impact on the safety of health IT. From 2010 to 2013, 120 health IT-related Sentinel Events (SEs) – an event that has resulted in an unanticipated death or major permanent loss of function – were reported to the Joint Commission.1 Problems associated with user interfaces, poor support for workflows and communication, and inadequate clinical content are top contributors to patient safety events. Experts believe these SEs represent a small fraction of the total number of adverse events that go unreported and unanalyzed.
In March 2015, the Joint Commission published a Sentinel Event Alert to the nation’s hospitals warning them of increased risk to patient safety, and advising that each hospital take actions to ensure the safety and safe use of health IT.2 Further, an article published in the Journal of Patient Safety reviewed a medical malpractice claims database and found that while less than one percent of claims involved health IT, a total of 248 cases demonstrated that "Adverse events associated with health IT vulnerabilities can cause extensive harm and are encountered across the continuum of health care settings and sociotechnical factors."3
In order to develop a better understanding of how health IT contributes to or detracts from patient safety, the Office of the National Coordinator for Health IT commissioned a report, suggesting the need for a “trusted space where stakeholders could convene to review evidence and jointly develop solutions to critical health IT safety issues.”4 The report recommended a multi-pronged focus for a national center on health IT patient safety, including a need to:
- Collaborate on solutions to address health IT-related safety events and hazards;
- Improve the identification and sharing of information on health IT-related safety events and hazards;
- Report on evidence on health IT safety and solutions; and
- Promote health IT safety education and competency of clinicians in the appropriate and safe use of health IT.
"While this legislation is needed to help ensure innovative products can more easily come to market, we must have additional support from the federal government to tackle this mounting challenge," said AMIA Board Chair Thomas H. Payne, MD, PhD. "Now is the time to get serious about health IT patient safety. Now is the time to fully fund a collaborative, national center for health IT safety."
AMIA, the leading professional association for informatics professionals, is the center of action for 5,000 informatics professionals from more than 65 countries. As the voice of the nation’s top biomedical and health informatics professionals, AMIA and its members play a leading role in assessing the effect of health innovations on health policy, and advancing the field of informatics. AMIA actively supports five domains in informatics: translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics, and public health informatics.
- Castro G. Investigations of Health IT-related Deaths, Serious Injuries, or Unsafe Conditions. ONC Health IT Safety Webinar Series. Beginning slide 23. http://www.healthitsafety.org/uploads/4/3/6/4/43647387/webinar_1_full_de.... 2014.
- The Joint Commission Sentinel Event Alert No. 54: Safe Use of Health Information Technology (March 31, 2015) available at http://www.jointcommission.org/assets/1/18/SEA_54.pdf.
- Gruber, et al "Electronic Health Record – Related Events in Medical Malpractice Claims," Journal of Patient Safety Nov. 2015 http://www.ncbi.nlm.nih.gov/pubmed/26558652
- Office of the National Coordinator for Health IT. Health IT Safety Center Roadmap. http://www.healthitsafety.org/uploads/4/3/6/4/43647387/roadmap.pdf. 2015