Electronic Health Records: An Unfulfilled Promise and a Call to Action

Forty features which should be in most EHRs:
http://thehealthcareblog.com/blog/2016/06/09/features-which-should-be-in-most-emrsehrs/
http://thehealthcareblog.com/blog/2016/06/18/the-black-list-part-ii-features-which-should-be-in-every-ehr-but-for-some-reason-arent/

I also think that one way to improve EHRs is to ensure they contain no errors or bias. I had talked about this previously (http://thehealthcareblog.com/blog/2015/11/02/a-proposal-to-increase-the-transparency-and-quality-of-electronic-health-records/), and gave a presentation at the IHT2 Conference Nashville (8/12/16) entitled: A Proposal to Increase the Transparency and Quality of Electronic Health Records

A copy of the slide presentation is available here ...
https://www.icloud.com/keynote/0g5mY0SIzdyhy7ys56iILqEEA#IHTT_8/12/16

Hayward Zwerling, M.D., FACP, FACE
[email protected]

We agree with Dr. Hingle about the unfulfilled promise of Electronic Health Records (EHRs) (1). Current EHRs demand significant attention from physicians, which can sometimes detract from the quality of care provided to patients. However, the administrative burden that EHRs can impose is due in large part to a regulatory environment that does not demand EHR technology to undergo human factors testing nor require evidence that it is proven safe and effective.

The rapid transition from paper-based to electronic records has resulted in systems that can have a positive and negative impact on patient care. Just as some drugs and medical devices are safer or more effective than others, some EHRs have software flaws that can go undetected for months or years and cause serious medical errors (2). According to reports made to the Food and Drug Administration (FDA), these flaws have included incorrect patient information, wrong drug dosage calculations, or even displaying data for the wrong patient, resulting in adverse events such as “delays in diagnosis or treatments, unnecessary or emergency procedures and/or treatments, incorrect medication administration, patient injury or disability and death” (3).

Before any drug can be sold in the United States, it must be reviewed and approved by the FDA, based on data supporting its safety and effectiveness. EHRs are considered medical devices, which are held to a lower standard and often can be sold without evidence of safety or effectiveness (4). However, if the FDA determines that a drug or device has risks that outweigh the benefits, it can deny approval until manufacturers make significant improvements. Unfortunately, while the Federal government can certify that EHRs meet basic technical requirements, there is currently no process at the FDA or any other agency to conduct premarket assessment of the effectiveness and safety of most EHRs (5). As a result, EHRs are neither as usable nor as accurate as they would be if the FDA required robust evidence of their suitability for medical personnel. Without those requirements, poorly designed EHRs will continue to frustrate health professionals and expose patients to serious safety risks.

Although health professionals rely on the safety and usefulness of EHRs, these devices are not currently subject to most of the regulatory safeguards and oversight that are suitable for such important technology. Significant legislative and policy changes are needed in order to drive the evolution of EHRs towards the safe, effective, and efficient technologies needed by providers and patients alike.

References
1. Hingle S. Electronic Health Records: An Unfulfilled Promise and a Call to Action. Ann Intern Med. 2016;ePub 6 Sep.
2. Graber ML, Siegal D, Riah H, Johnston D, Kenyon K. Electronic Health Record–Related Events in Medical Malpractice Claims. J Patient Saf. 2015;Nov 6:1–9.
3. Myers RB, Jones SL, Sittig DF. Review of Reported Clinical Information System Adverse Events in US Food and Drug Administration Databases. Appl Clin Inf [Internet]. 2011;2(1):63–74. Available from: http://www.schattauer.de/index.php?id=1214&doi=10.4338/ACI-2010-11-RA-0064
4. Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med [Internet]. 2011;171(11):1006–11. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21321283
5. Ratwani R, Benda N, Hettinger A, Fairbanks R. Electronic health record vendor adherence to usability certification requirements and testing standards. JAMA. 2015;314(10):1070–1.

Dear Dr. Ronquillo and Dr. Zuckerman,

Thank you for your thoughtful comments and perspective on regulatory changes needed to improve the safety and efficacy of EHRs. This is an interesting approach that I had not previously considered. Previous approaches focused on adapting work flows (1) as well as integrating additional technology, such as voice recognition software (2), are simply work arounds that do not address the root cause of the problem. I believe that your approach is extremely important as it does focus on the fundamental problem which is dysfunctional and flawed EHR systems. Some possible challenges with your approach include gaining buy in for additional regulation at the federal level as well as from the EHR vendors. That being said, I believe your proposal is clearly worthy of further exploration. Your engagement in coming up with solutions is exactly the call to action that I was hoping for by writing my editorial. Physicians comprise a wise profession; the exact people we need working on solutions. It is my sincere hope that medical organizations, like the ACP, and policy makers thoughtfully read and consider your suggestions for improving EHR safety and efficacy. Than you again for your commitment to working for a safer, more effective health care system.

Respectfully,
Susan Hingle, MD, FACP
1. Sinsky CA, Beasley JW, Medical Scribes and Electronic Health Records, JAMA. 2015 Aug 4;314(5):519. doi: 10.1001/jama.2015.6944.

2. Dela Cruz, JE, Shabosky JC, Albrecht M, Clark T, Milbrandt JC, Markwell SJ, and kegg JA, Typed versus voice recognition for data entry in electronic health records: emergency physician tiem use and interruptions. West J Emerg Med. 2014 Jul;15(4):541-7. doi: 10.5811/westjem.2014.3.19658.