MMIA comments on FDA's suggested mobile app guidelines

The American Medical Informatics Association has weighed in on federal plans to regulate mobile medical apps, cautioning officials that there’s a difference between an app that’s motivated by an electronic response and one that’s triggered by an actual human being.

The issue, AMIA members say, is the classification of clinical decision support (CDS) apps. According to Meryl Bloomrosen, the AMIA’s vice president for public policy and government relations, more attention should be given to apps “that provide CDS in an automatic and autonomous fashion, and which intervene directly, based on patient care data.”

In other words, watch out for apps that prompt a clinical decision without human input. It’s much better that an actual human being make that final decision on a healthcare action.

The U.S. Food and Drug Administration is accepting comments on its 30-page draft document, which spells out which mobile medical apps should fall under government regulation, through October 19.

Under the draft guidelines, of the thousands of medical apps now available, only a small portion would face review. They would fall into two categories:

1.Apps that serve as an accessory already regulated by the FDA, such as an app that allows a professional to diagnose a condition from an x-ray or other image viewed on his or her smartphone; or
2.Apps which turn a mobile platform into a medical device, such as an app that would allow a smartphone to receive ECG data and allow a physician to observe heart rhythm – and perhaps even diagnose a heart attack.

“AMIA's comments are premised upon practical evidence that the health sector is exploding with an array of clinical information systems for potential use in a broad range of settings,” AMIA President and CEO Edward H. Shortliffe, MD, PhD, FACMI, said in a press release. “A growing volume of research demonstrates that health information technology in many forms and on many kinds of devices can improve the quality and safety of patient care and promote efficiencies in overall care delivery. In this modern era of ubiquitous electronic data and access, it is important to have regulations that keep pace with clinicians – many of whom are becoming quite expert at using technology to access pertinent information, and thereby streamlining healthcare delivery and improving overall health.”

Following up on a workshop held Sept. 12-13 in which FDA officials and stakeholders discussed the proposed regulations, the AMIA warned that the FDA could run the risk of “blurring the lines” between apps and other medical devices intended for use by clinicians and those designed for use by the general public.

In addition, the AMIA questioned whether so-called “stand-alone” CDS delivered through “mobile medical devices” should comes under more scrutiny than other methods of delivery, such as through a PC.

AMIA officials called on the FDA to, among other things, better define CDS, and make sure it takes into account how new technologies and devices affect “new and evolving forms of patient care delivery (such as medical homes and accountable care organizations) and payment methods.”

The 12-page AMIA presentation can be found at http://www.amia.org/sites/amia.org/files/FINAL%20FDA%20Mobile%20Apps%20P...

Eric Wicklund

Editor of mHIMSS.org

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