The ECG app announced by Apple for the Series 4 Apple Watch has the potential to change how we think about and use our personal devices to improve our health and engage our healthcare providers. It also represents an important shift in thinking for the FDA on how they review medical apps. The agency is taking the approach that review should be focused on the app and software functions that have “greater ramifications for patient health” and where application safety and efficacy is critical. In this way they hope to encourage developers towards greater innovation, reduce time and cost of bringing apps to market, while ensuring patient safety. In this post, FDA Commissioner Dr. Scott Gottlieb says:

“With the watch, what we said was simple: sensors that are general purpose can also be decoupled from review of a medical app and we wouldn’t regulate or turn the entire platform into a medical device, just to enable a platform to host software with medical functionality. And the policy we advanced was to say that only the apps intended for a medical purpose, in this case to identify possible atrial fibrillation, would be reviewed and cleared as medical devices.”

I see this shift as creating an opportunity for developers to work on an app in a platform-agnostic way and evergreen their idea by porting to other mobile devices or extending the application to different platforms and other functions. One challenge will be data interoperability – our continued lack of data standards for medical records makes it harder for developers to create closer interactions between patients and providers.

The post goes on to discuss other agency initiatives to work with the tech industry to encourage investment in the U.S. digital technology industry to advance safe and effective innovation in digital approaches to public health issues. These include the Center for Excellence on Digital Health as well as cybersecurity and other initiatives that are part of the Digital Health Innovation Action plan (see my previous post on the first anniversary of the plan and this agency press release for additional details).

Text Copyright © 2018 Katrina Rogers