On LinkeIn this morning, I came across a couple of comments about the FDA’s recent draft guidance on mobile apps. Thoughtful comments by David Doherty and Nathan Billing in a LinkedIn discussion prompted the following. My imperfect interpretation of their comments was the impetus for this post.
David suggests that FDA regulation will stifle mobile app innovation, and observes that brand-name phone manufacturers are in a better position to shoulder FDA regulations than startups. He further wonders why an App Store that takes a 30% cut of app revenue does not appear to draw any regulatory attention from FDA.
Nathan agrees that over-regulation could stifle innovation and suggests that the regulatory burden should vary based on the intended user. Nathan implies, I think, that apps for health care professionals should face greater regulatory scrutiny than apps for use by patients. He also laments that FDA has not designated specific standards that would facilitate cross-vendor interoperability in the mHealth ecosystem.Read More
As medical applications for mobile devices have proliferated, regulatory questions have proliferated nearly as fast, at least in some quarters. The key questions are what kinds of apps are medical devices, and among those, which will the FDA focus on for regulatory action. To date these apps range from home use adviser’s, guides and “toys”, which may or may not have real health care implications, to serious medical devices which have clear health care functions, despite in at least some cases, pretending they do not really, perhaps in an attempt to avoid the FDA.
On July 19, 2011 the FDA announced its proposed official action in this regard, including defining “mobile medical applications” that are the subject of this action. (I will use the acronym MMA, although the FDA did not.) . This includes a new FDA web page for mobile apps (here), with links to a new Draft Guidance, information for consumers, and a press release. This action by the FDA has a parallel to the recent final rule on Medical Device Data Systems (MDDS), discussed by Tim here, which also addressed what is it, what is it not, and how that which is will be regulated.Read More
This new report (download page) is focused on the factors that contribute to effective home health care: integrated and easy to use medical devices and information systems, and the physical characteristics of a home that is supportive (or at least does not present barriers) to home health care delivery. There is quite a mix of recommendations in this report, from the insane (numbers 6 and 7) to the most excellent (numbers 4 and 9).
I came across this via a Modern Healthcare blog post by Joseph Conn. Like me, Conn was drawn to the first recommendation (from the NRC report):
Recommendation 1. The U.S. Food and Drug Administration and the Office of the National Coordinator for Health Information Technology should collaborate to regulate, certify, and monitor health care applications and systems that integrate medical devices and health information technologies. As part of the certification process, the agencies should require evidence that manufacturers have followed existing accessibility and usability guidelines and have applied user-centered design and validation methods during development of the product.