FDA’s Proposed Mobile App Regulations – The Fog Lifts
Friday, July 22, 2011
| Rob Havasy
About the Author: Rob Havasy (@rob_havasy) is a Business Analyst and mHealth Strategist at the Center for Connected Health.
On Tuesday, the Food and Drug Administration (FDA) released a long anticipated guidance document outlining proposed regulations for mobile medical apps. With its release, the FDA has opened a 90-day comment period for interested parties to provide feedback on the proposed rulemaking scheme. (The official Federal Register publication of this document dated 21 July 2011 is found in 76 FR 140 pp. 43689 – 43690 and is docket # FDA-2011-D-0530 see here for a PDF download).
In the guidance document, the FDA outlines the basis for their decision to specifically target mobile medical apps for regulatory oversight:
“As is the case with traditional medical devices, mobile medical apps can pose potential risks to
public health. Moreover, mobile medical apps may pose additional or different risks due to the
unique characteristics of the platform. For example, the interpretation of radiological images on a
mobile device could be adversely affected by the smaller screen size, lower contrast ratio, and
uncontrolled ambient light of the mobile platform; FDA intends to take these limitations into
account in assessing the appropriate regulatory oversight for these products.”
I don't think many people can argue with this basic premise, and most of my healthcare colleagues welcome the idea of some form of oversight and regulatory scrutiny of the growing mHealth industry. The concern of course is the form and flexibility of the proposed regulations and their effect on the pace of innovation. Certainly, and understandably, many of my entrepreneur and startup friends are scared stiff of the possibility of the FDA showing interest in adding regulation to an industry traditionally associated with rapid innovation, trial-and-error development, and risk-taking. This may simply be a new front in a long-standing culture clash between what Gartner Analyst Wes Rishel described a few years ago as “the Internet crowd” and the “healthcare informatics crowd.” But sensible regulatory oversight doesn't have to stifle this industry. Just because the FDA drops its chocolate into the Internet crowd's peanut butter doesn't mean we won't come up with something better in the end (sorry – the 80s were my formative years). Entrepreneurs will adapt and startups will innovate, regulations or not.
My take on the guidance document is that clarity is always better than ambiguity, and I'm therefore relieved to have something to work with. The FDA's previous foray into this area, the release of the MDDS rulemaking last February, reminded the industry that the FDA's “ongoing enforcement discretion may not be a viable long-term regulatory alternative.” At least we now have some idea bout what that actually means.
The substance of the proposal is very interesting. At first glance it is largely consistent with the guidance offered earlier this year by the mHealth Regulatory Coalition, of which the Center for Connected Health is a member, but still leaves some key issues unaddressed. The FDA outlined a framework in the proposal which offers two new categories of mobile apps that will fall into the new regulatory structure: apps which are “used an accessory to a regulated medical device” or an app which “transforms a mobile platform into a regulated medical device.” The first point is a clear extension of the current “accessory rule” logic and is straightforward, though it might be a bit conservative. The second point however does little to address the fundamental concerns of many people in mHealth right now, which is more clearly defining the boundary between something intended for wellness and general health and something “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” We all understand that apps meeting the latter definition are and always have been regulated medical devices; we are more interested in those mobile apps which might or might not reasonably fit that definition and where they will fall in the regulatory framework. It is clear from the proposal that the FDA has thought about this issue and hasn't yet reached an internal consensus.
This draft guidance document represents another incremental step in the FDA coming to grips with the proliferation of mobile technology and is certainly not the last we will hear from the agency on this matter. It also presents an important opportunity for the industry to have their voices heard in Washington. People and companies with ideas for mHealth need to understand that FDA regulation is an inevitable and important part of healthcare in the United States. Make sure your voices are heard as that regulation is being formed and offer your comments. This is too important to ignore if we want to realize the vision we have for mobile technologies truly changing healthcare.