Fourth, there are governmental policy forums beginning to study and debate FDA regulation of mHealth. An example is an NIH initiative to gather leaders from throughout government and the private sector to look broadly at the policy and regulatory issues associated with mHealth research. A small group of those people met June 7-8 to debate some of the basic issues, and then the NIH Foundation will hold a broader meeting on November 8-10 to “convene leaders in research, technology and policy to share their expertise and draft a blueprint for the future of mobile health.”
Fifth, per the National Broadband Plan, the FCC will engage FDA directly in a meeting at the end of July. While that announcement has not yet come out (expect it very soon), the meeting is likely to address specifically the areas of overlap between the two agencies. At the same time, it’s clear that FCC sees the benefit of mHealth and wants to identify ways to encourage it through public policy.
Sixth, at least some industry participants are beginning a dialogue with members of Congress regarding the nature and scope of the regulatory issues. At this juncture, those meetings seem to be mostly educational for members of Congress, but they may at some juncture result in further letters from members to the Administration expressing opinions on where the Administration should take mHealth policy.
Those proactive discussions may not be the last word: we may see some reactive discussions. As an observer of FDA over the years, I’m guessing that in addition to the direct dialogue, we will see the agency reacting through an enforcement action or two against what the agency considers to be egregious conduct. Often the agency will pick activity that is both egregious and high profile to be the subject of a warning letter. Sending such a letter begins a dialogue with the recipient, but also communicates to a broader audience. There may be some high profile products out there stepping over the line in a way that makes them likely targets.
II. The open substantive questions
Okay, so these forces collide in either proactive or reactive communication: where does that mean FDA is going? To address that, I will identify six basic open questions, and suggest how they might be resolved through these discussions.
1. Scope of FDA Regulation
Hardware and software companies need to know which mHealth products FDA regulates, but unfortunately the answers aren’t always clear. For example, FDA generally regulates medical intended uses for products, but not products directed at general wellness or fitness. The problem is there’s a whole lot a gray area between those categories. As examples, there are mobile phone apps focused on helping people with weight loss and everyday management of diabetes. When might certain claims in those areas trigger FDA regulation?
Further, it might be obvious that a blood glucose meter is a medical device. But as that device connects to a cell phone which connects to a server somewhere which connects to a doctor’s computer, where does FDA regulation begin and end?
Rather than just focusing on what the statute authorizes, I would hope that industry and FDA through discussion could arrive at a risk-based model that limits FDA’s active regulation to those devices where a malfunction could realistically hurt someone.
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