There have been a few posts over the last couple months concerning the FDA potentially monitoring medical apps. Some think it’s a great idea, others, not so much. Well, the latest news has arrived: It is potentially being delayed until 2013.
The reason for the delay? Iowa Senator Tom Harkin recently proposed a bill (S.3187) that, if passed, would require the FDA To provide a “full-scale report to Congress on its plans for regulating mobile medical apps.” In addition, Senate would have to give its sign off before the FDA could even finalize its mobile apps guidance.
If passed, the FDA would have 18 months to finalize this report, which would take a lot of effort to get it completed.
This has caused a bit of an uproar among different people. Bradley Thompson, an FDA-expert for the Epstein Becker Green law firm said he hopes this doesn’t happen. According to the Fierce Mobile Healthcare article, “he and other proponents are ‘actively talking with Senate Staff’ about the FDA’s timeline, and pushing for the guidance ‘not to be held up.’ With the pace the market is growing and changing, healthcare providers, app developers and other need clarity now on what the FDA expects, and what the regulatory process will be—not in late 2013.”
To me, it seems like if this bill is passed, the mHealth market growth might be hindered. I mean, are the developers of mHealth technology going to want to put a ton of effort into creating different products, when there is a possibility that it may not be in-line with FDA guidelines a year later? I don’t think so. While I am still not sure how I even feel about the FDA monitoring mobile health apps, if it’s going to happen, I’d rather it occur in whatever fashion will be most beneficial for developers. The article I mentioned above says that “it will be interesting to see if it turns into a partisan battle on Capitol Hill.” That it will.