The good news in the world of mobile health technologies and the regulatory framework around them may be that the picture didn’t get any more confusing, if that’s any consolation.
The U.S. Food and Drug Administration — in its release of long-awaited mHealth guidance — clearly moved away from micro-regulating.
As with just about any issue in Washington, there was a bunch of noise about it all. Misunderstandings — deliberate or otherwise — fueled the partisan posturing. At a slew of hearings following the September 23 release of the mHealth final guidance, Republican leaders worked to uproot any hidden plans for future over-regulation of mobile health and IT devices.
FDA officials assured: There are none.
The guidance, at a mere 41 pages, is after all only that - guidance. The FDA has no enforcement power over apps that don’t fall under its jurisdiction. So few apps qualify for the need for FDA approval, the point is nearly moot. And anyway, those apps that require approval have always required approval. They are the ones that have and always will behave as medical devices.
[See also: Top 10 mHealth stories 2013.]
The biggest problem with mHealth is its explosive growth. No lawmaker — of any political party — said innovation should be stifled. Despite what some might say, innovation is safe. Garages across America are still highly regarded and even treasured as high-tech corporate petri dishes.
Which leads to the question of how to guide such a fast-moving target? This was a legitimate issue this year and, of course, another unresolved one.
Congress is leaning heavily toward jumping into the fray. Several House leaders say legislation would be most adept at taking care of this mHealth regulation business. The FDA and Congress are both part of the federal machine. And there is no denying its lack of agility, though the FDA made a valiant effort to approve apps inside of three months this year, some developers reported.
In recapping 2013, one can't forget FDASIA. It’s a workgroup mandated under the U.S. Food and Drug Administration Safety and Innovation Act comprised of private sector volunteers and federal officials from the FCC, FDA and ONC. The 32-person group has been commissioned to sort out the tangle that is mHealth regulation and offer recommendations for a regulatory framework to be released in early 2014.
[See also: mHealth — what's the hold up?]
In August of 2013, a paper to the ONC by Bradley Merrill Thompson, an attorney with Epstein Becker Green and the legal counsel for the mHealth Regulatory Coalition, emphasized the need for a tri-agency approach including the ONC, FDA, FCC in providing regulatory framework for mHealth. In the fall, the ONC sought public comments on the issue as it prepares to develop the framework with the other two agencies.
When the framework finally comes out of the FDASIA workgroup, it will likely spark even more debate, if history is to repeat itself.
This article originally appeared on Government Health IT.
