FDA Announces Precertification Program For Digital Health Tools

Posted on October 5, 2017 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she’s served as editor in chief of several healthcare B2B sites.

The FDA has recruited some the world’s top technology and medical companies to help it pilot test a program under which digital health software could be marketed without going through the through the agency’s entire certification process.

The participants, which include Apple, Fitbit, Johnson & Johnson, Samsung and Roche, will give the agency access to the measures they’re using to develop, test and maintain their software, and also how they collect post-market data.

Once armed with this information, the FDA will leverage it to determine the key metrics and performance indicators it uses to see if digital health software meets its quality standards.

Companies that meet these new standards could become pre-certified, a status which grants them a far easier path to certification than in the past. This represents a broad shift in the FDA’s regulatory philosophy, “looking first at the software developer digital health technology developer, not the product,” according to a report previously released by the agency.

If the pilot works as planned, the FDA is considering making some significant changes to the certification process. If their processes pass muster, pre-certified companies may be allowed to submit less information to the FDA than they currently must before marketing a new digital health tool.  The agency is also considering the more radical step of allowing pre-certified companies to avoid submitting a product for premarket review in some cases. (It’s worth noting that these rules would apply to lower-risk settings.)

The prospect of pre-certifying companies does raise some concerns. In truth, the argument could be made that digital health software should be regulated more tightly, not less. In particular, the mobile healthcare world is still something of a lawless frontier, with very few apps facing privacy, security or accuracy oversight.

The fact is, it’s little wonder that physicians aren’t comfortable using mobile health app data given how loosely it can be constructed at times, not to mention the reality that it might not even measure basic vital signs reliably.

It’s not that the healthcare industry isn’t aware of these issues. about a year ago, a group of healthcare organizations including HIMSS, the American Medical Association and the American Heart Association came together to develop a framework of principles dressing app quality. Still, that’s far short of establishing a certification body.

On the other hand, the FDA does have a point when it notes that a pre-certification program could make it easier for useful digital health tools to reach the marketplace. Assuming the program is constructed well, it seems to me that this is a good idea.

True, it’s pretty unusual to see the FDA loosen up its certification process – a fairly progressive move for a stodgy agency – while the industry fails to self-regulate, but it’s a welcome change of style. I guess digital health really is changing things up.