Whereas the FDA might not call the final guidance it handed down an experiment into the debate about whether regulations slaughter or spark innovation, the way it unfolds has precedent-setting potential.
“This is a really big deal for garage entrepreneurs, or whatever you would call them — people working in health institutions and even academics,” said Robert Jarrin, senior director of government affairs for Qualcomm. Morgan Reed, executive director and mHIMSS legal/policy task force chair for the Association for Competitive Technology said that for the first time in a long, long while, FDA “recognized that they aren’t going to tell us how to innovate.”
That stance was but one of the surprises that Jarrin and Reed outlined during a HIMSS virtual briefing on the finer points of the FDA mobile health guidance.
- Labeling will play a big part in whether or not a product is intended as a medical device. “It comes down to the intent of the person responsible for labeling the devices,” Jarrin said. He uses an analogy of an ink pen. If it is not stamped with any medical terms, it is clearly not a medical device. If somewhere in fine print, however, it is labeled as “sterile,” this implies the pen could be used for medical purposes.
- Footnote 27. Another interesting revelation in the guidance is found in footnote 27, regarding medication reminders. FDA gave a “very clear impression” it won’t be enforcing medication reminders on a platform or an app.
- Most apps, in fact, don’t even need regulation. “Many mobile apps are not mobile devices,” Jarrin added. “This is important.” Some will meet the definition of mobile devices, but since they pose a lower risk to the public, the FDA won’t regulate them. Rather, FDA will only look at products that function as mobile medical devices and could pose a risk if they don’t work as intended.
“There are issues that remain to be clarified by the FDA, including some on clinical decision software,” Jarrin said. “But overall, the guidance is chock full of anecdotes that provided better clarity.”
For any apps residing in the murky territory left up to FDA’s discretion, the agency is taking “the watchful waiting” approach, Reed said. “I think it’s really critical we understand that the regulatory discretion the FDA is providing here resembles an `I need to see progress’ and then we’ll make a decision down the road. But it’s also really important that we don’t treat this as a total free-for-all.”
Instead, developers and providers who want to build an app should know that architecture matters. Build it right, with transparency and auditability included, Reed said, and don’t get too hungry.
“Make it do one thing very well,” Reed said, that will be one of the best ways to keep patients safe and the FDA off your back.