3 surprising aspects of FDA mHealth final guidance

Experts think there are three "surprises" in the U.S. Food and Drug Administration's final guidance on mobile medical applications, as reported by GovernmentHealthIT.

The article cites Robert Jarrin, senior director of government affairs for Qualcomm, and Morgan Reed, executive director and mHIMSS legal/policy task force chair for the Association for Competitive Technology--both of whom spoke at a recent HIMSS virtual briefing.

According to Jarrin and Reed, the three surprising aspects of the FDA final guidance are:

  • Labeling will play a big part in whether 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.

Nevertheless, "there are issues that remain to be clarified by the FDA, including some on clinical decision software," Jarrin says in the article. 

The FDA's final guidance explicitly states that the document does not address software that performs "patient-specific analysis to aid or support clinical decision-making." Because the FDA provides no clarification on what types of apps would be viewed as clinical decision support (CDS) software outside the scope of its final guidance, this software category remains a gray area leaving app developers unclear as to how to market these products. 

CDS software will be addressed separately in the congressionally mandated plan for a risk-based regulatory framework for health IT which includes mobile health. The FDA, in collaboration with the Federal Communications Commission and Office of the National Coordinator for Health IT, is preparing a report to Congress on the proposed regulatory approach for health IT. Required by the Food and Drug Administration Safety and Innovation Act (FDASIA), the report is due to Congress by January 2014. 

Last month, a bipartisan group of House members--three Democrats and three Republicans--introduced a bill to "provide regulatory clarity regarding mobile medical applications, clinical decision support, electronic health records and other healthcare related software." The Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act seeks to amend Section 201 of the Federal Food, Drug, and Cosmetic Act to regulate medical software and to provide guidance to the FDA about mobile medical app regulations.

The SOFTWARE Act defines three classification levels of software--clinical software, health software and medical software. However, the proposed legislation has gotten mixed reactions from industry groups.

To learn more:
- read the article in GovernmentHealthIT

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