Brief: FDA app guidance not a formal law or regulation

A new Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation exploring mHealth promises and challenges makes the case that the regulation of apps will become more important as mobile devices become even more  ubiquitous.

In late September, the U.S. Food and Drug Administration issued its final guidance on mobile medical apps outlining the regulatory agency's "tailored approach" and its intention to focus on a "small subset" of the app market, namely those apps that present the greatest risk to patients. 

The "final guidance, while similar to the July 2011 draft guidance, does introduce information and language that has not yet gone through a public vetting," the brief points out. "As with the draft guidance and the many outside comments it drew, some industry experts have said that portions of the final guidance are not entirely clear, which could lead to conflicting interpretations, although these are peripheral issues."

However, more significant, as the policy brief argues, is the fact that the FDA's final mobile medical app guidance is not a formal law or regulation.

"To date, there is no congressional law on mHealth apps," states the policy brief, though lawmakers have introduced bills that address the issue in one form or another.

On December 3, 2012, Rep. Michael Honda (D-Calif.) introduced H.R. 6626, the Health Care Innovation and Marketplace Technologies Act of 2012, and on June 13, 2013, he reintroduced it as H.R. 2363, the Health Care Innovation and Marketplace Technologies Act of 2013. Nevertheless, the bill is not expected to pass the congressional committees it was assigned to, asserts the brief.

When it comes to proposed legislation, one glaring omission by the brief is its failure to mention the SOFTWARE Act, a bipartisan bill that was introduced in late October by Rep. Marsha Blackburn (R-Tenn.), vice chair of the House Energy and Commerce Committee, to amend the Federal Food, Drug, and Cosmetic Act and to limit the FDA's regulatory authority in the area of medical software. 

The FDA and members of the House Energy and Commerce Committee are at odds over whether software should be regulated as a medical device. Both sides of the argument were made at a Nov. 19 hearing. At the center of the disagreement between the FDA and some members of Congress is the SOFTWARE Act.

As for formal regulations, "they are in the works," states the brief, referring to the FDASIA-mandated risk-based regulatory framework for health IT, which includes mobile medical apps. The FDA is currently working with the FCC and Office of the National Coordinator for Health IT to provide its report to Congress by January 2014. 

"Among many topics, it is expected to outline how mobile health regulation will work in practice," according to the brief. "If the agency follows the FDASIA work group's final recommendations, the framework will emphasize innovation, patient safety, and efficient regulation ...The January framework will also likely help the FDA and other agencies formulate guidance for clinical decision support application software and other details that the agency left out of its final guidance in September."

To learn more:
- read the policy brief