Path opens up for FDA regulation of mobile medical apps
In the rush to regulate the fast-growing industry of mobile medical apps, Congress has apparently sidestepped a potential power struggle with the Food and Drug Administration over the agency’s authority to regulate them.
According to multiple sources, House and Senate negotiators have modified section 618 of the FDA Safety and Innovation Act to allow the FDA to move forward on planned regulations for mobile medical apps. The move concludes weeks of back-and-forth discussion over whether the FDA has the authority to regulate the mobile medical apps industry.
[See also: Mobile health app market to reach $392M in 2015.]
As Section 618 of the FDA user fee bill now states, Congress will require the Department of Health and Human Services to draft a report, with input from the FDA, the Office of the National Coordinator for Health IT, the Federal Communications Commission and other stakeholders, on an "appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety and avoids regulatory duplication." That report, however, won't prevent the FDA from issuing its guidelines.
According to a brief posted June 19 on Politico, the Health IT Now Coalition had led the effort to stop the FDA from issuing its guidelines, asking instead for what amounted to a moratorium while the HHS report was completed.
“There are a lot of agencies that have at least some regulatory jurisdiction here: FDA, FCC, FTC, CMS, ONC all have a little piece of the pie,” said Joel White, executive director of Health IT Now, in a recent story on thenextweb.com. "For example, the Office of the National Coordinator for Health IT is pushing for electronic medical record standards, while the Center for Medicare & Medicaid Services is developing accountable care organization standards. Simultaneously, the Federal Communications Commission is creating requirements for enforcing communications requirements between mobile phones." As for mobile medical apps, said White, “Congress should have a role in helping develop a framework that makes sense for mobile health technologies as they exist today, but is flexible enough to evolve with the market.”
The coalition's move to stop the FDA met with opposition from several corners, including Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, and the mHealth Regulatory Coalition.
In a May 17 letter to Sen. Tom Harkin (D-Iowa), chairman of the Committee on Health, Education, Labor and Pensions, and Sen. Michael B. Enzi (R-Wyo.), a committee member, the MRC's general counsel, Bradley Merrill Thompson, urged legislators to allow the FDA to move forward.