House and Senate negotiators have modified section 618 of the FDA Safety and Innovation Act to allow the Food and Drug Administration to move ahead with planned regulations for mobile medical applications.
The move concludes weeks of back-and-forth discussion over whether the FDA has the authority to regulate this fast-growing industry.
As Section 618 of the FDA user fee bill now states, Congress will require the Department of Health & Human Services (HHS) to draft a report -- with input from the FDA, the Office of the National Coordinator for Health IT (ONC), the Federal Communications Commission (FCC) 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 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 in 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 (MRC).
In a May 17 letter to Sen. Tom Harkin, chairman of the Committee on Health, Education, Labor and Pensions, and Sen. Michael B. Enzi, a committee member, MRC General Counsel, Bradley Merrill Thompson, urged legislators to allow the FDA to move forward.
"[W]e recognize and call attention to the need for FDA to improve the current approach to regulation of mHealth technologies, beyond simply focusing on mobile medical applications," the letter stated. "To be sure, the MRC believes the guidance on mobile medical applications is a significant step toward the appropriate regulation of these technologies. Indeed, the guidance provides much needed clarity in some areas, limiting regulatory oversight for certain low-risk products."
"Yet, the final guidance must go further," continued Thompson, an attorney for the Washington D.C. law firm of Epstein Becker & Green P.C. "Gaps in the regulatory framework must be addressed in order to provide the predictability and robustness that investors and innovators require to further growth in an industry that promises to revolutionize healthcare in the United States. A moratorium on the publication of the guidance on mobile medical applications will only serve to delay this important, initial step toward a comprehensive regulatory scheme."
"The final bill orders the study to be done and reported to Congress, but the agency can move forward with the guidance before that," Politico's Brett Norman reported.
"[T]hose like the mHealth Regulatory Coalition who acknowledge that FDA has a legitimate role to play wanted to avoid any delay, in the desire to get needed clarity around the scope of FDA regulation," Brad Thompson, mHealth’s general counsel, wrote in an email to Politico. "We are breathing a sigh of relief."