Some lawmakers are attempting to put the kibosh on the U.S. Food and Drug Administration’s (FDA) plan to regulate some mobile medical apps.
The U.S. House of Representatives Committee on Energy and Commerce’s Subcommittee on Health held an informational hearing on Nov. 19, to discuss the FDA’s recent guidance document on mobile medical applications, including what constitutes a medical device for purposes of regulation. Ambiguity in the scope of that definition has been a source of concern for some lawmakers, leading to new legislation that seeks to further clarify the FDA’s intentions and restrict some of its regulatory authority.
Called the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, the bill must still be evaluated by both the House and Senate. Tuesday’s hearing was likely the start of intense debate around the issue. With numerous mobile applications on the market that help people better understand their own health care, technological advances have blurred the line between traditional medical equipment and consumer products.
In his opening statement during Tuesday’s hearing, subcommittee chairman Joe Pitts, R-Penn, said that while patients and industry representatives agreed that the FDA’s involvement and guidance was a positive, too much ambiguity exists around the definition of a medical device. He explained that companies need to know what the FDA will or will not regulate so innovation isn’t stifled because of red tape.
Rep. Frank Pallone, D-N.J., felt encouraging innovation is important, but so was shepherding technologies that were safe for patients. He said that the FDA’s guidance was “measured and risk-based,” and clearly states that the agency wouldn’t extend its reach to regulate smartphones and tablets, just applications that perform medical diagnoses and similar functions.
Pallone questioned whether the SOFTWARE Act or any legislation should be approved until the FDA’s guidance could be evaluated. He added that there wasn’t much logic in enshrining a process in statute when technology changes so rapidly.
Representing the FDA, Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health, testified at the hearing. He defended the guidance document and stressed that it provided good clarity to the issue. Shuren added that while the FDA could regulate electronic health records (EHRs) as medical devices, the agency has put into official policy that it will not do so.
Pitts pressed Shuren on whether or not the FDA could change its policy and regulate devices like EHRs in the future. Shuren replied that changing FDA guidance and policies is not something that can be done overnight and would require a “long process."
The SOFTWARE Act was introduced in October to codify what standard the FDA uses to regulate tech and give app developers clarity regarding the process. Sponsored by Reps. Marsha Blackburn, R-Tenn.; Gene Green, D-Texas; Phil Gingrey, R-Ga.; Diana DeGette, D-Colo.; Greg Walden, R-Ore.; and G.K. Butterfield, D-N.C.; the bipartisan bill defines three different categories of mobile health (mHealth) software — medical, clinical and health.
Under the act, only medical software would need FDA approval. Medical software refers to technology that changes the structure or functioning of the body, or would do so if instructions were followed.
Apps that don’t function as a regulated medical device wouldn’t be governed by the act. For example, if a mobile device attachment and app has the ability to detect an ear infection, it would be regulated. If it only provides information on the symptoms of an ear infection, it wouldn’t be.
The final FDA guidance document on the topic released in September attempts to explain current regulations regarding apps as medical devices under section 201 (h) of the Federal Food, Drug and Cosmetic Act. The guidance indicates that software is a medical device for purposes of regulation, leading some experts to believe the move enables the agency to regulate all mobile medical apps. The FDA has maintained that its intention is to regulate only a subset of all medical apps.