House hearing explores regulation of mobile medical apps

A House Energy and Commerce Committee hearing explored whether proposed rules governing the oversight of mobile medical device apps should be codified into law.

During the Nov. 19 hearing, stakeholders weighed in on legislation introduced in October that would clarify regulations for mobile medical apps and health IT systems. The bill, Sensible Oversight for Technology which Advances Regulatory Efficiency, or SOFTWARE, Act (H.R. 3303), would categorize software as either clinical, health or medical and amend the Federal Food, Drug and Cosmetic Act to give the FDA guidance on regulating mobile medical apps.

Stakeholders sparred over whether formal legislation regulating these apps is the best step forward.

Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, called the bill “premature,” especially on the heels of the publication of the FDA mobile medical app guidance.

Published on Sept. 25, the guidance stated FDA’s intention to exercise enforcement discretion for the majority of mobile apps that pose minimal risk to consumers while focusing on a subset of mobile apps that present a greater risk to patients. The FDA also said it would not regulate the manufacturers of smartphones or tablets.

“We spent two years on the guidance, and it’s 40 pages long with extensive explanations,” he said, adding that the guidance provides flexibility as it can be updated with changes as the industry evolves.  

“Taking a 40-page document and honing it down into a few sentence of statute is not only challenging, it becomes difficult to make changes because the statute is so inflexible.”

Also, Shuren said that lawmakers should wait until the Food and Drug Administration Safety Innovation Act Work Group release their report early next year. The report is expected to contain the workgroup's strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health IT, including mobile medical applications.

Health Subcommittee Chairman Joe Pitts (R-Penn.) expressed concern that the FDA can change the guidance on a whim, and that, in general, the lack of codification of the rules creates regulatory uncertainty that threatens innovation.

When Pitts asked if FDA could change the guidance at any time, Shuren responded, “Not overnight. There are statutory requirements that we have to comply with to change any such policy, which requires extensive public input and congressional oversight.”

Shuren also said that the bill as it stands now would not codify the guidance and would remove iFDA oversight of software classified as clinical or health-related. “It takes from our authority the ability to ensure the safety and effectiveness of devices we currently are regulating, including some high-risk devices.” For example, he said, under the legislation, the FDA would no longer be able to ensure safety of blood glucose meters or software for pap smear slides, which screen for cervical cancer.

However, some industry players are urging congress to create clearer rules for the regulation of mobile medical apps.

“It is critical to modernize the federal regulatory process so that health technologies keep pace with consumer use of IT applications," Joel White, executive director of the Health IT Now Coalition, said in a statement. "It was clear at the hearing today there is broad support for congressional action to clarify the duplicative and confusing regulatory framework for health IT. We look forward to supporting Congress and the administration in these efforts.”