A new House bill co-sponsored by a bipartisan group of lawmakers aims to cut deep into the FDA’s newly finalized oversight of mobile medical apps, keeping regulation only to programs that complement medical technologies or those that turn a mobile device into a medical one.
The bill would keep the FDA’s tendrils out of apps deemed to be ‘clinical’ or ‘health’ software, reserving oversight for programs that directly changes the structure or function of any part of the body, makes clinical recommendations for consumers and includes the use of a drug or device without the involvement of a healthcare professional.
Specifically excluded from the proposed regulation are programs that are a component of a device or whose primary purpose is vital to the function of a drug or device, according to the text of the bill. The measure was co-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 proposal would limit a bill that the FDA had designed to be "hands-off" to begin with. The agency had said, when it released its final rule late last month, that regulation would only apply to a subset of mobile medical apps that were deemed at increased risk to consumers. That means the majority of healthcare apps won’t be regulated under the FDA’s existing charter, as the agency deems them of minimal risk to consumers.
Apps that will get more attention include those that are developed as an "accessory" to a regulated device, ones that help healthcare providers view images for analysis and diagnosis and programs that effectively "transform" a mobile device into a medical device, such as smartphone-based heart rhythm monitors. For apps that fit the criteria of a regulated medical device but post little risk to consumers, the agency plans to prescribe ‘enforcement discretion’.