Regulations Proposed for Mobile Apps

The mobile-health industry is weighing in on the proposed regulation of mobile medical applications by the Food and Drug Administration, arguing that the FDA needs to broaden its definition of mHealth devices to avoid stifling innovation.

Because of the "great variety in the design, application and intended use of (mHealth) devices and applications," says the American Telehealth Association, it would be "misguided to treat them all the same" in the FDA's draft guidance on mobile medical applications.

In a letter to the FDA, the ATA suggests that the level of regulation be based on intended use, likelihood of failure and the severity of outcome if a failure occurs. The industry trade group recommends developing a risk-assessment algorithm to guide the regulation.

The ATA also recommended that the FDA:

• Classify mHealth hardware into one of five categories: medical information and measurement capture; data aggregators; communication technologies; network infrastructure; and health-care provider graphic user interfaces.
• Establish whether software on the devices is off the shelf or has a specific, intended use, and evaluate and classify the latter based on risk.

• Focus mHealth product regulation on moderate- to high-risk devices and define the boundary between health and wellness purposes and medical uses.
• Reclassify products that would be considered accessories.
• Adjust and clarify which regulatory body is responsible for mobile-health systems that include nonmedical products.
• Clarify when an electronic health record will be regulated under mHealth rules.
• Create a separate FDA division to set and enforce mobile-health regulations.