Revamped MEDTECH Act looks to exempt low-risk software from FDA guidance

Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) late Monday unveiled a revamped version of their Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act, which aims to exempt low-risk medical software and mobile apps from regulation by the U.S. Food and Drug Administration while clarifying which offerings fall under federal authority.

The new bill updates proposed legislation initially introduced to the Senate last December and is more granular in distilling which software should not be regulated by the FDA. Software intended to support administrative and operational functions for healthcare facilities, for instance, is excluded from regulation, as are tools to monitor wellness "unrelated to the diagnosis, cure, mitigation, prevention or treatment" of a specific disease or disorder.

What's more, the bill calls on the FDA to classify accessories to medical devices based on their intended use but separately from the device with which they will be used. It also specifies that electronic health records should be exempt as long as they're certified by the Office of the National Coordinator for Health IT.

"Some tools, whether a calorie counter or an activity tracker to monitor your exercise routines, are low risk and don't require in-depth oversight by the government," Bennet (pictured) said in a statement issued upon the bill's reintroduction. "Our bill provides certainty for innovators in the life sciences and the FDA by clarifying which devices and software should be monitored to keep consumers safe."

Bradley Merrill Thompson, an attorney with Epstein Becker Green who represents the CDS Coalition, among other groups, said in an email to FierceHealthIT that the bill "moves the ball forward" in terms of software regulation while working to avoid unintended consequences. In particular, he said that language around clinical decision support delicately strikes the right balance between how to approach software that helps a doctor vs. software that a doctor is not dependent on to make a patient care determination.

"Software that analyzes medical information to help a doctor, but presents the information in a way that does not force the doctor to rely on the software, would be unregulated by the FDA," Thompson said. "That's the right approach."

To learn more:
- here's the bill (.pdf)
- check out the announcement from Hatch and Bennet