Legislators are once again seeking to limit what medical software and apps the U.S. Food and Drug Administration would be able to regulate.
Sens. Michael Bennett (D-Colo.) and Orrin Hatch (R-Utah) have re-introduced the Medical Electronic Data Technology for Consumers’ Health (MEDTECH) Act. The bill was originally introduced last year, surfaced again this past January, then appeared in Congress this week in what its sponsors say is a more slimmed down version.
“We’ve worked to tighten the definitions for the different types of medical software that would be excluded from regulation based on feedback we’ve received from stakeholders and the FDA,” an assistant to Hatch toldPolitico. “We also clarify the regulation of products with multiple functionality that have some components that would be regulated and others that would not.”
Federal agencies like the FDA have long sought to separate mHealth technology that should be regulated with the growing collection of software and apps that don’t affect clinical outcomes, and should therefore be left alone. And while the FDA has published guidance on what it would and would not regulate, Congress is seeking to make sure those guidelines are codified.
Hatch and Bennett say their bill “limits and clarifies the FDA’s role regarding regulation of administrative and financial software, wellness and lifestyle products, certain aspects of electronic health records and software that aids health care providers in developing treatment recommendations for their patients.”
“As the rate of innovation rapidly increases in the medical technology field, this bill provides greater clarity to ensure that businesses understand the rules of the road and safe and effective products reach consumers as soon as possible,” the senators said in a press release.
Bradley Merrill Thompson, an attorney with the Washington, D.C.-based firm of Epstein Becker Green and spokesman for the CDS Coalition, said the new bill “moves the ball forward” in that it clarifies what has once been a long and complicated bill. But he said the new bill is still “very complicated and not nearly as much fun to read.”
“You have to read it carefully to understand whether we’re talking about something that is regulated or something that is not regulated,” he told mHealth News.
“I think the bill does a nice job of striking the balance where 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 FDA,” Thompson concluded. “That’s the right approach.”
Among the software singled out for exclusion from FDA regulation are solutions that target maintenance of financial records, appointment schedules, business analytics and communication, information about patient populations and laboratory workflow processes and wellness.
The bill also answers the FDA’s request to continue regulation software used in the manufacture and transfusion of blood and blood components, as well as software that deals with medical image data.
Accessories would be regulated based on their independent level of risk, POLITICO reported, and the bill would change the status of some currently regulated Class II and Class III software.
“As the possibilities for medical technology continue to defy expectations, we must provide innovators with clarity about the regulatory rules of the road,” Hatch said in the press release. “The MEDTECH Act is a commonsense approach to give medical software pioneers the certainty they need to continue developing new technology that will benefit both health-care professionals and consumers alike.”
“Medical innovation is helping our health care providers better take care of patients, and it’s putting tools into the hands of families to help them manage their own health,” Bennet added in the release. “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. 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.”