Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “Lawyer: FDA Digital Health Report Reassuring, But Short on Safety Tips.” (Read the full version – subscription required.)
Following is an excerpt:
A medical device industry lawyer said a recent report issued by FDA on digital health tools reassures stakeholders that the agency will not regulate five categories of software which Congress deemed safe when it passed the 21st Century Cures Act in 2016. Some stakeholders had worried that FDA might try to take back jurisdiction over those categories through a clawback provision in Cures.
“That's why this report is reassuring,” Brad Thompson, a member of the firm at Epstein Becker Green, said. “I think some folks were holding their breath, fearing that FDA might want to try to lay the foundation for clawing back some of the software into regulation.”
The report, which came out Thursday (Dec. 13), fulfills a Cures requirement that FDA file a report every two years that examines the risks, benefits, patient safety impacts and best practices for the five categories of health software that Congress determined to fall outside FDA’s jurisdiction.
The five categories are: administrative support of a health care facility; products that encourage a healthy lifestyle; certain types of electronic patient records; certain types of software that transfers, stores or displays clinical laboratory tests or other device data; and certain types of clinical decisions support software.
“The concern was that because the legislation came from Congress, not FDA, FDA may not agree that all of these categories of software were indeed safe,” said Thompson, who added that the report represents the agency’s first commentary on the safety of these congressionally directed exemptions.
Thompson said the report forms a baseline for the benefit/risk profiles for the five software categories, though those profiles could change when the agency releases its next report in two years.
FDA’s verdict: The five categories present more benefits than risk. In the report, FDA mentions several encouraging benefits of the new software: such as how daily activity trackers led to an estimated 73 percent increase in steps taken a day and, when used to support weight loss, provided “superior short term results” compared to standard weight loss programs in middle aged or older adults. …
“I think most folks believed that those categories of software were pretty safe, but it's nice to see FDA reach the conclusion that the benefits outweigh the risks,” he added. Still, he said, the agency’s view of the safety of the categories could change if it is presented with new information over the next two years.
However, Thompson said he was disappointed the report did not go further in providing best practices for stakeholders on the best ways to ensure safe and effective use of the software.
