Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MedTech Insight Pharma Intelligence, in “US FDA Medical Software Report Rests Concerns of Increased Regulation,” by Ferdous Al-Faruque. (Read the full version – subscription required.)

Following is an excerpt:

A new report from US FDA concludes, for the most part, that the benefits of a slew of non-device software functions not regulated by the agency outweigh their risks. The report sends a signal to industry that regulators are happy with the current situation and have no incentive to expand their oversight of such products.

Under the 21st Century Cures Act, five categories of digital health products were excluded from FDA’s oversight, including software for administrative support, certain healthy lifestyle software, certain electronic patient records software, certain software for handling medical data or displaying it, and certain clinical decision support software. Under the law, the agency is required to periodically present a biennial report outlining the risks and benefits associated with such software. …

When lawmakers insisted certain medical software be removed from FDA oversight but required the biennial reports, industry insiders were worried it could lead to FDA arguing for more regulation of such products. The law allowed a clawback provision that gives FDA the authority to use notices and public comments to expand regulation of such software based on what the agency finds in its analyses.

“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,” said Bradley Thompson, an attorney with the law firm Epstein Becker and Green.

“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,” he added. “So, this first report is really FDA's first commentary on the safety of these congressionally-directed exemptions. That's why this report is reassuring. 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.”

Thompson said the report also creates a baseline for future reports on how such devices affect the public, and any future assessment of safety of these products will likely be weighed against the report.

“My only real disappointment with the report is that FDA provided so little in the way of best practices,” Thompson said. “I think it was Congress' intent that FDA use this forum to educate the public broadly regarding best practices that will increase the safety and the benefits of such software. FDA took a very narrow interpretation of this provision and provided only cursory comments on best practices. That's an opportunity lost. I hope in the future FDA will choose to elaborate.”

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