Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “Senate Bill Takes Aim at Potential for FDA Overreach in IT Regulation.”
Following is an excerpt:
Senate lawmakers introduced a bill last week that would take the FDA out of most software regulation.
The Preventing Overreach to Enhance Care Technology (PROTECT) Act, introduced by Sens. Deb Fischer (D-Neb.) and Angus King (I-Maine), lays out a clear regulatory framework for health IT that is intended to promote innovation and job creation while protecting patient safety. ?…
“I think the drafters of the PROTECT Act tried to solve some of the technical problems and they solved a few, but not the biggest and most important ones,” said Bradley Merrill Thompson, an attorney with Epstein Becker Green and head of the mHealth Regulatory Coalition.
“The biggest issue with both the SOFTWARE Act and the PROTECT Act is that it would deregulate certain standalone software used for such things as guiding therapeutic decisionmaking,” Thompson told D&DL. “For example, under both acts, a radiation dosage calculator would be removed from FDA regulation even though there is considerable risk in using such a program.”
The attorney also expressed concern about handing responsibility for software regulation to NIST, which historically is not a regulatory body.