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 “Congress Wants to Kick the FDA Out of Digital Health with This New Bill.”
Following is an excerpt:
Bradley Merrill Thompson, a Washington, D.C.-based attorney with Epstein, Becker & Green, is concerned that the bill will violate patient safety. Thompson has been the most vocal and high-profile opponent of the PROTECT Act in the press.
“Some of the software [the PROTECT Act] would deregulate is virtually all clinical-decision support software,” said Thompson, who advises clients on navigating regulation and the FDA, in a phone interview. “That is software a doctor would use to help figure out what’s wrong with a patient or prescribe the right kind of medication.”
Thompson said he fears that all mobile medical apps would be unregulated. Those that are flawed or that simply don’t work would drag down the industry. ?…
But Thompson said he was perturbed by the timing of this bill, given that he dedicated months of his time over the summer to advising the FDA and other government agencies as part of a FDASIA workgroup. In the workgroup, the FDA asked experts in the space to convene regularly and prepare a report on an appropriate, risk-based regulatory framework pertaining to health IT, including mobile medical applications.