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 “FDASIA Workgroup Narrows Focus to Avoid Overregulation, Duplication Food and Drug Administration Logo.”
Following is an excerpt:
A federal advisory group tasked with laying the groundwork for a report on the potential safety risks posed by health IT tools should focus its efforts only on those technologies not defined by the Food and Drug Administration as medical devices, according to recommendations presented to the group May 30.
The Food and Drug Administration Safety and Innovation Act (FDASIA) workgroup, an advisory group to the Office of the National Coordinator for Health Information Technology, in August will issue draft recommendations on potential patient safety risks posed by health IT. At a day-long meeting, the workgroup debated the scope of the recommendations, with one subgroup suggesting the workgroup only consider unregulated technologies, such as health information exchanges and clinical decision support tools. ?…
The FDASIA workgroup is part of a congressionally mandated partnership between the Department of Health and Human Services, the Federal Communications Commission, and FDA. The three agencies are charged with developing a report with proposals for a risk-based regulatory framework for health IT that includes policies for mobile medical applications. ?…
Bradley Merrill Thompson, a workgroup member and attorney with Epstein Becker & Green, PC in Washington, said that while the workgroup was tasked with reducing regulatory duplication it was not asked to avoid issuing recommendations on potentially regulated technologies.
He said FDA exercises a right to choose not to regulate certain devices, such as EHRs, that fit the definition of medical devices but may pose a potential patient safety risk. ?…
The workgroup’s recommendations should “have a laser-like focus on safety issues,” Thompson said.
He said their recommendations should consider only “real risks, not imagined ones.”
“Standing in the way of innovation is what we want to avoid,” Thompson said.