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 “Proposed Oversight Strategy for Health IT Contains Few Surprises, Details, Sources Say.”
Following is an excerpt:
The release April 3 of a proposed frameworkfor regulating health information technologies contained no surprises and largely followed recommendations that were made to federal agencies as they crafted the report over the past year, industry sources told Bloomberg BNA. ?…
“Many in the industry have been waiting for years to find out more specifically the distinction between wellness and disease, exactly what constitutes medical device accessories, exactly what constitutes clinical decision support software that FDA would regulate, and parsing medical device software modules for regulation,” attorney Bradley Merrill Thompson, with Epstein Becker & Green PC in Washington, told Bloomberg BNA.
Thompson said the report explicitly mentioned each of those areas and noted that the FDA would eventually issue further clarity. But, he said, it would have been helpful to see more granularity in this report.