Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Modern Healthcare, in “FDA Takes Lighter Touch with New Health IT Guidance,” by Darius Tahir.
Following is an excerpt:
The final FDA documents are similar to drafts issued in June, but industry observers are pleased with a few changes. For example, the guidelines on medical-device-data systems have been expanded to include image-based data, noted Bradley Merrill Thompson, an attorney with Epstein Becker Green. …
Thompson noted that four years ago medical-data-device systems were subject to the highest category of FDA supervision and now they are exempt. He says that’s illustrative of the agency’s current approach to the broader health IT sector.
“The implications are profound,” he said. “The FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software.”