Bradley Merrill Thompson Quoted in “Industry Groups Asking Congress to Outline FDA Oversight of Health IT” – Bloomberg BNA

Bloomberg BNA

Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office was quoted by “BNA Snapshot” in “Industry Groups Asking Congress to Outline FDA Oversight of Health IT.”

Following is an excerpt:

Attorney Bradley Merrill Thompson, with Epstein Becker & Green PC in Washington, told Bloomberg BNA Oct. 7 that only when the FDASIA process is complete, “we can also have a meaningful discussion about legislative reform.”

Thompson noted the draft status of the April FDASIA recommendations from the agencies. He added, “Rushing to do something is a recipe for bad policy. If Congress acts precipitously, it can cause more harm than good, and bring more confusion than clarity.”

Thompson, who is general counsel to the mHealth Regulatory Coalition, said, “We agree fundamentally that for this HIT engine to drive improvements in healthcare, government regulation needs to be as clear as possible. That's why, while we are working with policymakers to identify the best approach, we are also urging FDA to publish guidance documents that really clarify at a granular level what gets regulated versus what doesn't.”

Thompson expressed hope that “this fall FDA will publish guidance documents on the difference between wellness and disease, the scope of medical device accessories, and the portion of clinical decision support software the agency regulates. We would like to see those guidance documents as soon as possible. We believe meaningful clarity in that area will help unleash the potential that is found in health IT.”