Bradley Merrill Thompson Quoted in “Tri-Agency HIT Report Pushes ‘Light Touch’ Oversight, Sets Up New Center”FDA Week April 3, 2014
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 "Tri-Agency HIT Report Pushes 'Light Touch' Oversight, Sets Up New Center."
Following is an excerpt:
FDA, the Office of the National Coordinator for Health IT and the Federal Communications Commission Thursday (April 3) issued a long-awaited proposal for a tri-agency, risk-based framework that breaks health information technology into three categories -- administrative health, health management and medical devices -- and limits FDA oversight to high-risk technology. Under the proposal, FDA would continue to regulate health IT systems that function as medical devices, including computer-aided diagnostics, but would not extend its authority to clinical decision support software categorized as health management IT. ?...
Bradley Thompson, an attorney and Epstein, Becker & Green and co-chair of a federal HIT working group that made recommendations to the agencies, said the agencies' proposal to maintain a "light touch" approach should appease lawmakers and stakeholders that had been concerned the space would be over-regulated by federal agencies.
"The bottom line is that HHS, and the three agencies, are proposing a very light touch to overseeing innovation in health IT, and that has to be good news for all of the HIT developers producing wonderful, important, cutting-edge technologies," he said.
He also noted that the report echoes a proposal from the Bipartisan Policy Center to divide HIT into three categories. Both House and Senate lawmakers have introduced legislation intended to clarify FDA's authority over HIT. The House bill also creates three categories, while the Senate legislation defines clinical and health software. However, Thompson, who leads industry coalitions, has opposed legislative efforts to amend FDA authority and has urged lawmakers to wait for issuance of the tri-agency report.