Bradley Merrill Thompson Quoted in “Lawmakers Question ONC Authority To Take on New Health IT Activities”

FDA Week

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 "Lawmakers Question ONC Authority To Take On New Health IT Activities."

Following is an excerpt:

House Republicans on Tuesday (June 3) questioned whether the Office of the National Coordinator for Health Information Technology has the authority to establish a proposed health IT safety center, impose new user fees on health IT vendors and developers, and regulate electronic health records. ONC would take on the additional responsibilities as part of a proposed risk-based framework it developed with FDA and the Federal Communications Commission, but the lawmakers said it is unclear under what authority ONC is pursuing the new activities.

The three agencies issued a FDA Safety and Innovation Act-mandated report in April outlining a health IT framework that would maintain FDA's authority over medical devices but also divide products into two additional categories: administrative health IT and health management IT. Under the proposal, ONC would oversee the latter and would also establish a health IT safety center – a public-private entity that would focus on patient safety and the creation of an integrated health IT learning system. ONC would also spearhead the development of standards and best practices for design and development, customization and interoperability, among other areas. …

An industry attorney said the lawmakers are raising good questions since the FDASIA report was vague about what regulatory role ONC would play in the framework. Bradley Merrill Thompson, an attorney at Epstein, Becker & Green who leads several industry coalitions, said while the report made it clear that ONC would not be expected to act in a regulatory role, the agency should still clarify how it plans to oversee technology development on a voluntary basis.

"It's hard to believe that we need a cheerleader; we have plenty of those," he said. "Further, private industry is pretty good at standards development. We do it through all sorts of nonprofit organizations and frankly they do that work more efficiently than the government can. The FDASIA report was very thin on details so I think Congress has a legitimate right to ask for more information before simply writing a large check."