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 "Industry Groups, Lawmakers Push Changes to Blackburn HIT Bill."
Following is an excerpt:
A coalition of device industry groups and manufacturers is weighing a regulatory framework to counter recent legislation, backed by health information technology groups, that would limit FDA's oversight of certain software products. The HIT regulatory framework should look at the functionality of the larger system in addition to the safety and effectiveness of individual components like software, Clinical Decision Support Coalition General Counsel Bradley Merrill Thompson told FDA Week. ...
Thompson also urged Congress to wait for FDA Safety and Innovation Act-mandated agency recommendations for the development of a risk-based health IT regulatory framework, due in February.
"What we'd like to do is wait for the first quarter," Thompson said. "We'd like to wait until seeing that report before deciding if legislation is needed."
He added, however, that if Congress is intent on passing legislation ahead of that report, lawmakers should consider revising the bill's approach of stratifying health IT software into three "buckets." ...
Thompson said the CDS Coalition is considering proposing a counter framework that would look more broadly at how to improve the functionality of the health IT system, as well as how to regulate individual HIT components to ensure safety and effectiveness. ...
Thompson said one of the key areas the group plans to focus on at the system-level is adverse event reporting. Thompson was a member of the FDASIA workgroup tasked with helping FDA, the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission develop recommendations for a risk-based health IT framework. He said one of the workgroup's key findings was that there was not enough adverse event reporting on the use of products.
"We want to learn if there are or are not issues," he said. "We don't want to overregulate. But right now we don't know what we don't know. We don't know if health IT is functioning splendidly, or if there are adverse events."
Thompson said that at a system-level there should be "more and better" information on system function, while component-level regulation should focus on the specific functionality of individual products. The point the CDS Coalition is trying to make is that the function of the system depends on the safety and functionality of the component, he said. And that is where it gets complicated because FDA medical devices are regulated according to intended use, Thompson added.
