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 “ONC Tells Lawmakers Health IT Safety Center Won’t Be a Regulatory Body.”
Following is an excerpt:
The Office of the National Coordinator for Health Information Technology recently wrote to House Republicans that its planned health IT safety center will not be a regulatory body, essentially rebuffing lawmakers’ concerns the office needs legislative authority to establish the center. But Rep. Marsha Blackburn (R-TX) said at a hearing July 17 she remains concerned the public-private center meant to focus on patient safety and the development of an integrated health IT system could take on a regulatory role, and she vowed to continue pushing legislation that would clearly delineate federal agencies’ roles in health IT oversight.
But Bradley Merrill Thompson, an attorney at Epstein, Becker & Green who also leads several industry groups, told FDA Week that it would be a mistake for Congress to “hastily draft something high level that would likely only add to the confusion, not resolve it.”
Thompson said some stakeholders are mulling asking Congress to craft legislation that would not draw lines among software products but instead mandate FDA develop policies and guidance documents — similar to mandates in user fee bills. Congress could direct FDA to clarify areas that are confusing to developers, like adverse event reporting and standalone software, Thompson added.
He also suggested questions about the health IT safety center focus less on ONC’s authority to establish the center and more on whether the agency plans to release more details, such as through a business plan. “It’s not a question of statutory authority principally because the center isn’t going to have any power,” Thompson said. “Set aside that issue, there are appropriations involved so it seems to me Congress has a legitimate cause to ask ‘If we’re going to spend the money, what are we spending the money on?'”
He added that private investors also will likely want to see some sort of business plan. Otherwise, no one in business would want to invest, Thompson said.