Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in the Bloomberg BNA Health Care Daily Report, in “Cures Bill Could Lift FDA Regulation of Physician Software,” by James Swann. (Read the full version – subscription required.)
Following is an excerpt:
The legislation incorporates the idea that if software is supporting a physician’s practice, it shouldn’t be regulated by the FDA, Bradley Merrill Thompson, a health-care attorney with Epstein Becker & Green PC in Washington, said. This should help resolve any regulatory uncertainties for software developers, he said.
The FDA says it regulates high-risk clinical decision support software but not low-risk software, but without guidance, companies have no idea how the FDA goes about deciding which is which, Thompson said. “Companies have to know the answer to that question because it’s fundamental to both the cost and timeliness associated with product development,” Thompson said.
Thompson said the FDA doesn’t explain in any guidance how it uses the transparency of the software as a basis for deciding whether to regulate or not. Software transparency refers to the ability of the end user to see through the software to the ultimate data, Thompson said.
“At least in oral statements, the FDA seems to use that factor in deciding, for example, whether to require a clinical trial, but laying out the concept of transparency in black and white is the most important change,” Thompson said.