Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO Morning eHealth,in “FDA Puts Out New Decision Support Guidance,” by Mohana Ravindranath.
Following is an excerpt:
The agency on Thursday released a long-awaited guidance on decision support software. The document is a response to critiques from a previous edition in December 2017, the agency’s digital health lead, Bakul Patel, told Darius.
…Those critiques included confusion about the distinction between decision support software for clinicians, and that of patients. That lead the FDA to create tiered standards for oversight, based on whether the intended user of the software is a health care provider, and whether the output of the software is reviewable by its user. Products whose output isn’t reviewable, or whose user isn’t a doctor, will get higher levels of scrutiny.
“This is progress, albeit maybe smaller steps than it might otherwise appear,” Epstein Becker Green lawyer Bradley Merrill Thompson told us. Thompson, who advises decision support software firms, said while he appreciated the FDA’s decision to explicitly tailor its oversight capabilities to each product’s level of risk, he believes the agency still overregulating certain low-risk products targeting non-serious conditions. In some cases, it will still have oversight responsibilities.