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 "Coalition Proposes FDA Regulatory Framework for Clinical-Decision Support."
Following is an excerpt:
After 18 months of discussion, the Clinical Decision Support (CDS) Coalition has unveiled a proposed framework to regulate clinical decision support software, hoping to stimulate comment and discussion from various stakeholders.
The group headed by Epstein Becker Green attorney Bradley Merrill Thompson, has 25 members representing payers, providers and software vendors who are trying to define the type of software that performs analytic functions on data to either propose clinical solutions or supplement a user's clinical decisions. CDS has been consulting FDA periodically since the formation of the group, after a 2011 FDA workshop on regulation of clinical decision support software.
The group is now releasing its findings "to start pressure-testing it," Thompson said during the webinar unveiling the framework July 17, "and getting as many comments as possible on issues we didn't think of."
