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 “Congress Sends Cures Legislation to President,” by Michael D. Williamson and Jeannie Baumann. (Read the full version – subscription required.)
Following is an excerpt:
“The device provisions are numerous, and probably anyone you ask will have a different provision they think will help most,” attorney Bradley Merrill Thompson told Bloomberg BNA Dec. 7. Thompson, who practices at Epstein Becker & Green PC in Washington, represents device and life science companies.
In particular, the software reforms in the legislation, which clarify that several categories of software are not devices at all, such as wellness apps and clinical decision support (CDS) programs, are a significant help to device makers, Thompson said.
CDS represents a wide range of technologies, from common automated alerts and reminders to software that relays data to and from implanted devices. The most commonly used CDS tools help providers with drug-prescribing decisions.
The CDS changes are particularly useful, Thompson told Bloomberg BNA. While the FDA has always acknowledged that such software is low risk, it could never seem to clearly say that such software is unregulated, Thompson said.
