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 multiple publications regarding the 21st Century Cures Act.
Following is an excerpt from FierceHealthIT:
In addition to those criticisms, Bradley Merrill Thompson, an attorney with Epstein Becker Green who represents the CDS Coalition and other groups, called updated language pertaining to clinical decision support regulation for the Sensible Oversight for Technology Which Advances Regulatory Efficiency (SOFTWARE) bill too open-ended, in an email to FierceHealthIT.
“The bill does not create a roadmap for innovators to discern whether a given piece of software is regulated or not,” Thompson said. “It simply provides some guidance to [the U.S. Food and Drug Administration] for it to make the decision. We need legislation that is self-executing, that provides the software development community with clear delineation as to what’s in and what’s out.”
Health Data Management, 5/20/2015
FDA Week, 5/13/2015