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 passage of the MEDTECH Act by the Senate Health, Education, Labor and Pensions Committee.
Following is an excerpt from FierceHealthIT:
Bradley Merrill Thompson, an attorney with Epstein Becker Green who serves as general counsel for the CDS Coalition, told FierceHealthIT in an email that the coalition supports the bill. However, he added that there must be guidance from "someone" on clearance of medical software, especially when it comes to clinical decision support tools. Currently, the uncertainty has stifled innovation and caused projects to be shelved.
"Given the complexity of the issues, there will almost certainly be a need for FDA guidance, whether Congress legislates or not. Our goal is to see a line that is both clearly drawn and sensibly determined," Thompson said. "Either Congress or FDA needs to act soon."
Related reading:
The Gray Sheet (subscription required), 3/10/2016
FDA Week (subscription required), 3/11/2016
The Digital Health Update by Paul Sonnier, 3/16/2016
