Bradley Merrill Thompson Quoted in “SOFTWARE Act Would Exempt EHRs, Other Health IT from FDA Regulation”BNA Snapshot January 29, 2015
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in BNA Snapshot, in “SOFTWARE Act Would Exempt EHRs, Other Health IT from FDA Regulation,” by Alex Ruoff.
Following is an excerpt:
Bradley Merrill Thompson, with Epstein Becker & Green PC, Washington, told Bloomberg BNA in a Jan. 23 e-mail the updated SOFTWARE Act would be “much more simple and straightforward” than the 2013 bill.
“It creates a dividing line between software that FDA will regulate and software that should be unregulated,” Thompson, who serves as general counsel for the mHealth Regulatory coalition, said. “In the new bill, medical software includes software that analyzes patient specific information but produces some direct output that does not require the need for professional interpretation. Such software would be regulated by FDA under a new regulatory program that FDA would design especially for medical software.”