Bradley Merrill Thompson Quoted in “mHealth Coalition Counters Blackburn Push Against Health IT Regs”The Gray Sheet January 6, 2014
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 "mHealth Coalition Counters Blackburn Push Against Health IT Regs."
Following is an excerpt:
The mHealth Regulatory Coalition, led by Bradley Merrill Thompson, a lawyer with Epstein Becker Green, is against Blackburn's bill, putting it at odds with another alliance of mobile health firms who are the main supporters of the SOFTWARE Act. ?...
FDA, the Federal Communications Commission and the Office of the National Coordinator for Health IT are in the final stages of hatching a regulatory framework proposal for health IT that the agencies are aiming to submit to Congress by next month.
Thompson participated in an FDA Safety and Innovation Act-mandated workgroup that advised the agencies on their pending report. ?...
Accordingly, the proposal from the coalition has many similarities with the workgroup's September report, though several details are different.
The proposal addresses five key issues: the need for better data; the need for systems-level regulation; nuanced categorization of technologies based on risk, rather than categories; utilizing private resources for regulation; and encouraging collaboration. ?...
In an email, Thompson stated that the purpose of the new risk class 0 would be to "to formalize, and make more concrete, the agency's present exercise of enforcement discretion."
He explained, "Right now the agency just announces what's going to be in enforcement discretion either through nonbinding guidance or worse yet in speeches," he wrote. "The idea of creating an actual class 0 is to have FDA more formally recognize low-risk devices as exempt, thus triggering a legal process — that is reclassification — if they ever wanted to regulate them."