Bradley Merrill Thompson Quoted in “mHealth Experts Analyze FDASIA Report”


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 Experts Analyze FDASIA Report."

Following is an excerpt:

With the attention that the ICD-10 delay and SGR vote have been getting this week, it would have been easy to overlook the release of the FDASIA report. But the long-awaited guidelines to federal regulation of health IT will have a lasting impact that can't be ignored. ?...

Thompson, an attorney with the Washington law firm of Epstein, Becker & Green, listed some of the document's more salient points:

  1. That with regard to the middle tier of software - health management software - we should avoid regulation and instead use voluntary standards and certification and other private sector tools;
  2. That adverse event reporting is important and should be improved, and can be approved by the creation of a quasi- governmental entity - the Health IT Safety Center - that would be controlled by the agencies in partnership with other stakeholders. At least one of the goals of creating that separate organization would be reducing the perceived liability and adverse publicity risks for an organization reporting adverse events;
  3. The report recommends taking numerous steps designed to facilitate the interoperability of medical devices, and health IT generally, used in systems. That's an important aspect that's been missing from other HIT policy initiatives.