Bradley Merrill Thompson Quoted in “mHealth Coalition Blasts Agencies for Ignoring HIT Framework Proposals”

FDA Week

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 Blasts Agencies for Ignoring HIT Framework Proposals."

Following is an excerpt:

The mHealth Regulatory Coalition slammed FDA, Office of the National Coordinator for Health IT and Federal Communications Commission for not incorporating a federal working group's recommendations into an FDA Safety and Innovation Act-mandated proposal for a risk-based HIT regulatory framework. By not resolving the issues highlighted by the working group, the agencies are failing to provide industry with the clarity it needs, the group said.

The working group, which included mHealth Regulatory Coalition General Council Bradley Merrill Thompson, was established to provide guidance to the agencies as they developed a proposal. The coalition complains that the report ignores many of the working group's recommendations. Examples of areas not covered include suggestions to develop a detailed, flexible taxonomy to allow for risk classification of specific items; consider specific risk factors that could be included in that taxonomy; and develop a plan for addressing weaknesses within the regulatory programs of each agency.