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 "FDA Urged to Modernize for Sake of mHealth Innovation."
Following is an excerpt:
A law firm in Washington D.C. recognized for its work with mHealth companies is asking the U.S. Food and Drug Administration to "adopt significant fundamental changes to keep pace with medicine and technology."
The request is part of a 12-page white paper submitted to the Office of the National Coordinator for Health Information Technology by Bradley Merrill Thompson, an attorney with Epstein Becker Green and the legal counsel for the mHealth Regulatory Coalition. The ONC is seeking public comments as it prepares to develop a health information technology regulatory framework with the FDA and Federal Communications Commission.
The paper, titled "Enhancing Innovation in e-Health through a Systems Approach to Regulation: A Blueprint for FDA Modernization," calls for the FDA to "modernize its regulatory approach to embrace the fact that we are witnessing a transformation of the medical technology landscape from one shaped by individual, discrete products to a new era of complex, connected diagnostic and therapeutic systems that deliver holistic care."
The white paper submitted this month by Epstein Becker & Green urges the various agencies involved to work together.
