The FDA will hold a public workshop on May 13-15, 2014, to discuss the Proposed Strategy and Recommendations for a Risk-Based Framework issued by the Food and Drug Administration, National Coordinator for Health Information Technology, and Federal Communications Commission on April 3, 2014. To help you prepare for the workshop or to submit comments, my colleagues, Sarah Hogan, Ellen Janos, and Kara Romagnino, and I prepared a client advisory which summarizes the key points from the report as well as the areas in which the agencies seek feedback. Our advisory can be read here.
Ellen L. Janos uses her in-depth knowledge of health care regulations to help Mintz clients with government investigations, financial transactions, and corporate compliance activities. She also advises traditional health care providers, investors, and start-ups on telehealth initiatives.