“The Committee will provide relevant skills and perspectives, in order to improve communication of benefits, risks, clinical outcomes and increase integration of patient perspectives into the regulatory process for medical devices,” CMS said. “It will perform its duties by discussing and providing advice and recommendation in ways such as: Identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy.”
The committee will consist of nine core members knowledgeable in clinical research, primary care patient experience and the healthcare needs of U.S. patient populations.
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