The Data Agenda

Monday, December 17, 2012

FDA Safety and Innovation Act & Health IT

Congress passed the Food and Drug Administration Safety and Innovation Act this summer.  included therein was Section 618 on Health Information Technology:


SEC. 618. HEALTH INFORMATION TECHNOLOGY.
    (a) Report- Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the `Secretary'), acting through the Commissioner of Food and Drugs, and in consultation with the National Coordinator for Health Information Technology and the Chairman of the Federal Communications Commission, shall post on the Internet Web sites of the Food and Drug Administration, the Federal Communications Commission, and the Office of the National Coordinator for Health Information Technology, a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.
    (b) Working Group-
      (1) IN GENERAL- In carrying out subsection (a), the Secretary may convene a working group of external stakeholders and experts to provide appropriate input on the strategy and recommendations required for the report under subsection (a).
      (2) REPRESENTATIVES- If the Secretary convenes the working group under paragraph (1), the Secretary, in consultation with the Commissioner of Food and Drugs, the National Coordinator for Health Information Technology, and the Chairman of the Federal Communications Commission, shall determine the number of representatives participating in the working group, and shall, to the extent practicable, ensure that the working group is geographically diverse and includes representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise, as determined by the Secretary.


FCC Health Care Initiatives

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