A new health IT workgroup will have an initial meeting to identify what is needed to improve patient safety and promote innovation in health IT including mobile medical applications. The workgroup will report to the Health IT Policy Committee which advises the Office of the National Coordinator for HIT.The topics to be discussed include possible health IT risks, approaches to developing a risk-based regulatory approach for health IT, and approaches to use to avoid overlapping regulatory requirements.
The workgroup’s first web conference will be held April 29, 2013 where members of the committee will include agency officials and experts representing patients, consumers, healthcare providers, startup companies, and health plans or other third-party payers. The workgroup will also include venture capital investors, information and HIT technology vendors, small businesses, purchasers, employers, and other stakeholders.
The FDA Safety and Innovation Act (FDASIA) requires the HHS Secretary acting through the Commissioner of FDA and in consultation with ONC and the Chairman of the FCC, to develop a report containing a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT to include medical mobile applications. The FDA, FCC, and the HHS ONC will then review and consider the recommendations provided by the Health IT Policy Committee.
Go to www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia for more details.