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Focus on Regulation

Tag Archives: Health IT

FDA Proposes Enforcement Discretion for Medical Device Data Systems, Medical Image Storage Solutions, and Medical Image Communications Devices

In a 20 June 2014 draft guidance, the Food and Drug Administration (FDA or Agency) proposed that, once the guidance is finalized, the Agency would refrain from enforcement of all regulatory requirements for a subset of hardware and software that transfers, stores, converts, formats, and displays medical device data or medical imaging data, which would

FDA Health IT Initiatives: OpenFDA and FDASIA Health IT Public Workshop

In the last month, the Food and Drug Administration (FDA) undertook two new steps related to Health IT in the United States While the FDA’s involvement in this area of technology remains very controversial, both projects sought to enhance collaboration with the Health IT industry. FDASIA Workshop First, on May 13-15, 2014, the FDA, Federal Communications Commission (FCC),