On April 3, the Food and Drug Administration (FDA), the Federal Communications Commission (FCC), and the Office of the National Coordinator for Health Information Technology (ONC) jointly issued a report that sets forth a proposed strategy and recommendations for a risk-based regulatory framework for health information technology (health IT). The report, which was mandated by Congress in the Food and Drug Administration Safety and Innovation Act (FDASIA), proposes that no new or additional regulations are needed to implement this regulatory framework. Instead, the three federal agencies propose a limited approach that “relies on ONC-coordinated activities and private sector capabilities.” In addition, the report proposes a mostly deregulatory approach for clinical decision support (CDS) technologies and states that the majority of these products would be considered to have “health management health IT functions,” which FDA does not intend to actively regulate. The precise scope of this deregulatory approach, however, has not yet been determined, and the agencies have requested input from the public on which types of CDS technologies should be considered health management health IT and which should be subject to FDA oversight.Overview of the Report Recommendations: Limited Regulatory Oversight ProposedThe FDASIA provision requiring this report was triggered by concern… Read full this story
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Health IT Update: Food and Drug Administration Safety and Innovation Act (FDASIA) Health IT Report Issued by FDA, FCC, and ONC have 314 words, post on www.natlawreview.com at April 8, 2014. This is cached page on Law Breaking News. If you want remove this page, please contact us.