• Regulatory NewsRegulatory News

    HHS Floats Digital Health PreCert Approach as CDRH Limits Pilot Participation

    In a proposed rule from the US Department of Health and Human Services (HHS), the agency is seeking input on whether to expand on the US Food and Drug Administration’s (FDA) digital health pre-certification (PreCert) program for purposes of health IT certification. Yet FDA has said it will limit PreCert participation, for now. The 724-page proposed rule was unveiled on Monday by HHS’s Office of the National Coordinator for Health Information Technology (ONC). The move h...
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    EHR Data in Clinical Trials: New FDA Draft Guidance

    The US Food and Drug Administration (FDA) on Monday released draft guidance to assist clinical trial sponsors, investigators, contract research organizations (CROs), institutional review boards (IRBs) and other using electronic health record (EHR) data in FDA-regulated clinical investigations. The 12-page guidance is meant to facilitate the use of EHR data in clinical trials and “promote the interoperability of EHRs and electronic systems supporting such trials.” Prepa...
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    UDIs for Implantable Devices Now Included in Common Clinical Data Set

    For the first time ever, unique device identifiers (UDIs) will have to be included as part of a set of common clinical data intended to help physicians better track patients' implanted devices. Background Back in 2013, a final rule from the US Food and Drug Administration (FDA) mandated that most devices marketed in the US will eventually be required to be marked with a UDI to distinguish devices from one another and make them easier to track, particularly for...
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    ONC Director Defends Health IT Safety Center as it Struggles to Take Shape

    • 21 July 2014
    In response to pressure from members of Congress, a group of federal health IT regulators is clarifying which authorities a proposed Health IT Safety Center would—and would not —have. Background In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed into law, and with it a requirement that US Food and Drug Administration (FDA), the Office of the National Coordinator (ONC) for Health IT and the Federal Communication Commission all work...
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    Perspectives on the FDASIA Health IT Report and Public Workshop

    On 7 April 2014, a Food and Drug Administration Safety and Innovation Act ( FDASIA )-mandated workgroup issued its strategy and regulatory framework document on health IT to Congress. 1 The workgroup is comprised of representatives from the US Food and Drug Administration (FDA), the Federal Communications Commission (FCC) and the Office of the National Coordinator for Health Information Technology (ONC). A public workshop was held 13–15 May 2014 to discuss the pr...
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    Congress Skeptical About FDA, ONC Effort to Coordinate on Health IT Regulation

    In April of this year, the US Food and Drug Administration (FDA), along with the Office of the National Coordinator for Health Information Technology (ONC), issued a new proposed framework indicating their desire to more consistently regulate health technology, including health software. Now members of Congress have written to the ONC regarding that proposal, saying parts of it go above and beyond its authority under the law. Background In 2012, the  Food and Drug...
  • FDA, ONC Issue Long-Awaited Health IT Framework

    The US Food and Drug Administration (FDA) has released for consultation a new proposed framework on how to regulate health information technology (IT), including mobile medical device applications ("apps") according to risk. Background Mobile medical applications can best be understood as programs run on a mobile device such as a smartphone or tablet that allow a user to access a medical technology wherever and whenever they wish. For example, a smartphone application t...