1. WG11 REMS Workflow to Transaction Task Group

    The WG11 REMS Workflow to Transaction Task Group is seeking member participation as it  reviews the FDA’s REMS Platform Standards Initiative: Needs Assessment document.

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  2. New LOINC and RELMA Releases Now Available

    LOINC® (Logical Observation Identifiers Names and Codes) was developed to provide a definitive standard for identifying clinical information in electronic reports.

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  3. FDA Requests Comments on Opioid Analgesics

    The Food and Drug Administration (FDA) is accepting comments on the safe use of Opioid Analgesics.

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  4. ONC Cybersecurity Report Released

    The Health Care Industry Cybersecurity Task Force, created by the Cybersecurity Information Sharing Act of 2015, has released its “Report on Improving Cybersecurity in the Health Care Industry.” The report outlines recommendations directed toward the healthcare industry in general, as well as to individual industry and government organizations.

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  5. Compliance Dates for Certain Class 1 and Unclassified Devices Extended

    The FDA intends to extend the compliance dates for the unique device identifier (UDI) system requirements for medical devices that generally present a lower risk to patients (certain class I and unclassified devices), such as manual surgical instruments and mechanical wheelchairs.

    Click here to read more, or to download a copy of the letter.

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