Inside CHIME: ICYMI – CHIME Advocates for Clear Policies on Medical Devices, EHR Cert

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Weinstock 70x70 5.12.16 by Matthew Weinstock
Director of Communications and Public Relations, CHIME

CHIME’s public policy team, including the Policy Steering Committee, has had a busy few weeks pulling together detailed comments on a trifecta of rules that will impact medical devices and EHR certification.

CHIME recently responded to a number of regulatory proposals, continuing to make the case for reasoned and harmonious health IT policy. While we do our best to keep you abreast of key policy developments every Monday in the Washington Debrief, we know that you are extremely busy. So here’s our ICYMI column.

  • Commenting on a Food & Drug Administration draft cybersecurity guidance, CHIME and AEHIS called for
    greater collaboration between healthcare organizations and medical device manufacturers. “For several decades,
    there has been a tension between the identification of medical device vulnerabilities and the device
    manufacturer’s capability to mitigate or manage those risks,” the groups noted. CHIME and AEHIS also called for
    a standardized cybersecurity framework for medical devices.
  • In a separate comment letter, CHIME called on FDA to collaborate more closely with the Office of the National
    Coordinator to establish a set of uniform interoperability standards for medical devices. “CHIME members seek
    assurance that the devices they purchase are able to connect with other devices and systems,” the letter stated.
  • Keeping with the theme of coordination, CHIME urged ONC to “collaborate with the Centers for Medicare and
    Medicaid Services to minimize the impact of suspended or decertified products on provider reimbursement.” At
    issue is the uncertainly providers face if ONC takes action on an electronic health record system for
    “non-conformities.” CHIME cautioned the agency of the unintended consequences of its proposal, including
    the impact on patient safety.

Lest we forget the 800-pound gorilla on the regulatory scene, CMS in late April issued proposed rules altering how physicians are paid, as required by the Medicare Access and CHIP Reauthorization Act of 2015. The 900-plus page proposal also seeks to dramatically restructure how physicians are scored for their use of health IT. CHIME’s policy team put together this detailed comparison of Meaningful Use and the Advancing Care Information proposal.

CHIME is creating a new workgroup to develop comments on the MACRA proposed rule. Calls will take place at 2:30 ET on May 13, 20, 27 and June 3. Email Mari if you want to participate.

More Inside CHIME Volume 1, No. 17: