On December 22, 2015, the ONC released the 2016 Interoperability Standards Advisory, which is meant to serve as a “single resource for those looking for federally recognized, national interoperability standards and guidance,” according to ONC’s Director of the Office of Standards and Technology Steven Posnack, MS, MHS, and Director of HIT Infrastructure and Innovation Division Chris Muir. The standards listed in this advisory focus explicitly on clinical health IT systems’ interoperability.  Specifically, the 2016 Advisory lists existing and emerging standards for different interoperability needs and discusses health information exchange related to areas including lab tests, medications, imaging, electronic prescribing, public health reporting, and clinical decision support.

The ONC states that one of the most significant changes between the 2015 and 2016 Advisories is the incorporation of six informative characteristics for each standard that “give readers an overall sense of maturity and adoptability” and provide more detailed information regarding implementation specifications.  These characteristics include:

  • Standards process maturity, which conveys a standard or implementation specification’s maturity in terms of its stage within a particular organization’s approval/voting process.
  • Implementation maturity, which conveys a standard or implementation specification’s maturity based upon its implementation state.
  • Adoption level, which conveys a standard or implementation specification’s approximate and average adoption level in health care within the United States.
  • Federal required (provided by a “Yes” or “No”), which conveys whether a standard or implementation specification has been adopted in regulation, referenced as a federal program requirement, or referenced in a federal procurement (i.e., contract or grant) for a particular interoperability need.
  • Cost, which conveys whether a fee is involved to purchase, license or obtain membership for access or use of the recommended standard or implementation specification.
  • Test tool availability, which conveys whether a test tool is available to evaluate health IT’s conformance to the standard or implementation specification for the particular interoperability need.

This year’s Advisory also includes an appendix of security standards sources “to point stakeholders to the entities that maintain and curate security standards information.”

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Covington Digital Health Team

Stakeholders across the healthcare, technology and communications industries seek to harness the power of data and information technology to improve the effectiveness and efficiency of their products, solutions and services, create new and cutting-edge innovations, and achieve better outcomes for patients. Partnering with…

Stakeholders across the healthcare, technology and communications industries seek to harness the power of data and information technology to improve the effectiveness and efficiency of their products, solutions and services, create new and cutting-edge innovations, and achieve better outcomes for patients. Partnering with lawyers who understand how the regulatory, IP, and commercial pieces of the digital health puzzle fit together is essential. Covington offers unsurpassed breadth and depth of expertise and experience concerning the legal, regulatory, and policy issues that affect digital health products and services. To learn more, click here.