HHS releases final rules on interoperability and information blocking


On March 9, 2020, two final rules on electronic health information were issued by the Office of National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS). According to the Department of Health and Human Services (HHS), these final rules make “transformative” changes to give “patients unprecedented safe, secure access to their health data.”

The ONC Cures Act Final Rule implements certain provisions of the 21st Century Cures Act, including:

  • Conditions and maintenance of certification requirements for health information technology developers under the ONC Health IT Certification Program
  • Voluntary certification of health IT for use by pediatric health care providers
  • Identification of eight “reasonable and necessary” activities that do not constitute information blocking
  • Additional modifications to the 2015 Edition Health IT Certification Criteria and Program to advance interoperability, enhance health IT certification, and reduce burden and costs, including two new technical certification criteria and two new attestation-structure privacy and security certification criteria

This rule will be effective 60 days after publication in the Federal Register. The ONC also noted that it is actively reviewing over 100 comments it received related to how the proposed rule impacts Opioid Use Disorder (OUD) prevention and treatment and whether there are additional steps ONC can take to help address the issue. 

The CMS Interoperability and Patient Access Final Rule includes various policies related to patient access to health information and to promote interoperability, including:

  • Patient Access API (applicable January 1, 2021)
  • Provider Directory API (applicable January 1, 2021)
  • Payer-to-Payer Data Exchange (applicable January 1, 2022)
  • Improving the Dually Eligible Experience by Increasing the Frequency of Federal-State Data Exchanges (applicable April 1, 2022)
  • Public Reporting and Information Blocking (applicable late 2020)
  • Digital Contact Information (applicable late 2020)
  • Admission, Discharge, and Transfer Event Notifications (applicable fall 2020)

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