More Time to Comment on Electronic Health Information Proposed Rules



The Department of Health and Human Services (HHS) is extending the comment period until June 3 for two proposed rules related to electronic health information and applicable to clinical trials. The HHS Office of the National Coordinator for Health Information Technology (ONC) has also released the second draft of the Trusted Exchange Framework and Common Agreement, which supports the exchange of electronic health information nationwide.

The ONC proposed rule: “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program” is designed to:

  • Ensure patients can access their health information for free

  • Standardize application programming interfaces (APIs), which would allow patients to have remote access from mobile devices

  • Implement the information blocking provisions from the 21st Century Cures Act

    • Information blocking interferes with or blocks access to health information

    • There are exceptions that allow information blocking, such measures needed for privacy or security of health information

Submit your comments on the ONC proposed rule here by June 3.

The Centers for Medicare & Medicaid Services (CMS) proposed rule on Interoperability and Patient Access is intended to:

  • Support patient-centric healthcare

  • Improve exchange of electronic health information

  • Promote coordination of care

  • Reduce the burdens on patients and healthcare providers by:

    • reducing duplicative testing and procedures,

    • enabling ease of transfer of services to a new provider, and

    • reducing time healthcare providers use for records transfers.

  • Allow data to be available for research

Submit your comments on the CMS proposed rule here by June 3.

The two proposed rules align to improve health information interoperability, which means that the user will be able to easily and securely use health information without it being blocked. Once the rules are finalized, stakeholders such as patients, healthcare providers, and researchers will be able to access and exchange healthcare information seamlessly, resulting in improved efficiency and reduced burdens. In addition, ONC’s Trusted Exchange Framework and Common Agreement (TEFCA) and the guidance, “Use of Electronic Health Record Data in Clinical Investigations” tie in with health information interoperability. The TEFCA proposes common principles, conditions, and terms for the development of a common agreement that supports nationwide exchange of electronic health information. One of the main purposes of the guidance is to promote the interoperability of Electronic Health Record (EHR) and Electronic Data Capture (EDC) systems. For additional information, read our blog on the guidance here.


- The Clinical Pathways Team

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