ONC Proposes Rule to Improve Patient Engagement, Information Sharing, and Interoperability
The U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) has published a proposed rule that seeks to improve patient engagement, information sharing, and public health interoperability.
The Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule implements provisions of the 21st Century Cures Act and aligns with ONC’s goals of advancing interoperability and improving information sharing among patients, providers, payers, and public health authorities.
The key proposals in the rule are:
- The establishment of two sets of new certification criteria that enable health IT for public health and health IT for payers to be certified under the ONC Health IT Certification Program to advance interoperability and support public health reporting and exchange
- Adoption of United States Core Data for Interoperability (USCDI) version 4 by January 1, 2028.
- Adjustments to certain exceptions to the information blocking regulations, including a new “Protecting Care Access” exception, which covers practices taken in certain circumstances to reduce the risk of legal exposure stemming from sharing information.
- Establishing Trusted Exchange Framework and Common Agreement (TEFCA) governance rules, including requirements that implement section 4003 of the 21st Century Cures Act.
- Technology and standards updates, that include the capability to exchange clinical images and the addition of multifactor authentication
The new certification criteria are intended to improve public health response and advance the delivery of value-based care and are heavily focused on standards-based application programming interfaces and will help to improve end-to-end interoperability between healthcare providers and public health organizations or payers. For instance, new standards are included for HL7® Clinical Decision Support (CDS) Hooks, HL7 FHIR® Subscriptions, and SMART Health Cards. SMART cards allow patients to carry verifiable, portable healthcare data that can be shared with providers via QR codes. SMART Health Cards help engage patients in the self-management of their own health data, which is expected to lead to improved outcomes.
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Exceptions to the information blocking regulations have been adjusted based on feedback from the regulated community to address scenarios such as when a healthcare provider chooses to limit the sharing of a patient’s reproductive health information in certain circumstances, which will improve patient and provider privacy and reduce legal exposure when individuals seek or provide legal reproductive care.
The proposed rule will also implement section 119(b)(3) of the Consolidated Appropriations Act, 2021 by including a new, real-time prescription benefit tool certification criterion. This will empower providers and their patients to make more informed decisions by providing them with more transparent information to compare the patient-specific cost of drugs and suitable alternatives.
“The HTI-2 proposed rule is a tour de force. We have harnessed all the tools at ONC’s disposal to advance HHS-wide interoperability priorities,” said Micky Tripathi, Ph.D., national coordinator for health information technology. The proposed rule is open to public comment for 60 days. ”As always, we look forward to reviewing public comments and engaging with the health IT community in the weeks and months ahead,” said Tripathi.
