On April 11, the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) announced a notice of proposed rulemaking entitled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing.” The rule is intended to further advance interoperability by updating the standards and criterion for the ONC Health IT Certification Program and modifying the information blocking regulations.
“In addition to fulfilling important statutory obligations of the 21st Century Cures Act, implementing these provisions is critical to advancing interoperability, promoting health equity, and supporting expansion of appropriate access, exchange, and use of electronic health information,” said Micky Tripathi, PhD, National Coordinator for Health Information Technology of the proposed rule in the HHS’ announcement.
Notably, regarding the certification program, the ONC proposed to adopt the third version of the United States Core Data for Interoperability (USCDI). This version was finalized in July 2022 and includes improvements to facilitate data capture and data sharing for public health and emergency response. USCDI v3 also provides a foundational approach to using data to promote health equity by expanding data elements regarding social determinants of health and expanded patient demographics. Currently, the certification program only requires USCDI v1, which the CMS proposed to expire as a standard, effective Jan. 1, 2025. Both USCDI v1 and USCDI v3 would be applicable standards through Dec. 31, 2024.
Other proposals for the certification program include removing the “edition” naming convention under the program, revised standards for application programming interfaces (APIs) to support patient and population services, a criterion to support patient-requested information privacy restrictions on certain uses and disclosures of protected health information, and new criterion for decision support interventions and predictive models. For the latter criterion, the ONC noted that it collaborated with the Agency for Healthcare Research and Quality, the Food and Drug Administration, HHS Office for Civil Rights, and the Department of Veterans Affairs to “promote greater trust in predictive decision support interventions used in healthcare.”
The ONC proposed several clarifications to the information blocking regulations. First, the agency proposed to define “offer health information technology” or “offer health IT” for purposes of the rules to codify its interpretation that providers do not “offer health IT” when they engage in certain common activities when they purchase certified health IT products or develop certified health IT. Additionally, the proposal explicitly excludes a provider’s implementation of APIs and issuance of login credentials to independent licensed professionals to use the hospital’s electronic health record to furnish and document care to patients in the hospital from the definition “to offer health IT.” Additionally, the ONC proposed changes to the existing Manner Exception to incorporate reasonable and necessary activities under the Trusted Exchange Framework and Common Agreement and to the uncontrollable events condition of the Infeasibility exception. The ONC also requested feedback from commenters on ways health IT can support data segmentation for privacy to better support patient preferences for the access, exchange, and use of electronic health information.
The agency also released a blog post and intends to hold informational webinars ahead of the comment deadline. Comments are due June 20. The AAMC intends to comment.