ATSP/ONC proposes deregulatory actions, withdraws HTI-2 proposals

The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT released Dec. 22 two proposed rules related to health data, technology and interoperability. The first proposed rule would withdraw remaining proposals from the HTI-2 proposed rule that were not finalized to date. ASTP/ONC proposes to withdraw remaining HTI-2 proposals related to United States Core Data for Interoperability, including proposals to adopt the USCDI standard v4, establish an expiration date for USCDI v3 and update certain USCDI certification criteria. The rule also proposes to withdraw remaining HTI-2 proposals related to Standards for Encryption and Decryption of Electronic Health Information, including proposals to adopt the updated version of Annex A of the Federal Information Processing Standards 140-2 and to establish an expiration date of Jan. 1, 2026, to the FIPS 140-2 (Oct. 8, 2014) version of the standard. Additionally, the proposed rule would withdraw HTI-2 proposals related to Public Health Data Exchange and the Infeasibility Exception – Responding to Requests Condition, among others. The non-finalized provisions of the HTI-2 proposed rule would be withdrawn as of the date of publication on Federal Register.

The second proposed rule (HTI-5) includes proposals related to certification criteria for certification programs and information blocking. The regulation intends to foster deregulation and further support the transition to Fast Healthcare Interoperability Resources-based application programming interfaces. First, ASTP/ONC proposes the removal of 34 certification criteria and the revision of seven others. Some of the certification criteria proposed for removal include clinical decision support, family health history, multi-factor authentication and audit reports, among others. Of the certification criteria proposed for removal, 24 would be removed as of the date of publication of the final rule, including certification criteria for clinical decision support. The remaining would be removed on Jan. 1, 2027, including certification criteria for family health history. Of those proposed for revision, all but one (transitions of care) would be effective as of the date of publication of the final rule.

HTI-5 also includes several information blocking proposals. First, it proposes to modify the definitions of “access,” “use” and “exchange” to emphasize that the definitions include automated means of access, exchange or use of electronic health information (including autonomous artificial intelligence). Second, it proposes to revise or remove exceptions to the infeasibility exception, including removing the third-party seeking modification use condition, revising the manner exception exhausted condition to narrow its application to reduce the risk of misuse, and removing the Trusted Exchange Framework and Common Agreement manner exception. Comments are due 60 days after publication in the Federal Register.