OMB Releases 2026 Federal Regulatory Unified Agenda. The Office of Management and Budget released the 2026 Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). The Unified Agenda identifies the regulatory actions under development by the various Departments. For the Department of Health and Human Services, items in the 2026 Unified Agenda include potential actions from the Centers for Medicare & Medicaid Services (CMS), the Office for Civil Rights (OCR), and the Office of the National Coordinator for Health IT (ONC) related to administrative simplification, privacy, interoperability, and price transparency.
CMS:
- Administrative Simplification: Modifications to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Electronic Transaction Standards (CMS-0061); Proposed Rule; Tentative Date: December 2026
- Requirements Related to Advanced Explanation of Benefits and Other Provisions Under the Consolidated Appropriations Act 2021 (CMS-9900); Proposed Rule; Tentative Date: September 2026
- Transparency in Coverage (CMS-9882); Final Rule; Tentative Date: July 2026
OCR:
- HIPAA Privacy Rule to Promote Individuals' Timely Access to their Protected Health Information; Proposed Rule; Tentative Date: November 2026
- HIPAA Privacy Rule: Changes to Support Coordinated Care and Individual Engagement and Reduce Regulatory Burdens; Final Rule; Tentative Date: August 2026
ONC:
- Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity; Final Rule; Tentative Date: August 2026
- Health Data, Technology, and Interoperability: Application Programming Interfaces and Information Blocking; Proposed Rule; Tentative Date: November 2026
It is important to note that dates provided in the Unified Agenda are not binding but serve as a guide for when the action items may be expected.
ONC Launches “Coordinator’s Quarterly” Newsletter. ONC launched a new publication, “Coordinator’s Quarterly,” focused on providing updates and important information on ONC activities during the previous quarter. The inaugural issue celebrates the successes with EHR adoption. It begins with leadership messages from Tom Keane, MD, National Coordinator for Health Information Technology and Steven Posnack, Principal Deputy National Coordinator for Health Information Technology. Several data briefs are highlighted and address hospital electronic health record (EHR) adoption, physician office-based EHR adoption, trends in perceived information blocking, and health information exchange organizations’ support of public health data exchange.
ONC Releases US Quality Core Implementation Guide v0.5.0. ONC released the 2026 US Quality Core Implementation Guide (IG) v0.5.0. The IG builds on the work first introduced at the Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) US Realm Connectathon in March and aligns with existing HL7 quality standards to implement U.S. Core Data for Interoperability (USCDI)+ Quality data elements for standardized quality data exchange. The companion US Quality Core Inferno Test Kit is available on GitHub for local use and will be deployed on the Inferno test kits page to support validating conformance to the IG. A recorded demonstration of the IG and test kit will also be made available.
ONC Releases Updates to USCDI+ Maternal Health and Postpartum TOC Datasets. ONC, in collaboration with the Assistant Secretary for Technology Planning and Evaluation, released updates to the existing USCDI+ Maternal Health Overarching Dataset (September 2025) and introduces the new Postpartum Transition of Care (TOC) Dataset. The purpose of the maternal health datasets is to improve care coordination, advance maternal health research, and reduce maternal mortality by ensuring that critical health information is consistently available and interoperable across clinical settings. The USCDI+ Maternal Health overarching dataset defines a comprehensive list of maternal health data elements intended to support perinatal care and enable consistent exchange across the health care ecosystem. The USCDI+ Postpartum TOC use case dataset defines the data and standards needed to support postpartum care after delivery.
House Committee on Education and Workforce Advances Health Data Legislation. The House Committee on Education and Workforce passed the "Health Data Access, Transparency, and Affordability Act of 2026,” introduced by Rep. Bob Onder (R-MO). The bill, if enacted, would amend the Employee Retirement Income Security Act of 1974 to allow health plan fiduciaries access to de-identified health information relating to claims, and for other purposes. The intent of the bill is to address current concerns by employer-sponsored self-funded health plans with their lack of access to the raw claims data needed to analyze costs by the insurers and third-party administrators. The bill now advances to the House floor for consideration.
TEFCA™ RCE Releases Exchange Purposes, Treatment, and Vetting Process SOPs. The Sequoia Project, the Trusted Exchange Framework and Common Agreement™ (TEFCA®) Recognized Coordinating Entity® (RCE®), along with ONC released the Exchange Purpose (XP) Implementation: Treatment Standard Operating Procedure (SOP) version 2.0, along with the updated XP Vetting Process SOP version 2.0 and XPs SOP version 5.1. The SOP is accompanied by new Frequently Asked Questions about the updated policy. The SOPs identify implementation specifications that Qualified Health Information Networks, Participants, and Subparticipants must follow when asserting the Treatment Exchange Purpose. The SOPs become effective August 3, 2026.
CMS Issues Guidance for RHCs and FQHCs Billing Distant Site Telehealth Services. CMS issued Transmittal R13776OTN providing guidance for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) billing for distant site telehealth services. CMS recommends that billing staff of RHCs and FQHCs be made aware of the requirement to bill the individual Current Procedural Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) code for distant site telehealth services they provide instead of HCPCS code G2025 along with the appropriate CPT modifier, effective October 1, 2026, for dates of service on or after October 1, 2026. More information can be obtained from the applicable Medicare Administrative Contractor.
NIST Provides Update on Cybersecurity for IoT. The National Institute of Standards and Technology (NIST) provided an update on the NIST Cybersecurity for the Internet of Things (IoT) Program. An initial public draft of NIST SP 800-213 Revision 1, “IoT Product Cybersecurity Guidelines for the Federal Government: Establishing IoT Product Cybersecurity Requirements” is currently available for review and comment, which are due on August 24. The draft reflects current needs, provides clearer guidance, more relevant content, and better aligns with the current environment. Next steps for the “NIST SP 800-213A, IoT Device Cybersecurity Guidance for the Federal Government: IoT Device Cybersecurity Requirement Catalog” is also under consideration, including updates to make it more useful for those securing IoT products as part of an overall risk management. In addition, the proceedings of the March 31 – April 1 Cybersecurity for IoT Workshop: Future Directions workshop have now been posted.