Regulatory Updates

WEDI Submits Comments on Draft USCDI v7. WEDI submitted comments to the National Coordinator for Health Information Technology (ONC) on the Draft U.S. Core Data for Interoperability (USCDI) Version 7 (v7). Draft USCDI v7 proposes 30 new and revised data elements across multiple data classes with the intent of standardizing health data exchange to support…

CMS released the display copy of the 2026 CMS Interoperability Standards and Prior Authorization for Drugs Proposed Rule (CMS-0062-P), which is set to be published in the Federal Register tomorrow (April 14). Look to WEDI for education on this significant regulation as well as a WEDI virtual Member Position Advisory event in the coming weeks to gather input from…

HHS Reorganizes Health Technology Offices. The Department of Health and Human Services (HHS) announced a reorganization of health technology offices within the Department, including changing the dual management title of Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ONC) to its previously titled office as ONC. ONC will continue to…

CMS Releases Claims Attachments Final Rule. The Centers for Medicare & Medicaid Services (CMS) released the “Adoption of Standards for Health Care Claims Attachments Transactions and Electronic Signatures (CMS-0053-F)” Final Rule via display on March 20 and will publish in the Federal Register on March 24. Compliance with the regulation will be 24 months from the effective date of…

ASTP Head Keane Testifies at Senate HELP Committee on Health Data. Thomas Keane, MD, Assistant Secretary for Technology Policy (ASTP) and National Coordinator at the Office of the National Coordinator for Health Information Technology (ONC), testified at the Senate Committee on Health, Education, Labor, and Pensions (HELP) on transforming health care through data. Senator Bill…

OCR Settles HIPAA Security Rule Investigation with Software Company Business Associate. The U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) announced a settlement with a Maryland software company for a potential violation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules. As a business…

Past Events (recorded) [9.25.25] Spotlight on State Medicaid: Strategies for CMS-0057-F Implementation [9.10.25] Beyond 0057 Compliance: Translating Mandated APIs into Impact. Sponsored by InterSystems [8.21.25] CMS-0057: Streamlining Prior Authorization and Delegated Vendor Collaboration (Part 1 of 2) Sponsored by Itiliti Health [6.11.25] WEDI Spotlight: CMS 0057 Implementation Update- Provider and EHR Perspective [4.9.25] WEDI Survey Insights: The State of Interoperability &…

CMS-0057-F Testing Directory Questionnaire for Organizations WEDI is creating a public directory of industry readiness for organizations that are interested in testing prior authorization and interoperability APIs in preparation for the January 1, 2027, compliance deadline for CMS-0057-F. The intent of the directory is to facilitate testing between organizations, gauge industry readiness for the compliance…

On February 8, 2024, CMS released the CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F). This final rule emphasizes the need to improve health information exchange to achieve appropriate and necessary access to health records for patients, providers, and payers. It also addresses the need to improve prior authorization processes through policies and technology, to…

CMS Prior Authorization of Drugs Proposed Rule Under Review by OMB. The Centers for Medicare & Medicaid Services (CMS) proposed regulation titled “Interoperability Standards and Prior Authorization for Drugs (CMS-0062)” is currently under review by the Office of Management and Budget (OMB). This proposed regulation was included most recently in the Spring 2025 Unified Agenda.…