Introduction

Health Level 7 (HL7®) Fast Healthcare Interoperability Resources (FHIR®) is a widely used, open standard for exchanging health information that is based on modern internet technology approaches. Thanks to considerable effort by technology developers and the HL7 standards development community, FHIR is now ready for prime time. It was incorporated into the ONC Health IT Certification Program to support essential provisions of the 21st Century Cures Act, which was passed in 2016 with strong bipartisan support. As a result, FHIR-based application programming interfaces (APIs) have become more prevalent and now offer a new baseline for accessing and exchanging electronic health information nationwide.

Federal agencies are uniquely positioned to capitalize on these successes and unlock the full potential of a truly digital health ecosystem. By embracing FHIR and fostering collaboration within the health IT community, agencies can strengthen health data interoperability, support innovative applications, and promote improved health outcomes nationwide.

FEDERAL AGENCY REGULATIONS AND HEALTH IT ALIGNMENT ACTIVITIES

Federal agencies, including ASTP, CMS, the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), and the Department of Veterans Affairs (VA) have played instrumental roles in maturing FHIR as a foundational standard to help reduce implementation costs and improve health outcomes. The graphic below shows some of the federal regulations and initiatives since passage of the 21st Century Cures Act that have led to progress and opportunities available today. This includes the establishment of FHIR Release 4 (R4) as the current, mature foundational version that health IT developers are relying on in the United States. FHIR R4 was released in 2018 and has evolved into a mature standard for federal agencies to adopt for their programs.

The Draft Federal FHIR® Action Plan also complements ongoing interagency efforts to harmonize data-related efforts within the Department of Health and Humans Services (HHS):

• New, mission-critical data elements are structured through ASTP’s United States Core Data for Interoperability (USCDI) initiative and its extension program USCDI+. Working together with partners across the National Institutes of Health (NIH), the National Cancer Institute (NCI), CMS, CDC, HRSA, the Food and Drug Administration (FDA), VA and other federal agencies, USCDI and USCDI+ help promote greater consistency and semantic interoperability for priority use cases identified by federal agencies to meet multiple needs across federal programs.
• To further promote and commit to nationwide interoperability, HHS launched the HHS Health IT Alignment Policy in FY 2023. This policy promotes greater alignment of health IT-related activities and utilization of health IT that meets standards and implementation specifications adopted under section 3004 of the Public Health Service Act.
• The HHS Data Strategy focuses on areas where investments are most critical to advance the safe and effective use of data across HHS. It also designates ASTP with the responsibility for leading the development and harmonization of interoperability standards between health and human services.

The FHIR standard offers more granular data specifications leading to a shared foundation for data exchange. Its versatility supports multiple workflows through a unified approach to interoperability.

Coordinated federal participation in FHIR is vital to ensure the implementation of high-priority FHIR-based capabilities that align with federal agencies’ common needs. This draft action plan represents a significant step forward, building upon existing federal policies and investments devoted to advancing FHIR and its associated technical specifications.