About the Draft Federal FHIR® Action Plan

The Draft Federal FHIR® Action Plan (“draft action plan”) is intended to help guide federal investment in and adoption of the Health Level 7 (HL7®) Fast Health Interoperability Resources (FHIR®) standard. In 2019, the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (formerly ONC and hereafter ASTP) convened a FHIR Work Group under the Federal Health IT Coordinating Council (FHITCC) to coordinate knowledge, implementation, and decision-making around the role and use of FHIR. This draft action plan builds off the work of that group and provides additional direction now that FHIR has matured and is being used more broadly by federal agencies to help facilitate shared decision-making, improve care coordination, and deepen patient engagement. (HL7® and FHIR® are the registered trademarks of Health Level Seven International and use of these trademarks does not constitute endorsement by HL7.)

In addition, recent regulations published by ASTP and CMS – ASTP’s Health, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule; the Centers for Medicare & Medicaid Services' (CMS) Interoperability and Prior Authorization Final Rule; and ASTP’s Health, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule – begin to lay out a path for the next generation of FHIR capabilities.

Federal agencies and implementation partners are encouraged to use this draft action plan to help:

  • Identify and address common needs.
  • Coordinate asks of the FHIR standards community and implementation partners.
  • Reuse and advance capabilities that have widespread adoption across industry and federal use cases to help benefit each other’s funded initiatives, avoiding redundancy and duplication of efforts.

In this draft version of the action plan, ASTP welcomes feedback from federal agencies, the standards development community, and subject matter experts. It will be updated to reflect improvements based on the recommendations received and periodically thereafter.

GOALS

This draft action plan’s primary goal is to align federal agencies’ adoption and use of FHIR around a set of essential components and capabilities that agencies have implemented or are planning to implement in the next two years. Many of these components are mature and already being used in production.

By publishing the draft action plan, we also seek to identify those areas in which additional development and investment is needed and to spur federal partners and the standards community to identify new components for their uses.

PURPOSE

The heart of the draft action plan lies in the component tables in the FHIR Ecosystem section. These tables group FHIR components into six categories:

  • Core Components
    Core FHIR specifications and components are the most foundational and have the broadest applicability across healthcare services. They are used for fundamental operations and serve as reusable building blocks to support many use cases.
  • Network Components
    Network specifications apply to FHIR capabilities for accessing and exchanging data between health information networks for securely sharing data on a nationwide scale.
  • Payment and Health Quality Components
    FHIR-based Payment and Health Quality specifications have been developed to reduce reporting burden for clinicians and caregivers.
  • Care Delivery and Engagement Components
    Care Delivery and Engagement specifications based on FHIR seek to ease patients’ access to their health data and to the healthcare system. They also seek to reduce provider burden and assist providers in areas such as decision support.
  • Public Health and Emergency Response Components
    Public Health and Emergency Response FHIR specifications seek to modernize public health data and infrastructure.
  • Research Components
    Research specifications are intended to drive toward a fully digital health system that uses FHIR for research activities.

The individual components described in the tables are those that ASTP considers to be best suited to address current agency needs, factoring in the level of current implementation in industry, regulatory requirement, component maturity, and readiness for future capability.

The draft action plan is designed to provide clarity, consistency, and predictability for the public regarding the standards and implementation specifications that are being considered by federal agencies.

Interested parties who administer government programs with clinical health IT interoperability components are encouraged to look first to the draft action plan to more fully inform their goals.

This site contains numerous links to other federal agencies and to private organizations. You are subject to these sites’ privacy policies when you access them. HHS is not responsible for Section 508 compliance (accessibility) on other federal or private sites. HHS is not responsible for the contents of any “off-site” web page referenced from this site.

DRAFT FEDERAL FHIR ACTION PLAN AND RELATIONSHIP TO ISA

The draft action plan represents the model by which ASTP will align federal agencies’ adoption and use of FHIR standards and related implementation specifications for meeting agency needs.

While the Interoperability Standards Advisory (ISA) and the draft action plan share similarities, including being published on the ASTP’s Interoperability Standards Platform (ISP), there are notable differences in the content and focus of these two activities.

The draft action plan focuses on a limited set of interoperability needs identified by federal agencies that are supported using the FHIR standard and related implementation specifications. On the other hand, the ISA has been designed to cover the breadth of interoperability needs (over 75 different standards areas in the latest edition) that are supported by various standards that are not limited to FHIR.

Another notable difference is the manner in which the draft action plan will be updated based on ASTP’s coordination with federal agencies as part of the HHS Health IT Alignment Policy.

ASTP will publish updated plans based on federal agency needs identified through existing activities including the Federal Health IT Coordinating Council, Federal Health IT Strategic Plan, and ongoing coordination with agencies.

We plan to work with federal agencies to institute a public feedback process in the future. In the meantime, we encourage interested parties to work with federal agency partners to further refine the action plan.

HOW TO COMMENT ON THE DRAFT FEDERAL FHIR® ACTION PLAN

Comments on the draft action plan are accepted year-round; changes will be made periodically based on comments and other changes to the health IT standards environment as ASTP becomes aware of them.

An ISP site account is required in order to comment on the draft action plan.

  • If you have an account already, click here or click the “LOG IN” button at the top right of the ISP and enter your log in information.
  • To create an account, click here or click the “LOG IN” button, then “Create new account” tab above the log in window. Account approval is required and is generally completed within 24 hours.

Once you’re authenticated to the ISP site, you can submit comments – scroll to the bottom of the page, enter the text of your comment (or provide attachments, if needed), and submit. Your comment will be reviewed by ONC or other HHS subject matter experts and considered for publication to the draft action plan.

Comment

Submitted by iletoj on

OCHIN Comments Draft Federal FHIR Action Plan

Please see OCHIN's comments attached.

Submitted by mutlee on

This Plan contains a list of…

This Plan contains a list of FHIR specifications with traction and a list of "early-stage" capabilities. It can provide ground for consensus prioritization: given a new requirement, the design solutions listed here are to be preferred to those not listed here. This is a useful approach, but it would be helpful if these decisions were annotated with reasons for selecting one solution over others. In many cases there is only one, so no rationale is necessary, but the Plan is of less value in these cases. In others, diverse designs exist, so it would be good to know why, e.g., CDex is not included.

The phrase "When these specifications reach a degree of common implementation such that they become the de facto standard" suggests a relatively passive role for the government. For capabilities for which the value can be realized by private concerns without adverse effects on citizens, this passivity makes sense. 

But that there are capabilities that the government is in a unique position to foster, including

              Support for sharing of profiles and terminologies in the US Realm

              Advancing FAST capabilities for finding information (patient data, endpoints)

              Facilitating leverage of other standards (V2, NCPDP, CDA, X12) data in FHIR ecosystem

              Demonstrating operational data quality monitoring

TEFCA and VSAC are good examples of programs that foster a common infrastructure and encourage mutual intelligibility by making it easier to do things right than to do them locally.

In addition, it might be useful to identify cross-agency interactions that can be used for socializing design decisions. 

I’d like to see a plan that specifies activities to promote design consensus, whether via advocacy, policy, or incentive.

Submitted by rbaker@cdisc.org on

Comments About the Draft Federal FHIR Action Plan

In response to the Federal Health IT FHIR Roadmap Action Plan request, we are pleased to submit our collective feedback as a collaboration among CDISC, Catalysis Research, and Piosoft. The full overview of the feedback is attached. The comments are further applied on the specific page. 

We applaud the efforts to leverage and harmonize the standards to benefit health and human services. The Action Plan states the FHIR standard will be essential, and we agree this is a good start. However, leveraging other available and applicable standards, particularly in the case of terminology, will move us all forward faster and perhaps better. Specifically, in the case of research standards, benefits and efficiencies have been proven over the past 25 years in a global research community, including NIH centers and FDA. These terminologies to support core data elements and data elements for over 50 therapeutic areas are mature and are maintained by NCI Enterprise Vocabulary Services. It is inefficient and will not enable interoperability to allow users a choice of terminologies.   To truly reach the goal in a reasonable timeframe, it will be important to leverage this past consensus-based work that is relevant to billions of patients worldwide. Otherwise, it could very well take another 20 years to redo work that has already been done.

Thank you for the opportunity to comment.

  • Catalysis (Rebecca D. Kush, PhD)
  • CDISC (Rebecca Baker, MS, MHA, BSN, RN)
  • Piosoft (Filippo Napoli, PMP)

CDISC_Catalysis Research_Piosoft_RE - About the Draft Federal FHIR Action Plan_FINAL_2024-11-18.pdf

Submitted by mike.hamidi on

On Behalf of the Vulcan Accelerator - Comments & Recommendations

This comment is done on behalf of the Vulcan Accelerator, which has prepared a detailed document, attached for your review. Below is a summary of the key recommendations for the Draft Federal FHIR® Action Plan:  

  • Increased emphasis on existing and future Clinical Research FHIR IGs with cross-interoperability applications
  • Broadening use cases for digital health and clinical research
  • Aligning OMOP and EHR data models for seamless integration
  • Extending mCODE applications to oncology and other disease areas
  • Expanding support for Real-World Evidence (RWE) generation
  • Create FHIR®-ready, analysis-ready datasets to enhance efficiency in generating insights and decisive actions
  • Enabling additional standards and terminologies for pre-market submissions to the U.S. FDA
  • Leveraging FHIR® to enhance efficiency and simplify data exchange for research purposes, ultimately driving a positive impact on patients' lives

The Vulcan Accelerator would like to thank the ASTP for the opportunity to provide comments. Additional details regarding the Vulcan Accelerator can be found here https://www.hl7vulcan.org/

Vulcan Accelerator Comments on Draft 2024 Federal FHIR Action Plan_0.pdf

Submitted by mutlee on

Identifying Information Silos

It states “The FHIR standard’s coordinated use across government will help break down the silos separating patients, providers, payers, public health, and research.”  Are these silos/barriers noted anywhere?  I believe understanding the perceived barriers is necessary to comment on the plan.  It appears to be pretty high-level and leaves a lot of room for interpretation.

Submitted by mutlee on

Medication Information Management

Medication information management requires standards, avenues for exchanging, documenting, storing med and allergy info before, during and after car with patients, caregivers and their healthcare teams for successful ad safe medication care.