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 brianscarpelli on
Comments of the Connected Health Initiative
The Connected Health Initiative (CHI, www.connectedhi.org) appreciates the opportunity to provide feedback on ASTP's Draft Federal FHIR Action Plan. We appreciate ASTP's focus on adopting FHIR and promoting collaboration within the health IT community to advance health data interoperability, drive innovation, and improve health outcomes nationwide. We also recognize the need for ASTP’s leadership in developing and harmonizing interoperability standards across the health sector, which will requires a holistic approach that extends beyond FHIR alone.
In response to ASTP's request for recommendations on additional specifications to include in the component tables, CHI encourages the inclusion of syntactic and semantic standards that are crucial to unlocking FHIR’s full potential. For the final draft, CHI suggests ASTP identify related standards including X12 and NCPDP, and provide clarity on their roles within the implementation guides for each component table. As an example, the X12 standard serves an important role in enabling critical electronic data interchange transactions like claims and payment processing, which are essential for streamlined administrative operations and HIPAA compliance.
CHI also includes its comments previously provided to ASTP on its HTI-2 proposed rule to supplement this input.
Submitted by mattreid on
AMA FHIR Action Plan Comments
The AMA values the opportunity to provide feedback on ASTP/ONC’s Draft Federal FHIR Action Plan. We support the emphasis on adopting FHIR and fostering collaboration within the health IT community to enhance health data interoperability, drive innovative applications, and improve health outcomes across the nation.
We also acknowledge ASTP/ONC’s role in leading the development and harmonization of interoperability standards across health and human services. Achieving successful harmonization requires a comprehensive approach that goes beyond FHIR alone.
As noted, ASTP/ONC invites recommendations for additional specifications to include in the component tables. We encourage ASTP/ONC to consider incorporating complementary syntactic and semantic standards essential for realizing FHIR's full potential. For the final draft, the AMA recommends that ASTP/ONC specify related standards—such as X12 and NCPDP—and clarify their roles within the implementation guides for each component table. For example, the X12 standard remains vital in the U.S. health care system because it facilitates essential electronic data interchange transactions, such as claims and payment processing, which are critical for efficient administrative operations and compliance with HIPAA regulations.
The AMA is also providing our HTI-2 comment letter which offers more detailed insights into specific HL7/FHIR implementation guides mentioned in the draft plan's component tables.
Submitted by kmartin on
NCQA Comments on Draft Federal FHIR® Action Plan
Please see attached for our comments. Thank you.
Submitted by michael.ciabatti on
Epic Comments on Draft Federal FHIR Action Plan November 2024
Please see attached.
Epic Comments on Draft Federal FHIR Action Plan November 2024.pdf
Submitted by Janice on
Comment from the Massachusetts Health Data Consortium (MHDC)
Attached please find our comment on the draft Federal FHIR Action Plan. We appreciate the opportunity to help FHIR recommendations for HHS and the wider industry.
Submitted by melanie.kourba… on
APHL Informatics Comments on Draft FHIR Action Plan
We are writing on behalf of the Association of Public Health Laboratories (APHL), an organization that works to strengthen laboratory systems serving the public’s health in the US and globally. APHL member laboratories - state and local governmental laboratories in the US - protect the public’s health by monitoring and detecting infectious and foodborne diseases; environmental contaminants; biological, chemical, and radiological agents; genetic disorders in newborns; and other diverse health threats.
APHL appreciates the opportunity to submit feedback on the Draft FHIR Action Plan.
General feedback: the UI of the ONC FHIR Draft Action Plan is cumbersome. The ONC FHIR Draft Action Plan relies on many external links, an approach which may confuse the end user as to the scope of what is covered by its guidance.
Identifying the Core Components based on US Core is on target and a good approach, but it neglects the fact that US Core elements apply to EHR-S and do not necessarily cover all the other data producing systems for all use cases that need to be supported by federal agencies. In addition, the approach for inclusion in USCDI generalizes several data elements into categories that are not reflective of data modeling in those systems, and more documentation is needed to properly define each of the data elements so they can be reused without fear of misinterpretation. Of note is that US Core elements called out in regulation are usually 3 years or so behind the latest US Core version reflecting the last published version of USCDI.
Note that eCR data exchange is highly reliant on an intermediary, the eCR FHIR App on the APHL AIMS Platform. This app converts incoming eCR from healthcare organizations to CDA, and that is the format that is currently received and ingested by most public health agencies. As APHL recently recommended in our comments on HTI-2, ONC should clarify that the use of intermediaries like AIMS is an important component of public health reporting and is an acceptable way to meet requirements.
APHL recommends that ONC not list the Cancer Pathology Reporting IG as ready to use at this time. This IG is not mature enough for production. Currently, public health must combine data received from the Central Cancer Registry Report and the Cancer Pathology Report (which are defined by two separate IGs) in order to form a complete cancer case. The HL7 FHIR Cancer Registry Reporting Workgroup are working with eCR leads at CDC to implement cancer reporting of the cancer registry incidence report, then use eRSD and RCKMS to support the time interval reporting of additional information on the case. It may be prudent to wait for these changes to be implemented before identifying the IG to use in this scenario.
Many eCR exchanges with public health currently involve (and will continue to leverage) CDA-to-FHIR and/or FHIR-to-CDA transformations. These transformations are critical to enabling PHAs to pursue FHIR readiness without disrupting existing dataflows. Many of the resources, tools, and capabilities that are being developed by APHL and others are in support of these transformations and are aimed at allowing the PHA to use eCR content.
- APHL recommends that ONC encourage trading partners to implement eCR Implementation Guide Version 2.1.2. While the draft FHIR Action Plan identifies V.2.1.0 as “most ready for adoption in certified health IT,” it is APHL’s experience that few trading partners are using 2.1.0 currently, so new implementations should focus on the latest implementation guide.
Under Early-stage Capabilities, APHL suggests modifying the following statement to apply more broadly: “The response to COVID-19 has demonstrated the need to make data available and able to be exchanged efficiently across the healthcare system.” should read “The response to COVID-19 as well as other public health emergencies such as Mpox has demonstrated the need to make data available and able to be exchanged efficiently across the healthcare system.”
Thank you again for the opportunity to comment on HTI-2. If you have any questions, please do not hesitate to let us know.
Melanie Kourbage (she/her)
Lead Specialist, Informatics
P +1 240.638.2056 | M +1 413.387.7032
melanie.kourbage@aphl.org | www.aphl.org
Submitted by melanie.kourba… on
APHL Informatics Comments on Draft FHIR Action Plan
We are writing on behalf of the Association of Public Health Laboratories (APHL), an organization that works to strengthen laboratory systems serving the public’s health in the US and globally. APHL member laboratories - state and local governmental laboratories in the US - protect the public’s health by monitoring and detecting infectious and foodborne diseases; environmental contaminants; biological, chemical, and radiological agents; genetic disorders in newborns; and other diverse health threats.
APHL appreciates the opportunity to submit feedback on the Draft FHIR Action Plan.
- General feedback: the UI of the ONC FHIR Draft Action Plan is cumbersome. The ONC FHIR Draft Action Plan relies on many external links, an approach which may confuse the end user as to the scope of what is covered by its guidance.
- Identifying the Core Components based on US Core is on target and a good approach, but it neglects the fact that US Core elements apply to EHR-S and do not necessarily cover all the other data producing systems for all use cases that need to be supported by federal agencies. In addition, the approach for inclusion in USCDI generalizes several data elements into categories that are not reflective of data modeling in those systems, and more documentation is needed to properly define each of the data elements so they can be reused without fear of misinterpretation. Of note is that US Core elements called out in regulation are usually 3 years or so behind the latest US Core version reflecting the last published version of USCDI.
- Note that eCR data exchange is highly reliant on an intermediary, the eCR FHIR App on the APHL AIMS Platform. This app converts incoming eCR from healthcare organizations to CDA, and that is the format that is currently received and ingested by most public health agencies. As APHL recently recommended in our comments on HTI-2, ONC should clarify that the use of intermediaries like AIMS is an important component of public health reporting and is an acceptable way to meet requirements.
- APHL recommends that ONC not list the Cancer Pathology Reporting IG as ready to use at this time. This IG is not mature enough for production. Currently, public health must combine data received from the Central Cancer Registry Report and the Cancer Pathology Report (which are defined by two separate IGs) in order to form a complete cancer case. The HL7 FHIR Cancer Registry Reporting Workgroup are working with eCR leads at CDC to implement cancer reporting of the cancer registry incidence report, then use eRSD and RCKMS to support the time interval reporting of additional information on the case. It may be prudent to wait for these changes to be implemented before identifying the IG to use in this scenario.
- Many eCR exchanges with public health currently involve (and will continue to leverage) CDA-to-FHIR and/or FHIR-to-CDA transformations. These transformations are critical to enabling PHAs to pursue FHIR readiness without disrupting existing dataflows. Many of the resources, tools, and capabilities that are being developed by APHL and others are in support of these transformations and are aimed at allowing the PHA to use eCR content.
- APHL recommends that ONC encourage trading partners to implement eCR Implementation Guide Version 2.1.2. While the draft FHIR Action Plan identifies V.2.1.0 as “most ready for adoption in certified health IT,” it is APHL’s experience that few trading partners are using 2.1.0 currently, so new implementations should focus on the latest implementation guide.
- Under Early-stage Capabilities, APHL suggests modifying the following statement to apply more broadly: “The response to COVID-19 has demonstrated the need to make data available and able to be exchanged efficiently across the healthcare system.” should read “The response to COVID-19 as well as other public health emergencies such as Mpox has demonstrated the need to make data available and able to be exchanged efficiently across the healthcare system.”
Thank you again for the opportunity to comment on HTI-2. If you have any questions, please do not hesitate to let us know.
Melanie Kourbage (she/her)
Lead Specialist, Informatics
P +1 240.638.2056 | M +1 413.387.7032
melanie.kourbage@aphl.org | www.aphl.org
Submitted by Nagassi on
Comments & Recommendations
25 November 2024
Micky Tripathi, PhD, MPP
National Coordinator for Health Information Technology, Acting Chief Artificial Intelligence Officer Assistant Secretary for Technology Policy (ASTP)/Office of the National Coordinator for Health Information Technology (ONC)
Department of Health and Human Services
Hubert Humphrey Building, Suite 729 200 Independence Avenue SW Washington, DC 20201
Avinash Shanbhag
Associate Deputy Assistant Secretary
Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT(ASTP/ONC)
Washington, District of Columbia, United States
Adam Wong
Senior Innovation Analyst at U.S. Department of Health and Human Services
Washington, District of Columbia, United States
Submission Channel
Submitted electronically: Health IT Interoperability Standards Platform (https://www.healthit.gov/isp/user/login)
RE: About the Draft Federal FHIR® Action Plan
Submission Details
Thank you for the opportunity to review the 2024 Draft Federal FHIR® Action Plan. We appreciate the ongoing efforts to advance interoperability and standardization across health care. After multiple discussions and consulting with numerous colleagues in informatics and health IT, we would like to surface the following key considerations:
Enhanced Attention to Stakeholders Represented within FHIR: For FHIR to fully mature, it is essential to address gaps in concept representation for many major healthcare stakeholders who are marginalized or overlooked. Example stakeholders include blood bank inventory and donor management systems, organ transplant and donor management systems, implanted device management systems, laboratory information systems, infusion medication systems.
Concepts and core healthcare data constructs for these major stakeholders and others are either insufficiently or not at all represented within the FHIR standard. This poses challenges to creating a comprehensive, universally applicable interoperability framework.
Integration of Existing Data Exchange Standards and Standard Terminologies: HL7 data exchange standards, along with established standard terminologies, have been utilized for decades. It is crucial to require bi- directional use of major terminology standards at both the structural and vocabulary levels, via appropriate and necessary transformations, to ensure complete, consistent lossless data representation and interpretability when information is exchanged between systems. This requirement will help maintain the integrity and usability of historical data, facilitate a smooth transition to FHIR-based frameworks, and ensure clean, robust data representation for true interoperability.
https://confluence.hl7.org/display/CGP/C-CDA+to+FHIR+and+from+US+Core+Mapping
https://build.fhir.org/ig/HL7/ccda-on-fhir/
We encourage ASTP/ONC to address these areas as a priority in the Action Plan to ensure FHIR evolves as an inclusive and robust standard, capable of meeting the dynamic needs of the healthcare ecosystem.
Thank you for your attention.
Sincerely,
Natalee Agassi, MD, PharmD,
Title as of Dec. 2, 2024, Director Oracle Terminologies and Ontologies, Oracle Health, and Artificial Intelligence
Catherine K. Craven, PhD, MA, MLS, FAMIA,
Biomedical Informatician and Consultant
Submitted by Solarf3050 on
Health Level Seven Draft Federal FHIR Action Plan Comments
Attached are HL7 International's Draft Federal FHIR Action Plan comments. Thank you for the opportunity to comment!
Submitted by knicholoff@ehra.org on
EHR Association Comments on Draft Federal FHIR® Action Plan
Please see attached.
EHR Association Comments on the ASTP Draft Federal FHIR Action Plan.pdf