Early-Stage Capabilities

ASTP collaborates with federal agency partners to align health IT initiatives and policies. This coordination occurs through groups like the Federal Health IT Coordinating Council and policies such as the HHS Health IT Alignment Policy. As part of its efforts, ASTP worked with agency partners to identify priority initiatives and use cases, which led to the development of early-stage capabilities. Many of these capabilities are being advanced through HL7 FHIR Accelerators.

FHIR Accelerators are collaborative, multi-organization groups focused on advancing the HL7 FHIR standard. These groups are organized around specific use cases and aim to address critical new functionalities required for the continued adoption and implementation of FHIR. By tackling pressing challenges, FHIR Accelerators play a key role in driving innovation and interoperability in health IT systems, ensuring that FHIR evolves to meet the needs of diverse stakeholders in healthcare.

Argonaut – Focuses on expanding information sharing for electronic health records (EHRs) and other health information technologies, driving interoperability and data exchange in clinical settings.
CARIN Alliance – Works to advance consumer-directed exchange across the U.S., empowering patients to access and manage their health information securely and efficiently.
CodeX – Develops guidance on interoperable data modeling and implementation around CodeX FHIR standards,
Da Vinci – Assists payers and providers in improving clinical, quality, cost, and care management outcomes by creating FHIR-based solutions for value-based care and payment models.
FHIR At Scale Taskforce (FAST)– Identifies and addresses challenges faced by FHIR implementers when scaling FHIR solutions, ensuring robust and scalable interoperability.
Gravity Project – Develops standards and technologies to address the social determinants of health (SDOH), aiming to meet individuals' social need and, improve health outcomes.
Helios – Focuses on developing FHIR-based standards and approaches for public health, enabling better data sharing and decision-making in public health initiatives.
Vulcan – Accelerates the development, refinement, and use of FHIR standards for clinical and translational research, supporting advancements in healthcare innovation and scientific discovery.

The list of early-stage capabilities highlights key advancements needed to develop the next generation of FHIR functionalities that will drive improvements in healthcare. These capabilities represent foundational steps toward enhancing interoperability, streamlining data exchange, and enabling innovative health IT solutions. ASTP will continue working closely with federal agencies to identify additional capabilities that align with interoperability goals. As new priorities and use cases are identified, they will be added to the list, ensuring that the evolving FHIR standard addresses emerging needs in healthcare and supports the broader vision of a connected and efficient health IT ecosystem.

Capability: Enable import of health information from external sources (FHIR Write)
As consumers increasingly use health-related technologies such as smartphone apps and wearable devices, the data generated by these tools has the potential to enhance clinical decision-making if integrated into a patient’s health record. A standardized "FHIR Write" approach, which allows external health organizations to contribute data to a patient’s record, could also help reduce the administrative burden on healthcare providers. While the FHIR standard supports "write" operations through RESTful APIs, these capabilities have not been widely implemented in health IT systems. This is largely due to security concerns and the lack of clear guidance for health IT developers on expected behaviors for enabling "write" functionality. Additionally, many health IT developers have created proprietary APIs that are limited to specific use cases, further hindering standardization. Advancing FHIR Write use cases in alignment with USCDI (United States Core Data for Interoperability) elements would be a significant step toward enabling this capability in a consistent and secure manner. Specifications that define applicable workflows and data types—such as clinical, administrative, and billing data—will be critical for implementing FHIR Write capabilities within existing health IT systems and infrastructure. The Argonaut Accelerator is actively pursuing multiple capabilities and timelines under the umbrella of FHIR Write. Interested parties are encouraged to follow these efforts to stay informed about developments and opportunities to contribute to the advancement of this capability.

Capability: Create and manage digital identities
As interoperability reduces data silos in healthcare, the ability of health IT systems to accurately match individuals' records from external systems becomes increasingly important. Digital identity and identity matching are essential capabilities for advanced data analytics, such as record linkage, which relies on precise identification of individuals across disparate systems. A key aspect of scaling FHIR is the development of robust digital identity and identity management solutions. The FHIR FAST Accelerator is actively working to create guidance that ensures health IT systems—and, by extension, care providers—can accurately match digital identities, particularly when external data is imported into a health IT system. The HL7® FHIR® FAST Interoperable Digital Identity and Patient Matching Implementation Guide is designed to establish best practices and standards for digital identity and person matching. This specification provides detailed guidance on defining the match operation used in cross-organizational FHIR data exchanges, supporting accurate identity management and person matching. Health IT developers and those that are interested in scaling FHIR are encouraged to follow the work being conducted by the FAST Accelerator.

Capability: Enhance and ease data exchange between public health institutions and provider organizations
Public health is a critical area for modernizing data exchange, as public health emergencies have highlighted the need for efficient and timely data sharing across the healthcare system, including public health organizations. The capabilities outlined in the Federal FHIR Action Plan’s Public Health & Emergency Response Components table represent significant progress toward achieving this goal. However, further collaboration and coordination between healthcare providers and public health entities, such as state health departments and federal partner agencies, are necessary to scale health data exchange effectively. Timely access to relevant data enables public health authorities to respond more quickly and appropriately to emerging health threats. Enhancing and simplifying data exchange capabilities for public health use cases, while ensuring data privacy and security, is essential to achieving these improvements. The Helios Accelerator is actively working on initiatives that support these goals, such as Delivering Aggregate Information to Public Health, Making Data in Public Health Systems Accessible in Bulk, and Using Query and Response to Address Public Health Data Needs. Health IT developers and those that are interested in advancing public health data exchange are encouraged to follow the work being conducted by CDC and by the Helios Accelerator.

Capability: Transmit cancer pathology information
ASTP is monitoring the HL7® FHIR® Cancer Pathology Reporting IG, a specification designed to facilitate the creation and transmission of cancer pathology laboratory values and results to central cancer registries (CCRs). Cancer pathology reporting plays a critical role in diagnosing cancer and assessing the progression of cases at the point of diagnosis. Early pilot results have shown that adopting this IG can significantly reduce the need for manual intervention and data cleansing, enable more timely reporting, and ensure the inclusion of data elements that are essential for public health action. By streamlining the reporting process, the IG supports more efficient and accurate data exchange. This specification provides best practices for FHIR-based transmission of pathology data, enabling interoperability between CCRs, EHRs, and Laboratory Information Systems (LIS). It focuses on structured data collection and exchange, offering guidance on common data models, defined data items, and relevant ontological standards and value sets.

Capability: Report digital quality measures for health care safety
The HL7® FHIR® National Healthcare Safety Network (NHSN) Digital Quality Measure (dQM) Reporting IG supports CDC’s data modernization efforts by enabling the electronic submission of digital quality measures to the NHSN, which is a CDC infection tracking surveillance system. This IG is designed to streamline the reporting process for healthcare facilities participating in NHSN. Building on previous work from the Quality Measure IG and the Data Exchange for Quality Measures IG, this specification aims to reduce the burden of reporting, improve the accuracy, quality, and validity of submitted data, and enhance the speed and efficiency of the reporting process. It achieves these goals by leveraging data from existing Certified Health IT APIs, including the US Core IG, ensuring interoperability and alignment with established standards. NHSN participants are encouraged to review this IG to explore NHSN-specific FHIR Profiles and example digital quality measures. The IG also provides details on terminology and ontological standards relevant to NHSN reporting, helping participants understand and implement the specification effectively.

Capability: Exchange information during public health emergencies
Public health emergencies expose significant gaps in the existing public health reporting infrastructure, particularly in the ability to monitor healthcare system stress and capacity. These challenges underscore the need to enhance capabilities for tracking and reporting public health metrics during emergencies. The US Situational Awareness Framework for Reporting (SAFR) IG establishes a standardized, FHIR-based approach to address these gaps. It supports public health decision-making during emergencies by standardizing FHIR interfaces and endpoints for public health organization; automating data collection to reduce manual effort; enabling real-time data exchange for timely insights; and providing a comprehensive view of healthcare capacity and trends. By implementing the US SAFR framework, healthcare facilities and public health authorities can exchange critical information and report metrics to federal agencies more efficiently. Implementers interested in the US Situational Awareness for Novel Epidemic Response (SANER) IG should review the SAFR implementation guidance.

Capability: Enhance and ease data exchange for research purposes
Enhanced data exchange and interoperability can significantly benefit the federal health research community, much like it does for public health. Provider-sourced healthcare data has the potential to contribute to various research areas, but this is currently complicated by differences in data models. There is a pressing need to bridge the gap between Certified Health IT data formatted in FHIR and research data formatted in Common Data Models (CDMs) such as OMOP and i2b2. Addressing this gap can help researchers tackle challenges related to data granularity, data quality, and missing data. Advancements in harmonizing terminologies and bindings will further support data exchange in critical research areas, including real-world evidence generation, clinical trials data, and adverse events monitoring. These improvements will enable researchers to leverage healthcare data more effectively for insights and innovation. Health IT developers and stakeholders interested in FHIR capabilities for research use cases are encouraged to follow the work being conducted by FDA and by the CodeX and Vulcan Accelerators.

Capability: Retrieve Real-World Data for clinical research
With the adoption of Certified Health IT, researchers are increasingly looking to use Real-World Data (RWD) — data collected outside of controlled clinical settings — for various purposes, including clinical trials, real-world evidence generation, post-market safety surveillance, and training data for machine learning (ML) and artificial intelligence (AI) models. While the potential of RWD is significant, there is a need to define a minimum set of FHIR resources to enable the standardized digital exchange of clinical research data. The HL7® FHIR® Retrieval of Real-World Data for Clinical Research IG aims to address this need by providing guidance for collecting and using RWD and real-world evidence. This IG focuses on retrieving RWD from Certified Health IT systems via FHIR APIs. The specification does not provide guidance on how RWD should be used downstream after it is obtained. The scope of this IG is limited to Certified Health IT, though future iterations may expand to include other data sources such as registries, payer systems, and health information networks. The Retrieval of Real-World Data for Clinical Research IG uses the International Patient Access (IPA) IG as its baseline. While it leverages the IPA IG to access RWD, it also provides additional specifications tailored to clinical research, including specific data elements and FHIR Resources. Health IT developers and stakeholders interested in HL7 FHIR capabilities for research use cases are encouraged to follow the work being conducted by the FDA and by the Vulcan Accelerator.

Capability: Obtain adverse events data for clinical research
There is a significant opportunity to leverage adverse events from Real-World Data (RWD) sources to support and enhance clinical research studies. The collection and use of adverse event data are critical for clinical research, as they help capture essential information such as cause-and-effect relationships, seriousness, severity, and outcomes of adverse events. The HL7® FHIR® Adverse Event Clinical Research IG aims to establish a baseline standard for the FHIR Adverse Event Resource specifically for clinical research purposes. This IG enables implementers to collect adverse event data from RWD sources, such as Certified Health IT systems and post-market surveillance systems, using FHIR APIs. The collected adverse event data can be used to supplement clinical research studies in various ways, including post-market surveillance, public health emergencies, and clinical trials. While the specification is developed for FHIR R5, the HL7® FHIR® Adverse Event Clinical Research R4 Backport IG is available for implementers whose Certified Health IT systems are configured to FHIR R4. This IG allows implementers to adopt the functionality of the FHIR R5 specification. Health IT developers and stakeholders interested in FHIR capabilities for research use cases are encouraged to follow the work being conducted by the FDA and by the Vulcan Accelerator.

Capability: Report genomics data
Genomic variations play a critical role in healthcare, as they can significantly impact a patient’s health outcomes. To effectively leverage genomic data in clinical and research settings, there is a need for standardized, consistent, and computable methods for exchanging this data. The HL7® FHIR® Genomics Reporting Implementation Guide (Genomics Reporting IG) provides a framework for reporting genomic data in an interoperable manner using the FHIR standard. This specification offers standardized guidance and examples for reporting multiple types of genomic data. The Genomics Reporting IG has been piloted through the ASTP-led Sync for Genes program, demonstrating its potential for real-world application. While the specification is still in the early stages of adoption, ASTP has identified Version 2.0.0 of the Genomics Reporting IG as ready for consideration by health IT developers. This version is particularly relevant for use cases that require the integration of genomic data with other health data, supporting advancements in personalized medicine, research, and clinical decision-making.

Capability: Harmonize interoperability standards between health and human services
HHS seeks to leverage data safely and effectively to improve the health and well-being of all Americans. A key focus is addressing critical gaps in data interoperability, particularly in human services programs. This includes developing standards, use cases, and tools, as well as establishing minimum system requirements for EHRs to support human services programs and ensure seamless interoperability with healthcare systems. The FHIR standard is a crucial component for achieving robust data interoperability between health and human services systems. By enabling standardized data exchange, FHIR can help bridge the gap between healthcare and human services, facilitating better coordination and outcomes.