Early-Stage Capabilities

ASTP engages in coordination activities with federal agency partners through groups like the Federal Health IT Coordinating Council and via policy such as the HHS Health IT Alignment Policy. In producing this draft action plan, ASTP collaborated with agency partners to identify priority initiatives and use cases. This activity generated the early-stage capabilities, listed below, several of which are underway in HL7® FHIR® Accelerators. This list represents important next steps for ushering in the next generation of FHIR capabilities that will power improvements in healthcare. ASTP will continue to collaborate with federal agencies to identify new capabilities that support interoperability goals and will be added to the table below.

Capability: Standard approach to enable writing health information from external sources into the patient health record (“FHIR Write”)
  • As consumers leverage technology such as health related smartphone apps and wearable devices, the data they generate can be used to improve clinical decision making if they can become part of a patient’s health record. The ability to aggregate data from external health organizations via a standard based “FHIR Write” approach would also reduce provider burden.
  • While the FHIR standard provides support to “write” via RESTful operations, these operations have not been widely enabled in health IT systems due to security concerns and limited guidance to health IT developers on expected behavior. Additionally, health IT developers have developed “proprietary” APIs for limited use cases. 
  • Enabling FHIR Write use cases in the context of USCDI elements would be an important step in advancing this capability in a consistent manner. 
  • For health IT developers and those that are interested in this capability, please follow the work conducted in HL7 by the Argonaut Project.
Capability: Standardized approach to giving patients flexible options to save and share access to their health data (SMART Health Links)
  • The increasing digitization and standardization of patient health data allows data to be shared, in part or in whole, in new ways to new individuals and organizations. However, any data sharing standard must prioritize privacy and security and keep data in the control of the appropriate people, including the patients themselves. The ability for patients to share data securely with the entities of their choice through a standard such as SMART Health Links will reduce complexity and burden in data exchange.
  • SMART Health Links is a FHIR-based standard that helps increase the portability and shareability of health information. SMART Health Links uses a similar approach to SMART Health Cards, in allowing an individual to maintain a limited amount of information in the form of a secure QR code, but supports larger and more dynamic records. Both enable patients to share data securely with entities of their choice using a standards-based approach.
  • For developers interested in this capability, please follow the HL7® FHIR® SMART Health Cards and Links IG.
Capability: Enhance and ease data exchange between public health institutions and provider organizations
  • Public health is an area ripe for data exchange modernization. The response to COVID-19 has demonstrated the need to make data available and able to be exchanged efficiently across the healthcare system. The capabilities detailed in the draft action plan’s Public Health & Emergency Response Components table, in the FHIR Ecosystem section, make substantial progress toward this goal. However, the ability of providers and public health organizations to exchange health data at scale can be improved even further. The need is clear – the sooner that public health authorities receive relevant data, the faster they can take appropriate action. Enhancing and easing exchange capabilities while maintaining data privacy and security are essential to achieving to these improvements.
  • Helios Accelerator initiatives 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 would assist in achieving these capabilities.
  • For health IT developers and those that are interested in this capability, please follow the work conducted in HL7 by the Helios Accelerator.
Capability: Enhance and ease data exchange for research purposes
  • Similar to public health, enhanced data exchange and interoperability can provide outsized benefits to the federal health research community. Healthcare data sourced from providers can contribute to multiple areas of interest, though currently this is complicated by data model differences. The gap between EHR data formatted to the FHIR data model and research data formatted to the OMOP data model is an area requiring continued advancement. Progress here can help address researcher questions such as data granularity, data quality, and missing data. Further advancements in harmonizing terminologies and bindings will support data exchange in, for example, real-world evidence, clinical trials data, and adverse events. Additionally, processes impacted by regulatory functions, such as drug trials, would also benefit from FHIR-based exchange.
  • The use of FHIR to enhance and ease data exchange, on a broader level, will also aid in achieving the guiding principles of the HHS Data Strategy. It addresses multiple elements of the strategy, including making data available and interoperable, with lower barriers to sharing. For health IT developers and those that are interested in these capabilities, please follow the work conducted in HL7 by the CodeX and Vulcan Accelerators.
Capability: Development and harmonization of interoperability standards between health and human services
  • The HHS Data Strategy outlines the department’s priorities and initiatives to safely and effectively harness data to enhance the health and well-being of all Americans. A core element of the strategy is to develop human services standards, use cases, and tools that address the most critical gaps, including minimum system standards for EHRs to support human services programs and interoperability with health care systems.
  • The FHIR standard will be essential to providing robust support for data interoperability between health and human services.
  • Health IT developers can review the HHS Data Strategy and look for future direction from the department on a roadmap for advancing the FHIR standard.

Comment

Submitted by ravi.kafle@doh… on

Enhance data exchange between Public Health & Healthcare Orgs

Listed below are the two capabilities that are recommended for addition to the section 'Capability: Enhance and ease data exchange between public health institutions and provider organizations':

  • Development and use of a federated contact tracing system that could be used to pull data to the State systems and vice versa. This is an infrastructure that is needed for responding to localized, widespread, and multi-state epidemics.
  • Implementing FHIR at Scale Taskforce (FAST) IG including directory services and other use cases, as part of the federal infrastructure, for publishing the FHIR APIs and respective documentation for authentication/authorization, consent management etc.

Submitted by choward2323 on

FHIR Write

This capability is still in its early stages but holds significant promise for the future by enabling more seamless bidirectional integration between systems exchanging data with a FHIR server. Currently, when a bidirectional interface is needed, a hybrid approach is often required. For example, vendors might request healthcare data using FHIR while sending data back into the EMR via direct HL7 interfaces. FHIR write functionality could potentially eliminate the need for such hybrid solutions, depending on the types of data sets supported as a standard.

Submitted by rbaker@cdisc.org on

Public Health

HL7 FHIR Electronic Case Reporting IG (eCR IG) is noted as pilot. There is an opportunity for leveraging these data elements to align case reports with the CDISC standards case report forms that are used in both public health and pharma trials by NIH centers, CROs, and researchers around the world. They are built into RedCap and OpenClinica, and the specifications are available on the CDISC website for other vendors to use. This would enable data aggregation more efficiently.  Such forms could be used with IHE RFD as mentioned previously.  CDISC has worked with NIH and others on standards for different Therapeutic Areas and sample case report forms have been provided for Ebola, Vaccines, Virology, COVID-19 and others including Oncology (various types of cancers), Asthma and Alzheimer’s and Parkinsons’ Diseases. The work was done through the Coalition For Accelerating Standards and Therapies (CFAST) with many different organizations and SMEs including CPath, FDA, NIH, CDISC, TransCelerate and Oxford. These standards and their terminology are required by FDA for submissions of data to support the approval of new therapies.  Why would these not be leveraged as a starting point to accelerate the development and adoption of FHIR for research?

Submitted by:
Catalysis (Rebecca D. Kush, PhD), CDISC (Rebecca Baker, MS, MHA, BSN, RN), and Piosoft (Filippo Napoli, PMP)

Submitted by rbaker@cdisc.org on

Enhance and ease data exchange for research purposes

Research would benefit from leveraging the volumes of great work done through the NIH NCI EVS team to curate and maintain controlled terminology for clinical research. This terminology was developed with the CDISC community and is required by FDA and Japan’s PMDA. This body of knowledge has been available since 2008 and has been growing each year, now supporting foundational research needs as well as over 50 therapeutic areas. The terminology was developed through a consensus-based process involving thousands of volunteers from a variety of different organizations around the world to supports research from protocol and data collection through data tabulation, analysis and reporting. These standards are harmonized globally to be synergistic.  It would save significant time and cost to start with this controlled terminology to support research with USCDI and US Core.

Connecting previously defined data elements for research (as developed by the CDISC community) and their codes within the NCI EVS Metathesaurus to the healthcare coding systems, codes, and labels (aka healthcare terminology) will streamline the path to using FHIR and to achieving interoperability.

Currently the only documents mentioned in the draft Federal FHIR Action Plan are the mCode IG and the Genomics Reporting IG.  

We recommend adding the following FHIR IGs in support of research, there may be additional public health IGs that would be beneficial to highlight.  

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.

Submitted by:
Catalysis (Rebecca D. Kush, PhD), CDISC (Rebecca Baker, MS, MHA, BSN, RN), and Piosoft (Filippo Napoli, PMP)