The Tool Desk
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What does an open health data architecture need?
Each layer answers a different question. A system can exchange data in a standard format and still fail to exchange the right information, use the same meaning for a code, or establish that a requester is allowed to see it.
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| Layer | What it specifies | What it does not settle by itself |
|---|---|---|
| Exchange standard and API | How systems represent and request information. FHIR provides reusable resources and interaction patterns for clinical and administrative health data exchange. | Which profiles, data elements, vocabularies, users, or access rules apply to a particular exchange. |
| Profiles and implementation guides | How a base standard is constrained and applied to a defined use case, including which content and behaviors participating systems should support. | Whether two implementations use compatible guide versions or meet applicable legal obligations. |
| Common data baseline | Which data classes and elements should be available for exchange, as specified by the United States Core Data for Interoperability (USCDI). | How every element is coded, or which USCDI version is required for every API. |
| Terminology | Which codes or value sets convey the intended clinical meaning. | Whether a recipient has interpreted or mapped a concept correctly in its own system. |
| Identity and authorization | Who a user is and what an application may access. | Whether a data request has a permissible purpose or satisfies privacy requirements. |
| Operations and governance | How participants find records, exchange larger data sets, manage permissions, and meet their responsibilities. | That records are complete, patients are matched correctly, or every exchange is legally permitted. |
FHIR is the API-focused exchange layer, not a complete interoperability policy. CMS technical material identifies FHIR Release 4.0.1 and notes that it includes the first normative FHIR resources. The applicable release and companion specifications still need to be selected for the exchange at hand.
What are HL7 FHIR implementation guides?
They apply a general standard to a specific exchange
An implementation guide (IG) describes how to use a standard for a defined context. It commonly relies on profiles, which constrain or extend the base FHIR resources and behaviors for that context. In practice, an IG can specify which resource elements are required, how they relate, which codes to use, and how systems interact. The purpose is to make implementations more consistent than if every organization independently decided how to apply FHIR.
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FHIR compliance alone therefore does not prove that two systems implement the same exchange. A useful compatibility check names the FHIR release and the specific guide and profile versions, then checks the required data, terminology, and interaction behavior against those versions.
Use the guide that matches the use case
CMS points implementers to US Core and use-case guides including CARIN Blue Button and Da Vinci PDex, as well as FHIR Bulk Data guidance in relevant provider and payer settings. CMS recommends using published guides rather than inventing independent approaches. Its technical materials are version-specific, and some previously adopted standards expired on January 1, 2026; an implementation should verify the versions applicable to its particular API rather than relying on a guide name alone.
How do USCDI and terminology fit together?
USCDI describes the data to exchange
USCDI defines common data classes and elements. Examples include clinical notes, allergies and intolerances, laboratory test results, and medications. It is a content baseline, not an API protocol or a complete code system.
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CMS’s voluntary framework criteria refer to USCDI v3 or later. ONC released USCDI v7 on July 23, 2026, following v6 on July 24, 2025. The latest published version is not automatically the version required by every API rule: CMS technical materials identify standards by API, so the applicable rule and API specification determine what a participant must implement.
Terminology helps preserve meaning
Two systems can exchange the same FHIR resource and still disagree about what a coded value means. CMS’s framework gives laboratory results in LOINC, medications in RxNorm, and conditions in SNOMED as examples of terminology compliance. These are examples, not a complete inventory of terminology requirements. Implementers need to follow the bindings specified for their use case and validate coded data against them.
ONC’s Cartos is a public FHIR-enabled terminology service for finding and using terminology content connected to certification, the Standards Version Advancement Process (SVAP), and supported guides. It can help locate terminology content; it does not replace profiling, governance, or validation.
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How should identity, authorization, and privacy be handled?
Authentication and identity answer who the user is; authorization answers what an application may access. CMS describes SMART on FHIR as a way for applications to request OAuth 2.0 access tokens from authorization servers and then retrieve FHIR resources. It describes OpenID Connect as an identity layer on OAuth 2.0 that lets clients verify end-user identity. These mechanisms support access flows, but a successful technical exchange is not, by itself, proof that the request is permitted.
Open APIs do not displace privacy law. CMS says its framework does not supersede federal or state privacy law, and covered entities and business associates retain their HIPAA duties. Depending on the exchange, responsibilities can include verifying the requester’s identity and authority, confirming a permissible purpose, applying the minimum-necessary standard where it applies, honoring individual rights, handling breach notifications, and maintaining required business associate agreements.
What changes for bulk exchange and network operations?
Individual API requests and bulk exchange address different operational needs. CMS includes FHIR Bulk Data access among relevant guides for provider and payer exchange settings; its voluntary framework says networks should leverage bulk exchange to reduce load on existing systems and support exchange of full records. Bulk transfer can change the scale and timing of an exchange, but it does not itself establish permission to disclose data or guarantee that a record is complete.
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The framework also identifies record locator functionality and event notifications as criteria. A record locator helps participants determine where relevant records may be held; an event notification can signal that a relevant event has occurred. The framework describes these capabilities at a criteria level, not as a single mandated technical design. Participants still need to determine implementation details, patient matching, authorization, and the legal basis for each exchange.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.How does the U.S. CMS framework differ from payer regulations?
The distinction is important: CMS presents its Interoperability Framework as a voluntary blueprint for networks seeking to meet CMS-aligned criteria, while CMS-0057-F is a final rule imposing specified API obligations on defined payer types. The framework is not itself a regulation and is not intended to add regulatory burden; existing legal obligations remain in force.
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| Program or rule | Status and scope | What to take from it |
|---|---|---|
| CMS Interoperability Framework | Voluntary network framework | Its criteria call for FHIR APIs using US Core, USCDI v3 or later, and terminology compliance. CMS also identifies operational capabilities such as bulk exchange, record locator functionality, and event notifications. |
| CMS-0057-F | Final rule for specified Medicare Advantage organizations, state Medicaid and CHIP programs and plans, and Qualified Health Plan issuers on Federally Facilitated Exchanges | It adds or enhances Patient Access, Provider Access, Payer-to-Payer, and Prior Authorization APIs. API development and enhancement requirements generally begin January 1, 2027, but exact dates vary by payer. |
| CMS-0062-P | Proposed rule identified in CMS technical materials | It includes proposed updates to standards and implementation guides. Proposed provisions should not be treated as final requirements. |
For the Provider Access API, CMS-0057-F covers specified claims and encounter data, USCDI data, and certain prior-authorization information, and requires a patient opt-out process. The obligations and dates depend on the payer category and API, so an organization should consult the rule and CMS’s version-specific technical standards for its role. ONC’s Health IT Certification Program is voluntary; ONC says certified health IT uses USCDI, which is distinct from a blanket requirement that every system be certified.
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How can an organization assess an implementation?
“FHIR compliant” is too broad to serve as an interoperability sign-off. For each connection, document the implementation choices that determine whether the parties can exchange the intended information under the right conditions.
- Define the exchange. Record the use case, participant roles, intended data scope, and whether the exchange is request/response or bulk.
- Pin the specifications. Identify the FHIR release and the exact implementation guide and profile versions that apply to the use case.
- Check data and meaning. Map the required USCDI elements and any permitted extensions; document terminology bindings and how coded values will be validated.
- Specify access flows. State whether the design uses user-facing or backend authorization, how identity is established, and what the application is permitted to retrieve.
- Map obligations and safeguards. Establish the participant’s regulatory role, applicable consent or opt-out behavior, permissible purpose, and privacy and security controls before enabling exchange.
ONC’s versioned USCDI publications and CMS’s technical standards organized by API are useful starting points for resolving version questions. For a certification-related terminology lookup, Cartos can help locate content, but implementers still need to validate the actual exchange against the applicable guide and rules.
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