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Health data interoperability is not a single standard or API. It is a layered arrangement: an exchange standard such as FHIR provides the technical interface; profiles and implementation guides specify how to use it for a particular purpose; data and terminology baselines align what is exchanged; and identity, authorization, privacy, security, and operating rules govern who can exchange which information and how.
In the United States, CMS’s voluntary Interoperability Framework describes one way networks can align around these layers. Separate CMS rules impose API obligations on specified payer types. Those are different things: following the framework is voluntary, while applicable final-rule requirements are not.
What are HL7 FHIR implementation guides?
FHIR—Fast Healthcare Interoperability Resources—is an API-focused standard for exchanging electronic clinical and administrative health data. It defines reusable resources and interaction patterns, but a FHIR API alone does not settle which data elements a use case requires, which codes carry their meaning, or what access and privacy controls apply.
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1Fix the driver behind crashes, sound loss and screen glitches2Repair Windows errors before they cause bigger problems3Scan for outdated or missing drivers - takes under a minuteAn implementation guide (IG) applies a base standard to a defined exchange context. It can identify the profiles, data, terminology, and behavior expected for that use case. A profile, in turn, constrains or extends how a FHIR resource or interaction is used. Together, profiles and IGs make a general-purpose standard more specific and implementable. HL7’s implementation training describes the practical task as learning “how to use the profiles and implementation guides.”
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CMS points implementers to US Core as well as use-case guides such as CARIN Blue Button and Da Vinci PDex. The specific guide and version matter: a claim that an interface is “FHIR compliant” does not, by itself, tell a partner which implementation conventions it follows.
How the interoperability layers fit together
Each layer addresses a different source of incompatibility. A successful exchange depends on the layers agreeing with one another; using a common transport format does not automatically align the data’s meaning or authorize access.
| Layer | What it contributes | What it does not settle on its own |
|---|---|---|
| FHIR exchange standard | Resources and API interaction patterns for exchanging data. | The use-case-specific content, codes, access policy, or legal permission. |
| Profiles and implementation guides | Constraints and conventions for applying FHIR to a defined exchange context. | Whether an organization is legally required to participate or whether a particular disclosure is permissible. |
| USCDI data baseline | Common data classes and elements for exchange. | Every data element, code, or local implementation detail needed for every use case. |
| Terminologies | Shared codes and concepts that help preserve the meaning of clinical data. | Identity, access permissions, or agreement on the full exchange workflow. |
| Identity and authorization | Mechanisms to establish identity and control which data an application may access. | The clinical meaning or completeness of the information returned. |
| Privacy, security, and governance | Rules and safeguards for lawful, accountable exchange and operation. | Technical interoperability by themselves; organizations still need compatible interfaces and data conventions. |
1. Exchange standard: FHIR
FHIR is the API-facing exchange layer. CMS technical materials identify FHIR Release 4.0.1 for relevant technical work and note that it includes the first normative FHIR resources. The applicable release still needs to be checked for a given API or implementation: the existence of a FHIR endpoint does not establish which release or profiles it supports.
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2. Profiles and implementation guides
An IG turns broad capabilities into more consistent expectations for a particular scenario—for example, which resources and fields to exchange, how to represent them, and how interactions should work. CMS recommends using published guides rather than inventing independent approaches. Its technical materials list standards and versions by API, and note that some previously adopted standards expired on January 1, 2026. Implementers should therefore verify the guide and version relevant to their use case instead of assuming that “FHIR” names one fixed implementation.
3. Common data baseline: USCDI
The United States Core Data for Interoperability (USCDI) specifies data classes and elements for exchange. Examples listed by the Office of the National Coordinator for Health Information Technology (ONC) include clinical notes, allergies and intolerances, laboratory test results, and medications. CMS’s voluntary framework criteria refer to USCDI v3 or later.
Version context matters. ONC released USCDI v7 on July 23, 2026, following v6 on July 24, 2025. That publication does not, on its own, make v7 the required baseline for every API. CMS’s technical materials identify versions applicable to particular API rules; use the version required or supported for the specific obligation and implementation.
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4. Terminology: preserving meaning
Two systems can exchange data in the same format and still interpret a clinical concept differently. Terminology bindings address that semantic layer by specifying which coded vocabulary to use for particular information. CMS’s framework gives laboratory results in LOINC, medications in RxNorm, and conditions in SNOMED as examples. These are examples, not a complete inventory of terminology requirements.
5. Identity and authorization
Authentication and identity answer who a user is; authorization answers what an application is allowed to 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. CMS describes OpenID Connect as an identity layer on OAuth 2.0 that lets a client verify an end-user’s identity. These functions support access control, but they do not replace the need to determine whether a disclosure is legally permitted.
6. Exchange patterns and operating infrastructure
Not every exchange is a single request for one patient’s information. CMS includes FHIR Bulk Data access among relevant implementation guides for provider and payer exchange settings. Its voluntary framework also says networks should leverage bulk exchange to reduce load on existing systems and support exchange of full records. Record locator functionality and event notifications are additional framework criteria. Their use still depends on implementation details, participant roles, and applicable legal permissions.
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7. Privacy, security, and governance
Open APIs do not repeal privacy law. CMS states that its framework does not supersede federal or state privacy requirements; covered entities and business associates retain their HIPAA duties. CMS’s examples include verifying a requester’s identity and authority, confirming permissible purpose, applying the minimum-necessary standard where it applies, honoring individual rights, meeting breach-notification duties, and using business associate agreements when required.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.How the U.S. CMS framework differs from payer rules
CMS’s Interoperability Framework is a voluntary blueprint for networks that want to meet CMS-aligned criteria. It calls for FHIR APIs using US Core, USCDI v3 or later, and terminology compliance. CMS says the framework is not intended to add regulatory burden and does not displace obligations under existing healthcare and privacy laws.
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CMS-0057-F is a separate final rule. It covers specified Medicare Advantage organizations, state Medicaid and Children’s Health Insurance Program (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 for the payer types and circumstances covered by the rule.
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CMS says API development and enhancement requirements generally begin January 1, 2027, but exact dates vary by payer. The Provider Access API covers specified claims and encounter data, USCDI data, and certain prior-authorization information, and requires a patient opt-out process. The relevant obligation, scope, and deadline must be checked against the payer category and API rather than inferred from the voluntary framework.
CMS-0062-P is identified on CMS’s technical standards page as a proposed rule that includes proposed updates to standards and implementation guides. Proposed provisions should not be treated as finalized requirements.
How to assess whether two FHIR implementations can work together
Before integrating, compare the actual implementation expectations rather than relying on the label “FHIR.” These questions help identify mismatches early:
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- Use case and data scope: Is this patient access, provider access, payer-to-payer exchange, prior authorization, or another workflow? Which resources and data are in scope?
- FHIR release and guide: Which FHIR release, profiles, and implementation-guide versions are supported or required for this API?
- Data baseline: Which USCDI version applies, and are additional elements or lawful extensions part of the agreed implementation?
- Terminology: Which vocabulary bindings apply to each coded field, and what validation support is available?
- Exchange pattern: Does the workflow use individual request-and-response interactions, bulk exchange, or both?
- Identity and authorization: Is access user-facing or backend-to-backend, and how are identity verification, token issuance, and permissions handled?
- Participant role and safeguards: What legal obligations attach to each participant, and what consent, opt-out, opt-in, privacy, and security controls apply?
For terminology implementation, 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 assist with terminology work, but it is not a substitute for selecting the right profiles, establishing governance, or validating an implementation.
Certification and version checks
ONC describes the Health IT Certification Program as voluntary and says certified health IT uses USCDI. Certification can provide useful context about a product, but it should not be mistaken for proof that every interface supports the exact API, guide version, terminology, or workflow another organization needs.
For a U.S. implementation, confirm the applicable final rule and API category, then check the CMS technical standards and implementation guides for the specified versions. Treat the latest published USCDI version as a publication fact—not as automatic evidence of a requirement that applies to every exchange.
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