SMART on FHIR is an HL7 standard that layers OAuth 2.0 and OpenID Connect onto FHIR so third-party, provider, and patient-facing apps can be authorized against an EHR with scoped, revocable permissions. It defines the SMART App Launch flow (EHR-launch and standalone launch), SMART Backend Services (system-to-system client-credentials with signed JWT), health-specific scopes (patient/.read, user/.read, system/*.rw), and a discoverable .well-known/smart-configuration document. It is the de-facto authorization contract for modern healthcare APIs.
SMART on FHIR
SMART on FHIR is what turns a FHIR server from a raw data endpoint into something an app — or an agent — can be authorized against. It is a health-specialized profile of OAuth 2.0 and OpenID Connect that answers the questions base FHIR leaves open: how an app launches, how a user consents, and exactly what slice of a record a token may touch.
- Two launch modes - EHR-launch (an app opened from inside the clinician’s chart, inheriting patient context) and standalone launch (a patient-facing app the user connects on their own).
- Health-scoped permissions - Scopes like
patient/Observation.read,user/*.read, andsystem/*.rwexpress access at the resource level — the closest thing healthcare has to a machine-legible permission grant. - Backend Services for machines - A client-credentials profile with signed-JWT client authentication for bulk and system-to-system access, the pattern most population-scale FHIR runs on.
- A discovery document -
/.well-known/smart-configurationadvertises the auth endpoints and capabilities, the SMART equivalent of an OpenAPI security scheme.
When I score healthcare APIs, SMART is the dividing line between a provider that publishes real, agent-legible authorization and one that hands out an opaque bearer token. It is also where the sector’s biggest gap shows up: scopes tell an agent what it may technically call, but almost no provider serves the smart-configuration that makes those scopes discoverable, and none exposes consent state as a first-class surface — the layer the agentic era in a HIPAA world will make load-bearing.
Governed by these regulations
A standard is the machine-readable contract; a regulation is the law that requires it. These are the regulations that mandate or drive this standard, catalogued at regulations.apievangelist.com.
21st Century Cures Act
The information-blocking rule makes standardized FHIR + SMART access a legal obligation for certified EHRs.
ONC Health IT Certification Program
The (g)(10) 'Standardized API' criterion requires SMART App Launch + SMART Backend Services.