US Medication Risk Evaluation and Mitigation Strategies (REMS) FHIR IG
2.0.0-ballot - STU 2 Ballot

US Medication Risk Evaluation and Mitigation Strategies (REMS) FHIR IG, published by HL7 International / Pharmacy. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-medication-rems-ig/ and changes regularly. See the Directory of published versions

## CapabilityStatement: Medication REMS Capability Statement - Provider System

Official URL: http://hl7.org/fhir/us/medication-rems/CapabilityStatement/provider-system | Version: 2.0.0-ballot
Standards status: Draft | Maturity Level: 2 | Computable Name: MedicationRemsCapabilityStatementProviderSystem

This CapabilityStatement describes the expected capabilities of a Provider System that conforms to the conventions of the Medication REMS FHIR implementation guide.

This section describes base system capabilities a Provider System must support to be conformant with the Medication REMS FHIR IG.

Additional behavior and data population expectations are defined in the Technical Background, Formal Specification and CDS Hooks Card Profiles sections.

### SMART App Capabilities

The Provider System:

- SHALL support the SMART App Launch Implementation Guide
- SHALL support the EHR-based app launch interaction pattern
- SHALL support the standalone app launch interaction pattern

### CDS Hooks Capabilities

The Provider System:

- SHALL support the CDS Hooks 2.0 Implementation Guide
- SHALL support immediate provider actions in response to a CDS Hook suggestion or action
- SHOULD support CDS suggestions with associated actions to defer the launch of SMART application

### FHIR RESTful Capabilities

The Provider System:

- SHOULD enable a REMS Administrator’s SMART app to create a DocumentReference resource associated to the patient
- SHALL support the JSON source format
- SHOULD support the XML source format

### Security

- Communication security implemented by the Provider System SHALL conform with the guidelines stated in FHIR Security for all exchanges covered in this IG.
- For general security considerations refer to FHIR Security and Privacy Considerations.

Raw OpenAPI-Swagger Definition file | Download

## Medication REMS Capability Statement - Provider System

- Implementation Guide Version: 2.0.0-ballot
- FHIR Version: 4.0.1
- Supported Formats: `xml`, `json`
- Supported Patch Formats: `application/json-patch+json`
- Published on: 2024-04-01 00:00:00-0500
- Published by: HL7 International / Pharmacy

> Note to Implementers: FHIR Capabilities

> Any FHIR capability may be 'allowed' by the system unless explicitly marked as 'SHALL NOT'. A few items are marked as MAY in the Implementation Guide to highlight their potential relevance to the use case.

### SHALL Support the Following Implementation Guides

- http://hl7.org/fhir/smart-app-launch/ImplementationGuide/hl7.fhir.uv.smart-app-launch

### SHOULD Support the Following Implementation Guides

- http://cds-hooks.hl7.org/ImplementationGuide/hl7.fhir.uv.cds-hooks

## FHIR RESTful Capabilities

### Mode: `server`

When participating in exchanges described in the Medication REMS FHIR IG, the Provider System SHALL 1. Implement RESTful behavior according to the FHIR specification. 1. Support the JSON source format. When participating in exchanges described in the Medication REMS FHIR IG, the Provider System SHOULD: 2. Support the XML source format.

Security

> 1. Communication security implemented by the Provider System SHALL conform with the guidelines stated in FHIR Security for all exchanges covered in this IG. 2. For general security considerations refer to FHIR Security and Privacy Considerations.

Summary of System-wide Interactions