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Section 1c: FHIR®
Section 3: Implementation Guides

HL7 FHIR® Implementation Guide: Medication Risk Evaluation and Mitigation Strategies (REMS), Edition 2- US Realm

DESCRIPTION

Guidance on the use of FHIR to facilitate interactions between providers and REMS Administrators during treatment of a patient using a REMS medication (a drug with an associated Risk Evaluation and Mitigation Strategies program). Includes notifications and data exchange associated with provider registration, patient enrollment, medication fulfillment, ongoing monitoring and related activities.

See the specification at http://hl7.org/fhir/us/medication-rems/STU2.

ALTERNATIVE NAMES

HL7 FHIR® Implementation Guide: Medication Risk Evaluation and Mitigation Strategies (REMS), Edition 2- US Realm may also go by the following names or acronyms:

"HL7 FHIR® IG: Medication Risk Evaluation and Mitigation Strategies (REMS), E1",Medication REMS,FHIR-us-medication-rems

BENEFITS

  • Enables interactions between a provider and REMS Administrator to occur at the earliest opportunity and automates the related data exchanges--minimizing burden on the provider.
  • Enables timely completion of required REMS steps so that the patient can start their medication without delay and continue without interruption.

DEVELOPMENT BACKGROUND

This Implementation Guide was developed with participation of the US Food and Drug Administration, REMS administrator organizations and the National Council for Prescription Drug Programs (NCPDP) under the auspices of the CodeX FHIR Accelerator.

RELATED DOCUMENTS

HL7 FHIR® Implementation Guide: Medication Risk Evaluation and Mitigation Strategies (REMS), Edition 2- US Realm

STU DOCUMENTS

HL7 FHIR® Implementation Guide: Medication Risk Evaluation and Mitigation Strategies (REMS), Edition 2 - US Realm See the standard at http://hl7.org/fhir/us/medication-rems/STU2. (Submit Feedback on STU)
HL7 FHIR® Implementation Guide: Medication Risk Evaluation and Mitigation Strategies (REMS), Edition 1- US Realm See the standard at http://hl7.org/fhir/us/medication-rems/STU1. Expiration Aug 2026

TOPICS

  • Decision Support
  • Medical Records
  • Patient Care
  • Pharmacy

BALLOT TYPE

  • STU

STATUS DATE

2025-11-17

RESPONSIBLE WORK GROUP

Pharmacy

PRODUCT TYPE

  • Implementation Guide

STAKEHOLDERS

  • EHR, PHR Vendors
  • Health Care IT Vendors
  • Healthcare Institutions
  • Regulatory Agency

FAMILY

  • FHIR

CURRENT STATE

  • Active

REALM

  • US Realm