Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

Getting Started

This page helps you initiate a project or form a team to implement ePI using the HL7 FHIR standard within your organization.

Prerequisites

To begin, ensure your organization has:

  • Basic understanding of HL7 FHIR R5 (http://hl7.org/fhir/modules.html).
  • Access to FHIR tools (e.g., FHIR server like HAPI FHIR, FHIR authoring tool).
  • Basic understanding of how to comply with regional regulations.

Steps to Start an ePI Implementation Project

The following table outlines recommended steps to establish a project or team for ePI implementation:

Step Description Actions
Step 1: Define Project Goals Establish the purpose and scope of ePI adoption. - Identify objectives (e.g., replace PDFs, integrate with EHRs).
- Review the [use cases page](./usecases.md) to help define objectives.
- Align with regulatory and organizational priorities.
Step 2: Assemble the Team Form a multidisciplinary team to drive implementation. - Include FHIR experts, regulatory specialists, content authors, and IT staff.
- Appoint a project lead to coordinate efforts.
Step 3: Assess Current Capabilities Evaluate existing systems and skills. - Review current product information formats (e.g., PDFs).
- Check IT infrastructure and staff expertise with FHIR, XML, JSON, XHTML, and API.
- Identify gaps to address.
Step 4: Engage Stakeholders Involve key internal and external parties. - Consult regulatory authorities (e.g., EMA, FDA).
- Engage internal departments and external partners.
- Set up communication channels.
Step 5: Plan the Project Create a structured project plan. - Define timeline, milestones, and budget.
- Specify scope (e.g., target products or regions).
- Use the Base ePI Profile as the technical foundation.
Step 6: Set Up Infrastructure Prepare the technical environment. - Install FHIR IG Publisher for validation.
- Deploy a FHIR server (e.g., HAPI FHIR).
- Acquire ePI authoring software.
- Use the FHIR Validator for compliance checks.
- Ensure support for FHIR resources (e.g., Bundle, Composition).
Step 7: Validate the Approach Test the project setup for readiness. - Stakeholder Review: Hold workshops to confirm goals with regulators and teams.
- Gap Analysis: Document skill/tool gaps and plan remediation.
- FHIR Authoring Tool Testing: Run sample ePIs through validator, and server.
- Regulatory Alignment: Verify compliance with regional standards.
Step 8: Build and Test ePI Types Develop and validate initial ePI documents. - Build an ePI Type 1, following the [build ePI Type 1 page](./build-epi1.md).
- Confirm it is valid and works with the FHIR server and APIs.
- Build an ePI Type 2, following the [build ePI Type 2 page](./build-epi2.md), and validate.
- Repeat testing and refinement until satisfied with results.
Step 9: Implement in Stages Roll out ePI implementation incrementally. - Technical Pilot (Voluntary, Small Scale).
- Production Pilot (Voluntary, Small Scale).
- Full Production (Voluntary).
- Full Production (Mandatory).

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