2022 - 09 Vulcan/Gravitate Health - ePI/IPS (Phase 4)

Short Description

This track is Phase 4 of an ongoing series, spanning multiple Connectathons, to test the creation, exchange and display of electronic Product information (ePI)  and the International Patient Summary (IPS) as FHIR Documents.  

Each phase will include increased numbers of product information and increasingly complex healthcare/life scenarios. 

Track Objective is to test and gather feedback on the following: 

1. Draft Core ePI Implementation Guide before ballot 
2. Core ePI Profile vs national/regional profiles 
3. G-Lens business rules and its connection to HL7 accelerators besides Vulcan 
4. Gravitate Health Federated Open-Source Platform and Services (FOSPS) a’ version and its support to end-to-end scenarios. 

The track is supported by the EU IMI Project Gravitate Health, the EU funded project UNICOM and supports the ePI pilot project at the European Medicines Agency. 

Long Description

Problem Statements 

1. Existing ePI formats are not meeting the needs of patients, professionals and developers. 
2. The lack of harmonization is leading to fragmented approaches where multiple differing standards are developing internationally e.g., eLabeling in HL7 SPL in North America, ePI in HL7 FHIR in the European Union; and custom XML standards in Asia. 
3. Expressing rules for G-lens and Persona characteristics in HL7 FHIR to tailor the presentation of ePI. 

 Vision 

The vision of the Gravitate Health ePI /Vulcan accelerator ePI/ eLabeling project is to define a common structure for medicinal product information that improves the patient experience and supports interoperability across the international healthcare clinical and regulatory environment.  

ePI Track Phase 4 builds towards this vision by incorporating lessons learned from the previous 4 connectathons 28-29-30. Also, by testing more complex real-world scenarios; additional FHIR resources; and more advanced product label data we expect the IG to be more mature and effective in covering a wider range of products. 

Background 

A medicine’s product information is a pivotal source of regulated and scientifically validated information that assists healthcare professionals in prescribing and dispensing the medicine and informs consumers about its safe use. 

ePI includes two primary forms of Information adapted for healthcare professionals and patients/consumers. Frequently there are additional risk minimization measures like a patient card, videos, pictures, etc. 

These documents are currently mostly based on PDF and they are unstructured electronic paper. As a result, they are difficult to search, difficult to find, and the content does not always meet patient needs lacking e.g., large fonts, accessibility support, multimedia, multiple languages, uptodate. 

Only a few regions/countries have XML ePI’s, but the number and interest is growing. For example, US FDA uses HL7’s SPL; Japan’s PMDA uses custom XML; EU’s EMA is developing a FHIR XML ePI. Without harmonization, there is a high risk of divergence. 

Hence the need to transition to a dynamic structured format that can be used as an international standard; i.e., FHIR documents with the added benefit of tailoring to individual patient/consumer needs. 

Type

Test an Implementation Guide

Track Prerequisites

Track Lead(s)

Craig Anderson, Catherine Chronaki, Jens Villadsen 

Track Lead Email(s)

Craig.Anderson2@pfizer.com; chronaki@gmail.com;  jvi@trifork.com

Specification Information

Vulcan/Gravitate Health Core ePI IG 

Github Repository with sample instances (in FSH)  

IPS IG 

EMA ePI Specification 

Call for participants

Gravitate Health members; HL7 Vulcan Members; FDA; EMA; Project UNICOM; adopters; implementers; ePI and IPS data consumers

Zulip stream

https://chat.fhir.org/#narrow/stream/296557-Vulcan.2FePI 

#europe#GH 

LinkedIn Event on September 15, 2022, 07:00 to 08:00 EDT

https://www.linkedin.com/events/let-sdiscussfhirstandardforpati6974842522091028480/comments/

Testing Scenario:

Servers 

ePI Server  

Sample data for use with the testing scenarios noted below 

HTML, XML and JSON versions of the samples can be found in the Implementation Guide or the FHIR Shorthand (FSH) source files can be found in GitHub. 

Electronic Product Information (ePI) 

1. EU/EMA Sample ePI 
2. US/FDA Sample ePI 
3. Japan/PMDA Sample ePI 

International Patient Summary (IPS) 

1. Helen 
2. Maria 

ePI Profiles 

1. International Core 

Test Scenarios (Details to be shared closer to September)

1. Core ePI Implementation Guide 
2. Core ePI Profile
3. Regional/national profile(s)
4. G-Lens business rules and Gravitate Health Federated Open-Source Platform and Services (FOSPS)