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Short Description

This track is Phase 3 of an ongoing series, spanning multiple Connectathons, to test the exchange and display of electronic Product information (ePI) and the International Patient Summary (IPS) as FHIR documents.

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

Track Objective is to test and gather feedback on the following

  1. Vulcan ePI Profile.
  2. ePI instances (EU, US and Japan).
  3. Searching lists for a particular ePI.
  4. Adjust presentation of the ePI to the profile of the individual personas.
  5. Rules for the presentation of the ePI and classified extended materials.

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 approach where multiple differing standards are developing internationally. E.g., HL7 SPL in North America, FHIR in the European Union; and custom XML standards in Asia.


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

ePI Track Phase 2 builds towards this vision by incorporating lessons learned from connectathon 28. Also, by testing more complex real-world scenarios; additional FHIR resources; and more advanced product label data.


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 is often presented in two forms: Information for healthcare professionals and/or information for patients.

Since these documents are currently based on PDF, they are unstructured electronic paper. As a result, they are difficult to search, difficult to find, and the content does not meet patient needs (e.g., larger fonts, accessibility support, multimedia, multiple languages, always current).

Only a few 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 that   

Hence the need to transition to a dynamic structured format that can be used as an international standard; i.e., FHIR documents.


Test the design of a set of resources.

Submitting Work Group/Project/Accelerator/Affiliate/Implementer Group  

HL7 Vulcan Accelerator and Gravitate Health

Track Lead(s)

Craig Anderson, Catherine Chronaki, Jens Villadsen

Track Lead Email(s)

Related Tracks

No direct relationships at this time

FHIR Version

FHIR Release 5.0.0-snapshot1

Specification(s) this track uses

Vulcan/Gravitate Health ePI IG

Github Repository with sample instances (in FSH)


EMA ePI Specification

Artifacts of focus

FHIR Vulcan ePI Profile

FHIR Resources

  1. List
  2. Bundle
  3. Composition
  4. Organization
  5. RegulatedAuthorization
  6. MedicinalProductDefinition
  7. PackagedProductDefinition
  8. AdministrableProductDefinition
  9. ManufacturedItemDefinition
  10. Ingredient
  11. ClinicalUseDefinition
  12. Binary
  13. Substance

Expected participants

Gravitate Health members, HL7 Vulcan Members, FDA, EMA, Project UNICOM, adopters and implementers

Zulip stream


Supporting Artifacts

Kickoff meeting presentation

Gravitate Health Overview YouTube

Track Schedule

Day #1 May 2, 2022

7:00 AM to 9:00 AM EST

Track Kick Off                 Track kick off

Day #2 May 3, 2022

7:00 AM to 8:00 AM EST              

LinkedIn Event  (Outside of the connectathon) Discuss FHIR standard for Patient Information Leaflets of Medicines

Day #2 May 3, 2022

8:00 AM to 9:30 AM EST

Touchpoint                     Touchpoint 1 - Discuss sample data and scenario walkthrough

9:30 AM to 12:00 PM EST

Build/Test/Validate         Work offline Session 1- Build/test/validate (teams work on their own, mentors available)

12:00 PM to 1:00 PM EST

Touchpoint                     Touchpoint 2 - Review developments from offline work

1:00 PM to 3:00 PM EST

Build/Test/Validate         Work offline session 2 - Build/test/validate (teams work on their own, mentors available)

3:00 PM to 4:00 PM EST

Touchpoint                     Touchpoint 3 - Recap of the day

Day #3  May 4, 2022        

8:00 AM to 9:00 AM EST

Touchpoint                      Touchpoint 4 - Review plan for the day

9:00 AM to 10:30 AM EST

Build/Test/Validate         Work Offline Session 4 - Build/test/validate (teams work on their own, mentors available)

10:30 AM to 12:00 PM EST

Touchpoint                     Touchpoint 5 - Review work session, discuss feedback, results, IG changes

1:00 PM to 2:00 PM EST

Track Highlight               Wrap up session 5

Track Details


See ConMan for full connectathon track and testing details Connectathon (

See ePI Server for the Humalog, Monuril and Exemestane samples

See the following links for the servers meant to mimic a Medicinal Product Dictionary:

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.

Humalog sample data

  1. List - Humalog (EMA)
  2. Bundle - Humalog (EMA) Package Insert v1
  3. Bundle - Humalog (EMA) Package Insert v2
  4. List - Humalog (UK)
  5. Bundle - Humalog (UK) Package Insert v1
  6. Bundle - Humalog (UK) Package Insert v2

Monuril sample data

  1. List - Monuril (EMA)
  2. Bundle - Monuril (EMA) Package Insert v1
  3. Bundle - Monuril (EMA) Package Insert v2
  4. List - Monuril (UK)
  5. Bundle - Monuril (UK) Package Insert v1
  6. Bundle - Monuril (UK) Package Insert v2

Exemestane sample data

  1. Bundle - Package Insert (Japan/PMDA)
  2. Bundle - Patient Package Insert (US/FDA) 

International Patient Summary (IPS)

Bundle - Helen

Bundle - Maria

EMA Test Scenarios

Test #1 = Alert that PL section 4 was updated

A patient is watching section 4 of the package leaflet for updates to possible side effect information. They receive an alert to say new information has been added in this section.

Test #2 = Compare two pregnancy sections side by side

A patient taking 2 medicines and planning a pregnancy wants to look at the pregnancy sections of her 2 medicines side by side.

Test #3 = Find all ePI's that contain the excipient lactose

A patient with a lactose intolerance wants to search all medicines with a particular ATC code to find which ones contain/do not contain lactose as an excipient.

Test #4 = search a List of ePIs

There is a List with several ePI documents (e.g., Multiple versions of a Package Leaflet; multiple languages) and they want to search from the list to find individual ePI documents.

UNICOM Test Scenario

This scenario is meant as a demonstrator to show how the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) can be used to:

  1. facilitate safer cross-border e-prescription processes
  2. e-dispensation processes
  3. improve pharmacovigilance in general

This use case will show how various systems can be interconnected by using IDMP identifiers. Particularly with the global Pharmaceutical Product Identifier (PhPID) which establishes the connection between national identifiers for medicinal products; i.e., Medicinal Product Identifier (MPID) and Packaged Medicinal Product Identifier (PCID). The PhPID functions as the ‘glue’ between medicinal product dictionaries (MPD’s) and other databases like those governed by the European Medicines Agency (EMA )or the US Food and Drug Administration's (FDA) Substance Registration System (SRS) and healthcare provider IT-systems.

We will also use IDMP identifiers to make connections between the IPS and the ePI in a digital format to help improve patient experience.

The scenario is built around the Helen persona. A UK resident who travels to Europe and is prevented from receiving the wrong medication as a result of the above mentioned systems, processes and standards. See below for more detail on the Helen scenario:

  1. Helen is a  UK resident and travels to the Netherlands.
  2. Helen has Diabetes Type 1 and therefore takes Humalog Mix50 daily.
  3. However, during her trip, she notices she might have a Urinary Tract Infection (UTI), She doesn’t know what product to take in the country where she is now, but in UK usually she takes Monuril.
  4. Since she is not feeling well, she goes to the emergency department of a hospital. At the emergency department she shows her app which includes her International Patient Summary (IPS). In this case the IPS shows, next to the brand name, strength and dose form, the PhPID (L4) of the medicines that are prescribed to Helen in her home country for her Diabetes type I,   Humalog Mix 50 daily (0x073AF2E5B92AE19E8B67635AFFB3D6CA).
  5. The IPS also contains her previous prescribed medicinal products and therefore shows he PhPID (L4) for Monuril® fosfomycin (as trometamol) 3g per sachet granules for oral solution (0xE857DA811B4A6F3BD57810C45D2EA1ED).
  6. The Helen’s IPS is shared with Hospital EHR-S.
  7. The doctor/pharmacist retrieves from the National MPD the list of national medicinal products (Brand name, strength and dose form) having the same PhPID (Humalog and Monuril) reported in the Helen’s IPS.
  8. The doctor/pharmacist chooses the best option of the retrieved products and dispenses it to Helen.
  9. Helen scans the barcode on the medicinal product she received to include it in the medication list in her app.
  10. Helen uses her app to connect to the ePI service which can give her the ePI in her own language