Our
Events.

Find out about the upcoming events with Gravitate Health participation. You will also find selected events by third parties within the scope of the project below.

ePI track for the HL7 Vulcan Accelerator in the 28th FHIR Connectathon

On September 13-15, 2021, during the next HL7® FHIR® Connectathon, there will be a Vulcan Accelerator track dedicated to Electronic Product Information (ePI).

We are looking for app developers, electronic health record vendors, business developers, and software engineers interested in developing ideas and solutions at the 28th HL7 FHIR Connectathon – virtual, 13-15 September 2021.  Deadline for registrations: August 30, 2021.

The vision of the Vulcan HL7 accelerator [1] is to connect clinical research and healthcare bringing together stakeholders across the translational and clinical research community in order to bridge existing gaps, strategically connecting industry collaboratives, maximize collective resources, and deliver integrated tools and resources.

Find out more on the virtual 28th HL7 FHIR Connectathon and Vulcan / Gravitate Health track’s Agenda:

Who is who in the Vulcan/Gravitate Health ePI track

Craig Anderson, Track Lead, Pfizer, technical mentor, labeling
Amy Cramer, Vulcan Co-Lead, Pfizer
Anne Moen, Gravitate Health Coordinator, use case mentor,
Jens Kristian Villandsen, Trifork, Gravitate Health, technical mentor
Petter Hurlen, MD, PhD, Gravitate Health, technical/clinical mentor
Esther Peelen, NICTIZ, Unicom Project liaison
Giorgio Cangioli, HL7 Europe, HL7 FHIR IPS mentor
Rob Hausam, HL7 FHIR IPS mentor
Gustavo Rodriguez, EMA, ePI standard technical mentor,
Achilleas Voutsas, EMA, ePI standard technical mentor
Philippe Michiels, Datapharm, ePI technical mentor
Evinn Drysys, AEMPS, ePI technical mentor
Catherine Chronaki, HL7 Europe, Gravitate Health use case mentor
Michael van Campen, Vulcan Project Manager
Beverly Buckta, Pfizer, Gravitate Health use case mentor

Background

The HL7® Structured Product Labelling standard (SPL) used by FDA to present medicinal product information is well known. The European Medicine’s Agency (EMA) has Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) formats for electronic product information (ePI).

A medicine’s ePI is regulated, scientifically validated information to assist healthcare professionals in prescribing and dispensing, and informs patients and consumers about their medicine and its safe use. Thus, trusted access and understanding of up-to-date product information on medicines when and where it is needed is extremely important. In Europe, the EMA in collaboration with Heads of Medicines Agencies in member states and the European Commission, has developed key principles through stakeholder consultations to guide the development and use of ePI in the EU.

These principles highlight how ePI benefits public health, creates efficiency gains for regulatory systems, aligns with the existing legislative framework and complements the paper package leaflet, fits into the EU’s multilingual environment, and interacts with other ongoing digital initiatives at EU and global level [2].

Earlier this summer, EMA released the first version of the Draft ePI Application Program Interface (API) specification in HL7® FHIR® [3] that was open for consultation until the end of July. During the month of July 2021, a series of webinars and hands on workshops helped stakeholders get acquainted with the standard using an experimental FHIR server hosted by EMA.

The Connectathon

The upcoming HL7® FHIR® connectathon will explore more specific consumer centered use cases that make use of the specification in the context of the larger eHealth ecosystem. These use cases are linked the Gravitate Health project.

The Gravitate Health project, under the Innovative Medicines Initiative, explores how to use the ePI standard in conjunction with the HL7® FHIR® International Patient Summary (IPS) and other services such as those under myHealth@EU or EMA’s own SPOR implementation of ISO IDMP, to increase access, understanding, adherence, and safe use of medicines.

The Gravitate Health use case explores the story of Maria, an elderly Norwegian lady, a real-life advocate of the Gravitate Health project, who spends her life between Oslo and Cyprus and struggles with a long medication list, multiple conditions, and allergies.

If you are interested in joining the FHIR Connecthon ePI track, do not hesitate to contact us. We are looking for app developers, electronic health record vendors, business developers, software engineers interested in developing ideas and solutions!

  • ePI track in the 28th HL7 FHIR Connectathon