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A session dedicated to Gravitate Health at DIA Europe

Building on recent developments in Europe, the session “Gravitate Health: Unlocking the Value of the Electronic Product Information (ePI) and More for Patients in EU and Beyond” was held on March 23rd, and explored how use of new FHIR standards for ePI will bring new value for the patient and the health care professional. As illustrated by the joint statement by EMA and Gravitate Health, these developments in Europe have been a starting point that supports a truly global approach for ePI.
Session Summary | Gravitate Health: Unlocking the Value of the Electronic Product Information (ePI) and More for Patients in EU and Beyond | 23.03.2023

During the event, experts discussed the implementation of electronic product information (ePI) for medicines in the EU. Mark Duman, a patient representative, highlighted the need for healthcare providers to understand patients as individuals rather than just focusing on their medical condition. Juan Garcia-Burgos from EMA emphasized that the implementation of ePI would require changes in current practices and provide significant public health benefits. Giovanna Ferrari from Pfizer―and Gravitate Health project lead―discussed the progress made in offering a more individualized experience to patients through the G-lens platform and the development of a global HL7 FHIR ePI Implementation Guide. Dag R. Jordbru from NoMA emphasized that simply making ePI available was not enough and that transitioning patients to ePI would require time and concerted efforts. Catherine Chronaki from Gravitate Health underscored the global relevance of ePI and the importance of the FHIR ePI Implementation Guide. Finally, Anne Moen from the University of Oslo―and Gravitate Health coordinator―highlighted the potential opportunities for multilingual ePI to support the deployment of eDispensation and ePrescription under the European Health Data Space, and mitigate medication shortages by increasing flexibility in the distribution of medicines across Europe.

Electronic Product Information is a topic of global relevance, where the opportunities with jurisdiction-agnostic, relevant multi-lingual ePI can drive safe use, better access, and ease distribution of medicines.

Quoting Dr Giovanna Ferrari, Senior Director, Pfizer and Gravitate Health Project Lead:

Gravitate Health is reaching an exciting stage now – in the EU, the introduction of electronic product information (ePI) based on modern interoperability standards (such as the EU ePI Common Standard) is offering us the opportunity to start to drive a more integrated digital health information approach.”

At DIA Europe, she added, “We will be sharing some of the progress we have made in demonstrating how ePI resources, along with other trusted information such as health record data, and digital tools we are developing -the federated open source platform/services with G-lens functionality- will be able to deliver a more focussed, individualized experience for the patient and other end-users, as well as addressing some immediate needs such as facilitating cross border care.”

Gravitate Health’s scope, which encompasses electronic product information, spans beyond Europe. “Gravitate Health has been actively collaborating with a range of different stakeholders to help connect and align across key initiatives and accelerate progress – an important outcome from this has been the recent publication of an HL7 FHIR electronic product information implementation guide (FHIR ePI IG) that can be used globally and so enable greater harmonization in standards and processes for electronic product information, with benefits for end users as well as industry and regulators,” Dr Ferrari said.

Chair

Anne Moen, Professor, Faculty of Medicine, University of Oslo, Norway; Gravitate Health Coordinator

Speakers

Introduction to Gravitate Health and recent developments in the EU and beyond, Giovanna Ferrari, Pfizer Ltd, United Kingdom & Gravitate Health Project Lead

Update of ePI developments in the EU, Juan Garcia-Burgos, European Medicines Agency, The Netherlands

How will the FHIR ePI standard help support our promise to the patient? Catherine Chronaki, HL7 Europe Foundation, Belgium; Gravitate Health WP5 Co-Lead & Interoperability Lead

A National Health Authority’s perspective: Going digital – so what? Dag Jordbru, NOMA, Norway

A Patients Perspective – Benefits and potential pitfalls, Mark Duman, Diabetes UK, United Kingdom

Take 5 & Closing, Anne Moen, Professor, Faculty of Medicine, Coordinator, Gravitate-Health, University of Oslo, Norway

About DIA Europe 2023

The 35th anniversary edition of DIA Europe will take place from 22-24 March 2023 in Basel’s Congress Center, Switzerland. DIA Europe is the largest neutral event in the European life science industry – the knowledge hub between science, healthcare, and regulation.

Visit the DIA Europe 2023 website for detailed information

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