The Vulcan HL7® FHIR® Accelerator and Gravitate Health announce the publication of a FHIR® implementation guide (IG) for ePI
Therefore, to maximize international cooperation and accelerate progress, the Vulcan HL7® FHIR® Accelerator and Gravitate Health collaborated to engage the global community and drive development of this IG which outlines how to create and exchange Medicinal Product Information using HL7’s standard for Fast Healthcare Interoperability Resources (FHIR).
A medicine’s Product Information is a pivotal source of regulated and scientifically validated information that assists healthcare professionals in prescribing and dispensing medicine and informs consumers or patients about its safe and effective use. Product Information can have different names depending on the country:
- USA: Prescription Drug Label and/or Patient Package Insert and/or United States Prescribing Information (USPI)
- Europe: Summary of Product Characteristics (SmPC) and Package Leaflet
- Japan: Package Insert (JPI) and/or Drug Guide for Patient
- Canada: Product Monograph and Patient Medication Information
Usually, Product Information is made available to users in paper and/or ePI – whereby the latter version is mostly based on Portable Document Format (PDF) and available online. These formats do not always meet user and, specifically, patient needs. For example, they can be difficult to search, you cannot increase font size, and they offer low accessibility support.
FHIR is an important enabler for innovation since it has a strong foundation in web standards, is free for use, fast and easy to implement. As a result, it allows us to leverage an international community of experts and modern health solutions built for the internet age. Particularly important is how FHIR enables interoperability between ePI and healthcare use cases like ePrescribing, eHealth records, and data sharing across devices.
Importantly, through this standard, it will be easier to create patient-focused digital information tools that will help empower patients, make them more confident in their healthcare journey and encourage safe use of medicines for better health outcomes and quality of life.
We encourage all international health authorities, national medicinal product compendia, and the biopharmaceutical industry to come together as a global community to facilitate rapid implementation of this standard and for continued maintenance throughout its lifecycle, delivering a transformational future landscape for all.
About Health Level Seven International (HL7)
Health Level Seven® International (HL7) is an ANSI-accredited, not-for-profit standards developing organization with the mission of empowering global health interoperability. With affiliates in over 30 countries, HL7’s global membership envisions a world in which everyone can securely access and use the right data when and where they need it. Widely implemented by vendor and healthcare systems, and required by governing bodies around the world, HL7 standards deliver solutions for health information technology, including HL7® Fast Healthcare Interoperability Resources (FHIR®), Version 2 (V2) and Clinical Document Architecture (CDA®). For more information, visit www.HL7.org
About Vulcan
An HL7® FHIR® Accelerator, Vulcan’s mission is to accelerate interoperability of health data to seamlessly integrate clinical and translational research with clinical care in order to reduce burden, enable learning health systems, and improve patients’ lives. Vulcan is a diverse research community that creates FHIR® implementation guides for the exchange of health and research data, creating alignment at the development of standards through to implementation. Vulcan is currently accepting new members. To learn more about participating in Vulcan, please contact vulcan@hl7.org or visit www.hl7vulcan.org
About Gravitate Health
Gravitate Health is a public – private partnership with the mission to equip and empower citizens with digital information tools that make them confident, active, and responsive in their patient journey, specifically encouraging safe use of medicines for better health outcomes and quality of life. The partnership has 40 members from Europe and the US, co-led by University of Oslo (coordinator) and Pfizer (industry lead), and funded under contract no 945334 by the Innovative Medicines Initiative (IMI) – a joint undertaking of the European Commission, the European Federation of Pharmaceutical Industries and Associations (EFPIA), IMI2 Associated Partners. For more information, visit www.gravitatehealth.eu
