During the next HL7 VULCAN Accelerator, the focus will be on the FHIR specification set up by the European Medicines Agency on Electronic Product Information and more partcularly FHIR standard for Patient Information Leaflets of Medicines.
This track starts from the following findings:
- Existing ePI formats are not meeting the needs of patients, professionals and developers.
- 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.
This accelerator aims to define a common structure for medicinal product information that improves the patient experience and supports interoperability across the international healthcare community.
This is already the 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. This connecthaton will take place between May 2 and 4.
It will test more complex real-world scenarios; additional FHIR resources; and more advanced product label data. During this accelerator, the focus will be on the exchange and display of electronic Product information (ePI) as FHIR documents with particular emphasis on terminology addressing specific use cases presented by European Medicines Agency (EMA)
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 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.
No registration is required to attend the meeting: Link to the meeting
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