Details
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Project Scope Statement
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Resolution: Unresolved
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Medium
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None
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Biomedical Research & Regulation
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Structured Documents -
Vulcan
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Gravitate Health; US Food and Drug Administration (FDA); European Medicines Agency (EMA); Project UNICOM
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US Food and Drug Administration (FDA); European Medicines Agency (EMA); structured content authoring developers.
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Vulcan ePI
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none
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N/A
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Yes
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Gravitate Health; US Food and Drug Administration (FDA); European Medicines Agency (EMA); Project UNICOM
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No
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Gravitate Health, HL7 Vulcan, health authorities (e.g., EMA, FDA)
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Academic/Research, Association/Goverment Agency, Consultant, Healthcare IT Vendors, Healthcare Provider/user, Patients, Payer/Third Party Administrator, Pharmaceutical/Biotech, Regulatory Agency, Standards Development Organizations (SDOs), Vendor/Manufacturer
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Patient advocacy associations; providers delivering medicinal product dictionary services; providers delivering product information aggregation services; health insurance companies.
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Universal
Description
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 and effective use.
ePI is often presented in the following three forms:
- Information for healthcare professionals
- Information for patients
- Information on the package label
ePI goes by different names depending on the region of the world. For example,
- Drug Product Label in the US
- Summary of Product Characteristics (SmPC) in the EU
- Package Insert in Japan
Since these documents are often 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).
Experience has show that current procedures based on PDF are not adequate to support electronic initiatives. To support new programs, the international community is adopting a new technology for exchanging medicinal product information between computer systems based on FHIR.
Adoption of FHIR by regulators and industry is anticipated to stimulate the delivery of healthcare applications from innovative 3rd parties. A common standard for ePI exchange will allow the creation of aggregated cross-industry content which is a foundational element for creation of more personalized ePI directing patients to the most relevant content and facilitating integration with other datasets such as Electronic Health Records (EHR) and data from wearable devices and diagnostics which will ultimately lead to a step-change in patient centric solutions.
Attachments
Issue Links
1.
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Biomedical Research & Regulation | Agreed | |
2.
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PBS Metrics | Agreed | |
3.
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FHIR Management Group | Agreed | |
4.
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Structured Documents | Agreed | |
5.
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External Terminology | Agreed |