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  1. Project Scope Statements/Proposals
  2. PSS-2102

Electronic Product Information FHIR Implementation Guide

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    • Icon: Project Scope Statement Project Scope Statement
    • Resolution: Unresolved
    • Icon: Medium Medium
    • None
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      1. A common international standard for structuring and exchanging ePI is needed. 
      2. Without such a common standard, the international trend toward divergence and fragmentation will continue to occur. In the absence of a common standard, regional/national health authorities are each likely to develop different standards for structured ePI. For example, Health Canada and the US FDA adopted SPL R5; PMDA developed a custom XML standard;  Taiwan FDA is developing a custom XML standard; EMA is developing a FHIR standard.
      3. FHIR is needed to improve interoperability; make it easier to exchange ePI content; and improve the accessibility of ePI content for healthcare practitioners and patients. 
      Show
      A common international standard for structuring and exchanging ePI is needed.  Without such a common standard, the international trend toward divergence and fragmentation will continue to occur. In the absence of a common standard, regional/national health authorities are each likely to develop different standards for structured ePI. For example, Health Canada and the US FDA adopted SPL R5; PMDA developed a custom XML standard;  Taiwan FDA is developing a custom XML standard; EMA is developing a FHIR standard. FHIR is needed to improve interoperability; make it easier to exchange ePI content; and improve the accessibility of ePI content for healthcare practitioners and patients. 
    • Biomedical Research & Regulation
    • Structured Documents
    • Vulcan
    • Gravitate Health; US Food and Drug Administration (FDA); European Medicines Agency (EMA); Project UNICOM
    • US Food and Drug Administration (FDA); European Medicines Agency (EMA); structured content authoring developers.
    • Hide
      1. International health authorities are developing differing approaches or standards for structured ePI.
      2. EMA and Gravitate Health are collaborating to develop a FHIR ePI specification. This ePI specification was adapted to work internationally.
      3. The US FDA is developing an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture.
      4. US FDA released a Federal Register Notice soliciting comments on PQ/CMC Project data elements and representation to FHIR Specifications. There is great value in having both PQ/CMC and ePI on the same FHIR platform due to the overlap product elements between the two.
      Show
      1. International health authorities are developing differing approaches or standards for structured ePI. 2. EMA and Gravitate Health are collaborating to develop a FHIR ePI specification. This ePI specification was adapted to work internationally. 3. The US FDA is developing an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture. 4. US FDA released a Federal Register Notice soliciting comments on PQ/CMC Project data elements and representation to FHIR Specifications. There is great value in having both PQ/CMC and ePI on the same FHIR platform due to the overlap product elements between the two.
    • Product Family Product Project Intent Lineage Ballot Type Target Cycle Actions
      		1
      FHIR
      Implementation Guide
      Create New R1 Standard
       
      STU
      January 2023
    • Vulcan ePI
    • none
    • N/A
    • Yes
    • Gravitate Health; US Food and Drug Administration (FDA); European Medicines Agency (EMA); Project UNICOM
    • No
    • Gravitate Health, HL7 Vulcan, health authorities (e.g., EMA, FDA)
    • 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
    • Patient advocacy associations; providers delivering medicinal product dictionary services; providers delivering product information aggregation services; health insurance companies.
    • 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:

      1. Information for healthcare professionals
      2. Information for patients
      3. 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

        1.
        		 Biomedical Research & Regulation PSS Approval Agreed
        2.
        		 PBS Metrics PSS Approval Agreed
        3.
        		 FHIR Management Group PSS Approval Agreed
        4.
        		 Structured Documents PSS Approval Agreed
        5.
        		 External Terminology PSS Approval Agreed

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            Hugh.Glover Hugh Glover
            Craig C. Anderson Craig C. Anderson
            Craig C. Anderson Craig C. Anderson
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            Dates

              Created:
              Updated: