This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR v5.0.0-ballot. . For a full list of available versions, see the Directory of published versions

Background

ePI

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 presented in 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,

• USA - Prescription Drug Label or Package Insert (USPI)
• Europe - Summary of Product Characteristics (SmPC) or Package Leaflet
• Japan - Package Insert (JPI)

Since these documents are often represented as a PDF, they are unstructured electronic paper. As a result, they are difficult to search, and the content does not meet patient needs (e.g., larger fonts, accessibility support, multimedia, multiple languages).

It is known that current procedures based on content represented as a 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.

FHIR is a next generation standards framework created by HL7. FHIR combines the best features of HL7’s previous product lines while leveraging the latest web standards and applying a tight focus on implementation.

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.

Gravitate Health

The Gravitate Health project is a public – private partnership with 39 members from Europe and the US, co-led by University of Oslo (coordinator) and Pfizer (industry lead), funded 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.

HL7 Vulcan Accelerator

HL7 FHIR® accelerators have been a successful catalyst for standards development and adoption.

The vision for an Accelerator dedicated to connecting clinical research and healthcare was solidified in September 2019 by a group of invested representatives from government agencies, academia, technology companies, standards development organizations, patients, and industry consortiums. The Vulcan Accelerator serves the needs of the clinical and translational research communities through the implementation of HL7 FHIR standardized data exchange.

Vulcan’s goal is to create an ecosystem where research stakeholders collaborate on common use cases with the purpose of simplifying the research communities exchange of data using common standards with health records. Vulcan consists of organizations who represent the entire research stakeholder community including vendors, sponsors, CROs, consulting companies, sites, patient organizations, government agencies and growing.

HL7 Biomedical Research and Regulation (BR&R)

BR&R creates and promotes standards to facilitate biomedical research and any subsequent regulatory evaluation of the safety, efficacy and quality of medical products that may arise from research.

The BR&R workgroup areas of interest encompass clinical and translational research, both regulated and non-regulated, and the subsequent regulatory submissions and information exchanges to bring new products to market and to ensure safe use throughout the product lifecycle.
This Work Group facilitates the development of common standards and the maintenance and enhancement of the research-focused domain analysis model for clinical research information management across a variety of organizations, including national and international government agencies and regulatory bodies, private researchers and research organizations, sponsored research, CROs and other interested entities.

Conformance and Validation

The ePI shall conform to this implementation guide.

Validation is the process of checking the XML or JSON version of the ePI to make sure it meets the established requirements prescribed in the schema.

For example,

• The XML is considered well-formed if it conforms to the W3C’s XML standard.
• The XML is considered valid if it conforms to the associated schema’s rules.

NOTE: for further details on validation with FHIR refer to the FHIR Validation page.