Background

The HL7® Structured Product Labelling standard (SPL) used by FDA to present medicinal product information is well known. The European Medicine’s Agency (EMA) has Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) formats for electronic product information (ePI).

A medicine’s ePI is regulated, scientifically validated information to assist healthcare professionals in prescribing and dispensing, and informs patients and consumers about their medicine and its safe use. Thus, trusted access and understanding of up-to-date product information on medicines when and where it is needed is extremely important. In Europe, the EMA in collaboration with Heads of Medicines Agencies in member states and the European Commission, has developed key principles through stakeholder consultations to guide the development and use of ePI in the EU.

These principles highlight how ePI benefits public health, creates efficiency gains for regulatory systems, aligns with the existing legislative framework and complements the paper package leaflet, fits into the EU’s multilingual environment, and interacts with other ongoing digital initiatives at EU and global level [2].

Earlier this summer, EMA released the first version of the Draft ePI Application Program Interface (API) specification in HL7® FHIR® [3] that was open for consultation until the end of July. During the month of July 2021, a series of webinars and hands on workshops helped stakeholders get acquainted with the standard using an experimental FHIR server hosted by EMA.

The Connectathon

The upcoming HL7® FHIR® connectathon will explore more specific consumer centered use cases that make use of the specification in the context of the larger eHealth ecosystem. These use cases are linked the Gravitate Health project.

The Gravitate Health project, under the Innovative Medicines Initiative, explores how to use the ePI standard in conjunction with the HL7® FHIR® International Patient Summary (IPS) and other services such as those under myHealth@EU or EMA’s own SPOR implementation of ISO IDMP, to increase access, understanding, adherence, and safe use of medicines.

The Gravitate Health use case explores the story of Maria, an elderly Norwegian lady, a real-life advocate of the Gravitate Health project, who spends her life between Oslo and Cyprus and struggles with a long medication list, multiple conditions, and allergies.

If you are interested in joining the FHIR Connecthon ePI track, do not hesitate to contact us. We are looking for app developers, electronic health record vendors, business developers, software engineers interested in developing ideas and solutions!