USA-EU Workshop at the FDA facilities in Silver Spring, MD

As the European Commission's Directorate General for Communications Networks, Content and Technology (DG CONNECT) and the United States Department of Health and Human Services (DHHS) have decided to strenghthen trans-atlantic cooperation in eHealth and health information technologies (IT) in 2010, the upcoming two-day workshop can be seen as a first step to advance the development and use of internationally recognized standards which support transnational interoperability of electronic health information and communication technology. A medium-term objective is to identify common vocabularies, message structures and tools suitable for the international exchange of electronic health record data.

The openMedicine project contributes to this policy by solving a problem of portability of ePrescriptions across Europe and globally. The main challenge is the univocal identification of medicinal products for human use to be dispensed by a community pharmacist in another country (cross-border ePrescription). Towards this end, the project will furthermore formulate a number of recommendations and a roadmap for implementation and sustainability. This will also support the full identification of any pharmaceutical or medicinal product in the patient summary and other documents.

The openMedicine project also addresses the different regulations regarding substitution, considering that a dispensing pharmacist has to comply with the respective national rules.

The project aims to reach a global consensus in order to describe and to identify unambiguously medicinal and pharmaceutical products, resulting in the authorised delivery of the appropriate medicine. It closely cooperates with the European Medicines Agency (EMA) in London, WHO, ISO, CEN, GS1, HL7 and other standardisation organisations.

For many years already, EMA and FDA have been closely cooperating and exchanging expertise on this same goal. This workshop will bring together these different activity strands, provide an overview of ongoing and planned activities, and deliver suggestions to further improve and intensify trans-Atlantic cooperation.

It is against this background that in the context of the openMedicine project, its Expert Council activities and long-standing cooperation between FDA and EMA a specific EU/USA cooperation event is arranged. The specific objectives are to

  • Present, discuss and further develop concrete, actionable results of the openMedicine project with respect to

    • a common data model for medicinal products (MPs)
    • a common vocabulary for the unambiguous identification and description of MPs
    • recommendations regarding the content of ePrescriptions, the Patient Summary and prescription drug databases
    • rules to harmonise practices of substitution at the point of dispensation
    • a global roadmap for post-project actions and implementations

  • Present similar and complementary activities and results from USA/FDA
  • Explore global cooperation opportunities in these domains with standards development organisations (SDOs)
  • Identify communalities, gaps, discrepancies and opportunities for closer cooperation and exchange, next steps.

The workshop is intended as a translational hands-on, pragmatic workshop serving as a collective venue for invited experts. It is to provide an overview of ongoing and planned activities, how to connect and intertwine all relevant activity strings of the authorities and other organisations involved. It will provide for a constructive exchange of opinions how to reach global consensus, and should lead to initial roadmap recommendations and proposals for further activities.