Vulcan, the HL7 Accelerator for Clinical Research, held its second European meeting -EuroVulcan 2- as part of Athens Digital Health Week with contributions from nearly 30 presenters from industry, regulators, and government. The full-day European Meeting of the Vulcan Accelerator extended in four sessions, and here are some highlights.
The Opening session (Q1) focused on the Clinical & Translational Research Landscape in Europe. Nick Halsey from the European Medicines Agency spoke of the work done on a Data Standardisation Strategy and emphasised the role that FHIR will play in all areas of standards development. Henrique Martins spoke about XpanDH and the development of EHR exchange mechanisms and of the Hospitals on FHIR initiative and called for more test implementations to help us all learn. There were other presentations on Data Protection, Shortages Monitoring and Cancer data interoperability.
The first Panel (Q2) looked at the development of ePI (electronic labelling) and the contributions of IDMP and SPOR. It was interesting to see the emergence of a virtuous circle of development of ePI and IDMP, leading to improvements in the way patient labels/leaflets are written, therefore better labels and through improved interoperability, better interchange of health data.
The second Panel (Q3) was about the development of a digital form of the Clinical Trial Protocol by ICH and a FHIR representation of this, as well as its utilisation across many areas of clinical research. Background on the development of the ICH standard was given by Becky Kush and Ron Fitzmartin and the view, looking forward, was given by the other speakers. Professor Meletios-Athanasios Dimopoulos of the University of Athens gave a simple but very clear account of the benefits of a digital protocol concluding “… [this] represents a paradigm shift in the way clinical trials are conceptualised and conducted.”
The third Panel (Q4) titled Regulators Moving to FHIR with support from the Vulcan Accelerator began to look forward for some of the work discussed earlier. Peter van Reusel from CDISC spoke about terminology development for the digital protocol while João Almeida spoke about further developments for ePI and IDMP. Finally, Christos Schizas, President of the National eHealth Authority – Cyprus, described their plans for EHR interchange in Cyprus.
The slide decks can be found on the Vulcan website HL7Vulcan.org: View and download
Sessions’ recordings are also available on request. Email Vulcan [at] HL7.org
