Regulatory experts speaking at the opening plenary of RAPS 2022 Euro Convergence on 10 May discussed the potential to improve patient outcomes by harnessing the power of registries and other large databases, including Eudamed and the recently proposed European Health Data Space (EHDS).
Data, Sharing and Improving Patient Outcomes
Alan Fraser, chair of the Regulatory Affairs Committee of the Biomedical Alliance in Europe and a consultant cardiologist at the University Hospital of Wales, Cardiff, UK, said that all stakeholders in the medical field accept some level of risk. However, he added stakeholders also have a responsibility to balance that risk by conducting pragmatic high-quality clinical trials and shortening timeframes where possible.
“That means sharing data and using registries curated by professionals to high standard both for registry-based randomized trials and for postmarket surveillance,” Fraser added. He shared the stage with experts from industry, notified bodies, and the European Medicines Agency (EMA), who discussed how information from large databases, such as Eudamed, could revolutionize how devices get to market and improve patient outcomes.
“We will have access to some information from Eudamed in the field of medical devices but the clinical trials that will be summarized there are only those that are being done in Europe and approved and registered in Europe,” Fraser noted. “They’re not all clinical investigations, and clinicians will not have access to many of the modules even in the clinical part of Eudamed.”
Leveraging Digital Technologies
Peter Schroeer, vice president of EMEA and Canada regulatory affairs at Johnson & Johnson, said that digital technologies have made the world more connected but some of that connectivity hasn’t been fully embraced by healthcare providers and regulators. He said that while there is a strong focus on high-risk medical devices, the field of digital health has produced new technology that can revolutionize healthcare delivery. Thus, a step to improve patient outcomes.
The EHDS has been touted by the European regulators as a one-stop-shop where patients will have immediate and easy access to their medical data in electronic format, free of charge. It will allow patients to share that data with their healthcare providers and across member states where governments are supposed to ensure access to patient summaries, ePrescriptions, images and image reports, laboratory results, and discharge reports in a common European format.
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