During the opening plenary of RAPS 2022 Euro Convergence on May 10th, experts in regulatory affairs explored how registries and large databases, such as Eudamed and the proposed European Health Data Space (EHDS), could be leveraged to enhance patient outcomes.
Data, Sharing and Improving Patient Outcomes
Alan Fraser, who serves as both the chair of the Regulatory Affairs Committee of the Biomedical Alliance in Europe and a consultant cardiologist at the University Hospital of Wales in Cardiff, emphasized the importance of conducting pragmatic, high-quality clinical trials and shortening timeframes when possible to balance the risks accepted by stakeholders in the medical field.
Fraser joined experts from the industry, notified bodies, and the European Medicines Agency (EMA) on stage, where he emphasized the importance of sharing data and utilizing professional-curated registries to conduct high-quality registry-based randomized trials and postmarket surveillance. The group discussed how information obtained from large databases, including Eudamed, could revolutionize the process of bringing devices to market and ultimately enhance patient outcomes.
According to Fraser, while some information from Eudamed related to medical devices will be accessible, the clinical trials summarized there will only include those that are conducted, approved, and registered in Europe. It is important to note that not all clinical investigations will be included, and clinicians may not have access to several modules within the clinical part of Eudamed.
Leveraging Digital Technologies
Peter Schroeer, the Vice President of EMEA and Canada Regulatory Affairs at Johnson & Johnson, highlighted that while digital technologies have increased connectivity, the healthcare industry has not fully embraced this potential. Although there is a focus on high-risk medical devices, the field of digital health has created new technologies that can significantly transform healthcare delivery, ultimately leading to improved patient outcomes.
The European Health Data Space (EHDS) is being promoted by European regulators as a platform where patients can easily access their medical data electronically and free of charge. The EHDS will enable patients to share their data with healthcare providers and across member states, with governments ensuring access to patient summaries, ePrescriptions, images, laboratory results, and discharge reports in a common European format.
