The reuse of patient data plays a crucial role in scientific research. However the disclosure of patient data to third parties is a complex and sensitive matter, governed by a web of EU and national health and data protection laws, as well as (ethical) codes and international standards. We draw up agreements that ensure compliance with data protection laws for hospitals and researchers.  

Our client was a significant academic hospital that conducts a wide variety of clinical trials, during which valuable sets of patient data are collected, including clinical and genetic data. These datasets are made accessible to eligible third-party researchers for use in scientific research projects – but only after being carefully pseudonymized with high-end encryption and pseudonymization techniques.  

We were asked to develop a standard researcher contract with two main goals: ensure legal compliance for all parties; safeguard patient interests. Together with our client we drafted a balanced but robust contract that ensures access to, and the use of, well-defined datasets exclusively for pre-approved research projects. Furthermore, the contract provides for reasonable publication guidelines and acknowledgment requirements, and as researchers are located around the world, it includes measures to safeguard an international transfer of patient data. Patient re-identification is prevented to protect their privacy, and the boundaries of their informed consent are considered.  

We are very proud to have been able to contribute to our client’s commitment to promoting scientific research while protecting patient privacy. Doing so allowed us to combine our expertise in data protection laws with our knowledge of the healthcare regulatory framework and our experience of contracting in the health sector.