Safeguarding compliant use of patient datasets for scientific research

We were engaged by a leading Dutch academic hospital to draft a standard contract for third-party researchers worldwide to access and use patient datasets for scientific research.  

As an important academic hospital conducting a variety of clinical trials, our client has collected valuable datasets of patient data, including clinical and genetic data. Further to our client’s core mission to improve and advance healthcare through scientific research, these datasets are made accessible to eligible third-party researchers for use in their scientific research projects (of course after being carefully pseudonymized by using high-end encryption and pseudonymization techniques).  

The disclosure of patient data to third parties for scientific research is a complex and sensitive matter. Such secondary use of patient data is governed by a web of EU and national health and data protection laws as well as (ethical) codes and international standards. Ensuring legal compliance and safeguarding patient interests while upholding shared values, demand a robust but straightforward and balanced contract. And that is where we came in. 

Together with our client we drafted a standard researcher contract that considers the boundaries of patients’ informed consent, ensures the access to and use of well-defined datasets for pre-approved research projects only and prevents re-identification of patients. The contract also provides for reasonable publication guidelines and acknowledgment requirements and includes measures to safeguard an international transfer of patient data as the third-party researchers accessing those data are located globally. 

We are very proud to have been able to contribute to our client’s commitment to promote scientific research while respecting patients’ privacy, allowing us to combine our expertise in data protection laws with our knowledge of the healthcare regulatory framework and our experience in contracting in the health sector.  

Dutch academic hospital

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