Research

Legal research into health data is at a pivotal juncture. There is more European regulation than ever before: the EHDS, the GDPR, the Open Data Directive, and all related regulations such as the MDR and the AI ​​Act. Precisely because of this rapid evolution, many urgent questions remain unanswered. How much can be charged for making data available? What are the implications of the new Archives Act for European data obligations? Has the Netherlands been misapplying the Open Data Directive for the past 25 years? Dr. Antoinette Vlieger conducts legal research on health data at the intersection of national and European law.

Research that others don’t do

Many legal experts write about legislation that is already entirely clear—following a ruling by the Supreme Court or the European Court. Yet waiting for such a ruling can lead to harm. Dr. Vlieger therefore takes a different approach. She raises questions while legislation is being drafted or implemented—at a time when the answers still matter. This requires a broad legal foundation encompassing EU law, national law, administrative law, private law, and the sociology of law. It is precisely this combination that enables her to identify connections that specialists in a single field might overlook.

Moreover, she is willing to write what others shy away from. For instance, as early as 2023, she published the view that data sharing was evolving from a mere favor into a right, and she concluded that the Netherlands had been incorrectly applying open data law for a quarter of a century. These pieces met with both resistance and emulation. That is precisely the intention.

Commissioned legal research

In addition to independent research, Dr. Vlieger conducts commissioned legal research. This includes addressing questions that an organization cannot answer internally and where an independent legal analysis offers added value. She has previously conducted research for, among others:

• Health-RI↗ : legal interpretation of GDPR roles and data rights within the national health data infrastructure.
• ZonMw : policy research on the implementation of the EHDS and its interaction with Dutch subsidy law.
• Zorginstituut Nederland (National Health Care Institute) : policy advice regarding the EHDS.
• Palga : research into the division of roles regarding the provision and reuse of pathology data.
• International research infrastructures : legal structuring of collaborative partnerships (ERICs and EDICs), including the 1 Million Genomes Initiative.

For whom is legal research into health data relevant?

This research is relevant to any organization that works with health data and faces legal questions that cannot be answered internally. This includes academic hospitals and university medical centers (UMCs), research funders, pharmaceutical companies, government bodies, policymakers, and data infrastructure organizations. International organizations wishing to understand how Dutch and European data law applies to them are also welcome.

Do you have a research question you need help with?

Please get in touch. Dr. Vlieger is happy to collaborate on the question, the approach, and the potential publication of the findings. Some questions deserve more than just an internal memo—they deserve an answer that benefits others as well. Click here to contact us. The more detailed your message, the sooner we can gain a clear understanding of your question.