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Legal advice

What does the EHDS mean for your organization? Get clear advice on rights and obligations, on primary and secondary use of health data.

Legal advice on the EHDS: prepare effectively

Dr. Antoinette Vlieger provides legal advice regarding the EHDS and its impact on your organization. Her approach goes beyond merely summarizing the regulation’s contents; instead, she offers concrete answers to the questions that truly matter to your organization: what does this mean for us, and what is the smartest way to handle it? Two examples:

Implementing legislation

The EHDS Regulation has direct effect. At the same time, it allows Member States—including the Netherlands—to make specific choices regarding its implementation. These choices are currently being made through implementing legislation. This presents an opportunity for organizations to influence how the EHDS is structured in practice. However, doing so requires a well-founded position—one that is legally sound, clearly articulated, and aligned with your organization's specific interests. Dr. Vlieger helps you formulate this position and communicate it to the relevant parties.

Trusted data holder or data intermediary?

Under the EHDS, certain data holders may be designated as trusted data holders, trusted entities that make data available for reuse. Alternatively, you could opt for the role of data intermediary, an entity that facilitates exchanges between data holders and users. However, it is not possible to fulfill both roles simultaneously. Which role best suits your organization? What are the legal and practical implications of that choice? And would the role of trusted data holder be an advantage or a burden for your organization?

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What can Dr. Vlieger do for your organization?

Dr. Vlieger is happy to help you determine the best way for your organization to prepare for the arrival of the EHDS. This includes:

  • Gaining insight into your legal position under the EHDS and Dutch implementation legislation
  • Advice on the role best suited to your organization (trusted data holder, data intermediary, or neither)
  • Support in formulating input regarding the implementation legislation
  • Strategic advice on how to communicate your interests effectively and in a timely manner
  • Concrete advice on data agreements, retention periods, and collaboration structures

Previous clients include Health-RI, ZonMw, the National Health Care Institute (Zorginstituut Nederland), and Palga.

Contact us without obligation

Do you have a question about the EHDS and its impact on your organization? Get in touch by clicking here. During an initial consultation, we will explore how Mr. Dr. Vlieger can assist you. This consultation is always free of charge and without obligation. Click here to contact us.