Publications
Publications by Dr. Antoinette Vlieger on the EHDS, GDPR, EU Open Data Law and the reuse of health data.
EHDS: Users’ Free Choice or Maximum Harmonisation?
The European Health Data Space (EHDS) Regulation establishes a governance framework for secondary health data use, yet its material scope remains contested. A dichotomy has emerged between ‘dualists’, who interpret Article 1(8) as granting health data users a permanent choice between the EHDS and national regimes, and ‘monists’, who view the Regulation as exhaustive maximum harmonisation. This research collects and groups the arguments supporting the two interpretations, in line with the textual, systemic, and teleological methods of the EU Court of Justice. As a result, the article analyses legislative evolution, the implications of the introduced ‘permit power’, and the effet utile of the Regulation. While legal ambiguity persists pending CJEU clarification, the article recommends pragmatic implementation strategies to prevent administrative bottlenecks and ensure future-proof compliance.
Open data ≠ public data
The Shortcomings of the Dutch Act transposing Open Data Directive 2019/1024
The proposed incorporation of the Open Data Directive into the Data Act (in the concept Digital Omnibus) appears to be merely a technical update to the rules governing the re-use of public sector data. However, this article argues that this transformation will have significant consequences in the Netherlands, as the transposing legislation has erroneously reduced the European concept of ‘open data’ to ‘public data’ under the Open Government Act. The Ministry of Economic Affairs will need to replace the Who with legislation that—in line with the EU’s objectives—ensures maximum data sharing to foster innovation and growth.
The EHDS and the "legal basis" problem of scientists
A political agreement has been reached in Brussels regarding the European Health Data Space Regulation (hereinafter: the EHDS). This European law will (also) bring about changes regarding the reuse of health data for healthcare evaluation and improvement, scientific research, statistics, policy, and innovation. In the Netherlands, there are voices saying that the EHDS solves the legality problem: the problem that data holders want to make health data available to researchers, but believe the GDPR prohibits this and therefore refuse.
The EHDS, science, law, ethics, interests and perception
The GDPR repeatedly mentions science as something that deserves space, and our strict Dutch Data Protection Authority (AP) agrees. Just look at the work of the Netherlands Institute for the Study of Crime and Law Enforcement, where legal sociologists also process special categories of personal data, including non-pseudonymizable images, without consent, yet with extremely high levels of security. Therefore, the principle of purpose limitation does not apply to science and statistics, regardless of whether this is practiced within or outside the data controller.
A false dilemma: privacy versus data solidarity
Monetizing data is becoming increasingly difficult; the EHDS also stipulates that when requesting data, only marginal costs may be charged. After all, healthcare data is a public good that should benefit the community. Therefore, like bicycle paths, data flows should be funded from the public purse. The discomfort and unease surrounding the debate about data sharing in healthcare, while the relevant legislation is actually quite sound, indicates that we need to jointly examine the soundness of our assessment frameworks.
Finally, data sharing is not a privilege but a right
This new data right, too, will only truly take effect when involved parties invoke it and test the exact scope of their rights. And that is precisely what healthcare administrators can and should do. Reluctance and non-commitment must give way to assertiveness and interaction. Scientists can legally demand datasets, effectively dispelling the idea that receiving data is a favor.
Artificial Intelligence & Horse Manure
There are real reasons for concern, they say, because AI is essentially superintelligence, but without empathy! But that seems fantastic to me: a super-brain without egotism, narcissism, jealousy, greed, or aggression. Fantastic, right? Yes, but doctors fear AI might replace us in the job market. But that also seems nonsense to me: first came the machines, then the robots, and both would make us humans redundant. But we still have a glaring shortage in the job market.
Arrange direct access to medical data for research into excess mortality
The adage “more is better” often applies to research. If larger numbers of researchers have access to more data, diverse questions about individual or collective public health can be tested. A national register listing those who object to the use of their pseudonymized data could significantly support science and improve healthcare. This would also enable research using AI. A computer could then alert us, for example, to side effects of combinations of different medications, something that is currently insufficiently researched.
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