Legal analyses and updates on the EHDS domain — health data, privacy and the EHDS Regulation.
The lex specialis rule is one of the three conflict rules taught to every (Continental) law student in the first weeks of their studies, yet it is consistently misapplied in Dutch health law. This article addresses three misconceptions: the rule concerns specific legal provisions rather than entire statutes; it applies only after the lex superior rule and solely between rules of equal rank; and it applies exclusively in the event of a genuine conflict—not when the specific provision is silent. For the EHDS, this implies, among other things, that European data law remains applicable in health care, and that the even special national laws cannot override the EHDS.
The Data Protection Officer must not receive instructions or be penalized for his work, is bound by a duty of confidentiality, and must not hold a second role that conflicts with his position.
The GDPR requires organizations not only to appoint a Data Protection Officer (DPO) but also to create the conditions necessary for them to effectively perform their duties. Part 1 on the DPO’s position: involvement, resources, and visibility.
The EHDS Implementation Act (GIS Act) conflicts with EU law. The Ministry of Health (VWS) disregards the internal data market, bypasses the Authority for Consumers and Markets, and establishes a non-independent supervisory authority.
The Draft GIS Act (concerning the EHDS) creates a supervisory body whereby the State imposes fines on itself. Without its own legal personality and separate from VWS, the GDA is not the independent HDAB required by the EHDS. This article explains why — and proposes an alternative.
Becoming HDAB means becoming an administrative body that makes administrative decisions. Dr. Vlieger explains what that means legally — for the HDAB itself and for those who wish to lodge an objection.
Many semi-governmental institutions believe that open data obligations do not apply to them. The legal reality is different: the EU Implementing Regulation on High-Quality Datasets applies directly.
EU countries build EHDS access services on top of their current national systems. But there is no discussion whether the EHDS allows this.
The debate on the EU definition of scientific research in the Digital Omnibus. Dr. Vlieger defends a neutral, factual definition without normative criteria.
The EHDS prescribes a comprehensive and uniform assessment by the HDAB. A separate ethical assessment adds nothing and hinders science.
Are jobs at risk due to AI? Antoinette Vlieger asked AI itself which tasks she is taking over, what that contributes, and what room remains for humanity in healthcare.
VWS consults on healthcare addressing. Dr. Vlieger points out tension with the free movement of services.
The EHDS has been in effect for a year. From PFAS to chronic complaints: this is how the reuse of health data works in practice.
It is argued in various publications that the draft Digital Omnibus (concerning, among other things, amendments to the GDPR) would nullify the legal effect of the Scania judgment. However, a careful reading of the text suggests otherwise. The Commission is not proposing a nullification, but a demarcation of scope.
The EHDS Council has been established. But who is eligible to sit on it on behalf of a Member State? Dr. Vlieger analyzes the conditions — and the ambiguities — in the regulation.
The EHDS grants the European Commission the authority to set requirements for EHR systems. What does this mean for hospitals, healthcare providers, and IT suppliers?
There’s a persistent misunderstanding regarding the EHDS. Data holders must have their datasets included in a data catalog. However, data users can apply for a permit, even for data not yet included in the catalog. Therefore, the application procedure cannot be (solely) tied to the catalog.
The Dutch WZL concerns body material, the EHDS concerns data. Nevertheless, there is overlap. Vlieger analyzes shortcomings of the draft law.
The EHDS requires significant preparation. A Health Data Access Body must be established, software and hardware must be built or interconnected, and additional legislation is required. Therefore, the EHDS will enter into force in phases. Read about the timeline here.
Anyone wishing to reuse data under the EHDS will not receive it, but will gain access to it in an SPE. What does such a Secure Processing Environment entail?
The Ministry of Health, Welfare and Sport will soon determine who will become the HDAB; who will be the source of permits for the beneficial reuse of health data. Who can be this, and who cannot? And what will this HDAB be responsible for?
The arrival of the EHDS is causing public unrest. Will our health data still be safe? The regulation will indeed make more data available for beneficial reuse. But at the same time, health data will also be much more secure. So, kudos to the EHDS.
As a medical scientist, you might think that you have little to do with the rule of law. Nothing could be further from the truth. Understanding the separation of powers is important to know when you can disregard a Privacy Authority. It is also useful to understand that lobbying starts with the question of what the right place is.
The EHDS introduces the role of health data intermediation entities or Data Hubs. Dr. Vlieger explains when and why this role is useful — for efficiency, scientific relevance, and trust.
Health data may currently be used for research with consent. Under the EHDS, this will become an opt-out. What will this look like? Who will oversee this? Is that ethical?
The free movement of health data is not a novelty of the EHDS: it is enshrined in Article 1 of the GDPR, among other. Dr. Vlieger explains which rights scientists can already claim.
The EHDS is regarded by people who distrust the government as a manipulative trick. But suspicious people will soon benefit enormously from the EHDS request.
In medico-legal discussions, law and ethics are often confused. Dr. Vlieger explains the fundamental distinction and what that means for the application of the EHDS.
Codes of conduct are not law — but are often treated as such in healthcare. Dr. Vlieger explains when soft law is legally binding and when you can disregard it.
The EHDS introduces the role of 'trusted health data holder.' Dr. Vlieger explains what this role entails and how it can contribute to an efficient health data infrastructure.
The prohibition on using the civil service number hinders medical-scientific research. Dr. Vlieger analyzes the legal knot and explains why the EHDS offers the opportunity to resolve this.
The GDPR principle of purpose limitation seems to be an obstacle to the reuse of health data for medical big data research. That is incorrect. Dr. Vlieger explains.
When is a Data Protection Impact Assessment mandatory? And what is the role of the Data Protection Officer? Dr. Vlieger explains what a DPIA is and isn't.
The EHDS, a European law on health data, introduces something special: a right to work with data, for anyone who wants to do something useful.
What is a directive or regulation? Dr. Vlieger explains the basics of European law for everyone working with the EHDS.
The European Health Data Space aims to make more health data available for medical research. What data are EHDS-data that have to be shared with researchers?
What is the EHDS and why does it exist? Dr. Vlieger explains the background, the European data strategy, and the objectives of the regulation.
Are pseudonymous data personal data? Dr. Vlieger explains the relative concept based on case law of the European Court.
All those contracts for medical scientific research? The differences clearly explained.
What is the difference between a subsidy and an assignment? People often think, “It’s been tendered, so it must be a commercial contract,” but that’s not true. The difference is important, a.o. for VAT purposes.
