Legal analyses and updates on EHDS — by Mr. Dr. Antoinette Vlieger.
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.
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.
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.
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?
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.
VWS consults on healthcare addressing. Dr. Vlieger points out tension with the free movement of services.
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.
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 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.
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.
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 EHDS introduces the role of intermediation entity or data collector. 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 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.
The EHDS introduces the 'trusted data holder'. Dr. Vlieger explains what this role entails and why many are better suited to take on this role than HDAB.
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.
The European Health Data Space aims to make more health data available for medical research. What data are EHDS-data?
What is the EHDS and why does it exist? Dr. Vlieger explains the background, the European data strategy, and the objectives of the regulation.
