The HDAB takes administrative decisions: what does that mean?

The HDAB takes administrative decisions. What are they?

Various organisations in the Netherlands want to become an HDAB or a sub-HDAB. They do not all seem to realise that this will make them an administrative authority. They will then be taking administrative decisions about health data, conducting legal proceedings and taking enforcement action. After all, an HDAB is a body comparable to the Dutch Data Protection Authority (AP) or the IGJ (the Dutch health and youth care inspectorate). Anyone lobbying to become an HDAB must realise that everything they do will from then on fall under the Dutch General Administrative Law Act. That starts with the fact that an objection can be lodged against every decision.

Conversely, there are parties that at present cannot obtain the data they need for their plans, even though they themselves consider this to be socially useful reuse. In future they will be able to apply to the HDAB for health data. At present nothing can be done following a refusal, because there is as yet no fully fledged right to data. But once the HDAB refuses something, will it then be possible to lodge an objection? Can one subsequently go to the administrative court? The answer to that question does not depend on what is currently customary in the reuse of health data. It depends on whether the decision you have received is a decision within the meaning of the Dutch General Administrative Law Act. Hence this explanation: what is an Awb decision?

What makes an HDAB decision an administrative decision?

The Dutch General Administrative Law Act (Algemene wet bestuursrecht, Awb) defines↗ a decision as a written legal act under public law by an administrative authority.

• In writing: an oral communication — however final it may sound — is not a decision. But an email, a letter or even a stamp on a rejected consignment of meat can be.
• Under public law: the decision must be based on a power under public law. Note that this must be interpreted broadly. Even where the government gives money to a foundation with instructions to distribute it to certain injured parties, these can be administrative decisions.
• Legal act: the decision must be aimed at producing a legal effect. A letter informing you of the state of affairs, but which does not itself change anything, is not a decision. A letter granting you a right, or indeed taking one away, is.

An objection can be lodged against administrative decisions — exceptions aside. It is also important to note that a refusal to take such a decision is itself a decision as well. Granting a permit is a legal act: afterwards one may do something that was not permitted before, such as building a dormer window. The permit is a legal act, and the refusal to grant a permit is therefore itself also a decision that must comply with the Awb.

When is a decision not a decision — and what then?

Where there is no decision but a factual act, no objection can be lodged. People regularly turn to lawyers because their objection has been declared inadmissible. It then turns out that they have challenged something against which a notice of objection simply does not lie.

For instance, someone once called me to ask whether I could lodge an objection against "the government" never listening to "the people". In such a case one should write newspaper articles, or vote for another party. Or take something that really is related to a government decision: someone was not objecting to the larger schoolyard behind her house, but was objecting to the fact that her request to plant a dense hedge there had not been acted upon. Not acting on such a request is not a decision, and so you cannot lodge an objection against it.

All of this applies to the HDAB as well. If it refuses to think along more actively with a researcher about where particular health data can be found, that is not a legal act. If the HDAB refuses to consult more extensively with a data holder, that too is not a legal act. No objection can be lodged in such cases. If a permit is subsequently granted after all, that permit is a decision against which all interested parties can lodge an objection — and it can then also be examined whether the administrative-law principles, such as due care in the preparation of the decision, have been observed.

How does the administrative court assess an HDAB decision?

Where there is a decision, an objection can therefore be lodged. That means that the same administrative authority once again carefully assesses whether it took the correct decision. In that reconsideration, the HDAB must assess the matter against the EHDS, because that Regulation sets out when a permit for the reuse of health data may be issued. Important in this respect: where the conditions are met, the permit "shall be" granted. The HDAB then has no discretion to refuse after all.

Because this concerns an administrative decision, the HDAB also assesses it against the Dutch General Administrative Law Act and the principles of good administration. Where privacy is at stake, the assessment is against the GDPR. Legally speaking, these are exceptionally complex decisions, in which several legal systems apply at the same time.

If, in your view, the HDAB then still gets it wrong, an appeal to the administrative court is available. This makes it very similar to the administrative decisions taken by other bodies in health law — such as the IGJ and the Dutch Data Protection Authority.

Like the IGJ: enforcement decisions in healthcare

The Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd, IGJ) supervises the quality and safety of care. Where the IGJ finds that a healthcare provider is breaching the rules, it can take enforcement action: an order subject to a penalty payment, a directive or — in serious cases — an order to close down. As a rule these are decisions within the meaning of the Awb, against which objection and appeal are available. But the IGJ also sends letters that are not decisions: a reminder, a warning letter, a request for information. Anyone lodging an objection against such a letter will be declared inadmissible. Anyone who misses the objection period for a genuine enforcement decision has a different problem. The same will apply mutatis mutandis to the HDAB. And that body therefore needs enough lawyers, in order to take the right primary decisions, to reconsider them in the right way at the objection stage, and to conduct proceedings in any appeal or further appeal. Many organisations currently working on secondary use of health data employ medical scientists and IT specialists, but hardly any lawyers; because sharing data for research is now a favour, but will soon indirectly become a right. All those organisations that have a great deal of experience with data, but are not cut out to become an administrative authority, would do better to become a trusted data holder or a data collector.

Who are the parties to appeal proceedings about health data?

If an appeal is lodged, there are incidentally two things that stand out. First of all, the appeal does not concern the first decision the HDAB took. An objection has already been lodged, and that first decision (the primary decision, besluit in primo, BiP) should by then have been thoroughly reconsidered. A new decision was subsequently taken, and it is that decision (the decision on the objection, besluit op bezwaar, BoB) that the administrative court reviews.

Another striking feature: if the HDAB grants a permit for access to health data and the data holder disagrees, then it is that data holder who litigates against the HDAB. The party that obtained the permit is indeed an interested party and can join the proceedings as such. But the permit holder is not the one conducting the proceedings. For an individual researcher that is an advantage: he does not have to litigate himself against an academic hospital that refuses data. In future the HDAB will do that for him.

In conclusion

For everyone who says they want to become an HDAB, it is worth pausing to consider what will then be in store for them. Whoever becomes an HDAB takes on a public-law responsibility that is fundamentally different from the responsibility of a care institution or a research organisation.

Do you have questions about the HDAB or your position under administrative law? Mr. Dr. Antoinette Vlieger completed the postdoctoral Grotius↗ programme in administrative law cum laude. She has also taught administrative law at university. You can get in touch by clicking here. An initial consultation is always without obligation.