The EHDS is about data, not bodily material. The Dutch draft Bodily Material Act is about material, not data. This might lead one to believe there's no overlap. But if you extract data from material, you're doing something with both data and material. That's why I'm discussing my thoughts on the draft act here. Spoiler alert: it's not good.
The law is not the same as ethics
Is ethics superior? Or is the law?
To properly understand our legal system and what the EHDS will bring us, it’s important to make a clear distinction between law and ethics. Morality is the question of whether we believe something is right, and the basis for that is ethics (although they are also referred to collectively as ethics). It is therefore a reasoned value judgment. Law, on the other hand, is the set of rules that determine what we may or may not do. Some believe that ethics is superior to law, more important, and more valuable. Others believe that ethics is simply an opinion, while law has been established by the majority of society through the democratic process. It is therefore more valuable than ethics. The question of who is right is irrelevant, as long as the difference is properly understood, and how they relate to each other.
Law is rules plus application
These rules of law are established by the legislature and then applied by courts in a specific case: for example, in the question of whether someone must pay damages. Law is therefore the totality of rules as applied by courts in specific cases. The system is structured in such a way that the highest court is always right; what the highest court declares to be law is, by definition, law. This ensures consistency in the application of law, allowing society to adjust its behavior accordingly. If the law is very clear, the court adds little, but rules are often somewhat vague; judges then elaborate on them. Law is therefore a sum of applied rules.
Ethics complements and forms new law
Ethics can be used by judges to flesh out open-ended norms, as is the case with the terms “good care” or “reasonableness and fairness.” Such vague terms are explained using interpretative methods such as dogmatics (what professors think), legislative history (what has been discussed in parliament), a purely linguistic application, or simply ethics. But when there is no open-ended norm, when it is crystal clear what a rule entails in a specific case, then ethics cannot really play a role; for example, with a statutory term of three years. Ethics is therefore used to give substance to open-ended norms. Moreover, ethics is an important guideline in determining what future law should look like. It then serves as an argument for legislative amendments. In this way, in a democratic society, law and ethics are achieved without significant differences, but that is not necessarily the case. Law is sometimes called “solidified ethics” in healthcare. But that’s only the case if ethics influenced the creation or interpretation of law. The rules on how to establish a private limited company are not solidified ethics, and the law of Nazi Germany was law, but not ethical.
A description of the law is not unethical
In discussions about the law surrounding medical research, which often has ethical implications, ethics and law are often confused. This complicates the discussions, which is why it’s important to clearly distinguish between them. One might feel that you should have a property right to data about yourself, for example, but as long as there’s no legal provision or case law (court rulings) that creates such a right, you don’t have one. One might argue on ethical grounds that an opt-in for secondary use of data would be preferable, but once the EHDS comes into effect, this European law will stipulate that an opt-out is sufficient. Lawyers who explain the law are sometimes accused of being unethical. But they don’t make any pronouncements on ethics; they merely explain how certain rules (probably or certainly) should be interpreted.
This is what the European Parliament thought
Ethics is thus used to define open standards. It also serves as a basis for drafting new laws. This also applies to legislators in Brussels. All Europeans have been patients at some point. They voted collectively on who should sit in the European Parliament. It was recently decided there that an opt-out is sufficient. Apparently, the majority considered this ethical.
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?
Under the EHDS, work must be performed in a Secure Processing Environment (SPE). Scientists don't receive data, but access it in a SPE that meets the strict technical and security standards established under the EHDS. What does this entail? And will everyone be required to work in such a SPE from now on? Will it become a supercomputer containing all our health data?