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.
Which data are covered by the EHDS?
This web text is primarily a request for input from medical scientists. The EHDS stands for European Health Data Space, a European Regulation that will apply directly as law in the Netherlands. Chapter 4 of this regulation focuses on making health data more readily and securely available for beneficial reuse, such as scientific research. This means that health data must be made available (securely!) if a new government body (the HDAB) so decides. Article 51 of the EHDS contains a list of data that must (in principle) be made available. However, it also states that Member States may add data to this list. It is therefore important that we carefully examine this list and consider which data are not included, even though they are still important for science and policy evaluations. What data do you, as a scientist, use that are not yet included on the list below? What are we missing? Please share your thoughts via the contact form.
The EHDS includes at least the following data:
- electronic health data from EHRs;
- data on factors impacting on health, including socioeconomic, environmental and behavioural determinants of health;
- aggregated data on healthcare needs, resources allocated to healthcare, the provision of and access to healthcare, healthcare expenditure and financing;
- data on pathogens that impact human health;
- healthcare-related administrative data, including on dispensations, reimbursement claims and reimbursements;
- human genetic, epigenomic and genomic data;
- other human molecular data such as proteomic, transcriptomic, metabolomic, lipidomic and other omic data;
- personal electronic health data automatically generated through medical devices;
- data from wellness applications;
- data on professional status, and on the specialisation and institution of health professionals involved in the treatment of a natural person;
- data from population-based health data registries such as public health registries;
- data from medical registries and mortality registries;
- data from clinical trials, clinical studies, clinical investigations and performance studies subject to Regulation (EU) No 536/2014, Regulation (EU) 2024/1938 of the European Parliament and of the Council, Regulation (EU) 2017/745 and Regulation (EU) 2017/746;
- other health data from medical devices;
- data from registries for medicinal products and medical devices;
- data from research cohorts, questionnaires and surveys related to health, after the first publication of the related results;
- health data from biobanks and associated databases.
So, as Member States, we can add categories here, but I can’t think of anything missing. Someone suggested that perhaps the data of a fetus, which is not yet (legally) a natural person, falls outside of this. But it seems to me that a fetus doesn’t have its own EHR, but is included in an EHR? Therefore, my question to you: what health data is missing, even though it is indeed important to medical science? I’d like to hear from you via the contact form, and I’ll pass this on to the authors of the EHDS implementing legislation.
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?