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.
EHDS Data collectors
The EHDS creates several new roles around the reuse of health data. A well-known example is the Health Data Access Body, a new government agency where licenses are requested to work with data in a secure processing environment. Much less attention is paid to the role of the trusted data holder, and the role of data collector is completely unknown. Yet, the data collector is crucial for unlocking data in a way that is more efficient, better for science, and, above all, can contribute to greater trust in the system.
Efficiency - as with the Dutch GGD
The EHDS obligates holders of health data to make them available for beneficial reuse, such as scientific research. To make the system more efficient, the Netherlands can designate certain organizations as intermediary entities. However, note that this is a different role than a data intermediary service as described in the Data Governance Regulation. Because this doesn’t make things any clearer, it’s wise to refer to these parties as data aggregators within the EHDS context; that is precisely what these parties do. They collect data from many similar data holders. The obligation to provide data to the Health Data Access Body is then taken over from the individual data holders by the aggregator. For example, in the Netherlands, there are many Municipal Health Services (GGDs), all of which hold data useful for medical-scientific research. It would be illogical for the HDAB to have to contact all the individual GGDs for every research project requiring GGD data. The Dutch government could therefore designate the GGD GHOR (umbrella organisaton for Municipal Health Services) as a data aggregator, assuming the EHDS responsibilities of all the individual GGDs.
Scientific interest - such as with general practitioners
The second area for which a data collector can be engaged is micro-data holders. The EHDS stipulates that small data holders are not required to provide data to the HDAB: that would be too much of an administrative burden for small organizations. However, some data that are scientifically extremely important are precisely in the hands of small data holders. In the Netherlands, for example, this is the case with general practitioners. If research is to be conducted on the earlier detection of lung cancer, the hospital patient records must be linked to the records of the general practitioners regarding previously reported health complaints. This is important research, but the data in question, due to the small size of the average general practice, will fall outside the scope of the EHDS. National legislation can therefore oblige such micro-data holders to provide data to a data collector, for example, a Nivel or an IPCI, thus making this data available securely and efficiently for important research. The same applies to data from, for example, dentists, physiotherapists, or dietitians.
For trust – such as with diabetes
The third purpose of data collectors is increasing trust in the system. For example, diabetes patients might worry about their privacy if commercial companies had direct access to their data. Because of this (very understandable) concern, they might therefore oppose the availability of their data. But imagine that Dutch legislation stipulates that real-time measurements are made available to the Dutch Diabetes Association, and that association (with the help of, for example, the Dutch Healthcare Institute) manages this data. Far fewer patients would likely object. The Dutch Diabetes Association could then anonymize the data or answer statistical questions. If, with the help of such organizations, trust in the system is increased, this will lead to broader data availability for scientific research and the development of new, useful healthcare products.
In secondary legislation
In short, there are many good reasons to make extensive use of the role of data collector: the system becomes more efficient, more data becomes available (securely) for medical research, and this can also lead to greater patient confidence in the system. The implementing legislation for the EHDS could stipulate that all data collectors will be assisted by the National Health Care Institute (Zorginstituut), which was already designated to oversee quality registrations. The specific data collectors should not, of course, be designated in the law itself, because if one of them proves to be dysfunctional, removing a data collector would have to go through Parliament. That would take too long. Therefore, the Minister of Health should be able to appoint data collectors (under Parliamentary supervision). I think it would be useful if we in the Netherlands thoroughly discussed at conferences how we can optimally design the EHDS system by using the role of data collector.
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?