The EHR must comply with Brussels requirements
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?
Why the EHR will soon have to meet requirements set in Brussels
A great deal is about to change for hospitals, healthcare providers and IT suppliers. The Dutch Electronic Data Exchange in Healthcare Act (Wet Elektronische Gegevensuitwisseling in de Zorg, Wegiz) was written to improve data exchange and data availability in healthcare. Because this is a very large operation, the choice was made to develop standards for ‘prioritised data exchanges’, using Orders in Council (Algemene Maatregelen van Bestuur, AMvBs). These are decisions adopted by the government which supplement legislation. The House of Representatives is therefore not directly involved. But while our government was working on the Wegiz and the AMvBs, Brussels was working on the European Health Data Space (EHDS) Regulation, which also addresses data availability in healthcare. Something that should not be overlooked: a considerable amount of legislative power has been transferred to the EU.
Not a cross-border affair only
Contrary to what is sometimes assumed, the EHDS will not apply only to cross-border data traffic. Just like the GDPR, which is also a European law, the EHDS always applies. There is nothing in it that leaves room to exempt purely Dutch healthcare from the law. And because European legislation always takes precedence over national legislation—just as a municipal by-law cannot set aside national law—the Wegiz may not conflict with the EHDS. Moreover, provisions of the EHDS may not be transcribed into national legislation. The Minister of Health, Welfare and Sport accordingly informed the House of Representatives that the EHDS is now being taken as the basis for the current work. The national objectives supplement it, and only in so far as they are in line with the EHDS. Given the legal hierarchy, that is a logical working method.
European Orders in Council too
To avoid unnecessary work for IT departments, it is important that we pause to consider the fact that the EHDS confers certain powers on the European Commission. The Commission is given the right to adopt Implementing Regulations, which are in effect a kind of European AMvB. Here too, the European Parliament is no longer really involved. The impact of this should not be underestimated, because the list of new Commission powers under the EHDS is quite long. What does this mean on the shop floor? The list includes, for example, the power to lay down data quality requirements for the registration of personal electronic health data in an EHR system. The way the EHR is set up will therefore no longer be determined in future by the Dutch government, but by decisions taken in Brussels.