As of December 1, 2023, the HDAB-NL Program was launched. This program will develop the technical functionalities for a yet to be designated coordinating Health Data Access Body (HDAB). An HDAB secures secure access to health data for research, innovation and policy. This program helps prepare the Netherlands for the upcoming European Health Data Space (EHDS) Regulation.
The EHDS bill states that each member state must establish at least one or more coordinating HDABs. These should facilitate data availability for scientific research, innovation and policy. The EHDS harmonizes how the HDABs should operate. This takes into account safeguards to protect the privacy of data subjects.
An HDAB should enable the discoverability of electronic health data. In addition, unify the process of data requests and handling and provide a secure processing environment. The coordinating HDAB also performs a supervisory role. This is to ensure that secondary use is always secure, responsible and within the framework of the law. Of course, cooperation with the Personal Data Authority on privacy issues is indispensable.
Responsible reuse of health data
This marks an important step toward the responsible reuse of anonymous or pseudonymous health data for scientific research, innovation and policy. This is also known as secondary use of electronic health data.
This contributes to the quality, accessibility and affordability of care for now and the future. The April 2023 parliamentary letter on vision and strategy secondary healthcare data use also mentions establishing a health data body. This is in line with the National Vision and Strategy for a Health Information System.
Advantages
An HDAB offers many advantages. Because the HDAB advocates a uniform process with unambiguous procedures and legal preconditions, researchers, policymakers and innovators will soon be better able to find, link and analyze the right data. This is cheaper for them than the current procedure(s) and it saves time. For citizens and patients, it will be safer and more transparent.
Program HDAB-NL
Over the past year, the Ministry of Health, Welfare and Sport (VWS) has been in discussions with a number of parties to participate in a program to develop the technical functionalities of the future coordinating HDAB. This program will also establish the governance and infrastructure that precedes the formal establishment of an HDAB-NL. This should in the future connect to the European network of HDABs: HealthData@EU.
The Ministry of Health, Welfare and Sport has asked project organization ICTU, Statistics Netherlands (CBS), Health-RI and the National Institute for Public Health and the Environment (RIVM) to investigate the functionalities of a Dutch HDAB. RIVM and CBS have important data that fall within the scope of the EHDS. They also have the knowledge and experience in handling requests for datasets and the technology to allow processing on these datasets to take place in a secure way. Health-RI was asked because its activities for the Growth Fund are complementary to those envisioned by the HDAB-NL Program. In time, other parties may also join this consortium. The program runs for four years.
The HDAB-NL Program is not concerned with the final designation of a coordinating HDAB. This process will be under the full direction of VWS. Of course, the HDAB-NL Program may provide advice and recommendations on this to VWS.
In the EHDS community on the VWS healthcare community, interested parties can, after registering on the platform, think, discuss and participate in the design of the HDAB or ask questions about it.
