Law and regulations

DATE: 01-11-2024 STATUS: UNDER DEVELOPMENT

Below, activities of Health-RI contributing to solution direction 3 'Integrated Legislation and Regulations' of the Obstacle Removal Trajectory (OVT) are briefly described. An overview of legislation and regulations relevant to the Health-RI ecosystem can be found in the article Preconditions.

In 2022, a list of obstacles related to the reuse of health data was developed in collaboration with the ministries of EZ, VWS, and OCW, and translated into an action program: the OVT. This program aims to systematically address these obstacles, categorized into three clusters (desire, permission, capability) for the reuse of health data and research data.

Cluster 2 focuses on the legal, ethical, and societal 'rules' for an integrated national infrastructure for health data. Cluster 2 is committed to providing the necessary insights into legislation and regulation and establishing a framework to enable the reuse of health data for the benefit of citizens and professionals, while establishing and adhering to important prerequisites regarding ethical and societal aspects. One of the solutions within cluster 2 is 'Integrated Legislation and Regulations', leading to the following action points:

• Providing clarity on the application and scope within current legal frameworks, such as the (U)AVG and WGBO. This includes practical examples and guidelines for the correct use of health data.

• Analysis of the legal framework for the processing of health data, to provide recommendations for improvement and clarification. This evaluation also considers future legislation such as the Wzl and the EHDS. This assessment also involves mapping societal support for striking the right balance between data availability, free access to healthcare, and privacy.

• Contributing to trust in secondary data usage by establishing technical and organizational safeguards such as IAAI and (medical-ethical) review.

Within several projects Health-RI is working on this solution:

Implementation of the Code of Conduct for Health Research

To provide clarity, the Code of Conduct for Health Research by COREON (2022), translates the laws and regulations for data protection in health research into a set of concrete and accessible standards.

In collaboration with COREON, NFU, STZ, FMS, NVVP, and other partners, Health-RI has worked on a practical guide based on these standards, specifically aimed at researchers. Although the guide is currently under review, it is already available on the ELSI Service Desk.

The ELSI Service Desk

The ELSI Service Desk is a nationally supported expertise center for societal, ethical, and legal issues related to the (re)use of data and body material in health research. The Service Desk provides advice on societal, ethical, and legal issues, including guidelines, best practices, and other information resources on its website. It also offers the opportunity to ask questions to a team of experts. The information and advice provided by the Service Desk outline a broad framework, accommodating multiple perspectives and interpretations. In its final recommendations, the Service Desk aims to provide guidance and be practical for direct implementation. Issues detected in the ELSI field and position statements of the Service Desk can fuel national discussions, ultimately contributing to harmonization and consensus-building.

Information about the EHDS

EHDS stands for European Health Data Space. The goal of the EHDS is to improve health care in Europe by achieving free movement of health data. There is also a goal to make it easier to retrieve data for secondary use. The European Commission expects that this will make healthcare cheaper and better, especially countries that offer quality and efficiency will benefit. The EHDS thus offers enormous opportunities. On the ELSI Service Desk, the first FAQ has been published about the EHDS. More FAQs on this topic will be posted in the near future.

Follow-up Trajectory Assessment Framework nWMO

In February 2024, the Assessment Framework nWMO was published as part of the VWS program 'Regeldruk in onderzoek'. The assessment framework contains clear guidelines and criteria enabling robust risk-based assessment. However, the framework alone is not sufficient. Institutions must also implement it, and agreements must be made about mutual acceptance of each other's assessment decisions to prevent unnecessary duplicate assessments. Attention should also be paid to bringing together the assessment of nWMO (retrospective) data research and nWMO (retrospective) research with body material. Currently, Health-RI is in discussions with VWS and other stakeholders about the appropriate ensuing course of action. The follow-up trajectory will focus on organizing information sessions about the assessment framework, conducting a pilot project, and working on joint models and templates.

See also this article on metadata for authorization and ELSI aspects.