datE: 14-08-2024 Status: ADOPTED

The preconditions describe the framework that the Health-RI ecosystem and the related Health-RI Architectural Design must meet. The preconditions are formed by applicable laws and regulations (see also solution 3 ‘Integrated legislation’ of the Obstacle Removal Trajectory) and other national or international agreements such as the reference architecture for a sustainable information system for healthcare (DIZRA) and the reference architecture for higher education (HORA). This article first lists the different preconditions (in no order). Subsequently, for each precondition, it describes what the most important characteristics are and how the precondition in the Health-RI Architectural Design is concretely fulfilled.

#	Precondition
C01	Data Governance Act
C02	Proposal on the European Health Data Space (EHDS)
C03	European regulation for electronic identification and trust services (eIDAS)
C04	Guideline (EU) 2019/1024 from the European parliament and the council of 20 juni 2019 regarding open data and the reuse of government information
C05	The National Vision and Strategy for the health information system of VWS
C06	General Data Protection Regulation (GDPR) and uitvoeringswet Algemene Verordening Gegevensbescherming (UAVG)
C07	Medical Treatment Agreement Act (WGBO)
C08	Electronic Data Exchange in Healthcare Act (Wegiz)
C09	Proposal on the Control of Body Material Act (Wzl)
C10	Government Information Reuse Act (Who)
C11	Databases Act
C12	The reference architecture for a sustainable healthcare information system (DIZRA)
C13	The Reference Architecture for Higher Education (HORA)
C14	National joint architecture model multiple use
C15	NEN 7522:2021 Medical informatics - Development and management of standards and systems of standards

C01 Data Governance Act

The Data Governance Act (DGA) is a European data governance regulation. It is part of a larger strategic policy plan to give the EU a competitive advantage in an increasingly data-driven society while increasing prosperity and well-being in Europe.

C02 Proposal on the European Health Data Space (EHDS)

The EHDS is a health-specific data sharing framework establishing clear rules, common standards and practices, infrastructures and a governance framework for the use of electronic health data by patients and for research, innovation, policy-making, patient safety, statistics or regulatory purposes.

C03 European regulation for electronic identification and trust services (eIDAS)

eIDAS stands for 'Electronic Identities And Trust Services'. With eIDAS, the European member states have made agreements to use the same concepts, reliability levels and mutual digital infrastructure. Part of the regulation is the cross-border use of European recognized login means. This is only possible with a reliable online identity check at the front door. On 29 February 2024, the European Parliament adopted the revisions to the eIDAS 2.0 proposal and the regulation entered into force on 20 May 2024. Implementing Acts must be adopted by 20 November 2024.

C04 Guideline (EU) 2019/1024 from the European parliament and the council of 20 juni 2019 regarding open data and the reuse of government information

This EU guideline has not been implemented in the Netherlands yet.

C05 National Vision and Strategy for the health information system of VWS

The vision is an elaboration of the future vision for the health information system in the Netherlands that extends to 2035. The vision takes the future of care, health and information provision into context. There are three foundations underlying the vision: 1. data availability, 2. trust and 3. control. In this document we explain the fundamentals. The three foundations form the basis for realizing the vision. Even after 2035, these foundations are still important.

C06 General Data Protection Regulation (GDPR) and uitvoeringswet Algemene Verordening Gegevensbescherming (UAVG)

In the Health-RI Architecture design and the Health-RI ecosystem, the General Data Protection Regulation (GDPR) role Controller is filled by the Data Holder role.

See also Solution 3 of the Obstacle Removal Trajectory.

C07 Medical Treatment Agreement Act (WGBO)

The Medical Treatment Agreement Act regulates the relationship between patient and Healthcare Professional, among other things. The patient is the client who is entitled to his/her information so the Healthcare Professional tells the patient in understandable language what is going on, what treatment is needed and what risks are associated with it. If necessary, the Healthcare Professional should point out alternatives, and he may only treat the patient if he gives permission to do so. The Healthcare Professional is also obliged to keep a medical record of the treatment and the patient's state of health. The patient has the right to inspect his medical file.

C08 Electronic Data Exchange in Healthcare Act (Wegiz)

The Wegiz is a framework law that makes it possible to designate data exchanges that are mandatory to take place electronically. This is done with a General Measure of Management (AMvB). To unify record agreements about the exchange, the AMvB refers to quality standards and Dutch Standards (NEN) standards. A NEN standard can then refer to an information standard

Regulations in the field of electronic data exchange in healthcare are also being worked on at European level. The European Health Data Space (EHDS) regulation has common ground with the Wegiz where the EHDS sets requirements for ICT systems that are used for the exchange of health data. The EHDS regulates access and availability for citizens and Healthcare Professionals to electronic health data. The Wegiz is at a further stage than the EHDS.

Concrete implementation

In the iWlz network model scheme, pre-sorting is done on the Wegiz and future relevant AMvBs by using existing (information) standards and NEN standards where possible. The information standards used are explained in the Information layer.

C09 Proposal on the Control of Body Material Act (Wzl)

This lawproposal sets conditions under which it is possible to use body material for, for example, scientific research or the development of medicines. The law ensures the careful handling of body material and increases the control of donors.

The law concerns body material from a donor or body material that has been taken in healthcare or medical or biological science.

The Wzl-proposal is an addition to existing regulations on the use of body material, including the Blood Supply Act, the Embryo Act, the Organ Donation Act and the Medical Research with Humans Act.

At the moment, the Wzl is still a proposal.

C10 Public Sector Information Re-use Act (Who)

The Re-use of Public Sector Information Act (Who) is a Dutch law that implements European Directives 2003/98/EC and 2013/37/EU on the re-use of public sector information.

The WHO gives citizens the right to request that already disclosed information from institutions with a legal task be allowed to be re-used for other purposes, including commercial purposes.

C11 Databases Act

The Databases Act protects the producer of a database and ensures that others are not allowed to retrieve and reuse substantial parts of that database without permission. Retrieval is the permanent or temporary transfer of the database or part of it to another medium. The re-use of the data shall include any form of making the contents of all or part of the database available to the public.

C12 The reference architecture for a sustainable healthcare information system (DIZRA)

The Health-RI ecosystem is being developed in line with the reference architecture for a sustainable information system for healthcare (DIZRA) established by the Care Information Council. The principles of DIZRA are:

control of health data
common language
data at the source
level playing field for all suppliers
sustainable information system
FAIR data
machine-readable
federated collaboration
open international standards

Implications

The way in which these principles are applied in the Health-RI Architectural Design is described in the article Principles.

C13 The Reference Architecture for Higher Education (HORA)

The Health-RI ecosystem is being developed in line with the established reference architecture for higher education HORA.

C14 National joint multi-use architecture model

Based on the narrative "Every relevant health data point and the associated context are available to every competent within set terms of use", together with leading parties in healthcare, including VWS, ZN, VZVZ, Nictiz, IHE, NFU/AcZie and Twiin, we worked on the joint health data architecture model. See also Joint health data architecture model

C15 NEN 7522:2021 Medical informatics - Developing and managing standards and systems of standards

The NEN 7522 is a standard for the development and management of standards and systems of standards. The Ministry of Health, Welfare and Sport is the system holder (Nictiz is the temporary system manager). The standard contains:

A blueprint on the basis of which the governance of a standard or system of standards can be set up.
A description of which roles can be distinguished in the development and management of a standard or system of standards.
Requirements that are set for the roles in the execution of development and management of a standard or system of standards.
A description of the activities that must be carried out in the development and management of
a standard or system of standards.
Requirements for products that must be delivered in the development and management of
a standard or system of standards.
A model for testing the process of developing and managing a standard or system of standards.

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Preconditions