datum: 01-05-2024 Status: FOR REVIEW

UDH01: Data holders strive not to increase the administrative burden for Healthcare Professionals.

The pressure on the healthcare sector is high, partly due to a high administrative burden. Further increasing the administrative burden for Healthcare Professionals is therefore quickly unacceptable. The determination and recording of data and metadata should therefore be as much as possible be an automatic result of conducting the operational care and administrative processes (registration at the source).

UDH02: Data holders gain control and insight into the use of their data

The data holder is usually legally responsible for the data. It is therefore important that data holders have control and insight into which organization and which person gets access to data, under what circumstances and conditions, and what happens to the data. Every data request can be traced to a natural person. Data subjects can then always ask a data holder for what purposes and by which organization (and which person) whom their data has been used, in accordance with GDPR.

UDH03: Data holders make data FAIR as close to the source as possible

For data, it is necessary to choose at an early stage how it is recorded, encoded and provided with metadata, in order to prevent additional operations later with interpretation risk. See also FAIR Principles - GO FAIR .

UDH04: Data holders facilitate the reproducibility of health data

Researchers are expected to make their research reproducible. To this end, research data must be available for a long time to, for example, other researchers who want to be able to reproduce a study. To this end, it is important that data holder provides version control and a data archive for sustainable accessibility.

UDH05: Data holders make data and context explicit and machine-interpretable

This is a reflection of the FAIR principles. Data only has meaning if it is clear within which context it was created. Implicit context should therefore be recorded as structured metadata as much as possible. This context is intended for both humans and machines.

UDH06: Data holders ensure that data is provided with clear terms of use

The secondary use of data must be handled with care. It is the responsibility of the data holder to draw up clear terms of use for this. These terms of use should be described in the metadata.

UDH07: Data holders and data subjects should experience the benefits of the learning care system for themselves

The doctors, researchers and citizens who participate in the generation of reusable data must experience sufficient incentive, or benefit, to do so consistently and with desired quality.

UDH08: Data holders make health data suitable for multiple use once

In principle, data holders only make the health data suitable for multiple use once. It is undesirable that data holders have to provide a dataset in a specific data model or format for each specific request. Data should be converted into a standardized form once as much as possible. However, new insights, data points, standards, or other maintenance can ensure that data must once again be made suitable for multiple use. The mapping of the data must also be maintained.

UDG01: Data users are explicit about their proposed use of the data

It must be possible for parties such as data holders, data subjects, and review committees to assess to what extent the proposed use of the data is acceptable. This is assessed from all kinds of perspectives, such as ethics, laws and regulations, terms of use and consent. Data users must therefore be explicit about, among other things, which data they want to use, which analyses they will do based on the data, which processing environment will be used, what they will do with the results of the analysis and how the feedback to the data holder takes place.

UDG02: Data users of the Health-RI ecosystem also share their results with the ecosystem

It is important for the success of the Health-RI ecosystem that sufficient data is available. Data users of the Health-RI ecosystem should in turn make the research results available for multiple use.

UDG03: Data users leave data at the source and do not copy when it is not necessary

Copying data leads to additional costs, a proliferation of clones, and the risk of inconsistencies and data leaks and should be avoided when not necessary. This is determined, among other things, by the characteristics of the source system and its use. A data holder can also indicate in the terms of use that it is not allowed to make a copy.

UHE01: The Health-RI ecosystem follows the principles of unity of language

There is a great diversity of standards. We opt for a limited number of semantic and syntactic standards, with which the different target groups can exchange data with minimal loss of quality. These standards must be mutually harmonized so that they can be translated to each other. In addition, it is important that interoperability is regulated at all levels, from legal to organization to process to application to data to technology.

UHE02: The Health-RI ecosystem is vendor-independent

Supplier dependence must be avoided, and the ecosystem must not unnecessarily disrupt market forces. This means, for example, that multiple purchased components from the same supplier cannot be inextricably linked. Couplings should be done via standardized interfaces. Supplier independence also calls attention to the size of a possible open source community, the application of generic and market-based technology and the sustainability of chosen solutions.

UHE03: The Health-RI ecosystem uses Data Protection by design and default

It is important to handle the protection of personal data and other forms of sensitive data with care. Privacy and information security must therefore be included in the design from the start and secure choices must be assumed by default. See also this article: Privacy by Design The 7 Foundational Principles Implementation and Mapping of Fair Information Practices. This takes into account, among other things, purpose and purpose limitation, basis, data minimization and data integrity, transparency and accountability, and secure processing of the personal data.

UHE04: The Health-RI ecosystem supports the most appropriate BIV classification

The Dutch term BIV stands for Availability, Integrity and Confidentiality. It is important that the ecosystem can handle different forms of data, including data that should be highly available, honest and confidential. Depending on the context, it must be possible to choose the most appropriate BIV classification.

UHE05: The Health-RI ecosystem prefers international standards to national standards

Research and policy both have a national and an international characteristic. Dutch researchers also want to use data from, for example, other European countries and vice versa. In addition, the viability of international standards is higher than national standards. We therefore prefer standards that have an international character rather than standards that are only used nationally.

UHE06: The Health-RI ecosystem opts for open standards and, where possible, open development

Open standards ensure supplier independence and are therefore preferred. If there are no suitable standards or solutions yet, we prefer to work together with other parties to achieve them.

UHE07: Participating parties are each responsible for meeting the agreements in the Health-RI ecosystem

An ecosystem exists because a collection of parties work together in accordance with a set of agreements. This can only work well if all parties adhere to the same agreements. These agreements are included in the Health-RI Architecture Design and participants in the Health-RI ecosystem commit to these agreements by means of a participant agreement.