Development of a digital risk-prediction tool based on family health history for the general population: legal and ethical implications.

Autor: Dijkstra T; Department of Genetics, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands., Ploem MC; Department of Ethics, Law and Medical Humanities, Amsterdam UMC (location AMC) / University of Amsterdam, Amsterdam, the Netherlands., van Langen IM; Department of Genetics, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands., Sieperda BMY; Department of Legal Affairs, University Medical Centre Groningen, Groningen, the Netherlands., Zaal J; Department of Legal Affairs, University Medical Centre Groningen, Groningen, the Netherlands., Lucassen AM; Clinical Ethics, Law and Society (CELS), Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, OX3 7BN, UK., Maeckelberghe ELM; Beatrix Children's Hospital, University Medical Centre Groningen / University of Groningen, Groningen, the Netherlands., Christiaans I; Department of Genetics, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands. i.christiaans@umcg.nl.
Jazyk: angličtina
Zdroj: Journal of community genetics [J Community Genet] 2024 Dec 14. Date of Electronic Publication: 2024 Dec 14.
DOI: 10.1007/s12687-024-00761-4
Abstrakt: Cardiovascular diseases, both inherited and familial, indicate a risk of early and preventable cardiovascular events for relatives of affected individuals. A digital risk-prediction tool that enables general population individuals to evaluate their cardiovascular risk based on family health history could be a responsible approach to facilitate early detection and improve public health, but development and use of such a tool is not without legal and ethical requirements. At the start of tool development, experts addressed potential legal and ethical implications. Especially European Union (EU) regulations could present potential obstacles for the tool's development, broader availability and general use. A first example is that the EU General Data Protection Regulation does not allow the tool to collect health data about relatives without their consent; the alternative is data anonymisation. This requirement has major consequences for the tool's usefulness and raises ethical concerns about who 'the owner' is of family data. A second example is related to the EU's Medical Device Regulation: if software generates health risks or provides medical advice, it requires a CE mark from a 'notified body', an extensive and costly procedure. In this article, we describe these implications in more detail and discuss possible solutions. To conclude, alongside national law, European law can impact on the development of digital tools that collect family health data to provide information on health risks. We recommend including experts in law and ethics in developmental stages of such tools which are likely to become more frequent in routine public care.
Competing Interests: Declarations. Ethics approval: This article does not contain any studies with human or animal subjects performed by the any of the authors. Competing interests: The authors declare no competing interests.
(© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
Databáze: MEDLINE
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