Ethical and governance considerations for genomic data sharing in the development of medical technologies for melanoma - The iToBoS Project.

Abstract

Balancing the risks and benefits of using genomics data in health service provision is a complex task. Social, ethical, and legal considerations are nuanced, often complicated by the fact that regulations lag behind rapid pace of technological development. Ethical considerations such as autonomy, beneficence, and non-maleficence are weighed against (and within) complex concepts such as privacy, security, safety, and proportionality. This paper will discuss European H2020 funded project IToBoS^[1], in which an AI diagnostic platform for the early detection of melanoma is being developed. Assuring the project's solutions are produced in an ethically and socially responsible manner, with regulatory compliance at their core, is one of the project's primary goals. This paper will communicate the existing tensions within the health sector, including between the European Commission’s desire for open-data – governed through its proposed Digital Strategy and practically achieved through the creation of a European Health Data Space^[2] – and the risks inherent with the generalised sharing of genomics (and other health related) data.

^[1] This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement  No. 965221. More information may be found at: https://itobos.eu/

^[2] https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en