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Clouds across the new dawn for clinical, diagnostic and biological data: accelerating the development, delivery and uptake of personalized medicine

Horgan, Denis; Capoluongo, Ettore; Dube, France; Trapani, Dario; Malapelle, Umberto; Rovite, Vita; Omar, Muhammad Imran; ... Subbiah, Vivek; + view all (2023) Clouds across the new dawn for clinical, diagnostic and biological data: accelerating the development, delivery and uptake of personalized medicine. Diagnosis , 10 (4) pp. 356-362. 10.1515/dx-2023-0022. Green open access

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Abstract

Growing awareness of the genetic basis of disease is transforming the opportunities for improving patient care by accelerating the development, delivery and uptake of personalised medicine and diseases diagnostics. This can mean more precise treatments reaching the right patients at the right time at the right cost. But it will be possible only with a coherent European Union (EU) approach to regulation. For clinical and biological data, on which the EU is now legislating with its planned European Health Data Space (EHDS), it is crucial that the design of this new system respects the constraints also implicit in the testing which generates data. The current EHDS proposal may fail to meet this requirement. It risks being over-ambitious, while taking insufficient account of the demanding realities of data access in daily practice and current economics/business models. It is marred by imprecision and ambiguity, by overlaps with other EU legislation, and by lack of clarity on funding. This paper identifies key issues where legislators should ensure that the opportunities are not squandered by the adoption of over-hasty or ill-considered provisions that jeopardise the gains that could be made in improved healthcare.

Type: Article
Title: Clouds across the new dawn for clinical, diagnostic and biological data: accelerating the development, delivery and uptake of personalized medicine
Location: Germany
Open access status: An open access version is available from UCL Discovery
DOI: 10.1515/dx-2023-0022
Publisher version: https://doi.org/10.1515/dx-2023-0022
Language: English
Additional information: This version is the version of record. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: in vitro diagnostics legislation, business models, clinical trials, diagnostics, EHDS, European health data space, healthcare data, policy, regulation, uptake
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > CRUK Cancer Trials Centre
URI: https://discovery.ucl.ac.uk/id/eprint/10178339
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