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

Denis Horgan* (Corresponding Author), Ettore Capoluongo, France Dube, Dario Trapani, Umberto Malapelle, Vita Rovite, Muhammad Imran Omar, Catherine Alix-Panabières, Piotr Rutkowski, Arnaud Bayle, Allan Hackshaw, Paul Hofman, Vivek Subbiah

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

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.

Original languageEnglish
Number of pages7
JournalDiagnosis
Volume10
Issue number4
Early online date10 Apr 2023
DOIs
Publication statusPublished - Nov 2023

Bibliographical note

This research was funded by Reducing
Disparities Across the European Union (BEACON) Project
Number: 101080005.

Keywords

  • business model
  • clinical trials
  • Diagnostics
  • EHDS
  • European health data space
  • healthcare data
  • in vitro diagnostics legislation
  • policy
  • regulation
  • uptake

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