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

  • Denis Horgan EMAIL logo , Ettore Capoluongo , France Dube , Dario Trapani , Umberto Malapelle , Vita Rovite , Muhammad Imran Omar , Catherine Alix-Panabières , Piotr Rutkowski , Arnaud Bayle , Allan Hackshaw , Paul Hofman and Vivek Subbiah
Published/Copyright: April 10, 2023
Diagnosis
From the journal Diagnosis Volume 10 Issue 4

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.

Keywords: business models; clinical trials; diagnostics; European Health Data Space (EHDS); healthcare data; in vitro diagnostics legislation; policy; regulation; uptake
Corresponding author: Denis Horgan, European Alliance for Personalised Medicine, Brussels, Belgium; Department of Molecular and Cellular Engineering, Jacob Institute of Biotechnology and Bioengineering Sam Higginbottom University of Agriculture, Technology and Sciences, Prayagraj, India, E-mail:

Funding source: European Union

Award Identifier / Grant number: 101080005

Acknowledgments

We would like to thank the members of the European Alliance for Personalised Medicine (EAPM), Piers Mahon from Digicore and the representatives of the European Commission and Member States for their kind input. The paper reflects EAPM and individuals’ opinions, not to be ascribed to the institutions of affiliation or possible other representative roles of the authors. Vita Rovite was supported by European Regional Development Fund within the project “DECIDE – Development of a dynamic informed consent system for biobank and citizen science data management, quality control and integration” (No. 1.1.1.1/20/A/047).

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

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Denis Horgan is an employee of the European Alliance for Personalised Medicine, which receives funding from both the public and private sectors. France Dube is an employee of Astra Zeneca.

  4. Informed consent: Not applicable.

  5. Ethical approval: Not applicable.

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Received: 2023-02-21
Accepted: 2023-03-22
Published Online: 2023-04-10

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/dx-2023-0022
Keywords for this article
business models; clinical trials; diagnostics; European Health Data Space (EHDS); healthcare data; in vitro diagnostics legislation; policy; regulation; uptake

Articles in the same Issue

  1. Frontmatter
  2. Reviews
  3. Diagnostic errors in uncommon conditions: a systematic review of case reports of diagnostic errors
  4. Routine blood test markers for predicting liver disease post HBV infection: precision pathology and pattern recognition
  5. Opinion Papers
  6. The challenge of clinical reasoning in chronic multimorbidity: time and interactions in the Health Issues Network model
  7. The first diagnostic excellence conference in Japan
  8. Clouds across the new dawn for clinical, diagnostic and biological data: accelerating the development, delivery and uptake of personalized medicine
  9. Original Articles
  10. Towards diagnostic excellence on academic ward teams: building a conceptual model of team dynamics in the diagnostic process
  11. Error codes at autopsy to study potential biases in diagnostic error
  12. Multicenter evaluation of a method to identify delayed diagnosis of diabetic ketoacidosis and sepsis in administrative data
  13. Detection of fake papers in the era of artificial intelligence
  14. Is language an issue? Accuracy of the German computerized diagnostic decision support system ISABEL and cross-validation with the English counterpart
  15. The feasibility of a mystery case curriculum to enhance diagnostic reasoning skills among medical students: a process evaluation
  16. Internal medicine intern performance on the gastrointestinal physical exam
  17. Scaling up a diagnostic pause at the ICU-to-ward transition: an exploration of barriers and facilitators to implementation of the ICU-PAUSE handoff tool
  18. Learned cautions regarding antibody testing in mast cell activation syndrome
  19. Diagnostic properties of natriuretic peptides and opportunities for personalized thresholds for detecting heart failure in primary care
  20. Incomplete filling of spray-dried K2EDTA evacuated blood tubes: impact on measuring routine hematological parameters on Sysmex XN-10
  21. Letters to the Editor
  22. The diagnostic accuracy of AI-based predatory journal detectors: an analogy to diagnosis
  23. Explainable AI for gut microbiome-based diagnostics: colorectal cancer as a case study
  24. Restless X syndrome: a new diagnostic family of nocturnal, restless, abnormal sensations of various body parts
  25. Erratum
  26. Retraction of: Establishing a stable platform for the measurement of blood endotoxin levels in the dialysis population
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