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Journal of Community Genetics

, Volume 9, Issue 3, pp 195–199 | Cite as

Risk stratification, genomic data and the law

  • Alison Hall
  • Thomas Finnegan
  • Susmita Chowdhury
  • Tom Dent
  • Mark Kroese
  • Hilary Burton
Review

Abstract

Risk prediction models have a key role in stratified disease prevention, and the incorporation of genomic data into these models promises more effective personalisation. Although the clinical utility of incorporating genomic data into risk prediction tools is increasingly compelling, at least for some applications and disease types, the legal and regulatory implications have not been examined and have been overshadowed by discussions about clinical and scientific utility and feasibility. We held a workshop to explore relevant legal and regulatory perspectives from four EU Member States: France, Germany, the Netherlands and the UK. While we found no absolute prohibition on the use of such data in those tools, there are considerable challenges. Currently, these are modest and result from genomic data being classified as sensitive data under existing Data Protection regulation. However, these challenges will increase in the future following the implementation of EU Regulations on data protection which take effect in 2018, and reforms to the governance of the manufacture, development and use of in vitro diagnostic devices to be implemented in 2022. Collectively these will increase the regulatory burden placed on these products as risk stratification tools will be brought within the scope of these new Regulations. The failure to respond to the challenges posed by the use of genomic data in disease risk stratification tools could therefore prove costly to those developing and using such tools.

Keywords

Risk assessment Stratification Genomics Cancer Law 

Notes

Acknowledgments

We gratefully acknowledge the participants in the international workshop for their valuable contributions: Ms. Teresa Bienkowska-Gibbs, Dr. Anne Cambon-Thomsen, Mr. Edward Dove, Dr. Christian Gleißner, Professor Aart Hendriks, Mr. Julian Hitchcock, Dr. Stephen John, Dr. Kiran Patel, Dr. Rupert Payne, Dr. Emmanuelle Rial-Sebbag, Dr. Mark Taylor, Dr. Holger Tönnies and Professor David Townend.

Funding

This work was part of the European Prospective Investigation into Cancer and Nutrition—Cardio Vascular Disease (EPIC-CVD) (http://www.epiccvd.eu/), funded by the Seventh Framework Programme of the European Commission under grant agreement 27923.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

This article does not contain any studies with human participants or animals performed by any of the authors.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  1. 1.PHG FoundationCambridgeUK

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