Q&As

Are biological samples treated as ‘personal data’ under EU Directive 95/46/EC and the UK Data Protection Act 1998?

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Published on LexisPSL on 17/10/2017

The following Life Sciences Q&A provides comprehensive and up to date legal information covering:

  • Are biological samples treated as ‘personal data’ under EU Directive 95/46/EC and the UK Data Protection Act 1998?
  • Directive 95/46/EC (Directive)
  • Data Protection Act 1998 (DPA)
  • Application of the Directive and DPA tests

Directive 95/46/EC (Directive)

Article 2 of Directive 95/46/EC (Directive) provides that ‘personal data’ is information relating to an identified or identifiable natural individual, an identifiable individual being one who can be identified, directly or indirectly, in particular, by reference to an identification number or to one or more factors specific to the individual’s physical, physiological, mental, economic, cultural or social identity.

Recital 26 of Directive 95/46/EC states that in determining whether an individual is identifiable, account must be taken of all the means reasonably likely to be used by the data controller or any other person to identify the said individual. In case Patrick Breyer v Bundesrepublik Deutschland, the ECJ held that the means reasonably likely to be used by the data controller or ‘any other person’ does not require that all the information enabling identification be in the possession of one person.

Articles  2–3 of Directive 95/46/EC provides that Directive 95/46/EC applies to the processing of personal data wholly or partly by automatic means.

Data Protection Act 1998 (DPA)

Section 1 of the Data Protection Act 1998 (DPA 1998) provides that:

  1. data includes information which is

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