Regulation (EU) 2016/679 of the European Parliament and of the CouncilShow full title

[F1 CHAPTER 8A U.K. Safeguards for processing for research, archiving or statistical purposes

Article 84A U.K. Research, archives and statistics

1. This Chapter makes provision about the processing of personal data—

(a) for the purposes of scientific research or historical research,

(b) for the purposes of archiving in the public interest, or

(c) for statistical purposes.

2. Those purposes are referred to in this Chapter as “RAS purposes”.

Article 84B U.K. Additional requirements when processing for RAS purposes

1. Personal data may only be processed for RAS purposes if—

(a) the processing consists of the collection of the personal data (whether from the data subject or otherwise),

(b) the processing is carried out in order to convert the personal data into information which can be processed in a manner which does not permit the identification of a data subject, or

(c) without the processing, the RAS purposes cannot be fulfilled.

2. Processing of personal data for RAS purposes must be carried out subject to appropriate safeguards for the rights and freedoms of the data subject.

Article 84C U.K. Appropriate safeguards

1. This Article makes provision about when the requirement under Article 84B(2) for processing of personal data to be carried out subject to appropriate safeguards is satisfied.

2. The requirement is not satisfied if the processing is likely to cause substantial damage or substantial distress to a data subject to whom the personal data relates.

3. The requirement is not satisfied if the processing is carried out for the purposes of measures or decisions with respect to a particular data subject to whom the personal data relates, except where the purposes for which the processing is carried out include the purposes of approved medical research.

4. The requirement is only satisfied if the safeguards include technical and organisational measures for the purpose of ensuring respect for the principle of data minimisation (see Article 5(1)(c)), such as, for example, pseudonymisation.

5. In this Article—

• “approved medical research” means medical research carried out by a person who has approval to carry out that research from—

  (a)

  a research ethics committee recognised or established by the Health Research Authority under Chapter 2 of Part 3 of the Care Act 2014, or

  (b)

  a body appointed by any of the following for the purpose of assessing the ethics of research involving individuals—

  (i)

  the Secretary of State, the Scottish Ministers, the Welsh Ministers or a Northern Ireland department;

  (ii)

  a relevant NHS body;

  (iii)

  United Kingdom Research and Innovation or a body that is a Research Council for the purposes of the Science and Technology Act 1965;

  (iv)

  an institution that is a research institution for the purposes of Chapter 4A of Part 7 of the Income Tax (Earnings and Pensions) Act 2003 (see section 457 of that Act);

• “relevant NHS body” means—

  (a)

  an NHS trust or NHS foundation trust in England,

  (b)

  an NHS trust or Local Health Board in Wales,

  (c)

  a Health Board or Special Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978,

  (d)

  the Common Services Agency for the Scottish Health Service, or

  (e)

  any of the health and social care bodies in Northern Ireland falling within paragraphs (b) to (e) of section 1(5) of the Health and Social Care (Reform) Act (Northern Ireland) 2009 (c. 1 (N.I.)).

Article 84D U.K. Appropriate safeguards: further provision

1. The Secretary of State may by regulations make further provision about when the requirement for appropriate safeguards under Article 84B(2) is, or is not, satisfied.

2. Regulations under this Article may not amend or revoke Article 84C(2), (3) or (4) (but may change the meaning of “approved medical research” for the purposes of Article 84C).

3. Regulations under this Article are subject to the affirmative resolution procedure.]

Textual Amendments

F1 Ch. 8A inserted (19.6.2025 for specified purposes) by Data (Use and Access) Act 2025 (c. 18), ss. 86(2), 142(1)(2)(h)