F1CHAPTER 8ASafeguards for processing for research, archiving or statistical purposes

Article 84CAppropriate 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—

  1. (i)

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

  2. (ii)

    a relevant NHS body;

  3. (iii)

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

  4. (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.)).