PART 4Medical devices

CHAPTER 4Disclosure of information and consequential etc provision

Disclosure of information

I139Disclosure of information

1

This section applies in relation to information which the Secretary of State holds in connection with medical devices.

2

The Secretary of State may disclose information for the purpose of warning members of the public about concerns that the Secretary of State has in relation to the safety of a medical device.

3

The Secretary of State may disclose information to a person who provides services or exercises functions relating to medical devices for the purposes of—

a

enabling or facilitating the exercise by the Secretary of State of a function relating to medical devices;

b

enabling or facilitating the exercise by another person of a function relating to medical devices;

c

enabling or facilitating the provision of a service relating to medical devices by another person.

4

The Secretary of State may disclose information for the purposes of—

a

civil proceedings;

b

criminal investigations or proceedings.

5

The Secretary of State may disclose information to a relevant person outside the United Kingdom where—

a

the disclosure is required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of medical devices, and

b

the Secretary of State considers that the disclosure is in the public interest.

6

But subsection (5) does not authorise a disclosure of patient information without the consent of the individual to whom that information relates.

7

The Secretary of State may not disclose commercially sensitive information in reliance on subsection (2), (3), (4) or (5) unless the Secretary of State—

a

considers that it is necessary to do so for one or more of the purposes mentioned in subsection (2), (3), (4) or (5), and

b

is satisfied that the making of the disclosure is proportionate to what is sought to be achieved by it.

8

Where information to which this section applies is disclosed to a person in reliance on subsection (3) or (4), the person may not use or further disclose the information except—

a

with the agreement of the Secretary of State and for a purpose mentioned in subsection (3) or (4), or

b

in accordance with an enactment or order of a court or tribunal.

9

Except as provided by subsection (10), the disclosure of information in accordance with this section does not breach—

a

an obligation of confidence owed by the person making the disclosure, or

b

any other restriction on the disclosure of the information (however imposed).

10

Nothing in this section authorises a disclosure of information which—

a

contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section), F1...

b

is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016 F2, or

F2c

contravenes any obligation or restriction created or arising by or under the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement, whether or not an obligation or restriction to which section 7A(2) of the European Union (Withdrawal) Act 2018 applies.

11

This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.

12

In this section—

  • “commercially sensitive information” means commercial information whose disclosure the Secretary of State thinks might significantly harm the legitimate business interests of the undertaking to which it relates;

  • “patient information” means information (however recorded) which—

    1. a

      relates to—

      1. i

        the physical or mental health or condition of an individual,

      2. ii

        the diagnosis of an individual's condition, or

      3. iii

        an individual's care or treatment,

      or is (to any extent) derived directly or indirectly from information relating to any of those matters, and

    2. b

      identifies the individual or enables the individual to be identified (whether by itself or in combination with other information);

  • “relevant person” means—

    1. a

      the government of a country or territory outside the United Kingdom;

    2. b

      a person who exercises functions on behalf of such a government;

    3. c

      any other person who exercises functions or provides services relating to medical devices in a country or territory outside the United Kingdom;

    4. d

      an international organisation that exercises functions or provides services relating to medical devices.