PART 2Human medicines
F1CHAPTER 1ARegulations: information systems
7AInformation systems
(1)
The appropriate authority may by regulations make provision about the establishment and operation by F2NHS England of one or more information systems for purposes relating to—
(a)
the safety of human medicines, including the safety of clinical decisions relating to human medicines;
(b)
the quality and efficacy of human medicines.
(2)
The regulations may (among other things) make provision—
(a)
about the information in relation to human medicines which may or must be entered or retained in an information system established under subsection (1);
(b)
requiring information to be provided to F3NHS England for the purposes of its functions under the regulations;
(c)
about the use or disclosure of information contained in an information system established under subsection (1);
(d)
requiring F3NHS England to have regard to specified matters in exercising its functions under the regulations.
(3)
(a)
information for specified purposes,
(b)
information that F3NHS England considers it necessary or expedient to have for the purposes of its functions under the regulations,
(c)
information (including information relating to individuals) which is of a specified description, or
(d)
information (including information relating to individuals) which is of a description set out in a direction in writing given by the appropriate authority.
(4)
The provision mentioned in subsection (2)(b) may include provision—
(a)
(b)
about the manner in which, and the time at which, those persons must provide information, or for those matters to be determined by F3NHS England;
(c)
about any procedural steps F3NHS England must follow in requiring a person to provide information to it;
(d)
(e)
in relation to the enforcement of any requirement imposed by or under the regulations.
(5)
This subsection applies to any person who provides services, or exercises any powers or duties, relating to—
(a)
human medicines,
(b)
health, or
(c)
education.
(6)
The provision mentioned in subsection (2)(c) may include provision about—
(a)
(b)
the publication by F4NHS England of information that is contained in an information system or has been analysed in combination with such information;
(c)
the disclosure (other than by way of publication) of information mentioned in paragraph (b) to specified persons or descriptions of persons, or for specified purposes;
(d)
the use or further disclosure by any person of information disclosed to them under the regulations.
(7)
Regulations conferring on the appropriate authority a power to give a direction by virtue of subsection (3)(d) must —
(a)
provide that the power includes power to vary or revoke the directions by a subsequent direction, and
(b)
in the case of a power exercisable in relation to Wales or Scotland, require the Secretary of State—
(i)
where a proposed direction relates to Wales, to consult the Welsh Ministers before giving it, and
(ii)
where a proposed direction relates to Scotland, to consult the Scottish Ministers before giving it.
(8)
Where regulations under subsection (1) include provision by virtue of subsection (4)(a) which requires, or enables F5NHS England to require, the provision of individual health information held for the purposes of the health service established under section 1 of the National Health Service (Scotland) Act 1978, the regulations must provide for the information to be collected by the Scottish Ministers, or a person designated by them, on behalf of F5NHS England, subject to specified exceptions.
(9)
Regulations by virtue of subsection (8) may—
(a)
confer powers or duties (including discretions) on the Scottish Ministers, a designated person or F5NHS England;
(b)
provide for powers or duties conferred on the Scottish Ministers to be treated for the purposes of section 2 of the National Health Service (Scotland) Act 1978 as functions relating to the health service (within the meaning of that Act).
(10)
Where regulations under subsection (1) include provision by virtue of subsection (4)(a) which requires, or enables F5NHS England to require, the provision of individual health information held for the purposes of the health service in Wales, the regulations must provide for the information to be collected by the Welsh Ministers, or a person designated by them, on behalf of F5NHS England, subject to specified exceptions.
(11)
Regulations by virtue of subsection (10) may confer powers or duties (including discretions) on the Welsh Ministers, a designated person or F5NHS England.
(12)
Regulations under subsection (1) may provide that the disclosure of information by virtue of 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), other than a restriction imposed by the data protection legislation.
(13)
In this section—
“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018;
“health service”, in relation to Wales, has the meaning given by section 206(1) of the National Health Service (Wales) Act 2006;
“human medicine” has the same meaning as in Part 2 (see section 9);
“individual health information” means information (however recorded) which relates to—
(a)
the physical or mental health or condition of an individual,
(b)
the diagnosis of an individual’s condition, or
(c)
an individual’s care or treatment,
or is (to any extent) derived directly or indirectly from information relating to any of those matters;
“specified” means specified in regulations under subsection (1).