Part 4: Medical Devices Chapter 2: Regulations: Information Systems, Advisory Committee Section 19: Information Systems
Section 19 confers a delegated power on the Secretary of State to make regulations providing for a database of information in relation to medical devices to be established and managed by the Health and Social Care Information Centre. The Health and Social Care Information Centre is also known as NHS Digital.
	Subsection (1) provides that regulations may be made about the establishment and operation by the Health and Social Care Information Centre ("the Information Centre") of one or more information systems. The power is restricted to purposes relating to monitoring and taking action to ensure: the safety and performance, including the clinical effectiveness, of medical devices; the safety of patients, and; the use of advances in technology to improve the safety and performance of medical devices.
	Subsection (2) outlines the type of provisions that may be made by regulations. This is a non-exhaustive list. Provisions may be about the type of information that could be gathered, the requirements on the provision of that information, the rules around the use or disclosure of that data and the requirements that may be placed on "the Information Centre" in exercising of its functions under the regulations.
	Subsection (3) sets out additional information that provisions relying on subsection (2)(b) could include.
	Subsection (3)(a) provides that provisions may be made requiring specified persons or descriptions of persons providing services, or exercising any powers or duties, relating to medical devices, to provide specified information to the Information Centre.
	Subsection (3)(b) provides that regulations may specify the time and manner in which the information required must be provided.
	Subsection (3)(c) provides that regulations may enable the Information Centre to determine the manner and timing of information required from specified persons or descriptions of persons providing services, or exercising any powers or duties, relating to medical devices. Provisions may enable the Information Centre to specify the description of the information, the purposes for which the information is to be gathered and specify any other information the Information Centre considers it needs to fulfil its functions.
	Subsection (3)(d) provides that regulations may describe any procedural steps the Information Centre must follow when requiring a person to provide information.
	Subsection (3)(e) provides that regulations may specify how required information is recorded or retained.
	Subsection (3)(f) provides that regulations may include enforcement requirements in relation to regulations may under section 19(1).
	Subsection (5) provides examples of the type of information that could be required to be provided under the power in subsections (2)(a), (3)(a) and (3)(c)(i). The list is not exhaustive.
	Subsection (6) provides non-exhaustive examples of the possible provisions that may be included in the regulations on the use and disclosure of information held within the information system (subsection (2)(c)). These include the analysis of that information (whether alone or linked with other information), the publication of it, the disclosure of it to specified persons or descriptions of persons or for specified purposes, and on the use or further disclosure by any person to whom information has been disclosed under the regulations.