Health And Care Act 2022

Part 2: Health and Adult Social Care Information

Section 92: Information about payments etc to persons in the health care sector

807. Subsection (1) enables the Secretary of State to make regulations requiring manufacturers and commercial suppliers of health care products, and connected persons, to either publish (subsection (1)(a)) or provide to the Secretary of State (subsection (1)(b)) information about payments or other benefits provided by them to relevant persons. The terms commercial supplier and manufacturer are defined in subsection (12). The terms connected person and relevant person are described in Subsection (11) and will be defined further in regulations made under this section.
808. Subsection (2) enables the regulations made under subsection (1) to make provision about when and how the information must be published or provided. For example, this could include specific requirements about the frequency that information must be either published or provided and the place where the information must be published.
809. Subsection (3) describes the type of provision the regulations may make about the information which must be published or provided pursuant to subsection (1). For example, this may include the name of the recipient or provider of the payment/benefit, the value of the payment/benefit, and the reason for which the payment was made or the benefit given. This is a non-exhaustive list.
810. Subsection (4) enables regulations to make provision permitting or requiring the further sharing, publication or use of the information. For example, this would enable regulations to make provision about the Secretary of State’s ability to share information received with others and provision about how those persons can use that information where this will assist with the publication of the information.
811. Subsection (5) enables regulations to make provision requiring manufacturers, commercial suppliers, and connected persons to retain information relating to payments or other benefits provided by them to relevant persons. This ensures that there is a record maintained which can be used to support enforcement activity.
812. Subsection (6)(a) enables regulations made under subsection (1) to authorise the Secretary of State to designate a reporting scheme operated by someone other than the Secretary of State as a "relevant scheme" if the Secretary of State considers that the provision of information under the alternative scheme would render compliance with some, or all, of the requirements imposed by regulations made under subsection (1) unnecessary. Subsection (6)(b) enables regulations made under subsection (1) to create exceptions from requirements to publish or provide information where manufacturers, commercial suppliers or connected persons provide information under a designated relevant scheme. The intention is that if a third party, (e.g. a trade association) operated a reporting scheme of an appropriate standard, persons participating in that scheme could be exempt from a requirement in the regulations made pursuant to subsection (1) to publish or provide information. Subsection (6)(c) enables provision to be made in the regulations requiring operators of relevant schemes to provide information they receive through the operation of relevant schemes to the Secretary of State and for the Secretary of State to publish this information. This would enable the Secretary of State to operate a comprehensive database of information about payments if necessary.
813. Subsection (7) enables the Secretary of State to place information retention requirements on persons running a relevant scheme as designated under subsection (6).
814. Subsection (8) clarifies that the provision for exceptions that may be made by the regulations includes authorising the Secretary of State to make discretionary exemptions from a requirement to publish or provide information in particular cases, on grounds specified in the regulations.
815. Subsection (9) enables the regulations to provide that the disclosure of information pursuant to the regulations will not breach an obligation of confidence or other restriction placed on the disclosure of the information. This is necessary to ensure policy aims around transparency are met and businesses are not prevented from publishing or providing information and the Secretary of State is not prohibited from making it publicly available. Subsection (9)(b) does not allow the creation of an exception from restrictions imposed by data protection legislation which will still need to be complied with.
816. Subsection (10) enables the regulations to limit the businesses subject to a requirement to report or provide information by reference to the manufacturers’ or commercial suppliers’ connection to the United Kingdom, or a part of it.
817. Subsection (11) defines connected person and relevant person. Subsection (11)(a) and (11)(b)(ii) allow these terms to be further defined in regulations.
818. Subsection (12) provides definitions for terms used in this section.

Section 93: Regulations under section 92 (information about payments etc to persons in the health care sector): enforcement

819. Subsection (1) enables regulations to make provision for the enforcement of the requirements set out in regulations made under section 92(1) including giving the Secretary of State the power to impose a financial penalty where a person, without reasonable excuse, fails to comply with a requirement imposed by regulations made under section 92 (Subsection (1)(a)) or provides false, misleading information (Subsection (1)(b)).
820. Subsection (2) requires the regulations to make provision about the amount of any financial penalty.
821. Subsection (3) provides that the regulations must include provision about the process for issuing a financial penalty including provision for an appeals process.
822. Subsection (4) enables regulations to make provision: enabling a notice of intent or final notice to be withdrawn or amended (paragraph (a)); enabling a final notice to be withdrawn in specified circumstances (paragraph (b)); enabling the financial penalty to be increased by a specified amount in the event of late payment (paragraph (c)); and detailing how a financial penalty would be recoverable (paragraph (d)).

Section 94: Regulations under section 92 (information about payments etc to persons in the health care sector): consent

823. Subsection (1) places an obligation on the Secretary of State to obtain the consent of the Scottish Ministers, Welsh Ministers, and Department of Health in Northern Ireland in relation to any provision in regulations made pursuant to section 92 which is within the legislative competence of the relevant devolved legislature, and is not merely incidental to, or consequential on, provision which would be outside the competence of that legislature. The subsection states that consent must be obtained before regulations are made.
824. Subsection (2) clarifies that the Secretary of State will not need to seek consent from the Northern Ireland Assembly where the provision would only incidentally affect a transferred matter and, if the provision were included in an Act of the Northern Ireland Assembly, the Act would require the consent of the Secretary of State under section 8 of the Northern Ireland Act 1998.

Section 95: Information standards

825. Subsection (2) amends section 250 (powers to publish information standards) of the 2012 Act, by substituting subsections (2) and (6), inserting new subsections (2A), (2B), and (6A) to (6D), and omitting subsection (5).
826. The substituted subsection (2) defines "an information standard" as a standard in relation to the processing of information (as opposed to as a document containing such standards).
827. New subsection (2A) provides that an information standard must specify to whom it applies.
828. New subsection (2B) describes the persons who an information standard may apply to, being the Secretary of State, NHS England, any public body which exercises functions in connection with the provision of health care or adult social care in England and any person other than a public body who is required to be registered under Chapter 2 of Part 1 of the Health and Social Care Act 2008 in respect of the carrying on of a regulated activity.
829. Subsection (5) of section 250 of the 2012 Act, which specified that an information standard must include guidance about implementation of the standard, is omitted.
830. The substituted subsection (6) requires the Secretary of State to have regard to any information standard published by NHS England which applies to the Secretary of State and to comply with any information standard published by the Secretary of State which applies to the Secretary of State.
831. New subsection (6A) provides that any other person to whom an information standard applies must comply with the standard, except in so far as the requirement to comply is waived as permitted in regulations made under subsection (6B).
832. New subsection (6B) enables regulations to empower a person publishing an information standard to waive the requirement to comply (wholly, partially, generally or for a specific period of time).
833. New subsection (6C) enables those regulations to limit the circumstances when a waiver may be granted, to set out a procedure for waivers, and to require specific information about waivers to be included in an information standard.
834. New subsection (6D) signposts to section 277E of the 2012 Act for enforcement of information standards against persons other than public bodies.
835. Subsection (3) substitutes section 251 of the 2012 Act and inserts a new section 251ZA into that Act. The substituted section 251 requires regulations to set out the procedure to be followed in connection with preparing and publishing information standards under section 250 and enables regulations to require information standards to be reviewed from time to time. It requires the Secretary of State to consult appropriate persons before laying draft regulations in Parliament and allows the Secretary of State and NHS England to adopt any information standard prepared or published by another person.
836. The new section 251ZA (information standards: compliance) enables the Secretary of State to require documents, records or other information from a person to enable the Secretary of State to monitor that person’s compliance with information standards. The Secretary of State must set out any requirement in writing and the requirement may set out how and when the person must provide the information. Subsection (4) of the new section 251ZA signposts to section 277E of the 2012 Act in respect of enforcement against persons other than public bodies.
837. Subsection (4) inserts the definitions of "Health services", "Adult social care" and "public body" into section 251C of the 2012 Act.
838. Subsection (5) ensures that any regulations containing provisions made under section 250(6B) (waivers of information standards) or 251(1) (the procedure for setting information standards), will be subject to the draft affirmative procedure.

Section 96: Sharing anonymous health and social care information

839. This section amends Chapter 1A of Part 9 of the 2012 Act. It inserts, after existing section 251C, a new section 251D relating to the sharing of anonymous information for purposes related to the functions of health or adult social care bodies in England.
840. Subsection (1) specifies that a public body which exercises functions in connection with the provision of health services or adult social care in England may require information, other than personal information, from another such public body or from another person who provides health services or adult social care in England. The power applies only in relation to information that relates to the activities of the relevant public body or private provider in connection with the provision of health services or adult social care in England (in pursuance of arrangements made with a public body in the case of a private provider).
841. Subsection (2) specifies that a health or social care body may only impose a requirement to provide information under subsection (1) for purposes relating to that body’s functions in connection with the provision of health services or adult social care in England.
842. Subsection (3) sets out that regulations may be made to create exceptions to the power to require information. Exceptions could apply to specific, named bodies, descriptions of bodies, descriptions of information, or other exceptions (such as where information is commercially sensitive).
843. Subsection (4) sets out that a body on whom a requirement may be imposed under subsection (1) is not required to process information so as to render it into a form in which it must be provided. They are only required to share information if they already hold it in a form that does not identify an individual, or enable the identity of an individual to be ascertained. The effect of subsection (4) is also that they would not be required to process information that would otherwise be subject to an exception introduced by regulations, for example, by redacting information that is subject to an exception.
844. Subsection (5) signposts to section 277E of the 2012 Act in respect of enforcement against private health or social care providers.
845. Subsection (6) sets out the definitions of certain terms for the purposes of the new section 251D.

Section 97: General duties of the Health and Social Care Information Centre etc

846. This section amends section 253(1) (general duties of the Information Centre) of the 2012 Act which sets out the matters which the Information Centre must have regard to when exercising functions. It inserts a new paragraph requiring the Information Centre to have regard to the need to promote the effective and efficient planning, development and provision of health services and of adult social care in England when exercising its functions. Section 253(1) is also amended to clarify that the Information Centre has to have regard to the need to balance the needs mentioned in section 253(1) so far as they compete.
847. This section also amends section 261 (dissemination of information) of the 2012 Act so that the Information Centre may only share information for purposes connected with the provision of health care or adult social care or the promotion of health. It is intended that this will put beyond doubt the Information Centre’s power to share data in connection with health care or adult social care. This could include for example commissioning, planning, policy analysis and development, population health management, assessment of the quality of services and individuals’ experiences of them, workforce planning, research for purposes which benefit or are relevant to the provision of health or adult social care and developing approaches to the delivery of health and adult social care.

Section 98: Collection of information from private health care providers

848. This section amends section 259(1) of the 2012 Act which sets out the Information Centre’s powers to require and request the provision of information. The effect of the amendment is to additionally enable the Information Centre to require private providers of health services to provide to the Information Centre any information it requires in order to comply with a direction from the Secretary of State under section 254 of the 2012 Act to establish an information system. This does not include information which the Information Centre requires in order to comply with requests under section 255 of the 2012 Act.
849. Paragraphs (c) to (g) of this section make consequential amendments to section 259.
850. Paragraph (h) of this section signposts to new section 277E of the 2012 Act for the enforcement of requirements against persons other than public bodies and defines "health care providers".

Section 99: Collection of information about adult social care

851. This section inserts into Part 9 of the 2012 Act a new Chapter 3 which contains sections 277A, 277B, 277C and 277D concerning information about adult social care.
852. New section 277A(1) enables the Secretary of State to require certain providers of adult social care services to provide to the Secretary of State information relating to themselves, their activities in connection with providing adult social care in England, or individuals they have provided adult social care to in England or, where those services are commissioned by a Local Authority in England, outside England.
853. Subsection (2) stipulates that the Secretary of State can only require information if it is for purposes connected with the health care system, or the adult social care system, in England.
854. Subsection (3) enables the Secretary of State to specify the form and manner in which information must be provided, and when the information must be provided.
855. Subsection (4) states that the requirement to provide information must be in writing.
856. Subsection (5) provides that providing information under this section does not breach any obligation of confidence (which would include the common law duty of confidentiality) but is subject to any other express restrictions on disclosing information imposed by any enactment. This would include restrictions under the Data Protection Act 2018 and the UK GDPR.
857. Subsection (6) signposts to section 277E in respect of enforcement.
858. Subsection (7) defines "adult social care", "English local authority", and "relevant provider of adult social care services" for the purposes of section 277A.
859. Section 277B imposes restrictions on the disclosure of information provided under section 277A.
860. Subsection (1) restricts the disclosure of information provided under section 277A so that it may only be disclosed for purposes connected with the health care system or adult social care system in England.
861. Subsection (2) further restricts the disclosure of that information so that commercially sensitive information may not be disclosed unless the Secretary of State considers disclosure to be appropriate, having taken into account the public interest as well as the interests of the person to whom that information relates.
862. Subsection (3) sets out that subsections (1) and (2) do not restrict the disclosure of information where: consent has been given or the information has previously been lawfully disclosed to the public; or where the disclosure is in accordance with any court order, is necessary or expedient for the purposes of protecting the welfare of any individual, is necessary or expedient for the purposes of a person’s exercise of functions under any Act, is in connection with the investigation of a criminal offence within or outside the United Kingdom, or is for the purpose of criminal proceedings within or outside the United Kingdom.
863. Subsection (4) defines the term "commercially sensitive information".
864. Section 277C(1) empowers the Secretary of State to direct the Health and Social Care Information Centre to exercise the functions of the Secretary of State under section 277A and provides that the restrictions on disclosure of information set out in section 277B apply in such a case.
865. Subsection (2) empowers the Secretary of State to direct a Special Health Authority performing functions only or mainly in respect of England to exercise the functions of the Secretary of State under section 277A and provides that the restrictions on disclosure of information set out in section 277B apply in such a case.
866. Subsection (3) empowers the Secretary of State to direct the Information Centre or the Special Health Authority in question about the exercise of any functions that it is directed to exercise under subsection (1) or (2). This includes directions as to the processing of information that the body obtains in exercising those functions.
867. Section 277D(1) enables the Secretary of State to make arrangements for a person (prescribed by regulations) to exercise the functions of the Secretary of State under section 277A and provides that the restrictions on disclosure of information set out in section 277B apply in such a case.
868. Subsection (2) enables those arrangements to provide for the Secretary of State to make payments to the person as well as to set out circumstances where the payments must be repaid.
869. Subsection (3) enables those arrangements to make provision of a kind which may be made in directions under the 2012 Act, such as provision for the person in question to exercise the Secretary of State’s functions wholly or to a limited extent and in specific cases or circumstances or more generally.

Section 100: Enforcement of duties against private providers

870. This section inserts into Part 9 of the 2012 Act a new Chapter 4 containing section 277E which concerns provision in relation to enforcement and section 277F which concerns directions to a Special Health Authority to exercise the enforcement functions under regulations made under section 277E.
871. Section 277E(1) provides a power for regulations to enable the Secretary of State to impose a financial penalty on various persons. Those persons are a person other than a public body who, without reasonable excuse: fails to comply with an information standard unless the relevant requirement has been waived (subsection (1)(a)); fails to comply with a requirement to provide information imposed under section 251ZA(1), 251D(1)(b), 259(1)(a) or (aa), or 277A(1); or provides false or misleading information (subsection (1)(c)).
872. Subsection (2) states that the amount of the financial penalty is to be specified in, or determined in accordance with, the regulations.
873. Subsection (3) requires the regulations to include provision requiring the Secretary of State to give a person written notice of intention to impose a financial penalty before it is imposed; ensuring a person is given an opportunity to make representations; requiring the Secretary of State, following representations, to decide whether to impose the financial penalty and to give a final notice in writing imposing the penalty; enabling a person to appeal to the First-tier Tribunal; and setting out the powers of the Tribunal on such an appeal.
874. Subsection (4) states that the regulations may include provision: enabling amendment or withdrawal of a notice of intent or final notice; requiring the Secretary of State to withdraw a final notice in circumstances specified in the regulations; for a financial penalty to be increased if paid late; and for recovery of financial penalties in the county court.
875. Subsection (5) sets out the definition of "public body".
876. Section 277F enables the Secretary of State to direct a Special Health Authority performing functions only or mainly in respect of England to exercise the enforcement functions under regulations under section 277E and to give directions to the Special Health Authority about the exercise of those functions.

Section 101: Medicine Information Systems

877. Subsection (1) provides that the following provisions amend the Medicines and Medical Devices Act 2021.
878. Subsection (2) substitutes "Regulations: general" for the heading of Chapter 1 of Part 2.
879. Subsection (3) inserts a new Chapter 1A (Regulations: Information Systems) after Chapter 1 of Part 2 of the Medicines and Medical Devices Act 2021, which consists of a section 7A and 7B. The new section 7A confers a power on the appropriate authority to make regulations providing for a system of information in relation to medicines to be established and operated by the Health and Social Care Information Centre ("the Information Centre"), and specifies the type of provision which can be included in the regulations. In relation to England, Scotland and Wales, the "appropriate authority" is the Secretary of State. In relation to Northern Ireland, the "appropriate authority" is the Department of Health in Northern Ireland acting alone, or the Secretary of State and the Department of Health in Northern Ireland acting jointly. "Appropriate authority" is defined in section 2 (Power to make regulations about human medicines) of the Medicines and Medical Devices Act 2021. The definition reflects the position whereby key functions under the Human Medicines Regulations 2012 (S.I. 2012/1916) are carried out by the Licensing Authority, which consists of both Secretary of State and Northern Ireland Minister.
880. New section 7A(1) provides that regulations may be made about the establishment and operation, by the Information Centre, of one or more information systems. The power is restricted to purposes relating to the safety of human medicines, including the safety of clinical decisions relating to human medicines, and the quality and efficacy of human medicines. Such purposes may include the generation of high-quality evidence regarding the use, benefits and risks of these medicines to inform regulatory decision making, supporting local clinical practice and providing patients and prescribers with the evidence they need to make better informed decisions.
881. Subsection (1)(a) and (c) of section 19 of the Medicines and Medical Devices Act 2021 makes specific provision relating to devices that are placed on the market, and about the improvement of medical device safety and performance through advances in technology. It was necessary for these subsections to be worded in this way to distinguish between devices on the market and those that are not, and to make specific provision about technological developments in relation to the latter. However, when it comes to subsection 7A(1), this wording was not necessary given the differences in the regulation of medicines and medical devices.
882. Section 7A(2) describes the type of provision that the regulations may make. This is a non-exhaustive list. Provision may be about the type of information that could be gathered, for example this may be information relating to a particular medicine, patients who are prescribed the medicine or prescriber information. Regulations may also impose requirements to provide that information to the Information Centre and make provision about the use or disclosure of that information and requirements that may be placed on the Information Centre in exercising its functions under the regulations. These provisions ensure that the Information Centre is able to mandate the provision of specific information to be included in the information system and that the Information Centre is able to use and disclose such information.
883. Section 7A(3) sets out additional information about the kind of provision which may be made pursuant to section 7A(2)(a) and (b). It provides that regulations concerning the information which is to be collected and entered into any medicines information system may relate to information for specified purposes, information that the Information Centre considers necessary or expedient to carry out its functions under the regulations, information which is of a specified description that may relate to individuals and information described in a written direction given by the appropriate authority, which may also relate to individuals. Relying on these powers, regulations can specify the type of information required so that for example, details of patients, and their prescribers can be recorded and monitored to improve pharmacovigilance. It also ensures that the appropriate authority can set out in a direction the details of what information must be collected. Directions may be used as a means to enable the appropriate authority to specify what information needs to be collected by the Information Centre for each registry. This will enable the appropriate authority to promptly amend what information is collected by the Information Centre, as public health needs change or develop, and the need for new or different information emerges. It also ensures that the appropriate authority can set out in a direction the details of what information must be collected.
884. Section 7A(4) goes on to specify the kind of provision which can be included in the regulations pursuant to section 7A(2)(b).
885. Section 7A(4)(a) provides that the regulations may specify the persons, or categories of persons who may be required to provide information to the Information Centre. Those persons or categories must fall within section 7A(5). For example, the regulations would be able to set out the types of healthcare providers who are required to submit information to the Information Centre, including private providers and providers in devolved administrations. This would enable the collection of comprehensive, UK-wide information.
886. Section 7A(4)(b) provides that regulations may specify the time and manner in which the information required must be provided or for those matters to be determined by the Information Centre. This provision can be used to ensure the Information Centre receives the information in a way that can be easily analysed by requiring providers to send information by a specific time and in a specific format.
887. Section 7A(4)(c) provides that regulations may describe any procedural steps the Information Centre must follow when requiring a person to provide information. This ensures secondary legislation can set out the way in which the Information Centre would need to request information from providers, for example taking into account that the process for collecting information may vary in devolved territories.
888. Section 7A(4)(d) provides that regulations may specify that required information is recorded or retained. Regulations can for example set out what information must be recorded and stored and the duration of storage of such information.
889. Section 7A(4)(e) provides that regulations may include provision about the enforcement of requirements imposed by regulations made under section 7A(1). This provides a mechanism to set out in secondary legislation how the collection of information would be enforced.
890. Section 7A(5) sets out who may be required to store information and/or provide it to the Information Centre. This is limited to any person who provides services, or exercises any powers or duties, relating to human medicines, health or education. This means that information can be collected from providers such as healthcare providers, private providers and providers of education services. For example, data relating to education and child development may be required in a registry to understand the potential for neurodevelopment disorders in those exposed to medicines in utero or transgenerational effects on the children of people who were exposed to the medicine.
891. Section 7A(6) provides a non-exhaustive list of provisions that may be included in the regulations on the use and disclosure of information held within the information system (section 7A(2)(c)). These include the analysis of that information (whether alone or linked with other information), the publication of that information (or of information that has been analysed in combination with it), the disclosure of that information to specified persons or descriptions of persons or for specified purposes, and the use or further disclosure of that information by any person to whom information has been disclosed under the regulations. This means that the Information Centre would be able to link non-information system data such as data already collected by the Information Centre, with information system data and share this with, for example, the MHRA for the purpose of establishing registries.
892. Section 7A(7) provides that where regulations confer a power on the appropriate authority to give a direction under section 7A(3)(d), they must provide that the power includes a power to vary or revoke the directions by a subsequent direction. This means previous directions can be changed or replaced if there are circumstances where a new direction was needed. For example, if further information was required to be collected for an existing medicines registry. This section also provides that where regulations confer a power on the appropriate authority to give a direction under section 7A(3)(d), the appropriate authority must consult with Scottish or Welsh Ministers before giving a direction that relates to Scotland or Wales respectively.
893. Section 7A(8) and (10) provides that where the Information Centre will require information from healthcare providers in Scotland and/or Wales, the regulations must allow for Scottish and or Welsh Ministers (as applicable), or a person designated by them, to collect the required data. Regulations will also be able to set out exceptions to this whereby, under certain circumstances, the Information Centre can collect the data directly. For these purposes, section 7A(9) and (11) enables regulations to confer powers or duties on Scottish or Welsh Ministers, or a person designated by them so that they have all of the powers or duties that they need to make this arrangement work.
894. Section 7A(12) enables regulations made pursuant to section 7A(1) to provide that disclosure of information for the purposes of medicines information systems does not contravene an obligation of confidence owed by the person making the disclosure or any other restriction on the disclosure of information, other than a restriction imposed by data protection legislation. These provisions will allow regulations to include provision setting aside duties of confidence as well as other restrictions on disclosure of information. No disclosure would be able to contravene data protection legislation. This provision would ensure that the Information Centre can disclose information, including information that has been lawfully linked under this section, onwards, for example to the MHRA for the purposes of establishing a registry.
895. Section 7A(13) defines terms used in section 7A.
896. Section 7B creates a new offence related to information disclosure.
897. Section 7B(1) provides that a person commits an offence if they receive information under regulations made under section 7A(1) and then use or disclose that information in contravention of those regulations. This is to ensure information included in the information system is used and disclosed appropriately and is consistent with the provision made for disclosure of information contained in medical devices information systems.
898. Section 7B(2) outlines the maximum penalties for these offences. These are:
     • As a result of a summary conviction in England and Wales, which is an offence that is triable in a magistrates’ court, a person can be imprisoned for up to 51 weeks, receive a fine, or both.
     • As a result of a summary conviction in Scotland or Northern Ireland, a person can be imprisoned for up to 6 months, or receive a fine not exceeding level 5 on the standard scale, or both. A level 5 on the standard scale references the scale of fines for summary offences as outlined in the Criminal Justice Act 1982.

899. Section 7B(3) outlines that the maximum 51 weeks imprisonment outlined in section 7B(2)(a) is to be read as 6 months if the offence is committed before section 281(5) of the Criminal Justice Act 2003 is commenced.
900. Subsection (4) amends section 19 (medical devices: information systems) of the Medicines and Medical Devices Act 2021 as described below.
901. Subsection (4)(a) amends subsection (6) of section 19 to provide for publication and other disclosure of information that has been analysed in combination with information contained in a medical device information system.
902. Subsection (4)(b) inserts a new subsection (7A) after section 19(7) that inserts the same provision as section 7A(12) into section 19, so allowing regulations to provide that a disclosure of information for the purposes of medical devices information systems does not contravene an obligation of confidence owed by the person making the disclosure or any other restriction on the disclosure of information, other than a restriction imposed by data protection legislation.
903. Subsection (5) amends section 43 (power to make consequential etc provision) of the Medicines and Medical Devices Act 2021. Where regulations made under sections 7A or 19 make consequential provision by virtue of section 43(2)(a), the new section 43(3) to will ensure that those regulations may change the territorial extent of provisions of Chapter 2 of Part 9 of the 2012 Act (constitution and functions etc of the Health and Social Care Information Centre), or otherwise amend that Chapter. In establishing and operating the medicines and medical devices information systems the Information Centre will have more substantial functions in relation to Scotland and Northern Ireland than it had prior to the Medicines and Medical Devices Act 2021 as amended by this Act. To ensure effective functioning and operation of the information systems it is therefore appropriate to ensure that certain provisions of the 2012 Act which relate to NHS Digital’s functions under the Medicines and Medical Devices Act, could form part of the law of the whole of the UK, rather than just England and Wales, if deemed necessary.
904. Subsection (6) amends section 44 (scope of Northern Ireland departments) of the Medicines and Medical Devices Act 2021 to require that regulations under section 7A(1) cannot be made by a Northern Ireland Department acting alone unless the provision would fall within the legislative competence of the Northern Ireland Assembly and would not require the consent of the Secretary of State.
905. Subsection (7) amends section 45 (consultation) to include 7A(1) in the list of sections in subsection (6)(a). This provides that consultation on regulations made pursuant to section 7A(1) is to be carried out by the appropriate authority. Subsection (7)(a) also provides a requirement for the appropriate authority to specifically consult Welsh and Scottish Ministers (as appropriate) on regulations under section 7A(1) if regulations concern Scotland or Wales.
906. Subsection (8) amends section 46 (reporting requirements) so that regulations made under section 7A(1) are subject to the same reporting requirements as medicines regulations made under section 2.
907. Subsection (9) amends section 47 (procedure for regulations) to ensure the procedure for making regulations under section 7A(1) is the same as that for medicines regulations made under section 2 of the Medicines and Medical Devices Act 2021 (the draft affirmative procedure).
908. Subsection (10) amends section 253 of the 2012 Act (general duties of Information Centre), to provide that subsections (1) and (2) of that section do not apply in relation to the functions of the Information Centre by virtue of the Medicines and Medical Devices Act 2021. This is because the duties in section 253 are England-specific and therefore not appropriate to the UK-wide functions conferred on the Information Centre by the Medicines and Medical Devices Act 2021.