The Health and Care Act 2022 received Royal Assent in April. Although the majority of the Act is about putting in place the new structures for Integrated Care Systems, there are a number of additional provisions in the Act which bring about certain changes in regulation of the healthcare sector. We outline a summary of the various changes being introduced by the Act below:
CQC Reviews of Integrated Care Boards (Sections 31-32) – set out the CQC’s new role in the regulation of integrated care systems. The CQC must review and report on the provision of health and adult social care within the area of each integrated care board (“ICB”) and the exercise of the functions of the board, its partner local authorities and registered service providers in each ICB and how they all work together. The Secretary of State has to set priorities for CQC to assess in its reviews, which must include leadership and the integration and quality and safety of services. The CQC must prepare, and from time to time revise, a statement setting out how often it will conduct reviews of ICBs and the indicators of quality and methods it proposes to use in assessing the ICB.
CQC Reviews of Adult Social Care Commissioning (Sections 163-165) – set out the CQC’s new role in the regulation of the commissioning of adult social care. The CQC must now conduct reviews and performance assessments of local authorities and publish a report of its assessment. The Secretary of State will set objectives and priorities for CQC to consider when carrying out its reviews. Where a local authority is considered by the Secretary of State to be failing to discharge its functions under Part 1 of the Care Act, the Secretary of State will now have the power to give directions to the local authority: requiring it to act in accordance with advice given by, and collaborate with, the Secretary of State or any nominated person; ultimately, to require the local authority to comply with any instructions and for any specific functions to be exercised by the Secretary of State or a nominated person; and to require the local authority to provide financial assistance in relation to the costs incurred by the Secretary of State or nominated person. Section 165 gives CQC the power to publish, in its reports, in what respects it considers the local authority to be failing and to make recommendations for addressing the failure.
The Health Services Safety Investigations Body (Sections 109-135) – establish the Health Services Safety Investigations Body (“HSSIB”) which will investigate patient safety incidents that occur during the provision of health care services in England. The investigations will not determine blame, civil or criminal liability or whether action needs to be taken in respect of an individual by a regulatory body, but will instead focus on identifying patient safety risks and improvements which can be made to address them. Its remit covers both the NHS and the independent sector; however, even for incidents in the independent sector, the HSSIB must consider potential patient safety learning for NHS services arising from that incident. The HSSIB is under a duty to publish its criteria for determining which incidents it investigates, details of its investigation process including how patients and their families are to be involved and the time periods within which it aims to complete investigations.
The HSSIB is granted various powers of entry, inspection and seizure, and the power to give notice to any person to provide information for the purposes of its investigations. The Act makes it an offence to intentionally obstruct an investigator or fail without reasonable excuse to comply with a notice to provide information, and to knowingly provide false or misleading information to the HSSIB. Although the Act imposes strict provisions limiting the ability of the HSSIB to disclose information it obtains during the course of its investigations, Schedule 4 gives the HSSIB the power to disclose information it obtains in circumstances where the HSSIB believes the disclosure is required to address a serious and continuing safety risk and the person to whom it is disclosed is in a position to address that risk; Schedule 4 also requires the HSSIB to publish guidance as to how and when information may be disclosed under this power. The Act also provides that regulations may be made to require or authorise disclosures of information obtained by the HSSIB in other circumstances. These Regulations are awaited but will be of great interest to providers.
Section 126 imposes duties upon the HSSIB and various other bodies (including any providers of NHS services, NHS England, CQC, and the relevant professional regulators) to cooperate with each other regarding practical arrangements when they are carrying out investigations into the same, or related, incidents. Although the Act requires the HSSIB to publish guidance about what are considered to be “related” incidents, there is no further detail provided as to the nature of the cooperation which is required.
The HSSIB is under a duty to publish a final report into any incident it investigates, which must contain findings of fact and make recommendations as to the action to be taken by any person. The HSSIB may also publish an interim report. The reports are not permitted to name any individual involved in the incident, or who has provided information, without their consent. Before publishing any report, HSSIB must first send a draft to those who could be adversely affected by the report to provide comments before a deadline specified by the HSSIB. Whenever a report makes recommendations for action to be taken by any person, that person is under a duty to respond to any recommendations setting out the actions they propose to take.
Section 117 states that any reports published by HSSIB are not admissible in any civil or criminal court proceedings, or any employment tribunal or hearing before a professional regulator unless authorised by the High Court.
Assistance to Providers – section 127 also requires the HSSIB to provide assistance to NHS bodies in connection with carrying out investigations into incidents occurring “at premises at which NHS services are provided”. This assistance may include providing advice, guidance or training. The HSSIB also has the power to provide such assistance to other bodies (which would include independent providers) and to charge for providing such assistance.
Mandatory training on learning disability and autism (Section 181) – gives the Secretary of State the power to amend the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (i.e. the CQC Fundamental Standards) to require people working in CQC regulated services to receive training on learning disability and autism as appropriate to their role. It also requires the DHSC to issue a code of practice around these training requirements. Interestingly, section 181(7) states that, even before the Fundamental Standards are formally amended in this way, regulation 18 (regarding suitably qualified, competent, skilled and experienced staff) is to be read as if there is already a requirement for all staff to receive training on learning disability and autism which is appropriate to their role.
Hospital Food Standards (Section 173) – gives the Secretary of State the power to make regulations to give CQC the power to regulate food standards in hospitals in England (whether in the NHS or independent sector). The regulations may impose requirements in connection with food or drink provided to any person on hospital premises in England which are regulated by CQC. The regulations may specify nutritional standards or requirements to be complied with, or require that specified descriptions of food or drink are not to be provided or made available. Providers will need to await the detail of any regulations setting out these requirements in terms of hospital food standards.
Early Medical termination Of Pregnancy (Section 178) – makes changes to the Abortion Act 1967 in relation to early medical termination of pregnancy. The amendments provide that prescription and administration of medicine for the purpose of terminating a pregnancy (provided that the registered medical practitioner terminating the pregnancy is of the opinion, formed in good faith, that the pregnancy will not exceed 10 weeks at the time when the medicine is administered) may take place at the usual place of residence of the registered medical practitioner or may be self-administered by the pregnant woman at their usual place of residence in England or Wales, and does not need to take place in an NHS hospital or in a place approved by the Secretary of State for terminations of pregnancy.
Virginity Testing and Hymenoplasty (Sections 136-159) – creates new offences of carrying out, offering to carry out, and aiding or abetting the carrying out of virginity testing (the examination of female genitalia, with or without consent, for the purported purpose of determining virginity) or hymenoplasty (the reconstruction of the hymen with or without consent). Upon conviction, the offence is punishable by a term of imprisonment of up to five years or a fine (or both).
Licensing of cosmetic procedures (Section 180) - gives the Secretary of State the power to make regulations requiring the licensing by local authorities of certain non-surgical cosmetic procedures (which are not regulated by CQC). The precise procedures will need to be specified in regulations but could include procedures that involve the injection of a substance, the application of a substance that is capable of penetrating into or through the epidermis, the insertion of needles into the skin, the placing of threads under the skin, and the application of light, electricity, cold or heat. It is envisaged that licences will be required by both the business proprietor using premises for carrying out specified cosmetic procedures (a premises licence) and the individual practitioners carrying out the procedures (a personal licence). The Regulations will also create offences of trading without a licence and failure to comply with any conditions which may be attached to a licence, as well as enabling local authorities to issue penalty notices. Again, the regulations, and the precise detail of the licensing regime they will impose, is awaited.
Regulation of Health Care and Associated Professions (Section 168) – gives government the power to deregulate regulated health care professionals and social care workers if it is considered that the profession does not appear to require regulation for the protection of the public. The section also gives government the power to abolish, or extend the powers of, healthcare professional regulatory bodies; such bodies may only be abolished if the professions regulated by the body will continue to be regulated by one or more other regulatory bodies, unless the profession has been deregulated altogether.
Medical examiners (Section 169) – relates to medical examiners who may be appointed by NHS bodies to discharge the functions conferred on medical examiners in the Coroners and Justice Act 2009: namely making enquiries and confirming the cause of death. The Act imposes a duty on DHSC (or the Welsh Ministers in Wales) to ensure NHS bodies: appoint sufficient numbers of medical examiners; make sufficient funds and other resources available to enable medical examiners to discharge their functions; and properly monitor the performance of medical examiners.
Extra-territorial commercial dealings of human material for transplantation (Section 170) - extends the remit of offences under section 32(1) of the Human Tissue Act 2004 (relating to the commercial dealings of human material for transplantation) to conduct taking place outside of the UK, where that conduct is carried out by a person who is habitually resident in England and Wales, or who is a UK national and is not habitually resident in Northern Ireland.
Storage of Gametes and Embryos (Section 171) – makes amendments to the Human Fertilisation and Embryology Act in terms of the storage of gametes and embryos. Subject to certain transitional provisions: gametes (and embryos kept in storage for treatment purposes) must not be kept in storage for longer than 55 years; and embryos stored for research or training purposes but not for treatment must not be kept for longer than 10 years beginning with the day on which consent was given. There are also amendments to the processes for renewing consent to the storage of gametes and embryos.
Commencement: With the exception of section 171, which comes into force on 1 July 2022, the above provisions will come into force on such day as the Secretary of State may by regulations appoint.