Memorandum of understanding - Systems regulators for the four nations

Published: 29 June 2024 Page last updated: 30 May 2024

Memorandum of understanding between Healthcare Improvement Scotland (HIS), Healthcare Inspectorate Wales (HIW), The Care Quality Commission (CQC), The Regulation and Quality Improvement Authority (RQIA), The Care Inspectorate (CI), and Care Inspectorate Wales (CIW).

Introduction and Purpose of the MoU

The purpose of this Memorandum of Understanding (MoU) is to set out the framework for working relationships between Healthcare Improvement Scotland (HIS), Healthcare Inspectorate Wales (HIW), the Care Quality Commission (CQC), the Regulation, Quality Improvement Authority (RQIA) for Northern Ireland, the Care Inspectorate (CI) and Care Inspectorate Wales (CIW).

HIS is the national healthcare improvement organisation for Scotland. HIW is the independent inspectorate and regulator of healthcare in Wales. The CQC is the independent regulator of health and social care services in England. The RQIA is the independent body responsible for monitoring and inspecting the availability and quality of health and social care services in Northern Ireland. The CI is the independent regulator of social care and social work services in Scotland. Care Inspectorate Wales is the independent regulator of social care and childcare in Wales.

The inspectorates will be referred to as “the parties” collectively and each will be referred to as “a /the party” throughout this document.

The working relationship between the parties is part of the maintenance of a regulatory assurance system for all services of a mutual interest operating in the UK, which promotes patient and social care service user safety and high-quality care. Due to the changing roles of professionals and technological advances, gaps have arisen in the regulatory landscape, potentially posing risks for patients, social care service users, providers, regulators and for the UK regulatory systems. There is a need to consider approaches which can be adopted at a UK level to mitigate these risks and maintain an effective regulatory landscape.

Each of the parties has different scopes of responsibility and regulatory powers, derived from different regulations. The responsibilities and functions of the parties are set out in Annex A: Responsibilities and Functions.

This MoU does not override the statutory responsibilities and functions of the parties and is not enforceable in law. However, the parties agree to adhere to the contents of this MoU and review its operation on a regular basis.

Principles of cooperation

The parties are committed to working together to improve the inspection and regulation system for all services of a mutual interest operating in the UK in line with the five principles of good regulation for non-economic regulators by the Better Regulation Task Force, which are:

  1. Transparency
  2. Accountability
  3. Proportionality
  4. Consistency
  5. Targeting

The parties agree that their working relationship will be characterised by the following standards:

  1. The need to make decisions which promote patient and social care service user safety and high-quality healthcare and social care.
  2. Respect for each party’s independent status.
  3. The need to maintain public confidence in the parties and their respective regulatory processes.
  4. Openness and transparency between the parties as to when cooperation is and is not considered necessary or appropriate.
  5. The need to use resources effectively and efficiently.
  6. Sharing of information, experience, materials and skills to learn from each other and develop effective working practices and work collaboratively to identify improvements that promote high-quality care and patient and social care service users’ safety.
  7. The need to act in good faith to support achievement of the purpose of this MoU and compliance with the principles set out herein.

The parties agree to adhere to statutory requirements and best practice and to comply with all applicable laws and standards including public procurement rules, data protection and freedom of information legislation. In particular, the parties agree to comply with the requirements of any data sharing arrangements set out in this MoU.

Areas of cooperation

The working relationship between the parties involves cooperation in the following areas in accordance with the parties’ respective statutory powers as set out in Annex A:

  1. Routine information sharing (lawful information sharing)
  2. Cross referral of concerns
  3. Strategic collaboration in regulating services, where lawful and appropriate

A named contact with responsibility for each area is identified in Annex B: Lead Contacts.

Routine Information Sharing: The parties will if lawful to do so, each make available information arising from their regulatory activity that may assist the other in its remit. For example, this could be thematic concerns or cross border issues.

Cross-referral of Concerns: Where any party encounter concerns which it believes may fall within the remit of the activities of another party to this MoU, the referring party will at the earliest opportunity convey the concerns and supporting information to a named individual with relevant responsibility at the other party. In the interests of patient and social care service user safety, the referring party will share information at the earliest opportunity, where it is lawful and in the public interest to do so.

  • Urgent concerns may include concerns and relevant information about individual healthcare or social care professionals responsible for users of health and care services as well as health or social care service providers. This would include concerns about leadership and the delivery of high-quality safe care.
  • If any concern falls within the remit of a party’s function, but there is uncertainty whether the concern is sufficiently serious to engage their formal investigation processes, this should be discussed with the party’s key Escalation Contacts identified in Annex B: Lead Contacts.
  • In particular, referrals may be made, if lawful to do so, relating to the following:
    i) Any significant concerns and relevant information about a registered health care or social care professional working in more than one home nation, which may call into question their fitness to practice or the quality of care at a health or social care provider.
    ii) Any significant concerns and relevant information about a health or social care provider operating in more than one home nation, which may call into question the robustness of the clinical or social care governance systems or patient or social care service user safety,
    iii) Any investigations into or follow ups of identified risks in which concerns about individual healthcare or social care professional’s practice have been identified. These may have been brought to the attention of the parties via the professional regulators of health and care professionals (i.e the General Medical Council, Nursing and Midwifery Council etc) across the four nations.
    iv) Any issues arising from its regulatory work which may be useful intelligence to inform the development of a party’s regulatory programme of scrutiny and improvement.
    v) Information about any investigations a party conducts that may be relevant to any or all of the other parties.

Strategic Collaboration: The parties will have regard to circumstances in which their objectives may be best served by collaboration. Each organisation will seek to consider the other when planning their work programmes and identify any possibilities for joint working. They may, by agreement, undertake joint inspection, investigation or other regulatory work, throughout such work the parties will retain and act in accordance with their own respective statutory powers and duties. This work could include:

  1. Joint reviews of information about a health or social care provider
  2. Site visits to a healthcare organisation or social care service
  3. The co-production of documents and reports
  4. Coordination of any follow-up action planning to address any recommendations.

Working arrangements

The parties agree to meet annually. However, when circumstances dictate that more frequent meetings are necessary then these will be arranged by the parties.

The annual meetings will be the forum for the consideration of:

  1. the provisions of this MoU, its effectiveness and updates required;
  2. areas of concern and developing trends involving health and adult social care services including health and care inequalities;
  3. Chains of concern about Fitness to Practise;
  4. Quality Assurance;
  5. Media and Publications; and
  6. any updates to information sharing activities or additional opportunities for information sharing, where possible and appropriate.

The parties shall share responsibilities for hosting these meetings whether in person or virtually and agree an agenda 7 days prior to the meeting. The party hosting the meeting shall take minutes for the meeting which shall be agreed by the parties within 14 days of the meeting taking place.

The representatives of each party with designated responsibility for different areas of cooperation are identified in Annex B: Lead Contacts. will liaise as required to carry out day-to-day business.

Information sharing – Data Protection Legislation

The parties agree to comply with all applicable data protection and privacy legislation in force from time to time in the UK including the Data Protection Act 2018 (DPA 2018) (and regulations made thereunder); the General Data Protection Regulation (UK GDPR) (which has meaning given to it in section 3(10) (as supplemented by section 205(4)) of the DPA 2018); the Privacy and Electronic Communications Regulations 2003 (SI 2003/2426) as amended (collectively referred to as the “Data Protection Legislation”) and all other legislation and regulatory requirements in force from time to time which apply to a party relating to the use of personal data, and any specific organisational codes of practice, frameworks or other policies relating to confidential personal information.

Implementing this MoU will require the partiesto exchange information. All arrangements for collaboration and exchange of information set out in this MoU and any supplementary agreements will be in accordance with the Data Protection Legislation and will take account of and comply with any related codes of practice, protocols or other policies relating to confidential personal information.

Information will only be used for the purposes stated in this MoU, as detailed in individual information sharing agreements or pursuant to each organisation’s statutory objectives and obligations.

The parties will promote isthe lawful, accurate, timely, secure and confidential sharing of information for the purposes stated in this MoU.

Where it is agreed that it is necessary to share confidential personal information it will be shared only if its lawful to do so and the legal basis will be detailed in the individual information sharing agreements.

Personal and sensitive information will only be shared under this MoU where there is a statutory power to do so and the conditions for processing as determined in the Data Protection Act 2018 can be met. Wherever possible, anonymised information should be shared.

The parties agree to ensure that they have in place adequate notifications, privacy notices, policies, procedures, and guidance to do so remains with them.

All information will be supplied in line with the relevant standards for and current best practice in, information quality and security.

Freedom of Information

If a party receives a request under Freedom of Information Act 2000 (FOIA), a Freedom of Information (Scotland) Act 2002 (FOISA), an Environmental Information Regulations 2004 (EIR) an Environmental Information (Scotland) Regulations 2004 (EIRS), or statutory powers request for information provided to it by the other party pursuant to this MoU, it will promptly inform the other party of the request. The other party will without delay consider whether in its opinion the information should be released under FOIA/FOISA/EIR/EIRS/statutory provisions and if not, notify the receiving party and provide details of the exemptions it considers apply and/or details of why it is not in the public interest to release the information within the statutory timescales provided for in FOIA/EIR so as to assist the receiving party in its decision making.

Any final decision in relation to an FOIA/FOISA/EIR/EIRS/statutory powers request is a matter for the party in receipt of the request and it will have absolute discretion in determining whether the information is exempt under the FOIA or FOISA or is to be disclosed in response to the request for information.

Intellectual Property

For the purposes of this MoU the term “Intellectual Property Right” shall have the following meaning: patents, rights to inventions, copyright and related rights, moral rights, trade marks and service marks, business names and domain names, rights in get-up, goodwill and the right to sue for passing off, rights in designs, rights in computer software, database rights, rights to use, and protect the confidentiality of, confidential information (including know-how and trade secrets) and all other intellectual property rights, in each case whether registered or unregistered and including all applications and rights to apply for and be granted, renewals or extensions of, and rights to claim priority from, such rights and all similar or equivalent rights or forms of protection which subsist or will subsist now or in the future in any part of the world.

The parties intend that any Intellectual Property Right created in the course of this MoU shall vest in the party whose employee created them.

Resolution of disagreement

Any disagreement between the parties will normally be resolved at working level through the parties’ contacts responsible for the operations identified in Annex B. If any dispute or disagreement remains unresolved, it may be referred through those responsible for the management of this MoU, up to and including the Chief Executives of the parties, who will be jointly responsible for ensuring a mutually satisfactory resolution.

Charges and Liabilities. Except as otherwise provided, the parties shall each bear their own costs and expenses incurred in complying with their obligations under this MoU.

The parties shall remain liable for any losses or liabilities incurred due to their own or their employee's actions and neither party intends that the other party shall be liable for any loss it suffers as a result of this MoU.

Duration and review of this MoU

This MoU shall commence on the date of signature by all the parties or date of signature by the last party signing it.

This MoU will be reviewed periodically but at a minimum of every three years.

Any party may terminate this MoU by giving at least three months' notice in writing to the other parties at any time.

All organisations have identified a person responsible for the management of this MoU, contact details are provided in Annex B: Lead Contacts. They will liaise as required to ensure this MoU is kept up to date, identify any emerging issues and resolve any questions that arise as to the interpretation of this MoU.

Status

This MoU is not intended to be legally binding, and no legal obligations or legal rights shall arise between the parties from this MoU. The parties enter into the MoU intending to honour all their obligations.

Nothing in this MoU is intended to, or shall be deemed to, establish any partnership or joint venture between the parties, constitute either party as the agent of the other party, nor authorise either of the parties to make or enter into any commitments for or on behalf of the other party.

Governing Law and Jurisdiction

This MoU shall be governed by and construed in accordance with English law and, without affecting section H above (Resolution of disagreement), each party agrees to submit to the exclusive jurisdiction of the courts of England and Wales.

All arrangements for collaboration and exchange of information set out in this MoU and any supplementary agreements will take account of and comply with the Data Protection Act 2018, UK General Data Protection Regulation, the Human Rights Act, the Freedom of Information Act 2000 and the Freedom of Information (Scotland) Act 2002.

Signatures

This MoU will be signed by the parties’ authorised representatives.

Robbie Pearson
Chief Executive
Healthcare Improvement Scotland
Date: January 2024

Alun Jones
Chief Executive
Healthcare Inspectorate Wales
Date: December 2023

Ian Trenholm
Chief Executive
Care Quality Commission
Date: January 2024

Briege Donaghy
Chief Executive
The Regulation and Quality Improvement Authority (Northern Ireland)
Date: December 2023

Jackie Irvine
Chief Executive
The Care Inspectorate
Date: December 2023

Gillian Baranski
Chief Inspector
Care Inspectorate Wales
Date: December 2023


Annex: Responsibilities and functions

The parties acknowledge the statutory responsibilities and functions of each other and will take account of these when working together.

The following text is intended to summarise the main legislative powers exercised by the parties. It is not intended to be exhaustive but is intended to broadly set out the legislative basis under which they operate. References to legislation include legislation as amended. There may be additional legislative provisions upon which the parties will rely from time to time.

Healthcare Improvement Scotland

Healthcare Improvement Scotland (HIS) was established in 2011 as a health body, constituted by the National Health Service (Scotland) Act 1978, as amended by Public Service Reform Scotland Act 2010 and the Public Bodies (Joint Working) Act 2014.

The purpose of HIS under the Act is to work with healthcare providers to drive and support improvements in the quality of healthcare and empower patients and the public.

Our support for the system is underpinned by a number of statutory duties and powers, including:

  • to further improve the quality of health and care
  • to provide information to the public about the availability and quality of NHS services
  • to support and monitor public involvement
  • to monitor the quality of healthcare provided or secured by the health service
  • to evaluate and provide advice to the health service on the clinical and cost effectiveness of new medicines and new and existing health technologies.

HIS strategy for 2023-2028 (Leading quality health and care for Scotland) will secure lasting, positive and sustainable improvements across the whole health and care system. We are uniquely placed to identify the connections and opportunities created by system wide working and to collaborate with all boards and other national organisations to deliver a relentless focus on the safe delivery of effective care.

HIS priorities

  • Priority 1: Enable a better understanding of the safety and quality of health and care services and the high impact opportunities for improvement.
  • Priority 2: Assess and share intelligence and evidence which supports the design, delivery and assurance of high-quality health and care service.
  • Priority 3: Enable the health and care system to place the voices and rights of people and communities at the heart of improvements to the safety and quality of care.
  • Priority 4: Deliver practical support that accelerates the delivery of sustainable improvements in the safety and quality of health and care services across Scotland.

HIS approach

As an improvement organisation we need to work within our resources and be agile in response to changing circumstances while at the same time maintaining a focus on our strategic priorities. HIS will:

  • be innovative, flexible and responsive to changes to the context in which health and care is delivered
  • be an exemplar public sector employer, and
  • play our part in building a more equitable and environmentally sustainable future for Scotland.

The regulatory framework for independent healthcare in Scotland is set out in the National Health Service (Scotland) Act 1978. Currently, the regualtion of Independent Hospitals, Private Psychatric Hospitals and Independent Clinics has been commenced.

Independent clinics are defined in the National Health Service (Scotland) Act 1978 as clinics that are not part of a hospital and from which a medical practitioner, dental practitioner, registered nurse, registered midwife or dental care professional (clinical dental technician, dental hygienist, dental nurse, dental technician, dental therapist, orthodontic therapist) provides a service, which is not part of the National Health Service. The term ‘service’ includes consultations, investigations and treatments. This definition excludes healthcare services that are provided wholly on-line.

Healthcare Inspectorate Wales

Healthcare Inspectorate Wales (HIW) is the independent inspectorate and regulator of healthcare in Wales.

HIW carries out regulation and inspection functions under part 2 of the Care Standards Act 2000 in relation to independent health care in Wales. The Care Standards Act 2000 provides for a registration and inspection regime for the following services:

  • Independent hospitals
  • Independent clinics
  • Independent medical agencies
  • Private Dental Practices

For a service to require registration, it must involve a GMC registered doctor. No other healthcare professionals bring a requirement to register. For online services, the service must be located within Wales.

The Health and Social Care (Community Health and Standards) Act 2003 provides the basis for HIW to undertake assurance work of health care provided by and for Welsh NHS bodies. This legislation gives HIW the power to enter and inspect NHS premises, and to require information and documentation from NHS bodies. The core focus of our work is on patient safety and risk, which is reflected in our methodologies / how we inspect and how we identify services to inspect via the review of intelligence.

The Strategic Plan 2022 – 2025 sets out the following four priority areas for HIW:

  • HIW will focus on the quality of healthcare provided to people and communities as they access, use and move between services.
  • HIW will adapt our approach to ensure we are responsive to emerging risks to patient safety.
  • HIW will work collaboratively to drive system and service improvement within healthcare.
  • HIW will support and develop our workforce to enable them, and the organisation, to deliver our priorities.

Care Quality Commission

The Care Quality Commission (CQC) is an executive non-departmental public body of the Department of Health and Social Care of the United Kingdom.

CQC was established under the Health and Social Care Act 2008 ( ‘the 2008 Act’) as the independent regulator of health and adult social care in England. Its purpose is to make sure health and care services provide people with safe, effective, compassionate, high-quality care and to encourage them to improve.

CQC does this by registering, monitoring, inspecting and regulating hospitals, adult social care services, dental and general practices and other care services in England, to make sure they meet fundamental standards of quality and safety. CQC sets out what good and outstanding care looks like and we make sure services meet these standards which care must never fall below.

CQC reports publicly on what it finds locally, to help people choose care and encourage providers to improve. It also reports annually to Parliament on the overall state of health and adult social care in England.

Schedule 4, Part 2 of the 2008 Act sets out the duties and powers which apply to CQCs interactions with other public authorities when exercising its’ functions. CQC may act jointly with another public authority where it is appropriate to do so for the efficient and effective exercise of its functions. CQC may, if it thinks it appropriate to do so, provide advice or assistance to another public authority for the purpose of the exercise by that authority of that authority's functions.

Disclosure of Information by CQC

Section 76 of the 2008 Act makes it an offence to disclose confidential personal information (personal data obtained by CQC on terms or in circumstances requiring it to be held in confidence) during the lifetime of the data subject. CQC will only disclose confidential personal information where a defence under section 77 of the 2008 Act is engaged.

Section 79 of the 2008 Act lists permitted disclosures of information (whether confidential personal information, or not) that the CQC may make. As with the section 77 defences, these permitted disclosures include disclosure of anonymised information, disclosure with consent, disclosure made in accordance with any enactment (i.e. where the CQC is required by law to provide certain information) or court order, disclosure is made where the information had previously been lawfully disclosed to the public, the disclosure is allowed by regulations relating to complaints about health or social services (under section 113 or 114 of the Health and Social Care (Community Health and Standards) Act 2003), disclosure is necessary or expedient for the purposes of protecting the welfare of any individual, disclosure is made for the purpose of exercising any of the CQC’s functions, disclosure is made in connection with the investigation of a criminal offence or for the purposes of criminal proceedings and where disclosure is necessary or expedient to assist another person or body in exercising statutory functions.

The Regulation and Quality Improvement Authority (Northern Ireland)

Responsibilities and functions of the Regulation and Quality Improvement Authority (Northern Ireland), (RQIA)

RQIA is an independent body established by the Department of Health and Social Services and Public Safety in April 2005, under the Health and Personal Social Services (Quality, Improvement and Regulation) Order (2003 NI) (The Order (2003)).

Under the provision of The Order (2003) the RQIA is required to keep the department informed about the provision, availability and quality or services; and also encourage improvement in the delivery of services.

RQIA has powers to conduct reviews and carry out investigations/inspections into the management, provision, quality of or access to and availability of HSC services; including clinical and social care governance arrangements.

Any person who carries on or manages an establishment or agency must make an application to RQIA to register. Once granted, RQIA issues a certificate of registration to the applicant. RQIA maintains a register of all approved establishments and Agencies.

Under the Mental Health Order (1986 NI) and from 1 October 2019, the Mental Capacity Act, 2016, RQIA undertakes a range of responsibilities for people with a mental illness and those with a learning disability.

RQIA is designated as a National Preventative Mechanism (NPM) under the Optional Protocol to the Convention against Torture and other Cruel, Inhumane or Degrading Treatment or Punishment (OPCAT); an international human rights treaty designed to strengthen protection for people deprived of their liberty. OPCAT requires NPMs to carry out visits to places of detention to monitor the treatment of and conditions for detainees and to make recommendations regarding the prevention of ill-treatment. All NPMs report to and work towards guidance and reports issued by the UN Subcommittee on Prevention of Torture and Other Cruel, Inhuman or Degrading treatment or Punishment.

The RQIA has four core values that underpin their work. In all that they do they will be FAIR – fair and accountable, and act with integrity and respect. RQIA has adopted the regional health and social care values. Which are:

  • Working together
  • Excellence
  • Compassion
  • Openness and honesty

The Care Inspectorate

Social Care and Social Work Improvement Scotland (“the Care Inspectorate”) is a non-departmental public body. It was established under section 44(1) of the Public Services Reform (Scotland) Act 2010 (“the 2010 Act”) as an independent organisation responsible for the scrutiny and improvement of social care, social work and child protection services in Scotland. It is accountable to Scottish Government Ministers and both its Board and Senior Management Team.

The Care Inspectorate has a number of duties and powers specified in the 2010 Act and regulations made thereunder. It has a general duty of furthering improvement in the quality of social services and in so doing, undertakes the registration and inspection of care services, the investigation of complaints about care services and the taking of enforcement action where necessary. The Care Inspectorate is also responsible for carrying out inspections of social work services whether alone or jointly with others and has specific jointresponsibilities to inspect and support improvement of strategic commissioning of integrated health and social care within integrated arrangements. The statutory duty of the Care Inspectorate is to improve the quality-of-care provision within social services in Scotland.

Care Inspectorate Wales

Care Inspectorate Wales (CIW) carries out regulation and inspection functions under the Regulation and Inspection of Social Care (Wales) Act 2016 for:

  • care home services
  • secure accommodation services
  • residential family centre services
  • adoption services
  • fostering services
  • adult placement services
  • advocacy services
  • domiciliary support services

Under part 2 of the Children and Families (Wales) Measure 2010, CIW also regulates and inspects:

  • Child minders
  • Day Care (including Play) for children under twelve

CIW also has powers to inspect independent schools, having regard to the welfare of children accommodated in such schools (part 12 of the Children Act 1989). It can also consider whether to grant a waiver from disqualification from carrying on or being involved in children’s homes under part 8 of the Act.

CIW reviews the operation of local authority social services departments in Wales. The Regulation and Inspection of Social Care (Wales) Act 2016 insert provisions in section 149 of the Social Services and Well-being (Wales) Act 2014 for CIW to review the exercise of local authority social services functions.