Regulations are the rules created to implement and enforce a particular legislative act, explaining the “how” to the legislation’s “what”.
As part of the understand step of your change project you should identify the regulations, statutory guidance, and standards relevant to your organisation and the specific services that will be affected by the change. It is important to ensure that any changes comply with regulations, statutory guidance, and standards.
The list below sets of out some the primary regulatory considerations for health and social care in Scotland. NOTE: This is not an exhaustive list.
Key regulatory bodies for health and social care in Scotland include:
- Healthcare Improvement Scotland:
- Conducts quality assurance inspections of NHS hospitals and services.
- Conducts joint inspections (with key partners) of adult support and protection arrangements in Scotland.
- Regulates independent healthcare services in Scotland (including independent hospitals, clinics, hospices, and medical agencies).
- Enforces the Ionising Radiation (Medical Exposure) Regulations (IR(ME)R)) in Scotland.
- Reviews adverse event (events that could have caused, or did result in, harm to people or groups of people).
- Works with His Majesty’s Inspectorate of Prisons for Scotland to manage the healthcare element of inspections of prisons.
Our website provides information on the standards we inspect against and our inspection methodology.
Healthcare Improvement Scotland’s Clinical Governance Standards help to provide assurance that organisations are providing high-quality and safe healthcare in line with best practice, national policy, and legislation.
We also host assurance and improvement programmes and other functions to support organisations to meet relevant statutory guidance and standards, including:
- Healthcare Staffing Programme which supports NHS boards to meet the obligations of the Health and Care (Staffing) (Scotland) Act 2019.
- Excellence in Care which supports staff as they work to deliver high-quality, person-centred care.
- Assurance of Engagement which supports organisations to meet the requirements of Planning with People when planning and commissioning services. Planning with People supports organisations to meet their statutory duties to engage with people and communities when health and social care services are being planned, or when changes to services are being considered, and supports them to involve people meaningfully.
- Care Inspectorate: registers and inspects care services (for example, care homes, nurseries, care at home) to ensure they meet the national standards and undertakes strategic joint inspections with key partners. The website provides details on:
The Care Inspectorate hosts improvement programmes to help those working in the care sector to meet regulatory requirements, including:
- The Safe Staffing Programme which supports the care sector to enact the Health and Care (Staffing) (Scotland) Act 2019.
- Scottish Social Services Council (SSSC): regulates the social care and social work workforce.
- Mental Welfare Commission: monitors the Mental Health (Care & Treatment) (Scotland) Act 2003 and the welfare parts of the Adults with Incapacity (Scotland) Act 2000.
- The health workforce in Scotland is primarily regulated through UK-wide professional bodies (e.g., General Medical Council, Nursing and Midwifery Council, Health and Care Professions Council, etc.)for individual practitioner standards.