Regulated activity
Regulated activity
All providers of regulated healthcare activities in the United Kingdom must be registered with the CQC and it is an offence to carry on a regulated activity without being registered (section 10(1) HSCA). Section 8(1) HSCA defines “regulated activity” as activity of a prescribed kind; the provision of treatment for a disease, disorder or injury (“TDDI”) by a healthcare professional is a prescribed regulated activity (section 8 HCSA 2008, read with paragraph 4(1) of Schedule 1 to the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (“the 2014 Regulations”)).
By section 20(1) HSCA, the Secretary of State must, by regulations, impose requirements that s/he considers necessary to secure that services provided in the carrying on of regulated activities cause no avoidable harm to the persons for whom the services are provided. By section 20(2), the Secretary of State may by regulations impose any other requirements in relation to regulated activities that the Secretary of State thinks fit, including in particular provision with a view to (a) securing that any service provided in the carrying on of a regulated activity is of appropriate quality, and (b) securing the health, safety and welfare of persons for whom any such service is provided. The relevant regulations made under section 20 include the 2014 Regulations and the Care Quality Commission (Registration) Regulations 2009.
- Heading
- This judgment was handed down by the Judge remotely by circulation to the parties' representatives by email and release to The National Archives. The date and time for hand down is deemed to be 2pm on
- Mrs Justice Eady DBE
- Preliminary issue
- The decisions under challenge and the issues for determination
- The factual background
- The context
- The chronology relevant to the decisions under challenge and the current proceedings
- The registration decision
- The assessment decision
- IP1 patient data
- Advocacy
- O v P
- The statutory framework
- Regulated activity
- Registration of persons who carry on regulated activity
- Reviews and performance assessments
- Fundamental standards
- Statutory guidance for registered persons
- Relevant legal principles
- Process rationality
- Outcome rationality
- The Padfield principle
- The parties’ arguments
- The position of the CQC
- IP1’s position
- Analysis and conclusions
- Process irrationality
- Outcome irrationality
- The Padfield challenge
- Conclusions
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