http://www.legislation.gov.uk/uksi/2012/921/part/2The Care Quality Commission (Registration) and (Additional Functions) and Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012National Health Service (NHS)Health, well-being and careBusiness practice and regulationCareHealth care services and specialismsenNATIONAL HEALTH SERVICE, ENGLANDSOCIAL CARE, ENGLANDPUBLIC HEALTH, ENGLANDStatute Law Database2026-07-19Expert Participation2015-04-01 These Regulations amend the Care Quality Commission (Registration) Regulations 2009 (“the Registration Regulations”), the Care Quality Commission (Additional Functions) Regulations 2011 (“the Additional Functions Regulations”) and the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 (“the Regulated Activities Regulations”). PART 2 2 The Care Quality Commission (Registration) Regulations 2009 are amended as follows in this Part. 3 In regulation 16 (notification of death of service user)— a for paragraph (1)(b) substitute— b which has, or may have, resulted from the carrying on of a regulated activity. ; b for paragraph (2) substitute— 2 Subject to paragraph (4), where the service provider is a health service body or a provider of primary medical services, the registered person must notify the Commission without delay of the death of a service user where the death— a either— i occurred whilst services were being provided in the carrying on of a regulated activity, ii has, or may have, resulted from the provision of services by a health service body in the course of carrying on a regulated activity, or iii has, or may have, resulted from the provision of primary medical services in the course of carrying on a regulated activity and those services were provided within the period of two weeks prior to the death of the service user; and b cannot, in the reasonable opinion of the registered person, be attributed to the course which that service user’s illness or medical condition would naturally have taken if that service user was receiving appropriate care and treatment. ; and c after paragraph (5) insert— 6 In paragraph (2), “provider of primary medical services” means a person who provides primary medical services pursuant to one of the following sections of the National Health Service Act 2006— a section 3 (Secretary of State’s duty as to provision of certain services), b section 83(2)(b) (primary medical services), c section 84 (general medical services contracts), d section 92 (arrangements for the provision of primary medical services), and provision of primary medical services shall be construed accordingly. . 4 In regulation 17 (notification of death or unauthorised absence of a service user who is detained or liable to be detained under the Mental Health Act 1983)— a in paragraph (1), after “death” insert “in any location” and after “absence” insert “from a relevant location”; b after paragraph (2) insert— 2A The registered person must notify the Commission without delay of the return to a relevant location after a period of unauthorised absence of a service user whose absence is required to be notified under paragraph (1). ; c in paragraph (3), after sub-paragraph (c) insert— ca “relevant location” means a location used to provide secure psychiatric services under a contract with an English NHS body or the Secretary of State; and ; and d omit sub-paragraph (d). 5In regulation 18 (notification of other incidents)—aomit paragraph (2)(c) and (d);bafter sub-paragraph (2)(g) insert—hany placement of a service-user under the age of eighteen in a psychiatric unit whose services are intended for persons over that age where that placement has lasted for longer than a continuous period of 48 hours.;cafter paragraph (4) insert—4AThe registered person must notify the Commission of the following events, which occur whilst services are being provided in the carrying on of a regulated activity, or as a consequence of the carrying on of a regulated activity—aany request to a supervisory body made pursuant to Part 4 of Schedule A1 to the 2005 Act by the registered person for a standard authorisation;bany application made to a court in relation to depriving a service user of their liberty pursuant to section 16(2)(a) of the 2005 Act.4BAny notification required to be given in respect of an event in paragraph (4A) shall be given once the outcome of the request or application is known or, if the request or application is withdrawn, at the point of withdrawal and shall include a statement as to—athe date and nature of the request or application;bwhether the request or application was preceded by the use of an urgent authorisation, within the meaning of paragraph 9 of Schedule A1 to the 2005 Act;cthe outcome of the request or application or reason for its withdrawal; anddthe date of the outcome or withdrawal.. 6 After regulation 22 (appointment of liquidators) insert— 22A Notifications made pursuant to regulations 14 to 18 and 21 and 22 must be made using the forms provided by the Commission for this purpose. . 7 Regulation 26 (penalty notices) is revoked. 8 After Part 6 (compliance, guidance and offences) insert— PART7 27 1 Before 1st October 2017, the Secretary of State must— a carry out a review of these Regulations; b set out the conclusions of the review in a report; and c publish the report. 2 The report must in particular— a set out the objectives intended to be achieved by the regulatory system established by these Regulations; b assess the extent to which those objectives are achieved; and c assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that imposes less regulation. . 9 In Schedule 3 (information to be included in the statement of purpose), for paragraph 3 substitute— 3 The following information— a in relation to the service provider and any registered manager— i full name, ii business address, iii business telephone number, iv electronic mail address where available; and b in relation to the registered person— i the address to which the Commission may send any document, notice or other communication required to be delivered by these Regulations or the Act, and ii where the registered person consents to service by such means, an electronic mail address to which the Commission may send any document, notice or other communication required to be delivered by these Regulations or the Act. . S.I. 2009/3112, as amended by S.I. 2010/49 2006 c.41. Paragraph 3 of Schedule 2 to S.I. 2010/781 which provides that the provision of primary medical services is not a regulated activity ceases to have effect on 1st April 2012 in relation to all activities carried on by providers of out of hours services and on 1st April 2013 for all other purposes: see Regulation 3(8) of S.I. 2010/781 as inserted by Regulation 2(3) of S.I. 2011/2711. 2008 c.14. “English NHS body” is defined by section 97(1). Schedule A1 was inserted into the Mental Capacity Act 2005 (c.9) by paragraph 1 of Schedule 7 to the Mental Health Act 2007 (c.12). Reg. 5(b) in force at 1.4.2013, see reg. 1(2)(c) Reg. 5(a)(c) in force at 18.6.2012, see reg. 1(2)(a)Reg. 4 in force at 18.6.2012, see reg. 1(2)(a)Reg. 6 in force at 18.6.2012, see reg. 1(2)(a)Reg. 7 in force at 18.6.2012, see reg. 1(2)(a)Reg. 8 in force at 18.6.2012, see reg. 1(2)(a)Reg. 9 in force at 18.6.2012, see reg. 1(2)(a)Reg. 2 in force at 18.6.2012, see reg. 1(2)(a)Reg. 3 in force at 1.10.2012, see reg. 1(2)(b)