Draft Regulations laid before Parliament under section 162 of the Health and Social Care Act 2008, for approval by resolution of each House of Parliament.
Draft Statutory Instruments
National Health Service, England
Social Care, England
Public Health, England
Made
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Coming into force
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The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 8(1) and 161 of the Health and Social Care Act 2008(1).
A draft of these Regulations was laid before Parliament in accordance with section 162(3) of the Health and Social Care Act 2008 and approved by a resolution of each House of Parliament.
1.—(1) These Regulations may be cited as the Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020.
(2) These Regulations come into force on the day after the day on which they are made.
2. In Schedule 2 (regulated activities: general exceptions) to the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014(2), after paragraph 11, insert—
“12. Any activity which—
(a)is carried on for the purpose of testing for the presence of severe acute respiratory syndrome coronavirus (“SARS-CoV-2”) in an individual, or for the presence of antibodies to SARS-CoV-2, or
(b)is carried on for the purpose of processing, analysing or reporting the results of a test for the presence of SARS-CoV-2 in an individual, or for the presence of antibodies to SARS-CoV-2.”.
Signed by authority of the Secretary of State for Health and Social Care
Name
Parliamentary Under Secretary of State
Department of Health and Social Care
Date
(This note is not part of the Regulations)
These Regulations make modifications to the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (“2014 Regulations”) which are needed as a result of the effects of the coronavirus pandemic.
The 2014 Regulations prescribe the kinds of activities that are regulated activities for the purposes of section 8 of the Health and Social Care Act 2008. Schedule 2 to those Regulations contains general exceptions to those regulated activities.
Regulation 2 to these Regulations inserts new paragraph 12 into Schedule 2 to the 2014 Regulations. This provides that any activity carried on for the purposes of testing for the presence of SARS-CoV-2 in an individual, or for the presence of antibodies to SARS-CoV-2, is not a regulated activity. In addition, any activity carried on for the purposes of processing, analysing or reporting the results of a test for the presence of SARS-CoV-2, or for the presence of antibodies to SARS-CoV-2, is not a regulated activity.
No regulatory impact assessment has been prepared for these Regulations. An explanatory memorandum has been published alongside this instrument at www.legislation.gov.uk.
2008 c.14. See section 97(1) of the Health and Social Care Act 2008 for the definition of “prescribed”. Section 161(3) of the Health and Social Care Act 2008 was amended by section 294(4) of the Health and Social Care Act 2012 (c.7).
S.I. 2014/2936, to which there are amendments not relevant to these Regulations.