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.