{
  "url": "https://openlegislation.uk/draft-health-and-social-care-act-2008-regulated-activities-amendment-coronavirus-regulations-2021/regulation-5",
  "json_url": "https://openlegislation.uk/draft-health-and-social-care-act-2008-regulated-activities-amendment-coronavirus-regulations-2021/regulation-5.json",
  "legislation": "ukdsi/2021/9780348224993",
  "legislation_title": "The Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021",
  "legislation_url": "https://openlegislation.uk/draft-health-and-social-care-act-2008-regulated-activities-amendment-coronavirus-regulations-2021",
  "path": "regulation/5",
  "kind": "regulation",
  "number": "5",
  "heading": "Amendment of regulation 12 (safe care and treatment)",
  "text": "In regulation 12, after paragraph (2), insert—\n“(3) For the purposes of paragraph (2)(h), a registered person (“A”) in respect of a regulated activity specified in paragraph 2 of Schedule 1 (accommodation for persons who require nursing or personal care) in a care home must secure that a person (“B”) does not enter the premises used by A unless—\n(a) B is a service user residing in the premises used by A;\n(b) B has provided A with evidence that satisfies A that either—\n(i) B has been vaccinated with the complete course of doses of an authorised vaccine; or\n(ii) that for clinical reasons B should not be vaccinated with any authorised vaccine;\n(c) it is reasonably necessary for B to provide emergency assistance in the premises used by A;\n(d) it is reasonably necessary for B to provide urgent maintenance assistance with respect to the premises used by A;\n(e) B is attending the premises used by A in the execution of B’s duties as a member of the emergency services;\n(f) B is a friend or relative of a service user and that service user is or has been residing in the premises used by A;\n(g) B is visiting a service user who is dying;\n(h) it is reasonably necessary for B to provide comfort or support to a service user in relation to a service user’s bereavement following the death of a friend or relative; or\n(i) B is under the age of 18.\n(4) A registered person provided with information as evidence in accordance with paragraph (3) may process that information.\n(5) Nothing in this regulation authorises the processing of personal data in a manner inconsistent with any provision of data protection legislation.\n(6) In this regulation—\n“authorised vaccine” means a medicinal product—\n(a) authorised for supply in the United Kingdom in accordance with a marketing authorisation; or\n(b) authorised by the licensing authority on a temporary basis under regulation 174 (supply in response to spread of pathogenic agents etc) of the Human Medicines Regulations 2012\nfor vaccination against coronavirus;\n“care home” has the meaning given in section 3 (care homes in England) of the Care Standards Act 2000;\n“complete course of doses” means the complete course of doses specified—\n(a) in the summary of product characteristics approved as part of the marketing authorisation for the authorised vaccine; or\n(b) in the instructions for usage approved as part of the authorisation by the licensing authority on a temporary basis under regulation 174 of the Human Medicines Regulations 2012 for the authorised vaccine;\n“coronavirus” means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);\n“data protection legislation” and “personal data” have the meaning given in section 3 (terms relating to the processing of personal data) of the Data Protection Act 2018;\n“marketing authorisation” has the meaning given in regulation 8(1) (general interpretation) of the Human Medicines Regulations 2012;\n“medicinal product” has the meaning given in regulation 2 (medicinal products) of the Human Medicines Regulations 2012; and\n“the licensing authority” has the meaning given in regulation 6(2) (the licensing authority and the Ministers) of the Human Medicines Regulations 2012.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "S.I. 2012/1916, to which there are amendments not relevant to these Regulations."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "2000 c. 14. Section 3 was amended by paragraph 4 of Schedule 5 to the Health and Social Care Act 2008 (c. 14). There are other amendments to section 3 which are not relevant to these Regulations."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2021/9780348224993/regulation/5",
    "retrieved_at": "2026-10-30T14:46:54.419371+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}