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EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations are made under the Care Standards Act 2000 (“the Act”) and they amend the Private and Voluntary Health Care (England) Regulations 2001 (“the 2001 Regulations”): they apply to England.

Regulation 2 amends regulation 2 of the 2001 Regulations to insert new definitions into the 2001 Regulations.

Regulation 3 amends regulation 3 of the 2001 Regulations in two ways.

First, it amends the definition of services whose provision requires an establishment to register as an independent hospital (“listed services”). Paragraph (a)(ii) removes from listed services hyperbaric oxygen therapy which is not carried out by or under the supervision or direction of a medical practitioner; paragraphs (a)(iii) and (b) remove fertility treatments that are already regulated under the Human Fertilisation and Embryology Act 1990; paragraph (e) removes medical treatment under sedation which is not intravenously administered.

Second, paragraph (c) amends the exemptions to the definition of independent hospital by clarifying the scope of the exemption in regulation 3(3)(h) of the 2001 Regulations relating to medical services provided solely under arrangements made by another person and by adding a new exemption for establishments which carry out certain minor surgery under local anaesthesia.

Regulations 4 and 5 amend the meaning of “independent clinic” and “independent medical agency” in regulations 4 and 5 of the 2001 Regulations by clarifying the scope of the exemption in those regulations relating to medical services provided solely under arrangements made by another person.

Regulation 6 amends regulation 26 of the 2001 Regulations to change the frequency at which the registered provider must undertake unannounced visits to an establishment or agency.

An impact assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available from The NHS Medical Directorate of the Department of Health, Standard and Healthcare Commission Relations Unit at Wellington House, London SE1 8UG and is annexed to the Explanatory Memorandum which is available alongside the instrument on the OPSI website.