National Health Service (Scotland) Act 1978

• Citation: 1978 c. 29
• Sections: 510

Section 1 General duty of Secretary of State.

(1) It shall continue to be the duty of the Secretary of State to promote in Scotland a comprehensive and integrated health service designed to secure—

(a) improvement in the physical and mental health of the people of Scotland, and,

(b) the prevention, diagnosis and treatment of illness,

and for that purpose to provide or secure the effective provision of services in accordance with the provisions of this Act.

(2) The services so provided shall be free of charge, except in so far as the making and recovery of charges is expressly provided for by or under any enactment, whenever passed.

Section 1A Duty of the Scottish Ministers to promote health improvement

(1) It is the duty of the Scottish Ministers to promote the improvement of the physical and mental health of the people of Scotland.

(2) The Scottish Ministers may do anything which they consider is likely to assist in discharging that duty including, in particular—

(a) giving financial assistance to any person,

(b) entering into arrangements or agreements with any person,

(c) co-operating with, or facilitating or co-ordinating the activities of, any person.

(3) Subsections (1) and (2) are without prejudice to section 1 and any other provision of this Act conferring or imposing functions on the Scottish Ministers.

Section 2 Health Boards.

(1) The Secretary of State

(a) shall by order constitute in accordance with Part I of Schedule 1 boards for such areas as he may by order determine, for the purpose of exercising such of his functions relating to the health service as he may so determine , and for the purpose of making arrangements on his behalf for the provision of the services mentioned in Part II; and those boards shall , without prejudice to subsection (1B), be called Health Boards and

(b) subject to subsections (1A) and (1C), may by order constitute boards, either for the whole of Scotland or for such parts of Scotland as he may so determine, for the purpose of exercising such of his functions relating to the health service as he may so determine; and those boards shall, without prejudice to subsection (1B), be called Special Health Boards.

(1A) An order made under subsection (1)(b) may determine an area for a Special Health Board constituted under that subsection which is the same as the areas determined—

(a) for any other Special Health Board; or

(b) for any Health Board or Health Boards constituted by an order or orders made under subsection (1)(a).

(1B) An order under subsection (1) may specify the name by which a board constituted by the order shall be known.

(1C) The Secretary of State may by order provide that such of the provisions of this Act or of any other enactment, or of any orders, regulations, schemes or directions made under or by virtue of this Act or of any other enactment, as apply in relation to Health Boards shall, subject to such modifications and limitations as may be specified in the order, so apply in relation to any Special Health Board so specified.

(2) The order or orders made under subsection (1)(a) determining the areas for which the Health Boards are to be constituted shall be separate from the order or orders constituting those Boards; and, before making any order determining such an area, the Secretary of State shall consult with such bodies and organisations as appear to him to be concerned.

(3) The Secretary of State may by order vary the area of any Health Board, whether or not the variation involves the constitution of a new Board, or the termination of the functions of an existing Board; and, before making such an order, the Secretary of State shall consult with such bodies and organisations as appear to him to be concerned.

(4) Any order under subsection (3) may make provision for any supplementary and incidental matters for which it appears to the Secretary of State to be necessary or expedient to provide, in particular for the transfer of officers and of property and liabilities.

(5) In carrying out the purposes mentioned in subsection (1) and in exercising any function otherwise conferred on them by or under this Act or by or under the 2021 Act each Health Board shall act subject to, and in accordance with, such regulations as may be made, and such directions as may be given, by the Secretary of State; and such regulations and directions may be made or given generally or to meet the circumstances of a particular area or matter.

(6) Regulations under subsection (5) shall make provision requiring each Health Board to submit to the Secretary of State a scheme for the exercise of their functions (other than functions conferred on them by or under the 2021 Act) , and enabling the Secretary of State to approve any such scheme with or without modifications, and to make such a scheme in the event of the failure of any Health Board to do so.

(7) A Health Board may at any time, and if directed by the Secretary of State shall, within such period as he may specify, submit a new scheme for the exercise of their functions, and regulations making the provision mentioned in subsection (6) shall, with any necessary modifications, apply to any such scheme.

(8) A Health Board shall, notwithstanding that it is exercising functions on behalf of the Secretary of State, be entitled to enforce any rights acquired, and shall be liable in respect of any liabilities incurred (including liability in damages for wrongful or negligent acts or omissions), in the exercise of those functions in all respects as if the Health Boared were acting as a principal; and all proceedings for the enforcement of such rights or liabilities shall be brought by or against the Health Board in its own name.

(9) A Health Board shall not be entitled to claim in any proceedings any privilege of the Crown in respect of the recovery or production of documents; but this subsection shall be without prejudice to any right of the Crown to withhold, or procure the withholding from production of, any document on the ground that its disclosure would be contrary to the public interest.

(10) Schedule 1 shall have effect in relation to the Boards constituted under this section.

(10A) Schedule 1A makes provision for the election of individuals to be members of Health Boards.

(11) Where it appears to the Secretary of State to be expedient in the interests of efficiency that a joint committee should be established for the areas of two or more Health Boards for the purpose of exercising some but not all of their functions, the Secretary of State may by order constitute such a joint committee and provide for the exercise by that committee or such of those functions as may be specified in the order, and for the application, with such modifications as may be so specified, to that committee of any provisions of this Act relating to those functions, and for any of the matters for which, in relation to a Health Board, provision is or may be made by or under Part II of Schedule 1.

Section 2A Duty of Health Board, Special Health Board , the Agency and HIS to promote health improvement

(1) It is the duty of every Health Board and Special Health Board and of HIS and the Agency to promote the improvement of the physical and mental health of the people of Scotland.

(2) A Health Board, a Special Health Board the Agency or HIS may do anything which they consider is likely to assist in discharging that duty including, in particular—

(a) giving financial assistance to any person,

(b) entering into arrangements or agreements with any person,

(c) co-operating with, or facilitating or co-ordinating the activities of, any person.

(3) Subsections (1) and (2) are without prejudice to any other provision of this Act conferring or imposing functions on a Health Board, a Special Health Board , the Agency or HIS .

(4) Anything done by a Health Board or Special Health Board in pursuance of subsection (1) or (2) is to be regarded as done in exercise of functions of the Scottish Ministers conferred on—

(a) the Health Board by the order under section 2(1)(a) which constituted the Board, or

(b) the Special Health Board by the order under section 2(1)(b) which constituted the Board,

as the case may be.

Section 2B Duty to encourage public involvement

(1) It is the duty of every body to which this section applies to take action with a view to securing, as respects health services for which it is responsible and services which it has the function of providing to individuals under the 2021 Act , that persons to whom those services are being or may be provided are involved in, and consulted on—

(a) the planning and development, and

(b) decisions to be made by the body significantly affecting the operation,

of those services.

(2) This section applies to—

(a) Health Boards,

(b) Special Health Boards, and

(c) the Agency.

(3) For the purposes of subsection (1) a body is responsible for health services if they are health services—

(a) which it is the function of the body to provide, or secure the provision of, and

(b) which are provided, or to be provided, to individuals by—

(i) the body, or

(ii) another person on the body's behalf, at the body's direction or in accordance with an agreement made by the body with that other person.

Section 2C Functions of Health Boards: primary medical services

(1) Every Health Board—

(a) must, to the extent that they consider necessary to meet all reasonable requirements, provide or secure the provision of primary medical services as respects their area; and

(b) may, to such extent, provide or secure the provision of primary medical services as respects the area of another Health Board,

and primary medical services provided, or the provision of which is secured, by a Health Board under or by virtue of this subsection may be performed outside their area.

(2) For the purpose of securing the provision of primary medical services under subsection (1), a Health Board may make such arrangements for the provision of the services as they think fit . . . .

(2A) But any contractual arrangement which a Health Board makes in pursuance of subsection (2) (other than an NHS contract) must be an agreement under section 17C, a general medical services contract or a contract which meets the requirement in subsection (2B).

(2B) The requirement is that, were the contract an agreement under section 17C, the parties to the contract (other than the Board) would be persons with whom the Board could enter into such an agreement by virtue of section 17CA.

(3) A Health Board must publish information about such matters as may be prescribed in relation to the primary medical services provided under this Part.

(4) Without prejudice to sections 12J and 13, Health Boards must co-operate with one another in discharging their respective functions relating to the provision of primary medical services under this Part.

(5) Regulations may provide that services of a prescribed description are, or are not, to be regarded as primary medical services for the purposes of this Act.

(6) Such regulations may in particular describe services by reference to the manner or the circumstances in which they are provided.

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(8) Anything done by a Health Board in pursuance of subsection (1) or (2) is to be regarded as done in exercise of functions of the Scottish Ministers conferred on the Health Board by an order under section 2(1)(a).

Section 2D Equal opportunities

(1) Health Boards, Special Health Boards , the Agency and (as respects its health service functions only) HIS must discharge their functions in a manner that encourages equal opportunities and in particular the observance of the equal opportunity requirements.

(2) In this section “ equal opportunities ” and “ equal opportunity requirements ” have the same meaning as in Section L2 (equal opportunities) of Part II of Schedule 5 to the Scotland Act 1998 (c. 46).

Section 2CB

Functions of Health Boards outside Scotland

(1) Where it is the function of a Health Board to provide or to secure the provision of a service, the Health Board may secure the provision of that service outside Scotland.

(2) For the purposes of securing the provision of any service referred to in subsection (1), a Health Board may make such arrangements for the provision of the service as they think fit (and may in particular make contractual arrangements with any person).

(3) Anything done by a Health Board in pursuance of subsection (1) or (2) is to be regarded as done in exercise of functions of the Scottish Ministers conferred on the Health Board by an order under section 2(1)(a).

Section 2CB Functions of Health Boards: planning of pharmaceutical care services

(1) Regulations may make provision requiring every Health Board, in accordance with the regulations, to—

(a) prepare a plan for the discharge of their duty under section 2CA(1);

(b) keep a plan prepared under paragraph (a) under review;

(c) prepare a revised plan; and

(d) without prejudice to section 2CA(3), publish a plan so prepared or revised.

(2) Regulations under subsection (1) may in particular make provision as to—

(a) identification by a Health Board in any such plan prepared by them of—

(i) what pharmaceutical care services they consider are necessary in order to discharge their duty under section 2CA(1);

(ii) whether as respects their area there is convenient access (as regards location and opening hours) to pharmaceutical care services; and

(iii) any under-provision of pharmaceutical care services as respects their area;

(b) the period within which a plan is to be prepared and published;

(c) consultation which a Health Board must undertake in relation to the preparation of a plan;

(d) the duration of a plan;

(e) the frequency with which a plan must be reviewed and revised by a Health Board;

(f) the availability and accessibility of a plan to persons who are resident in a Health Board's area; and

(g) such other matters as the Scottish Ministers consider appropriate.

(3) Regulations making provision as to a matter referred to in subsection (2)(a) may provide that the matter is to be identified in accordance with such criteria as may be specified in directions given by the Scottish Ministers.

Section 3 Scottish Medical Practices Committee.

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Section 4 Scottish Dental Estimates Board.

(1) For the purpose of carrying out such duties as may be prescribed with respect to . . . dental treatment and appliances, regulations shall make provision for constituting a board, to be called the Scottish Dental Estimates Board, (hereafter in this Act referred to as “ the Dental Estimates Board ”), of whom the chairman and a majority of members shall be dental practitioners.

(1A) Regulations may empower the Dental Practice Board—

(a) to direct a dental practitioner or body corporate entitled, by virtue of section 43 of the Dentists Act 1984 (c. 24), to carry on the business of dentistry to submit to the Board, in relation to treatment which he, or as the case may be, it has carried out or contemplates carrying out or to a description of such treatment specified in the direction, such estimates and information and such radiographs, models or other items as may be prescribed; and

(b) to direct a dental practitioner or such a body corporate not to carry out treatment, or a description of treatment specified in the direction, without first obtaining approval of an estimate from the Board.

(1B) If regulations include any such provision as is mentioned in subsection (1A)(b) above, regulations shall confer on a dental practitioner or body corporate in whose case a direction such as is mentioned in that paragraph has been given a right of appeal against the direction to a prescribed person or body, but before making regulations conferring such a right the Secretary of State shall consult such organisations as appear to him to be representative of persons providing general dental services.

(1C) Regulations may be made authorising or requiring the Dental Practice Board to carry on any such additional activity relating to the provision of general dental services as may be prescribed and, without prejudice to the generality of this subsection, to conduct or commission surveys or other research relating to the provision of such services.

(2) Regulations made in pursuance of this section shall include provision, in relation to the Dental Estimates Board, for any of the matters for which, in relation to a Health Board, provision is or may be made by or under Part II of Schedule 1.

Section 4A Community health partnerships

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Section 4B Community health partnerships: further provision

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Section 7 Local health councils.

(1) Every Health Board shall, within such period as the Secretary of State may specify, submit to him a scheme for the establishment of a local health council or councils for their area or for such districts covering their whole area as the Board thinks fit; and it shall be the general function of any such council to represent the interests of the public in the health service in the area or district for which they have been established.

(2) A scheme under subsection (1) shall provide for the appointment . . . by the Health Board, after consultation with such other organisations as may be specified in the scheme, of such number of members as may be so specified.

(3) The Secretary of State may approve, with or without modifications, any scheme submitted to him under subsection (1), or may refuse to approve it.

(4) A Health Board may at any time, and if directed by the Secretary of State shall, within such period as he may specify, submit a new scheme under this section, and subsection (3) shall apply to any such new scheme.

(5) The members of a local health council may appoint one of their own number as the chairman of the council.

(6) The Secretary of State shall pay to the members of a local health council, and of the committees and sub-committees thereof and of any body established under subsection (9)(g), such travelling and other allowances, including compensation for loss of remunerative time, as he may with the approval of the Minister for the Civil Service, from time to time determine.

(7) Allowances shall not be paid under subsection (6) except in connection with the performance of such powers or duties, in such circumstances, as the Secretary of State may determine.

(8) Health Boards shall consult with local health councils on such occasions and to such extent as may be prescribed.

(9) Regulations may make provision—

(a) enabling local health councils to consider questions relating to the health service in their area or district, whether at the request of their Health Board or otherwise, and to advise the Health Board thereon;

(b) enabling or requiring local health councils to submit reports to their Health Board on the operation of the health service in their area or district;

(c) requiring local health councils to submit annual reports on their activities to their Health Board and requiring Health Boards to transmit a copy of any such report to the Secretary of State;

(d) enabling local health councils to obtain information from their Health Board and from any NHS trust in their area or district on such subjects and subject to such conditions as may be prescribed;

(e) enabling or requiring members of a local health council to visit establishments administered by their Health Board and establishments in their area or district administered by NHS trusts , subject to such conditions as may be prescribed;

(f) relating to the submission of schemes under subsection (1) and to the functions, procedures, staffing and expenses of local health councils;

(g) for the establishment of a body—

(i) to advise local health councils with respect to the performance of their functions, and to assist those councils in the performance of their functions; and

(ii) to perform such other functions as may be prescribed;

(h) relating to the membership, proceedings, staff, premises and expenses of any body established under paragraph (g).

Section 8 University Liaison Committees.

(1) The Secretary of State may by order constitute, in accordance with Schedule 4, for the area of a Health Board or for the combined areas of two or more Health Boards, a University Liaison Committee for the purpose of advising that Board or those Boards and any NHS trusts in the area or combined areas on the administration of the health service in that area or those areas so far as relating to the provision of facilities for undergraduate or post-graduate clinical teaching or for research, and for the purpose of advising that Board or those Boards , any such NHS trust and the university or universities concerned on any matter of common interest to them.

(2) Paragraphs 11 to 15 of Schedule 1 (other than sub-paragraph (d) of paragraph 11) shall have effect in relation to the Committees constituted under this section.

Section 9 Local consultative committees.

(1) Where, a Health Board is satisfied that a committee formed for its area is representative —

(a) of the medical practitioners of that area, or

(b) of the dental practitioners of that area, or

(c) of the nurses and midwives of that area, or

(d) of the pharmacists of that area, or

(e) of the ophthalmic and dispensing opticians of that area,

the Health Board shall recognise that committee.

(2) Any committee so recognised shall be called—

(a) the area medical committee,

(b) the area dental committee,

(c) the area nursing and midwifery committee,

(d) the area pharmaceutical committee, or

(e) the area optical committee,

as the case may be, for the area concerned.

(3) Where, a Health Board is satisfied that a committee formed for its area is representative of any other profession engaged in the provision of care or treatment under this Act, and that it is in the interests of the health service to recognise that committee for the purposes of this Act, the Board may so recognise it.

(4) Where, a Health Board is satisfied that a committee formed for its area is representative of two or more of the professions mentioned in subsection (1) or (3), and that it is in the interests of the health service to recognise that committee for the purposes of this Act, the Board may so recognise it.

(5) It shall be the general function of a committee recognised under this section to advise the Health Board for its area and, where the Secretary of State so directs, an NHS trust on the provision of services under this Act or under a pilot scheme under section 1 of the National Health Service (Primary Care) Act 1997 , being services with which that committee is concerned in that area, but, except in so far as regulations otherwise provide, in exercising functions conferred by or under this section, such a committee shall not concern itself with the remuneration and conditions of service of practitioners or other persons of whom it is representative.

(6) In addition to any other functions which committees recognised under this section may exercise, they shall exercise such functions as may be prescribed.

(7) In exercising their functions under this Act, Health Boards or, where the Secretary of State so directs, NHS trusts shall consult with committees recognised under this section on such occasions and to such extent as the Secretary of State may direct .

(8) Any committee recognised under this section may, with the approval of the Health Board for its area, delegate any of its functions, with or without restrictions or conditions, to sub-committees and may appoint to any sub-committee persons who are not members of the committee.

(9) Health Boards shall defray the reasonable expenses of committees recognised under this section and shall pay to members of such committees and sub-committees thereof such travelling and other allowances, including compensation for loss of remunerative time, as the Secretary of State may, with the approval of the Minister for the Civil Service, from time to time determine; but payments under this subsection may only be made as respects the exercise of functions conferred by or under this section.

Section 10 Common Services Agency.

(1) There shall be constituted a body, to be called the Common Services Agency for the Scottish Health Service (hereafter in this Act referred to as “ the Agency ”), ...

(1A) The Agency has the functions conferred on it by—

(a) this Act, and

(b) section 62 of the Public Bodies (Joint Working) (Scotland) Act 2014.

(2) Schedule 5 shall have effect in relation to the Agency.

(3) The Secretary of State may by order delegate to the Agency such of his functions relating to the health service as he considers appropriate.

(4) After consultation with . . . , the Health Boards the NHS trusts and any other interests which appear to the Secretary of State to be concerned, the Secretary of State, where he considers it expedient for the efficient discharge of the functions of the Health Boards or of the NHS trusts , may by order provide that the performance of such functions as he may determine shall stand referred to the Agency and be discharged by it on behalf of any or all of the Health Boards or NHS trusts .

(5) The Secretary of State may by order withdraw from the Agency any function delegated or referred to it under this section.

(6) The Agency shall provide such services and carry out such tasks for bodies associated with the health service as the Secretary of State and those bodies may agree, and on such terms and conditions as may be agreed.

(7) In carrying out its functions the Agency shall act subject to, and in accordance with, such directions as may be given by the Secretary of State.

(8) The Agency shall, notwithstanding that it is exercising functions on behalf of the Secretary of State or any other body associated with the health service, be entitled to enforce any rights acquired, and shall be liable in respect of any liabilities incurred (including liability in damages for wrongful or negligent acts or omissions), in the exercise of those functions, in all respects as if the Agency were acting as a principal; and all proceedings for the enforcement of such rights or liabilities shall be brought by or against the Agency in its own name.

(9) The Agency shall not be entitled to claim in any proceedings any privilege of the Crown in respect of the recovery or production of documents; but this subsection shall be without prejudice to any right of the Crown to withhold, or procure the withholding from production of, any document on the ground that its disclosure would be contrary to the public interest.

Section 10A Healthcare Improvement Scotland

(1) There is established a body to be known as Healthcare Improvement Scotland (in this Act referred to as “ HIS ”) which—

(a) is to exercise the functions conferred on it by virtue of this Act and any other enactment (including the 2021 Act) ; and

(b) has the general duty of furthering improvement in the quality of health care and of services provided under the 2021 Act .

(2) In subsection (1)(b), “ health care ” means services for or in connection with the prevention, diagnosis or treatment of illness provided—

(a) under the health service; or

(b) by persons providing independent health care services.

(3) In carrying out its functions, HIS is to act subject to and in accordance with such directions as may be given by the Scottish Ministers.

(4) The Scottish Ministers may vary or revoke any direction given under subsection (3).

(5) Schedule 5A (which makes further provision about the status, constitution, proceedings etc. of HIS) has effect.

Section 10B Principles

(1) HIS must exercise its functions in accordance with the principles set out in the following subsections.

(2) The safety and wellbeing of all persons who use services provided under the health service or under the 2021 Act and independent health care services are to be protected and enhanced.

(3) Good practice in the provision of those services is to be identified, promulgated and promoted.

(4) The provision of those services in a manner which takes appropriate account of guidance and other information (including evidence) published or endorsed by HIS is to be promoted and encouraged.

Section 10C Health service functions

(1) HIS is to exercise the following functions of the Scottish Ministers—

(a) functions in relation to supporting, ensuring and monitoring the quality of health care provided or secured by the health service including, without prejudice to the foregoing generality, providing quality assurance and accreditation;

(b) functions in relation to supporting, ensuring and monitoring the discharge of the duty under section 2B by each body to whom that section applies;

(c) functions in relation to supporting, ensuring and monitoring the discharge of the duty under section 2D by each body to whom that section applies, other than HIS, insofar as the discharge of that duty is relevant to—

(i) the quality of health care provided or secured by the health service; or

(ii) the discharge of the duty under section 2B;

(d) functions in relation to the evaluation and provision of advice to the health service on the clinical and cost effectiveness of new and existing health technologies including drugs,

conferred on them by this Act including, without prejudice to the foregoing generality, those functions specified in section 1(1).

(2) HIS is to exercise the following functions of the Scottish Ministers subject to any limitations specified—

(a) the power of the Scottish Ministers under section 16(1) to assist voluntary organisations whose activities include the provision of a service similar to or related to the functions of HIS;

(b) the power of the Scottish Ministers under section 16B to give financial assistance to voluntary organisations whose activities consist of or include the provision of services similar to or related to the functions of HIS; and such assistance may be given only on such terms and conditions as the Scottish Ministers determine;

(c) the power of the Scottish Ministers under section 42 to disseminate, in respect of the functions of HIS, information relating to the promotion and maintenance of health and the prevention of illness;

(d) the duties of the Scottish Ministers under section 47—

(i) to make available such facilities as appear to HIS to be reasonably required for undergraduate and post-graduate clinical teaching and research and for the education and training of persons providing or intending to provide services under this Act; and

(ii) to conduct, or assist by grants or otherwise under that section any person to conduct, research into matters relating to the functions of HIS;

(e) the powers of the Scottish Ministers under section 79(1) to take on lease or to purchase moveable property and land so far as required for the purposes of HIS and to use for those purposes and manage any heritable or moveable property so acquired;

(f) the powers of the Scottish Ministers under section 79(1A) to dispose of land no longer required for the purposes of HIS.

(2A) HIS is to exercise the following functions—

(a) a duty of supporting, ensuring and monitoring the quality of services provided by Health Boards under the 2021 Act including, without prejudice to the foregoing generality, providing quality assurance and accreditation,

(b) a duty of supporting, ensuring and monitoring the discharge of the duty under section 2B by Health Boards, insofar as the discharge of that duty relates to services provided under the 2021 Act,

(c) a duty of supporting, ensuring and monitoring the discharge of the duty under section 2D by Health Boards, insofar as the discharge of that duty is relevant to—

(i) the quality of services provided under the 2021 Act, or

(ii) the discharge of the duty under section 2B (insofar as the discharge of that duty relates to services provided under the 2021 Act).

(3) HIS is to exercise the following functions—

(a) a duty to provide information to the public about the availability and quality of services provided under the health service or under the 2021 Act ;

(b) a duty to provide such information to a person in such form as that person may reasonably request;

(c) when requested by the Scottish Ministers, a duty to provide to the Scottish Ministers advice about any matter relevant to the health service functions of HIS;

(d) a power to provide such advice to Scottish Ministers at any time;

(e) when asked to do so, a duty to provide such advice to—

(i) persons who provide, seek to provide or may provide services under the health service or under the 2021 Act ;

(ii) persons, or groups of persons, representing those who use, or are eligible to use, such services;

(iii) persons, or groups of persons, representing those who care for those who use, or are eligible to use, such services;

(iv) local authorities;

(v) a Health Board, Special Health Board or the Agency (each a “ body ” for the purposes of subsection (4));

(vi) such other persons, or groups of persons as may be prescribed;

(f) a power to disseminate such information as HIS considers relevant of general or specific application arising out of or in connection with the exercise of its health service functions.

(3A) HIS is to exercise the functions in relation to staffing conferred by virtue of sections 12IP to 12IS and section 12IU.

(4) HIS may charge a reasonable fee determined by it for any advice, forms or documents provided for the assistance of any such person, authority or body as is mentioned in subsection (3)(e).

(5) References in this Act to the health service functions of HIS are, subject to subsections (6) and (7), to the functions conferred by virtue of this section and section 10D (including any functions delegated by order under that section) , and by virtue of sections 12IP to 12IS and section 12IU.

(6) Where a provision of this section which confers a function on HIS refers to the health service functions of HIS, that reference is to be construed as a reference to the functions conferred by virtue of this section , section 10D, sections 12IP to 12IS and section 12IU, other than the function conferred by the provision.

(7) Where a provision of this section which confers a function on HIS refers to the functions of HIS, that reference is to be construed as including a reference to the functions conferred by virtue of this section , section 10D, sections 12IP to 12IS and section 12IU, other than the function conferred by the provision.

Section 10D Health service functions: further provision

(1) The Scottish Ministers may by order delegate to HIS such of their functions relating to the health service as they consider appropriate.

(2) HIS is to provide such services, and carry out such tasks, for bodies associated with the health service as the Scottish Ministers and those bodies may agree; and is to do so on such terms and conditions as may be so agreed.

(3) Notwithstanding that it is exercising functions relating to the health service on behalf of the Scottish Ministers or other bodies associated with the health service, HIS—

(a) is entitled to enforce any rights acquired in the exercise of those functions;

(b) is to be liable in respect of any liabilities incurred (including liability in damages for wrongful or negligent acts or omissions) in the exercise of those functions,

in all respects as if HIS were acting as a principal.

(4) All proceedings for the enforcement of such rights or liabilities are to be brought by or against HIS in its own name.

Section 10E Independent health care functions

(1) HIS is to exercise the following functions—

(a) a duty to provide information to the public about the availability and quality of independent health care services;

(b) a duty to provide such information to a person in such form as that person may reasonably request;

(c) when requested by the Scottish Ministers, a duty to provide to the Scottish Ministers advice about any matter relevant to the independent health care functions of HIS;

(d) a power to provide such advice to the Scottish Ministers at any time;

(e) when asked to do so, a duty to provide such advice to—

(i) persons who provide, seek to provide or may seek to provide independent health care services;

(ii) persons, or groups of persons, representing those who use, or are eligible to use, such services;

(iii) persons, or groups of persons, representing those who care for those who use, or are eligible to use, such services;

(iv) local authorities;

(v) a Health Board, Special Health Board or the Agency (each a “ body ” for the purposes of subsection (2));

(vi) such other persons, or groups of persons as may be prescribed;

(f) a power to disseminate such information as HIS considers relevant of general or specific application arising out of or in connection with the exercise of its independent health care functions.

(2) HIS may charge a reasonable fee determined by it for any advice, forms or documents provided for the assistance of any person, authority or body as is mentioned in subsection (1)(e).

(3) References in this Act to the independent health care functions of HIS are, subject to subsection (4)—

(a) to the functions conferred on HIS, or on a person acting on behalf of HIS, by this section and by sections 10J, 10K, 10P to 10Z3, 10Z5, 10Z8 and 10Z19;

(b) to any functions delegated to HIS under section 10H(6) to the extent that such functions relate to standards and outcomes applicable to independent health care services;

(c) to the functions conferred on HIS by section 10M to the extent that such functions relate to inspections of independent health care services; and

(d) to the functions conferred on HIS by section 10N to the extent that such functions relate to reports on inspections of independent health care services.

(4) Where a provision of this section, or those sections, which confers a function on HIS refers to the independent health care functions of HIS, the reference is to be construed as a reference to the functions conferred by this section and those sections other than the function conferred by the provision.

Section 10F Meaning of “independent health care services”

(1) In this Act, an “independent health care service” is any of the following—

(a) an independent hospital;

(b) a private psychiatric hospital;

(c) an independent clinic;

(d) an independent medical agency;

(e) an independent ambulance service.

(2) In subsection (1)—

“ independent hospital ” means a hospital which is neither a health service hospital nor a private psychiatric hospital; and for the purposes of this definition includes part of a health service hospital if (not being a private psychiatric hospital)—

it is carried on as a separate unit;

it does not provide treatment or nursing in pursuance of this Act;

no part of it is contained within the same building as any such part which does provide treatment or nursing in pursuance of this Act;

“ private psychiatric hospital ” means any premises used or intended to be used for the provision of medical treatment to one or more patients subject to an order or direction under the Mental Health (Care and Treatment) (Scotland) Act 2003 (asp 13) or the Criminal Procedure (Scotland) Act 1995 (c. 46) (whether or not other persons are treated there), not being—

a health service hospital;

a state hospital; or

otherwise an independent health care service;

“independent clinic” means, subject to subsection (2A), a clinic which is not comprised in a hospital and in or from which services are provided by a medical practitioner, dental practitioner, registered nurse, registered midwife , registered pharmacist, registered pharmacy technician or dental care professional;

“ independent medical agency ” means, subject to subsection (2D), an undertaking which consists of or includes the provision of services, other than in pursuance of this Act, by—

a medical practitioner;

a dental practitioner;

a dental care professional;

a registered nurse;

a registered midwife;

a registered pharmacist; or

a registered pharmacy technician;

“ independent ambulance service ” means, subject to subsection (5), a service which consists of or includes—

provision (other than provision falling within paragraph (b) below) of medical treatment, medical care or other care to relevant patients while such patients are being transported to or from a place of medical treatment;

provision, at or in connection with a public event, of medical treatment outwith relevant premises under arrangements made between the provider of the service and another (whether or not the service includes a means of transport for transporting patients from the event to relevant premises).

(2A) A clinic does not fall within the definition of “independent clinic” in subsection (2) if it—

(a) is comprised in a post-16 education body;

(b) is comprised in a school;

(ba) is provided by the Agency, a Health Board or a Special Health Board;

(c) is provided by an employer and services are provided only to the employees of that employer;

(d) provides general dental services in accordance with an agreement pursuant to section 25 of this Act;

(e) provides primary medical services in accordance with an agreement pursuant to section 17C of this Act;

(f) provides services under a general medical services contract pursuant to section 17J of this Act; ...

(g) only provides one or both of the following services—

(i) first aid in situations requiring medical treatment or medical care;

(ii) therapy effected only through the provider of the therapy and the recipient communicating through speech;

(h) provides pharmaceutical services in accordance with arrangements made pursuant to section 27 of this Act; or

(i) is a registered pharmacy within the meaning of section 74 of the Medicines Act 1968.

(2B) In the definitions of “independent clinic” and “independent medical agency” in subsection (2)—

(a) “ dental care professional ” means a registered dental care professional and has the same meaning as in section 53 of the Dentists Act 1984 (interpretation); and

(b) “ registered pharmacy technician ” has the same meaning as in article 3 of the Pharmacy Order 2010 (interpretation).

(2C) In subsection (2A)—

“post-16 education body” has the same meaning as in section 35(1) of the Further and Higher Education (Scotland) Act 2005; and

“school” has the same meaning as in section 135(1) of the Education (Scotland) Act 1980.

(2D) An undertaking does not fall within the definition of “independent medical agency” in subsection (2) if it—

(a) is an independent clinic;

(b) is a hospital;

(c) is a registered pharmacy within the meaning of section 74 of the Medicines Act 1968;

(d) is a nurse agency registered with Social Care and Social Work Improvement Scotland by virtue of section 59 of the Public Services Reform (Scotland) Act 2010;

(e) is provided by an employer and services are provided only to the employees of that employer; or

(f) only provides one or both of the following services—

(i) first aid in situations requiring medical treatment or medical care;

(ii) therapy effected only through the provider of the therapy and the recipient communicating through speech.

(3) In paragraph (a) of the definition of “independent ambulance service” in subsection (2)—

“relevant patient” is a patient—

whose condition or recovery would or might be impaired were the treatment or care mentioned in that paragraph not to be provided;

whose condition affects the patient's mobility to such an extent that, were such treatment or care not to be provided while the patient is being transported as mentioned in that paragraph, the patient's condition or recovery would or might be impaired;

whose mobility is such that, without such treatment or care, it would be difficult or impossible for the patient to be transported as mentioned in that paragraph;

“ place of medical treatment ” means a hospital or other premises used or intended to be used for the provision of medical or dental treatment, and includes an independent health care service mentioned in paragraphs (a) to (d) of subsection (1).

(4) In paragraph (b) of the definition of “independent ambulance service” in subsection (2)—

“ public event ” means an event, function or other organised activity of any kind to which members of the public have access;

“ medical treatment ” includes medical care and medical advice;

“ relevant premises ” means premises used or intended to be used for the provision of medical treatment, medical care or medical advice, but does not include—

any means of transport as mentioned in that paragraph; or

any temporary premises at or near, and provided in connection with, the public event.

(5) A service does not fall within the definition of “independent ambulance service” in subsection (2) if it is provided under the health service, unless it is so provided for remuneration.

(6) In subsection (5), “ remuneration ” does not include remuneration payable by a health service body under arrangements made for the provision of the service.

(7) Where, by virtue of payment of remuneration, the provider of a service under the health service acts as an independent ambulance service, HIS's independent health care functions are exercisable in relation to that provider only where, and to the extent that, the provider is so acting.

Section 10G Power to modify definitions

The Scottish Ministers, after consulting such persons (or groups of persons) as they consider appropriate, may by order—

(a) modify the independent health care functions of HIS by amending, removing or adding to those functions;

(b) modify the definition of independent health care service in section 10F(1).

Section 10H Standards and outcomes

(1) The Scottish Ministers may prepare and publish standards and outcomes applicable to—

(a) services provided under the health service or under the 2021 Act ;

(b) independent health care services.

(2) The Scottish Ministers must keep any standards and outcomes so published under review and may under subsection (1) publish amended standards and outcomes whenever they consider it appropriate to do so.

(3) Before publishing under subsection (1) any—

(a) standards and outcomes;

(b) amended standards and outcomes which in the opinion of the Scottish Ministers are substantially different from the standards and outcomes (or amended standards and outcomes) last so published,

the Scottish Ministers must consult such persons, or groups of persons, as they consider appropriate.

(4) In relation to a service provided under the health service or under the 2021 Act , or an independent health care service, any applicable standards and outcomes published under subsection (1) must be taken into account—

(a) by HIS in making any decision under this Part;

(b) in any proceedings on an appeal under section 10Z4; and

(c) in any proceedings for an offence in relation to registration under section 10P.

(5) The Scottish Ministers may make different provision for different services under subsection (1).

(6) The Scottish Ministers may delegate their functions under subsections (1) to (3) to HIS or such other persons as they consider appropriate.

Section 10I Inspections of services provided under the health service or under the 2021 Act

(1) HIS may inspect any service provided under the health service—

(a) in pursuance of its general duty of furthering improvement in the quality of health care in Scotland, ...

(b) for any of the purposes mentioned in subsection (1B) , or

(c) in pursuance of its functions under sections 12IP to 12IS and section 12IU.

(1A) Where a service provided under the health service and social services are provided by virtue of an integration scheme approved under section 7 of the Public Bodies (Joint Working) (Scotland) Act 2014 (“ the 2014 Act ”), HIS may inspect the planning, organisation or co-ordination of those services for any of the purposes mentioned in subsection (1B).

(1B) The purposes are—

(a) reviewing and evaluating the extent to which the service is complying with the integration delivery principles and contributing to achieving the national health and wellbeing outcomes,

(b) reviewing and evaluating the extent to which the planning, organisation or co-ordination of services provided under the health service and social services is complying with the integration delivery principles and contributing to achieving the national health and wellbeing outcomes,

(c) reviewing and evaluating the effectiveness of a strategic plan prepared under section 29 of the 2014 Act in complying with the integration delivery principles and contributing to achieving the national health and wellbeing outcomes,

(d) encouraging improvement in the extent to which implementation of a strategic plan prepared under section 29 of the 2014 Act complies with the integration delivery principles and contributes to achieving the national health and wellbeing outcomes, and

(e) enabling consideration as to the need for any recommendations to be prepared as to any such improvement to be included in the report prepared under section 10N.

(1C) HIS may inspect any service provided under the 2021 Act in pursuance of its general duty of furthering improvement in the quality of those services.

(2) An inspection under this section must be conducted in accordance with a plan—

(a) prepared in accordance with section 10L; and

(b) approved by the Scottish Ministers.

(3) In this section—

“ integration delivery principles ” has the meaning given by section 31 of the 2014 Act;

“ national health and wellbeing outcomes ” has the same meaning as in section 5(1) of the 2014 Act;

“ social services ” has the meaning given by section 46 of the Public Services Reform (Scotland) Act 2010.

Section 10J Inspections of independent health care services

(1) HIS may inspect—

(a) any independent health care service;

(b) the organisation or co-ordination of any independent health care service.

(c) where services provided by an independent health care service and social services are provided in pursuance of an integration scheme approved under section 7 of the Public Bodies (Joint Working) (Scotland) Act 2014 (“ the 2014 Act ”), the planning, organisation or co-ordination of those services.

(2) The purposes of an inspection under subsection (1)(a) or (b) may include—

(a) reviewing and evaluating the effectiveness of the provision of the services which are the subject of the inspection;

(b) encouraging improvement in the provision of those services;

(c) enabling consideration as to the need for any recommendations to be prepared as to any such improvement to be included in the report prepared under section 10N;

(d) investigating any incident, event or cause for concern; and

(e) enabling consideration as to the need for—

(i) an improvement notice under section 10R;

(ii) a condition notice under section 10U.

(f) reviewing and evaluating the extent to which the independent health care service is complying with the integration delivery principles and contributing to achieving the national health and wellbeing outcomes,

(g) reviewing and evaluating the extent to which the planning, organisation or co-ordination of services provided by an independent health care service and social services is complying with the integration delivery principles and contributing to achieving the national health and wellbeing outcomes,

(h) reviewing and evaluating the effectiveness of a strategic plan prepared under section 29 of the 2014 Act in complying with the integration delivery principles and contributing to achieving the national health and wellbeing outcomes,

(i) encouraging improvement in the extent to which implementation of a strategic plan prepared under section 29 of the 2014 Act complies with the integration delivery principles and contributes to achieving the national health and wellbeing outcomes, and

(j) enabling consideration as to the need for any recommendations to be prepared as to any such improvement to be included in the report prepared under section 10N.

(2A) The purposes of an inspection under subsection (1)(c) may include any of those mentioned in subsection (2)(f) to (j).

(3) An inspection under this section may be in relation to—

(a) any independent health care service or combination of independent health care services;

(b) such of the services concerned provided to particular groups of persons;

(c) any part of Scotland.

(4) An inspection under this section must be conducted in accordance with a plan—

(a) prepared in accordance with section 10L; and

(b) approved by the Scottish Ministers.

(5) HIS may at any time require a person providing any independent health care service to supply it with any information relating to the service which it considers necessary or expedient to have for the purposes of its independent health care functions.

(6) References in this section to a person providing an independent health care service include, in the case of a service which is provided by a body corporate, a reference to a director, manager, secretary or other similar officer of the body.

(7) An inspection under this section may, subject to any regulations made under section 10O, take such form as HIS considers appropriate.

(8) In this section—

“ integration delivery principles ” has the meaning given by section 31 of the 2014 Act;

“ national health and wellbeing outcomes ” has the same meaning as in section 5(1) of the 2014 Act;

“ social services ” has the meaning given by section 46 of the Public Services Reform (Scotland) Act 2010.

Section 10K Authorised persons

(1) Any inspection under section 10J must be carried out by a person authorised by HIS (an “authorised person”).

(2) A person may be authorised by HIS to carry out inspections in relation to any independent health care service or all of them.

(3) An authorised person may at any time enter and inspect premises which are used, or which the person has reasonable cause to believe are used, for the purpose of providing the independent health care service which is the subject of the inspection.

(4) Where an authorised person is in possession of confidential information which has been obtained for the purposes of an inspection under section 10J the authorised person must not use or disclose that information other than—

(a) for the purposes of that inspection;

(b) so as to comply with an enactment or court order requiring disclosure;

(c) to the extent considered necessary by the authorised person for the purpose of protecting the welfare of—

(i) any child under the age of 16 years;

(ii) any adult at risk (within the meaning of section 3 of the Adult Support and Protection (Scotland) Act 2007 (asp 10)); or

(d) to the extent considered necessary by the authorised person for the purpose of the prevention or detection of crime or the apprehension or prosecution of offenders.

(5) For the purposes of subsection (4), information is “confidential information” where—

(a) the identity of an individual is ascertainable—

(i) from that information; or

(ii) from that information and other information which is in the possession of, or is likely to come into the possession of, the person holding that information; and

(b) the information was obtained or generated by a person who, in the circumstances, owed an obligation of confidence to that individual.

Section 10L Inspections: best regulatory practice

(1) HIS must prepare a plan for carrying out inspections in accordance with best regulatory practice.

(2) The plan—

(a) must set out arrangements for inspections to be so carried out (including inspections of those services subject to self evaluation);

(b) may make different provision for different purposes.

(3) For the purposes of subsection (1), “ best regulatory practice ” means practice under which (in particular) inspections should be carried out in a way that is transparent, accountable, proportionate and consistent.

(4) In preparing a plan under subsection (1), HIS must have regard to any guidance issued by the Scottish Ministers about those matters.

(5) HIS—

(a) must keep the plan under review; and

(b) may from time to time revise, with the approval of the Scottish Ministers, the plan.

(6) HIS must, in preparing a plan (or any revisal), consult such persons as it considers appropriate.

Section 10M Inspections at request of Scottish Ministers

(1) HIS must, at the request of the Scottish Ministers, inspect—

(a) any service provided under the health service or under the 2021 Act as they may specify;

(b) any independent health care service so specified;

(c) the organisation or co-ordination of any service mentioned in paragraph (a) or (b) so specified;

(d) any independent health care service so specified together with any service provided under the health service so specified.

(2) The Scottish Ministers may specify purposes for any inspection under this section.

(3) An inspection under this section is to be conducted in accordance with a timetable approved by the Scottish Ministers.

Section 10N Inspections: reports

(1) Where an inspection under section 10I, 10J or section 10M has been completed, HIS—

(a) must prepare a report on the matters inspected; and

(b) must without delay send a copy of that report to the person providing the service which has been inspected.

(2) Before finalising a report prepared under subsection (1), HIS must give the person providing the service an opportunity of commenting on a draft of the report.

(3) HIS must make copies of any report prepared under subsection (1) available for inspection at its offices by any person at any reasonable time; and it must take such other steps as it considers appropriate for publicising any such report.

(4) Regulations may make further provision concerning the preparation, content and effect of reports under subsection (1), and in particular may make—

(a) different provision in relation to different independent health care services and different services provided under the health service;

(b) provision requiring copies of reports to be sent to the Scottish Ministers (or such other persons as may be specified in regulations) in such circumstances as may be so specified;

(c) provision (including provision modifying any duties under this section) specifying circumstances in which—

(i) any right to receive;

(ii) access to;

(iii) availability of,

copies of reports (or of parts of such reports) may be restricted, refused or withheld.

Section 10O Regulations relating to inspections

(1) Regulations may make further provision concerning inspections under—

(a) section 10I;

(b) section 10J;

(c) section 10M.

(2) Regulations under subsection (1) may make different provision for different inspections provided for under the provisions mentioned in that subsection.

(3) Regulations under subsection (1) may, in particular, make provision—

(a) as to types of inspection which may be conducted;

(b) as to timing and frequency of inspections;

(c) as to seizure and removal of anything found during the course of an inspection;

(d) as to persons who may be authorised to carry out inspections;

(e) requiring or facilitating the sharing or production of information (including health records) for the purposes of an inspection;

(f) as to interviews and examinations (including physical and mental examinations) which may be carried out in connection with the inspections;

(g) requiring any person to provide to an authorised person an explanation of information produced to an authorised person;

(h) requiring information produced to an authorised person to be held in compliance with prescribed conditions and further disclosures to be made in compliance with such conditions;

(i) empowering an authorised person to disclose to a person prescribed for the purposes of this paragraph any information of a prescribed nature which the authorised person holds in consequence of an inspection;

(j) creating offences punishable on summary conviction by a fine not exceeding level 4 on the standard scale for the purpose of enforcing any provision of the regulations.

(4) In subsection (3)(e), “ health records ” means records relating to the physical or mental health of an individual (including dental records and medical records); and for the purposes of this subsection “ medical records ” means records which have been prepared by a medical practitioner who is, or has been, responsible for the clinical care of the individual.

Section 10P Registration of independent health care services

(1) A person who seeks to provide a independent health care service must apply to HIS for registration of the service.

(2) An application must—

(a) give such information as may be prescribed about prescribed matters;

(b) identify an individual (who may be the applicant) who is to manage the service;

(c) give any other information which HIS may reasonably require the applicant to give;

(d) without prejudice to subsection (1)(b) of section 10Z5, be accompanied by the fee imposed under subsection (2)(a) of that section;

(e) be accompanied by any annual continuation fee, or any instalment of an annual continuation fee, that remains due in respect of a previous registration of that service that has been cancelled.

Section 10Q Grant or refusal of registration

(1) HIS may grant or refuse registration of an independent health care service under section 10P.

(2) A grant of registration may be subject to such conditions as HIS considers appropriate.

(3) If HIS is satisfied, in relation to the application, that the requirements of—

(a) such regulations as are applicable under section 10Z7; and

(b) any other enactment which appears to HIS to be relevant,

will be complied with in relation to that service, it must give notice under section 10Z(1)(a), or as the case may be section 10Z2; otherwise it must give notice under section 10Z(1)(b).

(4) On granting a registration HIS must issue a certificate of registration to the applicant.

(5) The person for the time being providing the service must ensure that the certificate (or a copy of it) is, while the certificate is current, kept affixed in a conspicuous place in each of the premises in or from which that service is provided; and, if those premises do not include the principal (or only) office of the service, then in that office also.

Section 10R Improvement notices: independent health care services

HIS may at any time give a notice (an “improvement notice”) to the person for the time being providing a registered independent health care service that, unless within such reasonable period as may be specified in the notice, there is a significant improvement, of such a nature as may be so specified, in the provision of that service, it intends to make a proposal under section 10S.

Section 10S Cancellation of registration

(1) HIS may, at any time after the expiry of the period specified in an improvement notice under section 10R given in respect of an independent health care service, propose to cancel the registration of the service—

(a) on the ground that any person has been convicted of a relevant offence in relation to the service;

(b) on the ground that the service is being, or has at any time been, carried on other than in accordance with the relevant requirements; or

(c) on any other ground which may be prescribed.

(2) For the purposes of—

(a) paragraph (a) of subsection (1) the following are relevant offences—

(i) an offence under any of sections 10G to 10Z18 (in this section, “this group of sections”);

(ii) an offence under regulations made under this group of sections; or

(iii) an offence which, in the opinion of HIS, makes it appropriate that the registration should be cancelled; and

(b) paragraph (b) of that subsection, the following are relevant requirements—

(i) any requirements or conditions imposed by or under this group of sections; or

(ii) the requirements of regulations made under this group of sections.

(2A) HIS may propose to cancel the registration of an independent health care service where subsection (2B) applies.

(2B) This subsection applies where—

(a) the service has not paid the fee in respect of the annual continuation of the registration imposed under section 10Z5(2)(b) or, where the service has agreed with HIS to pay an annual continuation fee by instalments, an instalment of that annual continuation fee; and

(b) HIS has given notice that, unless within such reasonable period as may be specified in the notice the fee or instalment is paid, it intends to propose to cancel the registration of the service.

(3) Where a person providing a registered independent health care service ceases to provide the service, HIS may cancel the registration of the service.

Section 10T Emergency cancellation of registration

(1) HIS may apply to the sheriff for an order cancelling the registration of an independent health care service.

(2) The application may be granted if it appears to the sheriff that, unless the order is made, there will be a serious risk to the life, health or wellbeing of persons.

(3) The sheriff may make such interim order as the sheriff thinks fit.

(4) As soon as practicable after HIS has applied for an order under subsection (1), it must notify the appropriate authorities.

(5) Where the order applied for is made (or an interim order is made), HIS must as soon as reasonably practicable give a copy of it to the person who provides the independent health care service.

(6) The sheriff may determine an application under this section in the absence of the person providing the independent health care service to which the application relates.

(7) An order under this section has effect—

(a) from the time at which it is made; or

(b) from such other time as the sheriff considers appropriate.

(8) Within 14 days of the day on which an order under this section is made, an appeal may be made to the sheriff principal against the making of the order.

(9) On an appeal under subsection (8), the sheriff principal may—

(a) confirm the order;

(b) revoke the order;

(c) modify the order;

(d) make such other order as the sheriff principal thinks fit.

(10) The decision of the sheriff principal on an appeal under subsection (8) is final.

(11) An order under this section has effect notwithstanding the making of an appeal in relation to the order.

(12) For the purposes of this section, the appropriate authorities are—

(a) each—

(i) local authority; and

(ii) Health Board,

within whose area the independent health care service is provided; and

(b) any other body established by or under an enactment whom HIS thinks it appropriate to notify.

Section 10U Condition notices

HIS may at any time give notice (in sections 10V, 10W, 10Z1 and 10Z2 referred to as a “ condition notice ”) to the person for the time being providing a registered independent health care service that it proposes to—

(a) vary or remove a condition for the time being in force; or

(b) impose an additional condition,

in relation to the registration.

Section 10V Emergency condition notices

(1) Subsection (2) applies where—

(a) a person is providing a registered independent health care service; and

(b) HIS believes that the absence of a condition in relation to the registration of that service poses a serious risk to the life, health or wellbeing of persons.

(2) HIS may at any time give notice (an “emergency condition notice”) to the person providing the registered independent health care service specifying a condition, in relation to registration, in respect of that risk.

(3) The condition so specified takes effect immediately on receipt of the emergency condition notice.

(4) An emergency condition notice must—

(a) state that, within 14 days after service of the notice, the person to whom it is given may make written representations to HIS concerning any matter which that person wishes to dispute; and

(b) explain the right of appeal conferred by section 10X(1).

(5) HIS must consider any representations made under subsection (4)(a) and, following such consideration, must—

(a) give the person providing the registered independent health care service a condition notice stating that HIS proposes to vary or remove the condition specified in the emergency condition notice; or

(b) notify the person that it does not intend to give such a condition notice.

(6) When notifying a person under subsection (5)(b), HIS must explain the right of appeal conferred by section 10X(1).

(7) Where a condition notice has been given by virtue of subsection (5)(a) containing a proposal to remove the condition, HIS must implement the proposal unless it appears to it that it would be inappropriate to do so.

Section 10W Application of Act to condition notices following emergency condition notices

(1) Section 10Z1 does not apply to a condition notice given by virtue of section 10V(5)(a).

(2) The reference in section 10Z2(5) to a proposal in relation to which a condition notice has been given does not include a reference to a proposal contained in a condition notice given by virtue of section 10V(5)(a) to remove the condition mentioned in that provision.

(3) The reference to a proposal in section 10Z4(1) does not include a reference to a proposal contained in a condition notice given by virtue of section 10V(5)(a) to remove the condition mentioned in that provision.

Section 10X Emergency condition notices: appeals

(1) A person—

(a) who is given an emergency condition notice; and

(b) who—

(i) makes no written representations in accordance with section 10V(4)(a); or

(ii) makes such representations but is notified as mentioned in section 10V(5)(b),

may, within 14 days after the relevant date, appeal to the sheriff against the imposition of the condition.

(2) In subsection (1), “ relevant date ” means—

(a) where sub-paragraph (i) of subsection (1)(b) applies, the date of service of the emergency condition notice;

(b) where sub-paragraph (ii) of that subsection applies, the date notification mentioned in that sub-paragraph is given.

(3) The sheriff may, on an appeal under subsection (1)—

(a) direct that the condition specified in the emergency condition notice is to continue to have effect;

(b) direct that the condition is to cease to have effect;

(c) direct that the condition be varied as specified in the direction;

(d) impose an additional condition in relation to the registration.

Section 10Y Applications in respect of conditions

(1) A person providing a registered independent health care service may apply to HIS—

(a) for the variation or removal of any condition for the time being in force, or for the addition of a condition, in relation to the registration; or

(b) for cancellation of the registration,

but no such application is competent in circumstances mentioned in subsection (2).

(2) The circumstances are that HIS has given the person notice—

(a) under section 10Z(2) of its proposal to cancel the registration (unless HIS has decided not to take that step); or

(b) under section 10Z2(3) of its decision to cancel the registration and the time within which an appeal may be brought has not expired or, if an appeal has been brought, that appeal has not been determined.

(3) An application under subsection (1) must be made in such manner and state such particulars as may be prescribed; and, without prejudice to subsection (1)(b) of section 10Z5, must be accompanied by the fee imposed under subsection (2)(a) or, as the case may be, (c) of that section.

(4) If HIS decides to grant an application under subsection (1)(a) it must give the applicant notice of its decision (stating, where applicable, the condition varied, removed or added) and issue a new certificate of registration.

Section 10Z Further provision as respects notice of proposals

(1) If an application has been made under section 10P and HIS proposes—

(a) to grant that application but to do so subject to a condition which has not been agreed in writing between it and the applicant, it must give the applicant notice of the proposed condition;

(b) to refuse that application, it must give such notice of the proposed refusal.

(2) HIS must give any person who provides a registered independent health care service notice of a proposal to cancel the registration (other than in accordance with an application under subsection (1)(b) of section 10Y).

(3) HIS must give an applicant under subsection (1)(a) of section 10Y notice of a proposal to refuse that application.

(4) A notice under this section must give HIS's reasons for its proposal.

Section 10Z1 Right to make representations to HIS as respects proposals

(1) A condition notice or a notice under section 10Z must state that, within 14 days after service of the notice, the person to whom it is given may make written representations to HIS concerning any matter which that person wishes to dispute.

(2) Where such a notice has been given—

(a) HIS may not decide to implement the proposal until (whichever first occurs)—

(i) where the person to whom the notice was given makes such representations as are mentioned in subsection (1), it has considered those representations;

(ii) that person notifies HIS in writing that such representations will not be made;

(iii) the period of 14 days mentioned in that subsection elapses without such representations being made and without HIS receiving such notification; and

(b) where the circumstances are as mentioned in paragraph (a)(ii) or (iii) above, HIS must implement the proposal unless it appears to it that it would be inappropriate to do so.

Section 10Z2 Notice of HIS's decisions

(1) If HIS decides to grant unconditionally an application made under section 10P, or to grant such application subject only to a condition which has been agreed in writing between HIS and the applicant, it must give the applicant notice of its decision.

(2) A notice under subsection (1) must state the agreed condition.

(3) If HIS decides to implement a proposal in relation to which it has given a person a condition notice or a notice under section 10Z, it must give that person notice of the decision.

(4) A notice under subsection (3) must—

(a) explain the right of appeal conferred by section 10Z4; and

(b) in the case of a decision to implement a proposal—

(i) in relation to which a condition notice has been given, state the condition as varied, the condition which is removed or (as the case may be) the additional condition imposed; or

(ii) of which notice has been given under subsection (1)(a) of section 10Z, state the condition subject to which the application is granted.

(5) Subject to subsection (6), a decision to implement a proposal in relation to which a condition notice has been given or of which notice has been given under subsection (1)(a) or (2) of section 10Z does not take effect—

(a) if no appeal is brought, until the period of 14 days referred to in section 10Z4(1) has elapsed; and

(b) if an appeal is brought, until that appeal is finally determined or is abandoned.

(6) Where the decision is to implement a proposal of which notice has been given under subsection (1)(a) of section 10Z and the applicant notifies HIS in writing, before the period of 14 days referred to in section 10Z4(1) has elapsed, that there will be no appeal, the decision takes effect on receipt of that notification.

Section 10Z3 Conditions as to numbers

Without prejudice to the generality of section 10Q(2) or 10U, a condition imposed under either of those provisions in relation to an independent health care service may limit the number of persons to whom the service may be provided.

Section 10Z4 Appeal against decision to implement proposal

(1) A person given notice under section 10Z2(3) of a decision to implement a proposal may, within 14 days after that notice is given, appeal to the sheriff against the decision.

(2) The sheriff may, on appeal under subsection (1), confirm the decision or direct that is not to have effect; and where the registration is not to be cancelled may (either or both)—

(a) vary or remove any condition for the time being in force in relation to the registration;

(b) impose an additional condition in relation to the registration.

Section 10Z5 Registration fees

(1) The Scottish Ministers, after consulting such persons, or groups of persons, as they consider appropriate on the potential effect of so prescribing on the services which the persons, or persons they represent, provide, may prescribe—

(a) maximum fees which may be imposed by HIS under this section;

(b) circumstances in which fees so imposed are or are not to be payable.

(2) Subject to the provisions of this section, HIS must impose fees in respect of—

(a) any application made for registration of an independent health care service or for cancellation of any such registration;

(b) the annual continuation of any such registration;

(c) any application made for the variation or removal of a condition for the time being in force in relation to any such registration;

(d) issuing to a person a new certificate of registration—

(i) at the instance of that person;

(ii) by virtue of any application by that person; or

(iii) by virtue of any new information provided by that person in pursuance of regulations under this group of sections (within the meaning of section 10S(2)(a)).

(3) Without prejudice to subsection (1)—

(a) HIS must, in fixing fees under this section, have regard to its reasonable expenses in carrying out its functions; but

(b) where it appears to HIS to be appropriate it may charge a nominal fee, or remit the fee altogether.

Section 10Z6 Regulations: registers and registration

(1) Regulations may—

(a) make provision about the keeping of registers by HIS;

(b) make provision about registration under section 10P and in particular about—

(i) the making of applications for such registration;

(ii) the content of certificates of registration;

(iii) categories of applicant who cannot competently make certain applications;

(c) require HIS to secure that, on such conditions, in such circumstances and, subject to subsection (2) on payment of such fees as may be specified in regulations, any person is to be afforded access to, and provided with a copy of an entry in or with an extract from, a register kept by HIS;

(d) except such part of a register as may be specified in the regulations from any requirement made by virtue of paragraph (c);

(e) confer additional functions on HIS in relation to registration under section 10P.

(2) Regulations under paragraph (c) of subsection (1) may specify circumstances in which the fees mentioned in that paragraph are not to be payable; and the fees must in any event not be payable in any case where HIS consider it appropriate to provide the copy or extract in question free of charge.

Section 10Z7 Regulations: independent health care services

(1) Regulations may impose, in relation to independent health care services, any requirements which the Scottish Ministers consider appropriate for the purposes of this Part.

(2) Without prejudice to the generality of subsection (1) regulations may make it an offence to contravene or fail to comply with—

(a) any specified provision of the regulations; or

(b) a condition of registration for the time being in force.

(3) A person who commits an offence under the regulations is liable on summary conviction to a fine not exceeding level 5 on the standard scale.

(4) Before the Scottish Ministers make regulations containing provision as mentioned in subsection (2), they must consult such persons, or groups of persons, as they consider appropriate.