Open disclosure of Part 5 review: information and apology not to invalidate insurance,constitute admission of liability or fault or be admissible in proceedings 41. (1) Information provided, and an apology where it is made, to a patient or a relevant person (or both of them) by a health services provider at a Part 5 review disclosure meeting in respect of a Part 5 review, or pursuant to the provisions specified in subsection (3), the statement referred to in section 49
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(5)and the statements referred to in the provisions specified in subsection (3)— (a) shall not constitute an express or implied admission of fault or liability by— (i) that health services provider, (ii) an employee of that provider (whether the employee is a health practitioner or otherwise), (iii) a health practitioner who provides, or provided, a health service— (I) for, or on behalf of, that provider pursuant to a contract referred to in subparagraph (ii) of paragraph (a), (b) or (c) of the definition of “health services provider”, or (II) for, or on behalf of, or through or in connection with, that provider pursuant to an arrangement referred to in subparagraph (iv) of paragraph (a) of that definition, (iv) an agency health practitioner who provides, or provided, a health service for, or on behalf of, that provider, (v) a health practitioner including, in the case of a health services provider which is a partnership, a partner of a health practitioner, providing a health service for that provider, (vi) an agency worker assigned to that provider pursuant to an agency contract, (vii) a person who enters into a contract or arrangement, referred to in— (I) paragraph (a)(v) of the definition of “health services provider”, or (II) paragraph (b)(iv), or as the case may be paragraph (c)(iv), of that definition, with a health services provider, (viii) by another health services provider where the open disclosure of the Part 5 review is, pursuant to section 37
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(1), made by the health services provider in respect of a Part 5 review which did not occur when it was providing a health service to the patient, or (ix) a person referred to in subparagraph (ii) to (vii) who is an employee of, a health practitioner who provides a health service referred to in subparagraph (iii) to (vi) for, an agency health practitioner who provides a health service for, and a person who enters into a contract with, a health services provider referred to in subparagraph (viii), in relation to Part 5 review or a clinical negligence action which arises (whether in whole or in part) from the consequences of that Part 5 review, (b) shall not, notwithstanding any other enactment or rule of law, be admissible as evidence of fault or liability of— (i) that health services provider, (ii) an employee of that provider (whether the employee is a health practitioner or otherwise), (iii) a health practitioner referred to in paragraph (a)(iii), (iv) an agency health practitioner referred to in paragraph (a)(iv), (v) a health practitioner referred to in paragraph (a)(v), (vi) an agency worker referred to in paragraph (a)(vi), (vii) a person who enters into a contract or arrangement, referred to in— (I) paragraph (a)(v) of the definition of “health services provider”, or (II) paragraph (b)(iv), or as the case may be paragraph (c)(iv), of that definition, with a health services provider, (viii) a health services provider referred to in paragraph (a)(viii), or (ix) a person referred to in paragraph (a)(ix), in a court in relation to that Part 5 review or a clinical negligence action which arises (whether in whole or in part) from the consequences of that Part 5 review, and (c) shall not, notwithstanding— (i) any provision to the contrary in— (I) a policy of professional indemnity insurance, (II) any documentation that comprises an offer, or evidence, of an arrangement for indemnity between a medical defence organisation and a member of that organisation, or (III) a contract of insurance providing insurance cover for claims in respect of civil liability or clinical negligence actions, or (ii) any other enactment or rule of law, invalidate or otherwise affect the cover provided by such policy or contract of insurance that is, or but for such information and such apology would be, available in respect of the Part 5 review concerned or any matter alleged which arises (whether in whole or in part) from the Part 5 review.
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(2)Information provided, and an apology where it is made, to a patient or a relevant person (or both of them) by a health services provider at a Part 5 disclosure meeting in respect of Part 5 review or pursuant to the provisions specified in subsection (3), the statement referred to in section 49
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(5)and the statements referred to in the provisions specified in subsection (3)— (a) shall not constitute an express or implied admission, by a health practitioner, of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission, in the determination of— (i) a complaint under section 57 of the Medical Practitioners Act 2007 , (ii) an application under section 38 of the Act of 1985, (iii) a complaint within the meaning of section 33 of the Pharmacy Act 2007 , (iv) a complaint under section 55 of the Act of 2011, (v) a complaint under section 52 of the Act of 2005, or (vi) an allegation referred to in Article 37 of the Order of 2000, that is made in respect of the health practitioner and which arises (whether in whole or in part) from the consequences of the Part 5 review, and (b) are not, notwithstanding any other enactment, admissible as evidence of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission, in proceedings to determine a complaint, application or allegation referred to in paragraph (a).
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(3)This section shall— (a) in accordance with section 53
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(7), apply to— (i) additional Part 5 review information provided, and an apology where it is made, at the additional Part 5 review information meeting, and (ii) a statement referred to in section 53
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(3), and (b) in accordance with section 54
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(8), apply to information and statements provided in a clarification referred to in, and given under, that section.
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(4)Information provided by a health practitioner to a health services provider under section 38 — (a) shall not constitute an express or implied admission of fault by— (i) that health practitioner, (ii) that health services provider, (iii) a health services provider referred to in subsection (1)(a)(viii), or (iv) a person referred to in subsection (1)(a)(ix), whether the health practitioner is a practitioner referred to in subparagraph (iii) or (v) of subsection (1)(a) or an agency practitioner referred to in subsection (1)(a)(iv), (b) shall not, notwithstanding any other enactment or rule of law, be admissible as evidence of fault or liability of— (i) that health practitioner, (ii) that health services provider, or (iii) a health services provider referred to in paragraph (a)(iii), whether the health practitioner is a practitioner referred to in subparagraph (iii) or (v) of subsection (1)(a) or an agency practitioner referred to in subsection (1)(a)(iv), (c) shall not, notwithstanding— (i) any provision to the contrary in— (I) a policy of professional indemnity insurance, (II) any documentation that comprises an offer, or evidence, of an arrangement for indemnity between a medical defence organisation and a member of that organisation, or (III) a contract of insurance providing insurance cover for claims in respect of civil liability or clinical negligence actions, or (ii) any other enactment or rule of law, invalidate or otherwise affect the cover provided by such policy or contract of insurance that is, or but for such information would be, available in respect of the Part 5 review concerned or any matter alleged which arises (whether in whole or in part) from the Part 5 review, (d) shall not constitute an express or implied admission, by that health practitioner, of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission, in the determination of— (i) a complaint under section 57 of the Medical Practitioners Act 2007 , (ii) an application under section 38 of the Act of 1985, (iii) a complaint within the meaning of section 33 of the Pharmacy Act 2007 , (iv) a complaint under section 55 of the Act of 2011, (v) a complaint under section 52 of the Act of 2005, or (vi) an allegation referred to in Article 37 of the Order of 2000, that is made in respect of the health practitioner and which arises (whether in whole or in part) from the consequences of the Part 5 review, and (e) is not, notwithstanding any other enactment, admissible as evidence of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission, in proceedings to determine a complaint, application or allegation referred to in paragraph (d).
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(5)This section is in addition to, and not in substitution for, any enactment or rule of law relating to the disclosure of information in respect of the provision of a health service.
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(6)In this section— “clinical negligence” means anything done or omitted to be done in the provision of a health service by a health services provider in circumstances which could give rise to liability for damages for negligence in respect of personal injury or death; “clinical negligence action” means an action for the recovery of damages brought— (a) by or on behalf of a person alleging that he or she, or a deceased person of whom he or she is a personal representative, has suffered personal injury or death as a result of clinical negligence, and (b) against the health services provider alleged to have committed the act or omission giving rise to liability or any other person alleged to be liable in respect of that act or omission; “medical defence organisation” means a body corporate, or an unincorporated body, which provides professional indemnity insurance, on a discretionary or other basis, to a member of that body in relation to an incident of clinical negligence which gives rise to a claim against a member of that body; “professional indemnity insurance” means a policy of indemnity insurance to cover claims by or on behalf of a patient (or a relevant person) in respect of any description of civil liability for injury, harm or death that is incurred in the provision of a health service (including the carrying on of the business of the provision of a health service).
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Statement in relation to procedure for open disclosure of Part 5 review and application of section 41 to information and apology 42. (1) A health services provider shall prepare a statement in writing of— (a) its procedure for making an open disclosure of the Part 5 review pursuant to, and in accordance with this Part, and (b) the manner in which section 41 applies to the restrictions on the use, pursuant to this Act, of information provided, and any apology made, at the Part 5 review disclosure meeting, the additional Part 5 review information meeting, or the information provided in a clarification under section 54 and any statements in writing provided in respect of those meetings or that clarification.
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(2)Without prejudice to the generality of section 78 , the Minister may make guidelines in respect of the form of the statement referred to in subsection (1).
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Disclosure of information by health services provider and health practitioner 43. (1) When making an open disclosure of a Part 5 review under this Act, a health services provider shall provide all relevant information in relation to the provision of a health service to the patient (or relevant person as the case may be) that is being provided by that provider to the patient and where appropriate any other health service that is to be, or may be provided, to address the consequences of the Part 5 review.
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(2)When making an open disclosure of a Part 5 review under this Act, a health practitioner shall provide all relevant information in relation to the provision of a health service to the patient (or relevant person as the case may be) that is being provided by that provider to the patient and where appropriate any other health service that is to be, or may be provided, to address the consequences of the Part 5 review.
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(3)The Executive shall have regard to subsections (1) and (2)— (a) in the performance of its functions under section 7 of the Act of 2004, and (b) without prejudice to the generality of paragraph (a), in its management and delivery, under section 7(4) of the Act of 2004, of health and personal social services.
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(4)The Authority shall have regard to subsections (1) and (2) when setting standards referred to in section 8(1)(b) of the Act of 2007.
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(5)A professional regulatory body shall have regard to subsection (2) in the performance of its functions by or under— (a) the Medical Practitioners Act 2007 , (b) the Act of 1985, (c) the Pharmacy Act 2007 , (d) the Act of 2011, (e) the Act of 2005, or (f) the Order of 2000.
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(6)Without prejudice to the generality of subsection (5), a professional regulatory body shall make provision for the obligation referred to in subsection (2) in, having regard to each of the different health practitioners— (a) the standards of practice or guidance referred to in section 7
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(2)(i) of the Medical Practitioners Act 2007 , (b) the guidance referred to in section 66(2) of the Act of 1985, (c) the codes referred to in section 7
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(2)(a)(iii) of the Pharmacy Act 2007 , (d) the code referred to in section 9(2)(g)(iii) of the Act of 2011, (e) the guidance referred to in section 27(3)(c) of the Act of 2005, or (f) the guidelines referred to in Article 4(o) of the Order of 2000.
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(7)In this section— “Act of 2004” means the Health Act 2004 ; “professional regulatory body” means— (a) in the case of a registered medical practitioner or a medical practitioner referred to in paragraph (a) of the definition of “health practitioner”, the Council referred to in the Medical Practitioners Act 2007 , (b) in the case of a registered dentist referred to in paragraph (b) of the definition of “health practitioner”, the Council referred to in the Act of 1985, (c) in the case of a registered pharmacist or registered pharmaceutical assistant referred to in paragraph (c) of the definition of “health practitioner”, the Pharmaceutical Society of Ireland referred to in section 5
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(2)of the Pharmacy Act 2007 , (d) in the case of a registered nurse or registered midwife referred to in paragraph (d) of the definition of “health practitioner”, the Board referred to in the Act of 2011, (e) in the case of a registrant referred to in paragraph (e) of the definition of “health practitioner”, a registration board established by or under the Act of 2005, or (f) in the case of a person referred to in paragraph (f) of the definition of “health practitioner”, the Council referred to in the Order of 2000.
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Making of open disclosure of Part 5 review by health services provider 44. (1) For the purposes of section 37 , the open disclosure of a Part 5 review shall be made on behalf of a health services provider by— (a) the principal health practitioner, in relation to the patient to whom, or in respect of whom, the open disclosure of the Part 5 review is to be made, or (b) where the conditions specified in subsection (2) are satisfied, a health practitioner referred to in that subsection.
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(2)Where, for the purposes of subsection (1)— (a) the principal health practitioner referred to in paragraph (a) of that subsection is not available or otherwise not in a position to make the open disclosure of the Part 5 review, or (b) having had regard to the circumstances of the Part 5 review the health services provider, or the principal health practitioner referred to in paragraph (a) of that subsection, is satisfied that the open disclosure of the Part 5 review should be made by another health practitioner, the open disclosure of that review shall be made by a health practitioner whom the health services provider, having considered the review concerned, considers appropriate.
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Time of making of open disclosure 45. (1) For the purposes of making an open disclosure of a Part 5 review pursuant to section 37 , the health services provider shall make the open disclosure of that Part 5 review at a time when it considers to be appropriate having regard to— (a) the desirability, subject to paragraphs (b) and (c), of making the open disclosure as soon as practicable notwithstanding that— (i) as referred to in section 37
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(2), the health services provider does not have all of the information relating to the Part 5 review available to it when the open disclosure of that review is made, or (ii) without prejudice to subparagraph (i), the health services provider does not have all, or any, of the information in respect of the Part 5 review available to it when the open disclosure of the Part 5 review is made, (b) all the circumstances of the patient and the nature, and consequences, of the Part 5 review concerned, and (c) the requirements of section 46 .
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(2)Having considered the appropriate time for making the open disclosure of the Part 5 review, the health services provider shall take all steps reasonably open to it to make the open disclosure as soon as practicable following that consideration.
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(3)Where an open disclosure of a Part 5 review is not made as soon as practicable after the consideration referred to in subsection (2), nothing in this Act shall be construed as preventing section 41 from having effect in respect of that open disclosure of that review.
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Matters to be addressed by health services provider before making open disclosure of Part 5 review 46. (1) Before making an open disclosure of a Part 5 review a health services provider shall— (a) in order to determine the appropriate time at which to make the open disclosure to the patient or the relevant person (or both of them) and having regard to section 45
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(1)(a)— (i) make an assessment of all the circumstances of the patient and the nature of the Part 5 review, and (ii) consult, having had regard to the circumstances referred to in subparagraph (i), with such other person (if any) as the health services provider considers appropriate, (b) determine, subject to subsection (2), whether the open disclosure of the Part 5 review is to be made to the patient or the relevant person (or both of them) having had regard to— (i) the assessment referred to in paragraph (a)(i), (ii) the nature of the Part 5 review, and (iii) consultations, if any, referred to in paragraph (a)(ii), (c) determine whether, having regard to the nature and circumstances of the Part 5 review concerned, it is appropriate for an apology to be made to the patient or the relevant person (or both of them) at the Part 5 review disclosure meeting, (d) consider the information relating to the Part 5 review and, having regard to the complexity of that information, take all steps as are reasonably open to the health services provider to present that information in as clear a manner as is possible having regard to that complexity, (e) designate, in accordance with section 47 , a person to liaise with the health services provider and the patient or relevant person (or both of them) in relation to the open disclosure of the Part 5 review and in respect of a request for clarification under section 54 , and (f) having regard to the information available, make arrangements for the preparation of the statement, referred to in section 49
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(5), that is to be provided, in accordance with section 49
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(2)to the patient or relevant person (or both of them).
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(2)Subsection (1)(b) shall not apply where an open disclosure of a Part 5 review is made to a relevant person pursuant to section 39
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(1)(b)(ii), (iii) or (1)(c) as the case may be.
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Designated person 47. (1) For the purpose of making a designation under section 46
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(1)(e), where the health services provider making the designation is a health services provider referred to in— (a) paragraph (a) of the definition of “health services provider”, that health services provider may designate— (i) an employee of that provider, including an employee who is a health practitioner, (ii) a health practitioner who provides a health service for that provider pursuant to a contract referred to in paragraph (a)(ii) of that definition, (iii) a person with whom that provider has entered into a contract referred to in paragraph (a)(v)(II) of that definition, (iv) an agency health practitioner who provides a health service for that provider pursuant to an agency contract referred to in paragraph (a)(iii) of that definition, or (v) an agency worker, as the designated person for the purposes of section 46
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(1)(e), or (b) paragraph (b) of the definition of “health services provider”, that provider may designate— (i) himself or herself, (ii) the health practitioner providing the clinical care and treatment to the patient concerned, (iii) an employee of that provider, including an employee who is a health practitioner, (iv) a health practitioner who provides a health service for that provider pursuant to a contract referred to in paragraph (b)(ii) of that definition, (v) a person with whom that provider has entered into a contract referred to in paragraph (b)(iv)(II) of that definition, (vi) an agency health practitioner who provides a health service for that provider pursuant to an agency contract referred to in paragraph (b)(iii) of that definition, or (vii) an agency worker, as the designated person for the purposes of section 46
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(1)(e), (c) paragraph (c) of the definition of “health services provider”, that provider may designate— (i) the partner who is the health practitioner providing the health service to the patient concerned, (ii) any other partner who is a health practitioner in the partnership concerned, (iii) an employee of that provider, including an employee who is a health practitioner, (iv) a health practitioner who provides a health service for that provider pursuant to a contract referred to in paragraph (c)(ii) of that definition, (v) a person with whom that provider has entered into a contract referred to in paragraph (c)(iv)(II) of that definition, (vi) an agency health practitioner who provides a health service for that provider pursuant to an agency contract referred to in paragraph (c)(iii) of that definition, or (vii) an agency worker, as the designated person for the purposes of section 46
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(1)(e), or (d) paragraph (d) of the definition of “health services provider”, that health services provider may designate— (i) himself or herself, (ii) where applicable, the partner who is the health practitioner providing the health service to the patient concerned, (iii) where applicable, the health practitioner providing the clinical care and treatment to the patient concerned, (iv) where applicable, any other partner who is a health practitioner in the partnership concerned, (v) where applicable, an employee of that provider, including an employee who is a health practitioner, (vi) where applicable, a health practitioner who provides a health service for that provider pursuant to a contract referred to, where applicable, in paragraph (b)(ii) or (c)(ii) of that definition, (vii) where applicable, a person with whom that provider has entered into a contract referred to, where applicable, in paragraph (b)(iv)(II) or (c)(iv)(II) of that definition, (viii) where applicable, an agency health practitioner who provides a health service for that provider pursuant to an agency contract referred to, where applicable, in paragraph (b)(iii) or (c)(iii) of that definition, or (ix) where applicable, an agency worker, as the designated person for the purposes of section 46
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(1)(e).
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(2)A designation under this section shall be in writing and shall be kept in the records, referred to in section 56 , relating to the open disclosure of a Part 5 review made under this Act.
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Part 5 review disclosure meeting generally to be held in person
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48.(1) A Part 5 review disclosure meeting shall, subject to subsection (2), be held in person with the patient or relevant person (or both of them).
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(2)A patient or a relevant person (or both of them) may, when contacted by a health services provider pursuant to section 49 to make arrangements to meet with it for the purpose of making an open disclosure, request the provider that the proposed meeting be held other than in person.
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(3)A request under subsection (2) may be made orally.
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(4)Where a request under subsection (2) is made orally, the health services provider shall make a record of the request in writing and maintain it with the records referred to in section 56 .
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Part 5 review disclosure meeting
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49.(1) A health services provider shall, subject to section 45 , make arrangements— (a) to meet with the patient or relevant person (or both of them), or (b) where the patient or a relevant person has (or both of them have) made a request under section 48 , to hold the meeting other than in person, for the purpose of making an open disclosure of a Part 5 review in respect of which the patient, or patient to whom the relevant person is connected, is the subject of the Part 5 review (in this Act referred to as a “Part 5 review disclosure meeting”).
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(2)When making an open disclosure of a Part 5 review at a Part 5 review disclosure meeting, a health services provider— (a) shall provide the patient, or the relevant person (or both of them), with the information specified in subsection (3), which, having regard to section 45 , the health services provider has in its possession, at the time the Part 5 review disclosure meeting is held, (b) may provide the information specified in subsection (3) — (i) orally, and (ii) in the order in which the health services provider considers appropriate, having regard to all the circumstances of the patient or the relevant person (or both of them) and the findings concerned, (c) shall, in accordance with section 55 , give the patient or the relevant person (or both of them) a copy of the statement referred to in subsection (5), and (d) shall give the statement referred to in section 42
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(1)to the patient or relevant person (or both of them) in accordance with section 55 .
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(3)The information, referred to in subsection (2), that is to be provided in accordance with that subsection shall be as follows: (a) the names of the persons present at the Part 5 review disclosure meeting; (b) a description of the Part 5 review concerned; (c) the date on which— (i) the screening which gave rise to the request for the Part 5 review occurred (if known), and (ii) the request for the Part 5 review came to the notice of the health services provider; (d) the manner in which the request for the Part 5 review came to the notice of the health services provider; (e) where, in the opinion of the health services provider, physical or psychological consequences of the Part 5 review which, at the time the Part 5 review disclosure meeting is held, are present or have developed, information in respect of those consequences; (f) where the health services provider has reasonable grounds for believing that, in addition to the consequences referred to in paragraph (e) — (i) physical or psychological consequences which, at the time the Part 5 review disclosure meeting is held, have not presented, or developed, but which, notwithstanding such absence, the health services provider has such grounds for believing they are likely to present or develop at any time after the Part 5 review disclosure meeting, information in respect of those consequences, and (ii) physical or psychological consequences which, at the time of the Part 5 review disclosure meeting have not presented, or developed, and which the health services provider has such grounds for believing they are less likely or unlikely to present or develop at any time after the holding of the Part 5 review disclosure meeting, information in respect of those consequences; (g) where the health services provider has reasonable grounds for believing that no physical or psychological consequences are likely to present or develop from the Part 5 review, a statement to that effect; (h) where, at the time of the Part 5 review disclosure meeting— (i) any physical or psychological consequences arising from the Part 5 review have presented, or developed, and (ii) the patient is under the clinical care of the health services provider concerned, the health services provider shall provide the patient with information in respect of the treatment, and relevant clinical care, that the provider is providing (or proposes to provide) to the patient to address those consequences; (i) having regard to the consideration, by the health services provider, of the Part 5 review—
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(i) the actions the health services provider has taken, or proposes to take, and (ii) procedures or processes to be implemented, in order to, in so far as it is reasonably open to that provider to do so, address the knowledge the provider has obtained from its consideration of the Part 5 review and the circumstances giving rise to it.
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(4)Where, pursuant to section 46
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(1)(c), the health services provider has determined that an apology is to be made to the patient or the relevant person (or both of them), that health services provider may, at the Part 5 review disclosure meeting, make the apology to the patient or the relevant person (or both of them) in respect of the Part 5 review.
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(5)The statement referred to in subsection (2)(c) that is to be given to the patient or the relevant person (or both of them) in accordance with that subsection shall— (a) be in writing, (b) set out the information, specified in subsection (3), provided to the patient or the relevant person (or both of them) in accordance with subsection (2), (c) contain an apology referred to in subsection (4) where such apology was made, (d) state that the open disclosure of the Part 5 review was made pursuant to section 37
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(1), (e) specify the date on which the open disclosure of the Part 5 review was made, (f) state that the Part 5 review disclosure meeting was held in compliance with section 37
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(1), and (g) be signed in accordance with subsection (6).
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(6)The statement referred to in subsection (5), shall be signed by— (a) the principal health practitioner, or (b) the health practitioner referred to in section 44
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(2), who made the open disclosure of the Part 5 review on behalf of the health services provider.
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(7)The health services provider shall keep, in the records referred to in section 56 , the statement referred to in subsection (5).
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Refusal, by patient or relevant person, to participate in open disclosure of Part 5 review 50. (1) Nothing in this Act shall require a patient to engage with the health services provider in the open disclosure of a Part 5 review and— (a) a patient may authorise a relevant person not to attend the Part 5 review disclosure meeting, and (b) where a relevant person refuses to attend the Part 5 review disclosure meeting, the health services provider shall inform the patient of the refusal and the patient may specify another relevant person to attend that meeting.
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(2)Where a health services provider informs a patient or a relevant person that the provider proposes to hold a Part 5 review disclosure meeting in order to make an open disclosure of the Part 5 review and the patient or relevant person does not want to have the open disclosure made to him or her and refuses to attend that Part 5 review disclosure meeting, the patient, or a relevant person, shall inform the provider that he or she— (a) will not attend the Part 5 review disclosure meeting, (b) does not want to receive the information which is to be provided at that meeting, and (c) does not want to receive, having regard to section 37
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(2)and section 45 , any additional Part 5 review information that may be provided (or apology that may be made) pursuant to section 52 .
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(3)Where a patient or a relevant person informs a health services provider of the matters specified in subsection (2), the provider shall— (a) set out a statement in writing of those matters, (b) include, in the statement referred to in paragraph (a), a reference to the entitlement under subsection (7) for the patient to make a later request for a Part 5 review disclosure meeting despite the refusal referred to in subsection (2), (c) sign that statement and specify the date on which it was signed, (d) give the patient or relevant person a copy of that statement which has, in accordance with paragraph (c), been signed by the provider, as soon as practicable, (e) maintain the statement which has, in accordance with paragraph (c), been signed by the provider, in the records referred to in section 56 , and (f) pursuant to that statement, not proceed to hold the Part 5 review disclosure meeting.
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(4)Where section 39
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(1)(c) applies and a health services provider informs both a patient and a relevant person that the provider proposes to hold a Part 5 review disclosure meeting in order to make an open disclosure of the Part 5 review and both the patient and relevant person do not want to have the open disclosure made to them and refuse to attend that Part 5 review disclosure meeting, the patient and relevant person shall inform that provider that— (a) they will not attend the Part 5 review disclosure meeting, (b) they do not want to receive the information which is to be provided at that meeting, and (c) they do not want to receive, having regard to section 37
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(2)and section 45 , any additional Part 5 review information that may be provided (or apology that may be made) pursuant to section 52 .
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(5)Where a patient and a relevant person informs a health services provider of the matters specified in subsection (4), the provider shall— (a) set out a statement in writing of those matters, (b) include, in the statement referred to in paragraph (a), a reference to the entitlement under subsection (7) for the patient to make a later request for a Part 5 review disclosure meeting despite the refusal referred to in subsection (2), (c) sign the statement referred to in paragraph (a) and specify the date on which it was signed, (d) provide the patient and the relevant person who has informed the provider of those matters with a copy of the statement which has, in accordance with paragraph (c), been signed by the provider, as soon as practicable, (e) maintain the statement which has, in accordance with paragraph (c), been signed by the provider, in the records referred to in section 56 , and (f) pursuant to that statement, not proceed to hold the Part 5 review disclosure meeting.
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(6)Where a patient, or a relevant person, refuses to accept receipt of the statement referred to in subsection (3)(d), or subsection (5)(d), the provider shall— (a) make a note in writing of that refusal, (b) include, in the note referred to in paragraph (a), the Part 5 review to be disclosed and the date of the screening which gave rise to the request for the Part 5 review (if known), (c) sign the note referred to in paragraph (a) and specify the date of signing, and (d) keep, in the records referred to in section 56 , the note referred to in paragraph (a), which has been signed in accordance with paragraph (c).
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(7)Where a patient or a relevant person has, or as the case may be both of them have, refused to engage with the health services provider in the making of an open disclosure of a Part 5 review, the patient may, within 5 years from the date of the refusal, request the health services provider to make the open disclosure.
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(8)A request referred to in subsection (7) may be made orally and the provider shall keep a note of the request in writing specifying the date of the request and the person who made it.
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(9)Where the health services provider receives a request under subsection (7), it shall hold a Part 5 review disclosure meeting.
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(10)The health services provider shall keep, in the records referred to in section 56 , the note referred to in subsection (8).
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Failure to contact patient or relevant person (or both) for purpose of open disclosure of Part 5 review 51. (1) Where for the purposes of section 37
\n
(1), and arranging a Part 5 review disclosure meeting, the health services provider concerned is unable to contact a patient on the basis of the contact information provided to it by the patient, the provider shall take all steps reasonably open to it to establish contact with the patient in order to comply with section 37
\n
(1).
\n
(2)Where for the purposes of section 37
\n
(1), and arranging a Part 5 review disclosure meeting with a relevant person, the health services provider concerned is unable to contact him or her on the basis of the contact information provided to it by the patient or the relevant person, the provider shall take all steps reasonably open to it to establish contact with the relevant person in order to comply with section 37
\n
(1).
\n
(3)Where for the purposes of section 37
\n
(1), and arranging a Part 5 review disclosure meeting with a patient and a relevant person, the health services provider concerned is unable to contact either or both of them on the basis of the contact information provided to it by the patient or the relevant person, the provider shall take all steps reasonably open to it to establish contact with either or both of them in order to comply with section 37
\n
(1).
\n
(4)A health services provider shall— (a) set out, in a statement in writing, the steps taken by it to establish contact with a patient, a relevant person or, as the case may be, both of them, (b) include, without prejudice to the generality of paragraph (a), the contact information, referred to in subsection (1), or as the case may be, subsection (2), provided to the provider, (c) sign the statement referred to in paragraph (a) and shall specify the date of signing, and (d) keep, in records referred to in section 56 , the statement referred to in paragraph (a), which has been signed in accordance with paragraph (c) together with any document (or any copy or record of a document) used by the provider to contact the patient or relevant person (or both of them) and any record of the steps referred to in paragraph (a).
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(5)Where, at any time after the signing of the statement referred to in subsection (4)— (a) the health services provider makes contact with the patient or relevant person, or as the case may be, both of them, or (b) the patient or relevant person makes, or as the case may be both of them make, contact with the health services provider, the health services provider shall hold a Part 5 review disclosure meeting in order to make the open disclosure of the Part 5 review after that contact has been made.
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(6)In this section, “contact information” means information provided to a health services provider by the patient or a relevant person (or both of them) for the purpose of permitting the provider to contact the patient or relevant person (or both of them) as it may require when the patient is no longer in the care of the provider or has left the premises on which the health service concerned is provided to that patient.
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Additional Part 5 review information 52. (1) A health services provider may, at any time after the holding of the Part 5 review disclosure meeting, provide information that is additional to the information which was, in accordance with section 49
\n
(2)(a), provided to the patient or relevant person (or both of them) at the Part 5 review disclosure meeting (“additional Part 5 review”) that, having regard to— (a) section 37
\n
(2), and (b) subparagraphs (i) and (ii) of section 45
\n
(1)(a), was not available to the health services provider at the time of the Part 5 review disclosure meeting and which, after that meeting has become available and may, having regard to that additional Part 5 review information, make an apology.
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(2)An additional Part 5 review information meeting shall, subject to subsection (3), be held in person with the patient or relevant person (or both of them).
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(3)A patient or a relevant person (or both of them) may, when requesting the holding of an additional Part 5 review information meeting, request the provider that the proposed meeting be held other than in person.
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(4)A request under subsection (3) may be made orally.
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(5)A health services provider shall make arrangements— (a) to meet with a patient or a relevant person (or both of them), or (b) where the patient or relevant person has made a request under subsection (3), to hold the meeting other than in person, for the purpose of providing that additional Part 5 review information (in this Act referred to as an “additional Part 5 review information meeting”).
\n
(6)Additional Part 5 review information and an apology (if any) shall be provided, or made— (a) by the principal health practitioner who made the open disclosure of the Part 5 review in accordance with section 44 , (b) where, pursuant to section 44
\n
(1)(b), the open disclosure of the Part 5 review was made by a health practitioner referred to in section 44
\n
(2), by that health practitioner, or (c) by a health practitioner referred to in subsection (7).
\n
(7)Where additional Part 5 review information referred to in subsection (1) is to be provided (and an apology, if any, to be made), to a patient or relevant person (or both of them) and the person who, in accordance with section 44 , made the open disclosure of the Part 5 review— (a) is not available to provide that additional Part 5 review information (or make an apology), or (b) is otherwise not in a position to provide that information (or make an apology), that additional Part 5 review information (and apology, if any), shall be provided, or made, by a health practitioner whom the health services provider considers appropriate.
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(8)Nothing in this Act shall operate to prevent an apology being made on behalf of a health services provider at the additional Part 5 review meeting whether an apology was made (or was not made) at the Part 5 review disclosure meeting having regard to the additional Part 5 review information which has become available since that meeting.
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(9)Where a request is made orally under subsection (4), the health services provider shall make a note, in writing, of the request and it shall be kept in the records referred to in section 56 .
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Additional Part 5 review information to be provided at additional Part 5 review information meeting 53. (1) When providing the additional Part 5 review information referred to in section 52 at an additional Part 5 review information meeting, a health services provider— (a) shall provide the additional Part 5 review information in accordance with subsection (2), (b) may provide the additional Part 5 review information— (i) orally, and (ii) in the order in which the health services provider considers appropriate, having regard to all the circumstances of the patient or the relevant person (or both of them) and the Part 5 review concerned, and (c) shall, in accordance with section 55 , give the patient or relevant person (or both of them) a copy of the statement referred to in subsection (3).
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(2)When providing the additional Part 5 review information referred to in subsection (1)— (a) the health services provider shall provide the names of the persons present at the additional Part 5 review information meeting, (b) the health services provider shall have regard to the provisions of section 49
\n
(3)and shall specify the provisions of that section to which the additional Part 5 review information, provided at the additional Part 5 review information meeting refers, (c) without prejudice to paragraph (b), where having regard to the additional Part 5 review information provided, the health services provider has reasonable grounds for believing that further physical or psychological consequences referred to in section 49
\n
(3)(f), are likely to present or develop, the health services provider shall provide further information in respect of— (i) any physical or psychological consequences which, at the time the additional Part 5 review information meeting is held, have not presented, or developed, but which, notwithstanding such absence, the health services provider reasonably believes are likely to present or develop at any time after that meeting, and (ii) any physical or psychological consequences which, at the time of the additional Part 5 review information meeting, have not presented, or developed, and which the health services provider reasonably believes are less likely or unlikely to present or develop at any time after the holding of that meeting, (d) without prejudice to paragraph (b) and having regard to the additional Part 5 review information, where, at the time the additional Part 5 review information meeting is held— (i) any physical or psychological consequences arising from the Part 5 review have presented, or developed, (ii) the patient is under the clinical care of the health services provider concerned, (iii) having regard to the information referred to in section 49
\n
(3)(h) which was provided at the Part 5 review disclosure meeting, and (iv) the health services provider proposes to make changes to the treatment, and relevant clinical care, that the provider is providing to the patient to address those consequences, the health services provider shall provide information relating to those changes to the treatment and clinical care.
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(3)The statement referred to in subsection (1), that is to be given to the patient or the relevant person (or both of them) by the health services provider in accordance with that subsection, shall— (a) be in writing, (b) set out the additional Part 5 review information, specified in subsection (2), provided to the patient or the relevant person (or both of them) in accordance with that subsection, (c) contain an apology referred to in section 52 where such apology was made, (d) specify the date on which the additional Part 5 review information was provided to the patient or the relevant person (or both of them), and (e) be signed in accordance with subsection (4).
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(4)The statement referred to in subsection (3) shall be signed by— (a) the principal health practitioner referred to in section 52
\n
(6)(a), (b) the health practitioner referred to in section 52
\n
(6)(b), or (c) who provided the additional Part 5 review information to the patient or relevant person (or both of them) in accordance with this section.
\n
(5)The health services provider shall keep, in the records referred to in section 56 , the statement referred to in subsection (3).
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(6)Nothing in this Act shall operate to prevent the additional Part 5 review information being provided (and an apology, if any, being made), at the additional Part 5 review information meeting, to— (a) both the patient and the relevant person where the open disclosure of the Part 5 review (and an apology, if any) was made to either of them at the Part 5 review disclosure meeting, and (b) a relevant person where— (i) the open disclosure of the Part 5 review (and an apology, if any) was made to the patient concerned at the Part 5 review disclosure meeting, and (ii) the patient died after the Part 5 review disclosure meeting was held.
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(7)
\n
Section 41
\n
shall apply to— (a) any information provided (or apology made) to the patient or the relevant person (or both of them) at the additional Part 5 review information meeting, in the same way as section 41 applies to information provided, and an apology where it is made, at a Part 5 review disclosure meeting, and (b) the statement referred to in subsection (3) in the same way as it applies to the statement referred to in section 49
\n
(5).
\n
Clarification of information provided at Part 5 review disclosure meeting or additional Part 5 review information provided at additional Part 5 review information meeting 54. (1) A patient or relevant person (or both of them) to whom an open disclosure of a Part 5 review was made, may, at any time after the Part 5 review disclosure meeting, or the additional Part 5 review information meeting as the case may be, make a request, to the designated person, for the clarification of— (a) any information provided to the patient or relevant person (or both of them) at the Part 5 review disclosure meeting, or (b) any additional Part 5 review information provided to the patient or relevant person (or both of them) at the additional Part 5 review information meeting, and may request that the clarification be made other than in person.
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(2)Where a request is made under subsection (1)— (a) in the case of a request for clarification of the information provided at the Part 5 disclosure meeting, the designated person shall— (i) as soon as practicable, inform the person who, pursuant to section 44 , made the open disclosure of the Part 5 review or where the conditions in subsection (4) are satisfied, a health practitioner referred to in that subsection, of the request, and (ii) liaise with the person, or the health practitioner, referred to in subparagraph (i) in relation to the provision of a response to the request, (b) in the case of a request for clarification of the additional Part 5 review information provided at the additional Part 5 review information meeting, the designated person shall— (i) as soon as practicable, inform the person who, pursuant to section 52 , provided the additional Part 5 review information at that meeting or, where the conditions in subsection (4) are satisfied, a health practitioner referred to in that subsection, of the request, and (ii) liaise with the person, or the health practitioner, referred to in subparagraph (i) in relation to the provision of a response to the request, (c) in the case of a request for clarification of the information provided at the Part 5 review disclosure meeting, the person who, pursuant to section 44 , made the open disclosure of the Part 5 review at the Part 5 review disclosure meeting, or where the conditions referred to in subsection (4) are satisfied, a health practitioner referred to in that subsection, shall— (i) provide the clarification to the patient or relevant person (or both of them), in so far as it is reasonably open to him or her to do so having regard to the information available to him or her at the time at which he or she provides the clarification, and (ii) liaise with the designated person in relation to the provision of the clarification referred to in subparagraph (i), (d) in the case of a request for clarification of additional Part 5 review information provided at an additional Part 5 review information meeting, the person who, pursuant to section 52 provided the additional Part 5 review information at that meeting, or where the conditions in subsection (4) are satisfied, a health practitioner referred to in that subsection, shall— (i) provide the clarification to the patient or relevant person (or both of them) in so far as it is reasonably open to him or her to do so having regard to the information available to him or her at the time at which he or she provides the clarification, and
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(ii) liaise with the designated person in relation to the provision of the clarification referred to in subparagraph (i), and (e) the designated person shall— (i) set out, in a statement in writing— (I) the request for clarification made under subsection (1) and whether it was requested that the clarification be made other than in person, and (II) the date on which the clarification requested under subsection (1) was provided, and (ii) keep, in the records referred to in section 56 , the statement referred to in subparagraph (i).
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(3)For the purposes of providing the clarification requested under subsection (1), the person who, pursuant to section 44 , made the open disclosure of the Part 5 review at the Part 5 review disclosure meeting, the person who, pursuant to section 52 , provided the additional Part 5 review information at the additional Part 5 review information meeting, or, where the conditions referred to in subsection (4) are satisfied, a health practitioner referred to in that subsection, as the case may be— (a) may provide that clarification orally, and (b) shall, in accordance with section 55 , give a copy of the statement in writing referred to in subsection (5) to— (i) the designated person, and (ii) the patient or relevant person (or both of them) who made the request under subsection (1).
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(4)Where a request is made under subsection (1) and the person who— (a) pursuant to section 44 , made the open disclosure of the Part 5 review at the Part 5 review disclosure meeting, or (b) pursuant to section 52 , provided the additional Part 5 review information at the additional Part 5 review information meeting, is not available to provide the clarification requested under subsection (1)— (i) the designated person shall notify the health services provider, and (ii) the clarification shall be provided by a health practitioner whom the health services provider, having considered the Part 5 review concerned, considers appropriate.
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(5)The statement referred to in subsection (3)(b) that is to be given, in accordance with that subsection, to the persons specified in that subsection, shall— (a) set out the information provided in the clarification, (b) specify the date on which the clarification was provided to the persons referred to in subsection (3), and (c) be signed in accordance with subsection (6).
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(6)The statement referred to in subsection (5) shall be signed by the person who provided the clarification.
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(7)The health services provider shall keep, in the records referred to in section 56 , the statement referred to in subsection (5).
\n
(8)
\n
Section 41
\n
shall apply to— (a) information provided in a clarification made to a patient or relevant person (or both of them) pursuant to a request made under subsection (1) in the same way as that section applies to information provided to a patient or relevant person (or both of them) at a Part 5 review disclosure meeting or an additional Part 5 review information meeting as the case may be, and (b) the statement in writing referred to in— (i) subsection (2)(e), and (ii) subsection (5), in the same way as that section applies to the statement referred to in section 49
\n
(5).
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Statements specifying information given at certain meetings 55. (1) Subsection (2) shall apply for the purposes of— (a) a Part 5 review disclosure meeting that is held in person and the provision of the statement referred to in section 49
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(5)to a patient or relevant person (or both of them) in accordance with section 49
\n
(2)and the statement referred to in section 49
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(2)(d), (b) an additional Part 5 review information meeting that is held in person and the provision of the statement referred to in section 53
\n
(3)to a patient or relevant person (or both of them) in accordance with section 53
\n
(1), and (c) a clarification provided under section 54 and the provision of the statement referred to in section 54
\n
(3)(b) to a patient or relevant person (or both of them) in accordance with that section.
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(2)A health services provider shall— (a) give the statements referred to in subsection (1)(a) to the patient or relevant person (or both of them)— (i) at the meeting referred to in subsection (1)(a), or (ii) not later than 5 days from the date on which the meeting referred to in subsection (1)(a) was held, and (b) give the statement referred to in subsection (1)(b) or (1)(c), to the patient or relevant person (or both of them)— (i) at the meeting referred to in subsection (1)(b), or as the case may be at a clarification referred to in subsection (1)(c), or (ii) not later than 5 days from the date on which the meeting referred to in subsection (1)(b), or as the case may be the clarification referred to in subsection (1)(c), was held.
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(3)Subsection (4) shall apply for the purposes of— (a) a Part 5 review disclosure meeting that is held other than in person and the provision of the statement referred to in section 49
\n
(5)to a patient or relevant person (or both of them) in accordance with section 49
\n
(2)and the statement referred to in section 49
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(2)(d), (b) an additional Part 5 review information meeting that is held other than in person and the provision of the statement referred to in section 53
\n
(3)to a patient or relevant person (or both of them) in accordance with section 53
\n
(1), and (c) a clarification provided under section 54 that is made other than in person and the provision of the statement referred to in section 54
\n
(3)(b) to a patient or relevant person (or both of them) in accordance with that section.
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(4)A health services provider shall give— (a) the statements referred to in subsection (3)(a) to the patient or relevant person (or as the case may be both of them) not later than 5 days from the day on which that meeting was held, and (b) the statement referred to in subsection (3)(b) or (c) to the patient or relevant person (or as the case may be both of them) not later than 5 days from the day on which the meeting referred to in subsection (3)(b), or as the case may be the clarification referred to in subsection (3)(c), was held.
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Records relating to open disclosure of results of Part 5 review 56. (1) A health services provider shall keep and maintain records in relation to— (a) a copy of the designation referred to in section 47
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(2), (b) the statement referred to in section 49
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(7), (c) the statement referred to in section 50
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(3)(e) or section 50
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(5)(e), as the case may be, (d) the note referred to in section 50
\n
(6)(d), (e) the note referred to in section 50
\n
(10), (f) the statement referred to in section 51
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(4)(d), (g) the statement referred to in section 53
\n
(5), (h) the statement in writing— (i) of a request referred to in section 54
\n
(2)(e), and (ii) referred to in section 54
\n
(7), and (i) a record of a request (if any) referred to in section 48
\n
(4)or section 52
\n
(9).
\n
(2)The Minister may prescribe the form of the records to be kept and maintained by a health services provider under this section and any matter relating to the keeping and maintenance of such records.
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PART 6
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Clinical Audit Interpretation for Part 57. In this Part— “aggregated information”, in relation to data, means data obtained from a clinical audit which excludes information that identifies or could reasonably lead to the identification of a person in that clinical audit; “clinical audit” shall be construed in accordance with section 58 ; “clinical guideline” shall be construed in accordance with section 58 ; “clinically-led” means carried out by a health practitioner; “clinical standard” means a statement which— (a) specifies a level of healthcare outcome that is required to contribute to patient quality and safety, (b) sets out the care that patients should, having regard to a specific clinical condition, be offered by, or receive from, a health practitioner or health care provider (or both) for— (i) such specific clinical condition, or (ii) the treatment and prevention of different diseases and conditions, (c) is consistent with current evidence-based best practice, and (d) is measurable, and includes any such statement that is agreed for use, from time to time, at a national level or in respect of any region or other specific geographical area.
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Clinical audit and clinical guideline 58. (1) In this Part— “clinical audit” means a clinically-led quality improvement process in healthcare— (a) for the purpose of improving patient care and outcomes through systematic review of care against explicit specific clinical standards or clinical guidelines and taking action to improve care when clinical standards or clinical guidelines are not met, and (b) which selects aspects of the structure, processes and outcomes of care for systematic evaluation against explicit specific clinical standards or clinical guidelines; “improving patient care and outcomes”, in relation to a clinical audit, includes the contribution to the improvement of the safety and quality of care for patients by— (a) facilitating greater self-evaluation for health services providers and health practitioners, and (b) measuring clinical practice against evidence-based clinical standards or clinical guidelines, which provides information for health services providers and health practitioners for learning from the documented conclusions required for, and provided by, the clinical audit thereby improving patient care and outcomes.
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(2)In this Part, “clinical guideline” means a statement relating to clinical care— (a) that is used to assist in making decisions in relation to appropriate health care for specific clinical circumstances by— (i) a health services provider or a health practitioner (or both of them), and (ii) the patient and the health practitioner or the health services provider (or as the case may be, both of them) where a decision is made in consultation with a patient, and (b) which is repeatedly subjected to systematic review and evaluation.
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(3)In respect of a reference to clinical standards or clinical guidelines that are evaluated in a clinical audit, a clinical audit may be carried out for the purpose of establishing a new clinical standard or clinical guideline that will in turn be used for the carrying out of the clinical audit or be evaluated in a subsequent clinical audit and references to— (a) clinical audit, (b) clinical guideline, and (c) clinical standards, shall be construed accordingly.
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Clinical audit to which Part applies 59. This Part applies to a clinical audit that is carried out by a health services provider or a health practitioner (or both of them), where the data obtained from that audit is, or has been— (a) collected solely for the purpose of improving patient safety and quality improvement in healthcare of patients, (b) collected by the health services provider or the health practitioner (or both of them) or more than one health services provider or more than one health practitioner and analysed by the health services provider or the health practitioner (or both of them) or more than one health services provider or health practitioner, (c) published as aggregated information, and (d) used by that health services provider or health practitioner— (i) solely for the purpose referred to in paragraph (a) in relation to the manner in which that provider or the health practitioner provides, and improves, clinical care to patients, (ii) for sharing with another health services provider or health practitioner solely for the purpose referred to in paragraph (a), to provide information in respect of the provision and improvement of clinical care for the purpose of improving patient safety and quality in healthcare, or (iii) for the purpose and use referred to in subparagraph (i) and (ii).
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Restriction of Act of 2014 60. (1) A record referred to in subsection (2) shall not be disclosed under the Act of 2014.
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(2)A record— (a) of— (i) a clinical audit to which this Part applies, or (ii) a component of, or information provided in respect of, a clinical audit to which this Part applies, and (b) which is held by a health services provider or health practitioner.
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(3)In this section, “record” has the meaning assigned to it by the Act of 2014.
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Clinical audit data: information not to invalidate insurance; constitute admission of liability or fault; or not to be admissible in proceedings 61. (1) Information provided in a clinical audit, including data, referred to in section 59 , collected solely for the purpose referred to in section 59 (a) or provided for, or contained in, documentation or information derived from a clinical audit— (a) shall not constitute an express or implied admission of fault or liability by— (i) that health services provider, or (ii) a person specified in subparagraphs (ii) to (ix) of section 10
\n
(1)(a), in relation to any matter which arises (whether in whole or in part) from the circumstances with which the data is connected or the clinical audit is conducted, including a clinical negligence action which arises (whether in whole or in part) from the consequences of any such matter or circumstances, (b) shall not, notwithstanding any other enactment or rule of law, be admissible as evidence of fault or liability of— (i) that health services provider, or (ii) a person specified in subparagraphs (ii) to (ix) of section 10
\n
(1)(b), in a court in relation to a matter or circumstances referred to in paragraph (a) which is the subject of a clinical negligence action which arises (whether in whole or in part) from the consequences of that matter or those circumstances, and (c) shall not, notwithstanding— (i) any provision to the contrary in— (I) a policy of professional indemnity insurance, (II) any documentation that comprises an offer, or evidence, of an arrangement for indemnity between a medical defence organisation and a member of that organisation, or (III) a contract of insurance providing insurance cover for claims in respect of civil liability or clinical negligence actions, or (ii) any other enactment or rule of law, invalidate or otherwise affect the cover provided by such policy or contract of insurance that is, or but for such information would be, available in respect of a matter or circumstances referred to in paragraph (a) which is, or are, the subject of that data or clinical audit or any matter alleged which arises (whether in whole or in part) from that matter or those circumstances.
\n
(2)Information provided in data referred to in subsection (1) or a clinical audit referred to in that subsection— (a) shall not constitute an express or implied admission, by a health practitioner, of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission, in the determination of any matter specified in subparagraphs (i) to (vi) of section 10
\n
(2)(a), and (b) are not, notwithstanding any other enactment, admissible as evidence of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission, in proceedings to determine a complaint, application or allegation referred to in paragraph (a).
\n
(3)This section is in addition to, and not in substitution for, any enactment or rule of law relating to the disclosure of information in respect of the provision of a health service.
\n
(4)In this section— “clinical negligence” has the meaning assigned to it by section 10 ; “clinical negligence action” has the meaning assigned to it by section 10 ; “medical defence organisation” has the meaning assigned to it by section 10 ; “professional indemnity insurance” has the meaning assigned to it by section 10 .
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PART 7
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Amendment of Act of 2007 Amendment of section 2 of Act of 2007 62. Section 2 of the Act of 2007 is amended, in subsection (1)— (a) by the insertion of the following definitions: “‘Act of 2004’ means the Health Act 2004 ; ‘cancer screening service’ has the same meaning as it has in section 2 of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023; ‘complainant’ shall be construed in accordance with section 41A(5); ‘health service’ means the provision of clinical care or any ancillary service to a person for— (a) the screening (other than screening carried out by a cancer screening service), preservation or improvement of the health of the person, (b) the prevention, diagnosis, treatment or care of an illness, injury or health condition of the person, (c) the performance or surgery, or a surgical intervention, in respect of aesthetic purposes, or other non-medical purposes, that involves instruments or equipment being inserted into the body of the person, or (d) without prejudice to paragraph (a), a cancer screening service; ‘medical speciality’ means a medical speciality recognised by the Medical Council under section 89 of the Medical Practitioners Act 2007 ; ‘patient’ has the meaning assigned to it by section 41A(10); ‘prescribed private health service’ means a health service that is prescribed under section 101A; ‘private hospital’ means a hospital under the management or control of a person (other than the Executive)— (a) at which— (i) medical or surgical treatment for illness, injury, disability, palliative, obstetric or gynaecological care, or (ii) a health service, is provided to a person which provision of treatment is under the direction of registered medical practitioners from at least 3 different medical specialities who are registered in the Specialist Division of the register of medical practitioners, and (b) which is capable of accommodating one or more persons in that hospital when providing the treatment under paragraph (a), for a minimum period of 24 hours, but does not include— (i) a designated centre, (ii) a centre registered by the Mental Health Commission, (iii) a service provider to which paragraph (a) of the definition of service provider applies, or (iv) a hospital which is in receipt of assistance under section 39 of the Act of 2004; ‘register of medical practitioners’ has the same meaning as it has in the Medical Practitioners Act 2007 ; ‘registered medical practitioner’ has the same meaning as it has in the Medical Practitioners Act 2007 ; ‘Specialist Division’ has the same meaning as it has in the
\n
Medical Practitioners Act 2007 .”, and (b) by the substitution of the following definition for the definition of “service provider”: “‘service provider’ means— (a) a person who enters into an arrangement under section 38 of the Act of 2004 to provide a health or personal social service on behalf of the Executive, (b) a person who is in receipt of assistance under section 39 of the Act of 2004 in an amount that exceeds an amount prescribed for the purpose of this subparagraph, (c) a service provider under the Child and Family Agency Act 2013 , or (d) a private hospital;”.
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Amendment of section 8 of Act of 2007 63. Section 8 of the Act of 2007 is amended— (a) in subsection (1)— (i) in paragraph (b)— (I) in subparagraph (i), by the substitution of “a service provider to which paragraph (a), (b) or (c) of the definition of service provider applies” for “a service provider ”, and (II) by the substitution of “and advise the Minister, the Minister for Children and Youth Affairs” for “in this section called the ‘services’, and advise the Minister, the Minister for Children and Youth Affairs”, (ii) by the insertion of the following paragraph after paragraph (b): “(ba) to set standards on safety and quality in relation to services provided by a service provider to which paragraph (d) of the definition of service provider applies or a person carrying on the business of providing prescribed private health services;”, (iii) in paragraph (c), by the substitution of “paragraphs (b) and (ba)” for “paragraph (b)”, (iv) in paragraph (e), by the substitution of “services referred to in paragraph (b)” for “services”, (v) in paragraphs (f), (g) and (i), by the substitution of “services referred to in paragraph (b) or (ba)” for “services” in each place that it occurs, (vi) by the substitution of the following paragraph for paragraph (k): “(k) to set standards as the Authority considers appropriate for the Executive, the Agency, service providers or a person carrying on the business of providing prescribed private health services respecting data and information in their possession in relation to services and the health and welfare of the population;”, and (vii) in paragraph (l), by the substitution of “the Executive, the Agency, service providers and persons carrying on the business of providing prescribed private health services” for “the Executive and service providers”, and (b) by the insertion of the following subsection after subsection (1): “(1A) The Authority may, in setting standards referred to in subsections (1)(b), (1)(ba) or (1)(k), set different standards for different categories of services referred to in those subsections.”.
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Amendment of section 9 of Act of 2007 64. Section 9 of the Act of 2007 is amended— (a) in subsection (1)— (i) by the substitution of “Subject to subsection (1A), the Authority may undertake an investigation as to the safety, quality and standards of any of the services described in section 8(1)(b) or (1)(ba)” for “The Authority may undertake an investigation as to the safety, quality and standards of the services described in section 8(1)(b)”, (ii) by the substitution of the following paragraph for paragraph (a): “(a) there may be a serious risk— (i) to the health or welfare of a person receiving those services, or (ii) of a failure to comply with the provisions of the Act of 2013, notwithstanding that such a risk may also exist elsewhere in those services,”, and (iii) by the substitution of the following paragraph for paragraph (b): “(b) the risk may be the result of any act, failure to act or negligence on the part of— (i) the Executive, (ii) the Agency, (iii) a service provider to which paragraph (a) or (b) of the definition of service provider applies, (iv) a service provider to which paragraph (c) of the definition of service provider applies, (iva) a service provider to which paragraph (d) of the definition of service provider applies, (v) the registered provider of a designated centre to which paragraph (a)(ii), (iii) or (c) of the definition of designated centre applies, (vi) the registered provider of a designated centre to which paragraph (a)(i) or (b) of the definition of designated centre applies, (vii) the person in charge of a designated centre referred to in subparagraph (v), if other than its registered provider, (viii) the person in charge of a designated centre referred to in subparagraph (vi), if other than its registered provider, or (ix) a person carrying on the business of providing a prescribed private health service, and”, and (iv) by the insertion of the following paragraph after paragraph (b): “(c) an investigation may be in the interests of— (i) improving the safety, quality and standards of the services described in section 8(1)(b) or (1)(ba) which are the subject of the investigation, or (ii) the provision of health and personal social services for the benefit of the health and welfare of the public.”, (b) by the insertion of the following subsection after subsection (1): “(1A) The Authority shall notify the Minister in writing before undertaking an investigation under subsection (1).”, (c) by the substitution of the following subsection for subsection (2):
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“(2) The Minister may, if he or she believes on reasonable grounds that— (a) there may be a serious risk of the kind mentioned in paragraph (a) of subsection (1), notwithstanding that such a risk may also exist elsewhere in those services, (b) the risk may be the result of any act, failure to act or negligence of the kind mentioned in paragraph (b)(i), (iii), (iva), (v), (vii) or (ix) of subsection (1), and (c) an investigation may be in the interests of— (i) improving the safety, quality and standards of the services described in section 8(1)(b) or (1)(ba) which are the subject of the investigation, or (ii) the provision of health and personal social services for the benefit of the health and welfare of the public, require the Authority to undertake an investigation in accordance with this section.”, (d) by the substitution of the following subsection for subsection (2A): “(2A) The Minister for Children and Youth Affairs may, if he or she believes on reasonable grounds that— (a) there may be a serious risk of the kind mentioned in paragraph (a)(i) of subsection (1), notwithstanding that such a risk may also exist elsewhere in those services, (b) the risk may be the result of any act, failure to act or negligence mentioned in paragraph (b)(ii), (iv), (vi) or (viii) of subsection (1), and (c) an investigation may be in the interests of— (i) improving the safety, quality and standards of the services described in section 8(1)(b) or (1)(ba) which are the subject of the investigation, or (ii) the provision of health and personal social services for the benefit of the health and welfare of the public, require the Authority to undertake an investigation in accordance with this section.”, (e) by the insertion of the following subsection after subsection (3): “(3A) Where an investigation under this section is being undertaken in respect of the services specified in section 8(1)(b) or (1)(ba), the Authority shall— (a) give notice in writing to the relevant person of the matters to which the investigation relates, and (b) give the relevant person a copy of any document which in the reasonable opinion of the Authority is relevant to the investigation.”, and (f) in subsection (6), by the insertion of the following definition: “ ‘relevant person’ means a person or body referred to in subparagraphs (i) to (ix) of subsection (1)(b) ;”.
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Standards set by Authority 65. (1) The Act of 2007 is amended by the substitution of the following section for section 10: “10. (1) The Authority shall, prior to submitting a draft standard to the Minister for approval, publish a notice on the website of the Authority stating that— (a) it proposes to set a standard, (b) a draft of the proposed standard is available on that website for the period specified in the notice, and (c) submissions in relation to the draft standard may be made in writing to the Authority on or before that date.
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(2)Subject to subsection (3), the Authority may consult with such other persons on the draft standard referred to in subsection (1), as the Authority thinks fit.
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(3)The Authority shall notify the Minister and the Minister for Children and Youth Affairs, where appropriate, before undertaking a consultation under subsection (2).
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(4)After considering any representations made to it under subsection (1) or (2) on the draft standard and making any changes to the draft standard that the Authority thinks fit in view of those representations or otherwise, the Authority shall submit the draft standard to the Minister for approval and, where the standard relates to services provided under the Child and Family Agency Act 2013 , the Minister shall not approve the draft standard without the prior consent of the Minister for Children and Youth Affairs.
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(5)Where the Minister approves a standard under this section, he or she shall cause a notice of the approval to be published in Iris Oifigiúil and the notice shall specify the date from which the standard shall come into operation.
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(6)Subject to subsection (7), the Authority may revoke or amend a standard approved under subsection (5).
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(7)Subsections (1) to (5) shall, with all necessary modifications, apply to a standard that the Authority proposes to amend or revoke under subsection (6) as those subsections apply to a standard that the Minister approved under subsection (5).
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(8)In this section, ‘standard’ means the standards set by the Authority under section 8(1).”.
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(2)Notwithstanding the amendment of section 10 of the Act of 2007 by subsection (1), a standard set by the Authority before the coming into operation of subsection (1) and which is in force immediately before that commencement shall continue in force after such amendment unless revoked or amended by the Authority.
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Provision of information to Authority 66. The Act of 2007 is amended by the substitution of the following section for section 12: “12. The Authority may require— (a) the Executive, (b) the Agency, (c) a service provider, or (d) a person carrying on the business of providing a prescribed private health service, to provide it with any information or statistics that the Authority needs in order to determine the level of compliance by the Executive, Agency, service provider or the person carrying on the business of providing a prescribed private health service, as the case may be, with the standards set by the Authority in accordance with section 8(1).”.
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Amendment of section 41 of Act of 2007 67. Section 41 of the Act of 2007 is amended, in subsection (1), by the insertion of the following paragraph after paragraph (c): “(ca) undertake reviews in accordance with section 41A,”.
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Review of specified incident by chief inspector 68. The Act of 2007 is amended by the insertion of the following section after section 41: “41A. (1) This section applies where it appears to the chief inspector that a specified incident has occurred, following— (a) the receipt by the chief inspector of a complaint in relation to the specified incident concerned, (b) the notification of the specified incident concerned to the chief inspector by a relevant entity, or (c) the chief inspector otherwise becoming aware of the specified incident concerned.
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(2)Subject to subsection (4), the chief inspector may undertake a review of the specified incident where he or she considers it appropriate to do so, having regard to all of the circumstances, in order to— (a) identify, in so far as possible, how the specified incident concerned occurred, and (b) make any recommendations of a general character arising out of any findings under paragraph (a) that can be implemented to reduce risk and to improve the safety, quality and standards of services provided by the relevant entity or relevant entities, as the case may be, where the specified incident occurred.
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(3)The chief inspector may decide not to undertake a review under this section, or decide to discontinue such a review, if— (a) subsection (1)(a) applies and the chief inspector believes on reasonable grounds that the complaint is frivolous or vexatious, (b) the specified incident, the subject of the review concerned, has already been subject to a review under this section, (c) the chief inspector believes on reasonable grounds that the incident the subject of the review concerned is not a specified incident, (d) the chief inspector believes on reasonable grounds that, the subject matter of the review concerned has already been resolved or substantially resolved, (e) the subject matter of the review concerned is the subject of criminal proceedings, or (f) the review concerned is the subject of an investigation by An Garda Síochána.
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(4)The chief inspector shall not undertake a review of a specified incident under subsection (2)— (a) where subsection (1)(a) applies, after the expiration of one year from the later of the following dates: (i) the date on which the specified incident occurred; (ii) the date on which the complainant knew or could reasonably be expected to know that the specified incident occurred, or (b) where subsection (1)(b) or (c) applies, after the expiration of one year from the date on which the specified incident occurred.
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(5)Without prejudice to Part 9 of the Health Act 2004 , each of the following persons may make a complaint to the chief inspector in relation to a specified incident, and where he or she does so each such person shall, in this section, be referred to as a ‘complainant’: (a) the patient; (b) a parent, guardian, son, daughter, spouse or civil partner (within the meaning of the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010 ) of the patient; (c) a person who is cohabiting with the patient (including a cohabitant within the meaning of section 172 of the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010 ); (d) any person who, by law or by appointment of a court, has the care of the affairs of the patient; (e) any legal representative of the patient; (f) any other person, with the written consent of the patient.
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(6)Where a review under this section is being undertaken in respect of a specified incident, the chief inspector shall— (a) give notice in writing to the relevant entity concerned of the matters to which the review relates, and (b) give the relevant entity concerned a copy of any document which in the reasonable opinion of the chief inspector is relevant to the review.
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(7)A review of a specified incident undertaken under subsection (2) shall not— (a) consider or determine fault, or assign civil or criminal liability, (b) consider or determine whether any action should be taken in respect of an individual by any panel, committee, tribunal or professional regulatory body, or (c) be admissible as evidence of fault or liability in a court in relation to the specified incident, or a clinical negligence action which arises (whether in whole or in part) from the consequences of that specified incident.
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(8)Nothing in this section shall be construed as preventing a relevant entity from undertaking a review of a specified incident that may have occurred.
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(9)The chief inspector shall ensure that a review under this section does not interfere, or conflict, with the functions of any statutory bodies.
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(10)In this section— ‘complaint’ means a complaint, in any form, made by a complainant in relation to a specified incident that may have occurred during the provision of a health service by a relevant entity to a patient; ‘patient’ means a person to whom a health service is, or has been, provided by a relevant entity; ‘relevant designated centre’ means a designated centre to which paragraph (c) of the definition of designated centre in section 2 applies, that is registered in accordance with section 49 and includes— (a) a designated centre whose registration has been cancelled under section 51 where an appeal against the cancellation has been made and has not been determined or withdrawn or in respect of which an appeal has been made under section 62 and that appeal has not been determined or withdrawn, and (b) a designated centre in respect of which an application was made to the District Court under section 59 and the application has not been determined or withdrawn or in respect of which an appeal has been made under section 62 and that appeal has not been determined or withdrawn; ‘relevant entity’ means— (a) a service provider to which paragraph (a), (b) or (d) of the definition of ‘service provider’ in section 2 applies, (b) a relevant designated centre that is not a service provider referred to in paragraph (a), (c) a person carrying on the business of providing a prescribed private health service, or (d) the Executive; ‘specified incident’ means an incident that occurs on or after the coming into operation of this section— (a) that may have resulted in the unintended or unanticipated death or serious injury of a patient, and (b) that has occurred in the course of the provision of a health service to that patient by a relevant entity, where some or all of that health service was provided in a relevant designated centre.”.
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Amendment of section 72 of Act of 2007 69. Section 72 of the 2007 Act is amended, in subsection (1)— (a) by the insertion of “or a review referred to in section 41A” after “section 41”, (b) in paragraph (a), by the insertion of “referred to in section 41, or an inspection relating to the review referred to in section 41A, as the case may be” after “the inspection”, and (c) in paragraph (b), by the insertion of “referred to in section 41, or to the review referred to in section 41A, as the case may be,” after “the inspection”.
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Amendment of section 73 of Act of 2007 70. Section 73 of the Act of 2007 is amended— (a) in subsection (1), by the substitution of the following paragraphs for paragraphs (i) and (ii): “(i) owned or controlled by the Executive, the Agency, a service provider, or a person carrying on the business of providing a prescribed private health service, or (ii) used or proposed to be used, for any purpose connected with the provision of services described in section 8(1)(b) or (1)(ba).”, (b) by the insertion of the following subsection after subsection (2): “(2A) If the chief inspector considers it necessary or expedient for the purposes of a review referred to in section 41A, the chief inspector may enter and inspect at any time any premises— (a) owned or controlled by a relevant entity within the meaning of section 41A, or (b) used or proposed to be used for any purpose connected with the provision of a health service by a relevant entity within the meaning of section 41A.”, (c) in subsection (3)— (i) by the insertion of “or a review referred to in section 41A” after “section 41”, and (ii) in paragraph (b), by the insertion of “in the case of an inspection referred to in section 41, or any premises referred to in subsection (2A) in the case of a review referred to in section 41A” after “subsection (2)”, (d) in subsection (4)(a), by the substitution of “a service provider, a person carrying on the business of providing a prescribed private health service,” for “a service provider”, (e) by the insertion of the following subsection after subsection (4): “(4A) A chief inspector, in respect of premises referred to in subsection (2A), may— (a) inspect, take copies of or extracts from and remove from the premises any documents or records (including personal records) relating to the services provided by a relevant entity within the meaning of section 41A, (b) inspect the operation of any computer and any associated apparatus or material which is or has been in use in connection with the records in question, (c) inspect any other item and remove it from the premises if the chief inspector considers it necessary or expedient for the purposes of a review referred to in section 41A, (d) interview in private any person— (i) working at the premises concerned, or (ii) who at any time was or is in receipt of a service at the premises and who consents to be interviewed, and (e) make any other examination into the state and management of the premises or the standard of any services provided at the premises.”,
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(f) in subsection (5)— (i) by the insertion of “or (2A)” after “subsection (2)”, and (ii) in paragraph (ii), by the substitution of “section 41, or of a review referred to in section 41A” for “section 41”, and (iii) by the insertion of “or to the review” after “is relevant to the inspection”, (g) in subsection (6), by the insertion of “or (2A)” after “subsection (2)”, and (h) in subsection (8)— (i) by the insertion of “or (2A)” after “subsection (2)”, (ii) by the substitution of “an inspection referred to in section 41 or a review referred to in section 41A” for “an inspection under this section”, (iii) by the substitution of “subject of the inspection or review” for “subject of the inspection”, and (iv) in paragraph (b), by the insertion of “or review” after “the inspection”.
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Amendment of section 74 of Act of 2007 71. Section 74 of the Act of 2007 is amended by the substitution of the following subsection for subsection (1): “(1) In this section, ‘dwelling’ includes— (a) any part of a designated centre occupied as a private residence by the registered provider of the designated centre or by a member of the staff of the registered provider, and (b) any part of the premises of a person carrying on the business of providing a prescribed private health service occupied as a private residence by that person or by a member of the staff of that person.”.
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Amendment of section 75 of Act of 2007 72. Section 75 of the Act of 2007 is amended— (a) in subsection (1), by the substitution of the following paragraph for paragraph (b):— “(b) in relation to any premises referred to in section 73(2) or (2A), the chief inspector conducting an inspection referred to in section 41 or a review referred to in section 41A,”, and (b) in subsection (2)(a)— (i) by the insertion of “or, in the case of a review referred to in section 41A, section 73(2A)” after “section 73(1) or (2)”, (ii) in subparagraph (i), by the substitution of “section 8(1)(d),” for “section 8(1)(d), or” (iii) in subparagraph (ii), by the substitution of “subsection 41, or” for “section 41,”, and (iv) by the insertion of the following subparagraph after subparagraph (ii): “(iii) the chief inspector considers it necessary to inspect for the purposes of a review referred to in section 41A,”.
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Reports of Authority or chief inspector 73. The Act of 2007 is amended by the insertion of the following section after section 77: “77A. (1) The Authority or the chief inspector may prepare and publish a report relating to the functions and activities of the Authority, or the chief inspector, as the case may be.
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(2)A report prepared under subsection (1) may include information on— (a) the monitoring of compliance with standards under section 8(1)(c), (b) any investigation carried out under section 9, and (c) any review carried out under section 41A.
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(3)Where preparing a report providing information in relation to subsection (2), the Authority or the chief inspector as the case may be, shall give to the Executive, the Agency, a service provider, a person carrying on the business of providing a prescribed private health service, or the registered provider of a designated centre or the person in charge of that designated centre if other than its registered provider a draft of the report (in this section referred to as a ‘draft report’) along with a written notice stating that the person may, not later than 21 days from the date on which the notice was received by him or her, or such further period as the Authority allows, make written submissions to the Authority or the chief inspector on the draft report.
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(4)In the case of a report which includes information on a review referred to in subsection (2)(c), the chief inspector shall also give to the patient and, as the case may be, the complainant to whom the review relates an extract from the draft report which relates to the review concerned along with a written notice stating that the person may, not later than 21 days from the date on which the notice was received by him or her, or such further period as the chief inspector allows, make written submissions to the chief inspector on the extract from the draft report.
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(5)As soon as practicable after the expiration of the period referred to in subsections (3) and (4) and, having considered any submissions made pursuant to those subsections, the Authority or the chief inspector as the case may be, may amend the draft report and, prior to publication, shall furnish the final report to— (a) the Executive, (b) the Agency, (c) a service provider, (d) a person carrying on the business of providing a prescribed private health service, (e) the registered provider of a designated centre or the person in charge of that designated centre if other than its registered provider, or (f) in the case of a report which includes information on a review referred to in subsection (2)(c), the patient and, as the case may be, the complainant.
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(6)Without limiting the generality of section 78, the Authority or the chief inspector is not liable in damages arising from any report or communication made in good faith for the purposes of, or in the performance of, the functions under this section.”.
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Amendment of section 78 of Act of 2007 74. Section 78 of the Act of 2007 is amended, in paragraph (ii), by the insertion of “or section 41A” after “section 41”.
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Prescribed private health services 75. The Act of 2007 is amended by the insertion of the following section after section 101: “101A. (1) Without limiting the generality of section 98, the Minister, having consulted the Authority and any other person as he or she considers appropriate, may prescribe a health service to be a prescribed private health service for the purposes of this Act.
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(2)For the purposes of subsection (1), the Minister shall have regard to the following matters: (a) whether the service is provided on an in-patient, day-patient or out‑patient basis; (b) whether the service is provided in a hospital (other than a private hospital) where medical or surgical treatment for illness or injury, disability, palliative, obstetric or gynaecological care is provided; (c) whether a general anaesthetic is administered to a patient in the provision of that service; (d) whether the service is provided in a hospital (other than a private hospital) where the provision of the service is under the direction of registered medical practitioners from at least 3 different medical specialities who are registered in the Specialist Division of the register of medical practitioners; (e) whether the service that is being provided is arranged by the National Treatment Purchase Fund Board under the National Treatment Purchase Fund Board (Establishment) Order 2004 ( S.I. No. 179 of 2004 ); (f) whether the service that is being provided includes the performance of surgery, or a surgical intervention, in respect of aesthetic purposes, or other non-clinical purposes, that involves instruments or equipment being inserted into the body of the patient.
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(3)When prescribing a health service to be a prescribed private health service under subsection (1), the Minister shall not prescribe health services provided— (a) at a designated centre, (b) at a centre registered by the Mental Health Commission, or (c) at a retail pharmacy business.
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(4)In this section, ‘retail pharmacy business’ has the same meaning as it has in the Pharmacy Act 2007 .”.
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Repeal 76. Section 100 of the Act of 2007 is repealed.
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PART 8
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Offences and Penalties Offences 77. (1) A person who fails to comply with section 5
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(1)without reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a class A fine.
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(2)A person who fails to comply with section 19
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(9)without reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a class A fine.
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(3)A person who fails to comply with section 20
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(5)without reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a class A fine.
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(4)A person who fails to comply with section 27 , 28 or 29 shall be guilty of an offence and shall be liable on summary conviction to a class A fine.
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(5)A person who fails to comply with section 37
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(1)without reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a class A fine.
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(6)A person who fails to comply with section 50
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(9)without reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a class A fine.
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(7)A person who fails to comply with section 51
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(5)without reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a class A fine.
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(8)In proceedings for an offence under this Act, it shall be a defence for a person against whom such proceedings are brought to show that the person made all reasonable efforts to ensure compliance with such provisions of this Act as are alleged to have been contravened.
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(9)Where an offence under subsection (1), (2), (3), (4), (5), (6) or (7) is committed by a body corporate and it is proved that the offence was committed with the consent or connivance, or was attributable to any wilful neglect, of a person who was a director, manager, secretary or other officer of the body corporate, or a person purporting to act in that capacity, that person shall, as well as the body corporate, be guilty of an offence and may be proceeded against and punished as if he or she were guilty of the first-mentioned offence.
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(10)Where the affairs of a body corporate are managed by its members, subsection (9) applies in relation to the acts and defaults of a member in connection with his or her functions of management as if he or she were a director or manager of the body corporate.
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PART 9
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Miscellaneous and General Guidelines 78. (1) The Minister may, after consultation with the Authority, the chief inspector (within the meaning of Part 4), the Commission and the State Claims Agency (within the meaning of
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Part 4
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), and such other persons as he or she considers appropriate, prepare and issue guidelines for the purpose of providing practical guidance as regards the operation of, and compliance with, this Act and any regulations made under it.
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(2)The Minister shall publish guidelines made under this section.
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Regulations 79. (1) The Minister may by regulations provide for any matter referred to in this Act as prescribed or to be prescribed.
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(2)Regulations under this Act may contain such incidental, supplementary and consequential provisions as appear to the Minister to be necessary or expedient for the purposes of the regulations.
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(3)Every regulation made by the Minister under this Act shall be laid before each House of the Oireachtas as soon as may be after it is made and, if a resolution annulling the regulation is passed by either such House within the next 21 days on which that House sits after the regulation is laid before it, the regulation shall be annulled accordingly, but without prejudice to the validity of anything previously done thereunder.
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Review of operation of Act 80. (1) The Minister shall, not later than 2 years after the coming into operation of this section, carry out a review of the operation of this Act.
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(2)In carrying out a review under subsection (1), the Minister may consult with such persons as he or she considers appropriate.
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Amendment of Act of 2000 81. The Act of 2000 is amended by the insertion of the following section after section 11: “Notifications under Act of 2023 11A. (1) The Agency may provide the National Treasury Management Agency incident management system (within the meaning of the Act of 2023) as the means for making a notification under section 27 , 28 or 29 of the Act of 2023.
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(2)Subsection (1) shall apply whether the health services provider (within the meaning of the Act of 2023) making a notification referred to in that subsection is a State authority or otherwise.
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(3)In this section, ‘Act of 2023’ means the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023.”.
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Amendment of Act of 2017 82. The Act of 2017 is amended in the manner specified in Schedule 2.
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Savings and transitional provisions in respect of open disclosure under Part 4 of Act of 2017 83. (1) Where, before the coming into operation of this section, a health services provider had, under, and in accordance with, Part 4 of the Act of 2017 made an open disclosure of an incident (within the meaning of the Act of 2017) that is a notifiable incident specified in Schedule 1, that Part of the Act of 2017 shall continue to apply to that open disclosure of that incident.
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(2)Where, on or after the coming into operation of section 8 , a notifiable incident is specified in regulations under that section and a health services provider had, under, and in accordance with, Part 4 of the Act of 2017 made an open disclosure of an incident (within the meaning of the Act of 2017) that is a notifiable incident specified in those regulations made under section 8 , that Part of the Act of 2017 shall continue to apply to that open disclosure of that incident.
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SCHEDULE 1 Notifiable Incidents
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Section 2
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Part 1
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Item Notifiable Incident 1.1 Surgery performed on the wrong patient resulting in unintended and unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness.
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1.2 Surgery performed on the wrong site resulting in unintended and unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness.
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1.3 Wrong surgical procedure performed on a patient resulting in an unintended and unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness.
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1.4 Unintended retention of a foreign object in a patient after surgery resulting in an unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness.
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1.5 Any unintended and unanticipated death occurring in an otherwise healthy patient undergoing elective surgery in any place or premises in which a health services provider provides a health service where the death is directly related to a surgical operation or anaesthesia (including recovery from the effects of anaesthesia) and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.
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1.6 Any unintended and unanticipated death occurring in any place or premises in which a health services provider provides a health service that is directly related to any medical treatment and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.
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1.7 Patient death due to transfusion of ABO incompatible blood or blood components and the death was unintended and unanticipated and which did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.
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1.8 Patient death associated with a medication error and the death was unintended and unanticipated as it did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.
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1.9 An unanticipated death of a woman while pregnant or within 42 days of the end of the pregnancy from any cause related to, or aggravated by, the management of the pregnancy, and which did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.
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1.10 An unanticipated and unintended stillborn child where the child was born without a fatal foetal abnormality and with a prescribed birthweight or has achieved a prescribed gestational age and who shows no sign of life at birth, from any cause related to or aggravated by the management of the pregnancy, and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the child.
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1.11 An unanticipated and unintended perinatal death where a child born with, or having achieved, a prescribed gestational age and a prescribed birthweight who was alive at the onset of care in labour, from any cause related to, or aggravated by, the management of the pregnancy, and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the child or an underlying condition of the child.
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1.12 An unintended death where the cause is believed to be the suicide of a patient while being cared for in or at a place or premises in which a health services provider provides a health service whether or not the death was anticipated or arose from, or was wholly or partially attributable to, the illness or underlying condition of the patient.
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Part 2
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Item Notifiable Incident 2.1 A baby who— (a) in the clinical judgment of the treating health practitioner requires, or is referred for, therapeutic hypothermia, or (b) has been considered for, but did not undergo therapeutic hypothermia as, in the clinical judgment of the health practitioner, such therapy was contraindicated due to the severity of the presenting condition.
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SCHEDULE 2 Amendments of Act of 2017
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Section 82
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Item Provision of Act of 2017 Amendment to provision of Act of 2017 1.
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Section 7(1)
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The deletion of the definition of “Act of 2010”.
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2.
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Section 7(1)
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The substitution for the definition of “relevant person” of the following definition: “‘relevant person’ means— (a) a person specified in paragraphs (a) to (f) of section 12A(1), or (b) a person nominated pursuant to section 12A(2);”.
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3.
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Section 7(1)
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The insertion of the following definitions: “‘notifiable incident’ has the meaning assigned to it by the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023; ‘other than in person’, in relation to an open disclosure meeting, an additional information meeting or a clarification given under section 19, means holding such meeting or such clarification by means of the telephone or the internet (or other similar method of communication);”.
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4.
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Section 8(a)
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The insertion of “, other than a notifiable incident,” after “an incident”.
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5.
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Section 8(b)
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The insertion of “, other than a notifiable incident,” after “an incident”.
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6.
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New section 9A inserted The insertion of the following new section after section 9: “Disclosure of information by health services provider and health practitioner 9A. (1) When making an open disclosure of a patient safety incident under this Act, a health services provider shall provide all relevant information in relation to the provision of a health service to the patient (or relevant person as the case may be) that is being provided by that provider to the patient and where appropriate any other health service that is to be, or may be provided to address the consequences of that incident.
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(2)When making an open disclosure of a patient safety incident under this Act, a health practitioner shall provide all relevant information in relation to the provision of a health service to the patient (or relevant person as the case may be) that is being provided by that provider to the patient and where appropriate any other health service that is to be, or may be provided to address the consequences of that incident.”.
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7.
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Section 12(b)
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The substitution of the following paragraph for paragraph (b): “(b) a relevant person where— (i) in the opinion of the principal health practitioner providing clinical care to the patient, having regard to the clinical circumstances of the patient, who is the subject of the patient safety incident, the capacity of the patient is such that he or she is unable to— (I) participate in that open disclosure, and (II) consent to that open disclosure being made to a relevant person, and that capacity is unlikely to be of a temporary duration, and the health services provider is satisfied that a patient safety incident has occurred, it is appropriate the open disclosure of that incident is made to a relevant person, (ii) the patient has died, or (iii) the patient has requested the health services provider to make the open disclosure of the patient safety incident to a person whom the patient has nominated as a relevant person for the purposes of this Part and not the patient, or”.
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8.
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Section 12(c)
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The substitution of the following paragraph for paragraph (c): “(c) both the patient and a relevant person where, before the open disclosure meeting is held, the patient has requested that a person whom the patient has nominated as a relevant person for the purposes of this Part, attends that meeting to assist the patient and that in addition to making the open disclosure to the patient that the health services provider makes the open disclosure of the patient safety incident to that relevant person.”.
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9.
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New section 12A inserted By the insertion of the following new section after section 12: “Section 12: supplemental provisions 12A. (1) For the purposes of section 12(b)(i), and making an open disclosure of a patient safety incident to a relevant person, the health services provider shall make the open disclosure— (a) where an appointment has been made under Part 3, 4, 5, 7 or 8 of the Assisted Decision-Making (Capacity) Act 2015 in relation to health matters, to the person appointed, (b) where the patient has, under the Powers of Attorney Act 1996 , made an enduring power of attorney (within the meaning of that Act) which includes a personal care decision (within the meaning of that Act), to the attorney appointed pursuant to that Act, (c) where the patient is a ward of court, to the Committee of the Person of that ward, duly authorised in that behalf, (d) where the patient has nominated, in writing, a person to whom his or her clinical information may be disclosed, to that person, (e) where the patient is a child, to the parent or guardian of that child or where— (i) an order in respect of the child made under section 18 of the Act of 1991, (ii) the child has been taken into the care of the Agency under section 4 of the Act of 1991, or (iii) an order in respect of the child has been made under section 13, 17 or 20 of the Act of 1991, to the parents or guardian of the child and the Child and Family Agency (or an authorised person) or where an order under section 23H of the Act of 1991 has been made in respect of the child to the parents or guardian of the child and that Agency (or the social worker assigned responsibility for the child by the Agency), or (f) where the patient does not fall within the categories specified in paragraphs (a) to (e), to— (i) the spouse, civil partner or cohabitant of the patient, (ii) an adult son or daughter of the patient, or (iii) the mother, father, brother or sister of the patient.
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(2)For the purposes of a request referred to in— (a) section 12(b)(iii), and (b) section 12(c), without prejudice to subsection (1)(d), where a patient makes a request referred to in paragraph (a) or (b), the patient shall nominate the person in writing (including a person referred to in subsection (1)) as a person to whom clinical information may be disclosed in respect of information to be provided in an open disclosure of a patient safety incident.
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(3)For the purposes of section 12(b)(ii), and making an open disclosure of a patient safety incident, the open disclosure shall be made to a person specified in subsection (1).
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(4)Where an open disclosure of a patient safety incident is made pursuant to— (a) section 12(b)(i) or (b)(iii), to a relevant person, or (b) section 12(c), to both the patient and the relevant person, the relevant person shall consult with the patient in respect of the information provided at the open disclosure meeting, and shall convey, to the health services provider with the consent of the patient, the instructions, preferences and wishes of the patient in respect of any matter arising from that information.
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(5)Where, after a health services provider has, in accordance with section 12(b)(i), held the open disclosure meeting with the relevant person and after that meeting was held the patient regains capacity, the health services provider shall inform the patient that such meeting was held with the relevant person and shall provide the patient with the information given at that meeting.
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(6)In this section— ‘Act of 1991’ means the Child Care Act 1991 ; ‘authorised person’ in relation to a child referred to in subsection (1)(e) who is— (a) placed in residential care pursuant to the Act of 1991, has the same meaning as it has in the Child Care (Placement of Children in Residential Care) Regulations 1995 ( S.I. No. 259 of 1995 ), (b) placed in foster care pursuant to the Act of 1991, has the same meaning as it has in the Child Care (Placement of Children in Foster Care) Regulations 1995 ( S.I. No. 260 of 1995 ), or (c) placed with a relative pursuant to the Act of 1991, has the same meaning as it has in the Child Care (Placement of Children with Relatives) Regulations 1995 ( S.I. No. 261 of 1995 ); ‘civil partner’ has the meaning assigned to it by the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010 ; ‘cohabitant’ means one of 2 adults (whether of the same or opposite sex) who live together as a couple in an intimate and committed relationship and who are not married to each other or civil partners of each other.”.
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10.
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Section 15(1)(f)
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By the substitution for paragraph (f) of the following paragraph: “(f) having regard to the information available, make arrangements for the preparation of the statement referred to in section 16(5), that is to be provided, in accordance with section 16(2)(c) to the patient or relevant person (or both of them).”.
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11.
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Section 15A (inserted by section 82 of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023) By the insertion of the following section after section 15: “Open disclosure meeting generally to be held in person 15A. (1) An open disclosure meeting shall, subject to subsection (2), be held in person with the patient or relevant person (or both of them).
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(2)A patient or relevant person (or both of them) may, when contacted by a health services provider pursuant to section 16 to make arrangements to meet with it for the purpose of making an open disclosure, request the provider that the proposed meeting be held other than in person.
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(3)A request under subsection (2) may be made orally.
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(4)Where a request under subsection (2) is made orally, the health services provider shall make a record of the request in writing and maintain it with the records referred to in section 21.”.
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12.
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Section 16(1)(b)
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To substitute the following paragraph for paragraph (b): “(b) where a patient or a relevant person has (or both of them have) made a request under section 15A, to hold the meeting other than in person,”.
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13.
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Section 16(2)(c)
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To substitute the following paragraph for paragraph (c): “(c) shall, in accordance with section 20A, give the patient or the relevant person (or both of them) a copy of the statement referred to in subsection (5), and”.
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14.
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Section 16(2)(d)
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To substitute the following paragraph for paragraph (d): “(d) shall give the statement referred to in section 11(1) to the patient or relevant person (or both of them) in accordance with section 20A or, in the case of a meeting referred to in subsection (1)(b), shall give that statement to the patient or relevant person (or both of them) in accordance with section 20A.”.
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15.
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Section 16(5)(a)
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To delete paragraph (a).
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16.
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Section 17(1)
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The substitution for subsection (1) of the following subsection: “(1) Nothing in this Part shall require a patient to engage with the health services provider in the open disclosure of a patient safety incident and— (a) a patient may authorise a relevant person not to attend the open disclosure meeting, and (b) where a relevant person refuses to attend the open disclosure meeting, the health services provider shall inform the patient of the refusal and the patient may specify another relevant person to attend that meeting.”.
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17.
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Section 17(3)(a)
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In section 17(3), in paragraph (a), to delete “, in the prescribed form,”.
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18.
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Section 17(3) new paragraph inserted
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In section 17(3), to insert the following paragraph after paragraph (a): “(aa) include, in the statement referred to in paragraph (a), a reference to the entitlement under subsection (7) for the patient to make a later request for an open disclosure meeting despite the refusal referred to in subsection (2),”.
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19.
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Section 17(5)(a)
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In section 17(5), in paragraph (a), to delete “, in the prescribed form,”.
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20.
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Section 17(5) new paragraph inserted
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To insert the following new paragraph after paragraph (a): “(aa) include, in the statement referred to in paragraph (a), a reference to the entitlement under subsection (7) for the patient to make a later request for an open disclosure meeting despite the refusal referred to in subsection (4),”.
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21.
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Section 17(6)(i)
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In section 17(6), in paragraph (i), to delete “, in the prescribed form,”.
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22.
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Section 17(6)
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In section 17(6), after paragraph (i), to insert the following new paragraph: