IE-2023-act-10 — Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 | Law Reform

PART 1 Preliminary and General 1. (1) This Act may be cited as the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023. (2) This Act shall come into operation on such day or days as the Minister may by order or orders appoint either generally or with reference to any particular purpose or provision and different days may be so appointed for different purposes or different provisions. 2. (1) In this Act— “Act of 1985” means the Dentists Act 1985 ; “Act of 2000” means the National Treasury Management Agency (Amendment) Act 2000 ; “Act of 2005” means the Health and Social Care Professionals Act 2005 ; “Act of 2007” means the Health Act 2007 ; “Act of 2011” means the Nurses and Midwives Act 2011 ; “Act of 2014” means the Freedom of Information Act 2014 ; “Act of 2017” means the Civil Liability (Amendment) Act 2017 ; “additional notifiable information” shall be construed in accordance with section 21 ; “additional notifiable information meeting” shall be construed in accordance with section 21 ; “additional Part 5 review information” shall be construed in accordance with section 52 ; “additional Part 5 review information meeting” shall be construed in accordance with section 52 ; “agency contract” has the meaning assigned to it by section 7 of the Act of 2017; “agency health practitioner” has the meaning assigned to it by section 7 of the Act of 2017; “agency worker” has the meaning assigned to it by section 7 of the Act of 2017; “apology”, in relation to an open disclosure of a notifiable incident, means an expression of sympathy or regret; “Authority” means the Health Information and Quality Authority; “cancer screening service” means— (a) the service known as the national breast screening programme carried out by the National Cancer Screening Board and, since the dissolution of the Board on 1 April 2010, provided by the Executive, (b) CervicalCheck, and (c) the service known as the national colon cancer screening programme provided by the Executive, and a reference in this Act to a cancer screening service includes any or all of the services specified in paragraph (a) , (b) or (c) ; “CervicalCheck” has the meaning assigned to it by the CervicalCheck Tribunal Act 2019 ; “Commission” has the meaning assigned to it by the Mental Health Act 2001 ; “designated person” means— (a) in the case of a notifiable incident, the person designated under section 16 , or (b) in the case of a Part 5 review, the person designated under section 47 ; “employee”, in relation to a health services provider has the meaning assigned to it by section 7 of the Act of 2017; “employment agency” has the meaning assigned to it by section 7 of the Act of 2017; “enactment” has the same meaning it has in the Interpretation Act 2005 ; “Executive” means the Health Service Executive; “fixed-term employee” has the same meaning it has in section 7 of the Act of 2017; “health practitioner” means— (a) a registered medical practitioner within the meaning of the Medical Practitioners Act 2007 or a medical practitioner practising medicine pursuant to section 50 of that Act, (b) a registered dentist within the meaning of the Act of 1985, (c) a registered pharmacist, or registered pharmaceutical assistant, within the meaning of the Pharmacy Act 2007 , (d) a registered nurse, or registered midwife, within the meaning of the Act of 2011, (e) a registrant within the meaning of section 3 of the Act of 2005, or (f) a person whose name is entered in the register referred to in Article 4(s) of the Order of 2000; “health service” means the provision, by or under the direction of a health services provider, of clinical care or any ancillary service to a patient for— (a) the screening (other than screening carried out by a cancer screening service), preservation or improvement of the health of the patient, (b) the prevention, diagnosis, treatment or care of an illness, injury or health condition of the patient, (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 patient, or (d) without prejudice to paragraph (a) , a cancer screening service; “health services provider” shall be construed in accordance with section 3 ; “making an open disclosure of a notifiable incident” shall be construed in accordance with section 9 ; “making an open disclosure of a Part 5 review” shall be construed in accordance with section 40 ; “Minister” means the Minister for Health; “notifiable incident” means an incident specified in— (a) Schedule 1 , or (b) regulations made under section 8 ; “notifiable incident disclosure meeting” shall be construed in accordance with section 18 (1) ; “open disclosure of a notifiable incident” shall be construed in accordance with section 9 and references to the open disclosure of a notifiable incident, or open disclosure in relation to a notifiable incident shall be construed accordingly; “open disclosure of Part 5 review” shall be construed in accordance with section 40 and references to the open disclosure of Part 5 review, or open disclosure in relation to a Part 5 review shall be construed accordingly; “other than in person”— (a) in relation to a notifiable incident disclosure meeting, an additional information disclosure meeting or a clarification given under section 23 , and (b) in relation to a Part 5 disclosure meeting, an additional information disclosure meeting or a clarification given under section 54 , means holding such meeting or such clarification by means of the telephone or the internet (or other similar method of communication); “Order of 2000” means the Pre-Hospital Emergency Care Council (Establishment) Order 2000 ( S.I. No. 109 of 2000 ) amended by the Pre-Hospital Emergency Care Council (Establishment) Order 2000 (Amendment) Order 2004 ( S.I. No. 575 of 2004 ); “ Part 5 review” means a review conducted in accordance with section 35 and includes— (a) a request for a Part 5 review, (b) the process undertaken by the health services provider to carry out the review, and (c) the findings of the review; “ Part 5 review disclosure meeting” shall be construed in accordance with section 49 (1) ; “patient”, in relation to a health services provider, means a person to whom a health service is, or has been, provided; “partnership”, in relation to the provision of a health service, means 2 or more health practitioners who provide a health service in common; “prescribed” means prescribed in regulations made by the Minister under this Act; “principal health practitioner”, in relation to a patient, means a health practitioner who has the principal clinical responsibility for the clinical care and treatment of the patient and, in the case of a cancer screening service, means the health practitioner who has the principal clinical responsibility for the cancer screening service; “relevant person” means in relation to the making of an open disclosure of— (a) a notifiable incident, a person specified in paragraphs (a) to (f) of section 7 (2) , or a person nominated pursuant to section 7 (3) , or (b) a Part 5 review, a person specified in paragraphs (a) to (f) of section 39 (2) , or a person nominated pursuant to section 39 (3) ; “unintended”, in relation to a death, means a death arising from an unintended event occurring, or arising from, the provision of a health service. (2) References in this Act to— (a) “information provided” or “an apology made” at a notifiable incident disclosure meeting or a Part 5 review disclosure meeting, (b) “additional notifiable information provided”, or “apology made”, at an additional notifiable information meeting, or at an additional Part 5 review meeting, or (c) information provided in a clarification under section 23 or section 54 , as the case may be, includes information that is provided, or an apology that is made, orally or in writing. 3. (1) In this Act, “health services provider” means— (a) a person, other than a health practitioner, who provides one or more health services and for that purpose— (i) employs a health practitioner for the provision (whether for, or on behalf of, that person) by that practitioner, of a health service, (ii) enters into a contract for services with a health practitioner for the provision (whether for, or on behalf of, that person) by that health practitioner of a health service, (iii) enters into an agency contract for the assignment, by an employment agency, of an agency health practitioner to provide a health service for, or on behalf of, that person, (iv) enters into an arrangement with a health practitioner— (I) for the provision by that health practitioner of a health service (whether for, or on behalf of, that person, or through or in connection with that person), (II) for the provision by that health practitioner of a health service on his or her own behalf (whether through or in connection with, or by or on behalf of, that person or otherwise), or (III) without prejudice to the generality of clause (II) , to provide that health practitioner with privileges commonly known as practising privileges (whether such privileges are to operate through or in connection with, or by or on behalf of, the person or otherwise), or (v) insofar as it relates to the carrying on of the business of providing a health service— (I) employs one or more persons, (II) enters into a contract for services with one or more persons, (III) enters into an agency contract for the assignment of an agency worker, or (IV) enters into an arrangement with one or more persons, in respect of the carrying on of that business, (b) a health practitioner who provides a health service and does not provide that health service for, or on behalf of, or through or in connection with (whether by reason of employment or otherwise), a person referred to in paragraph (a) and includes a health practitioner who— (i) employs another health practitioner for the provision (whether for, or on behalf of, the first-mentioned health practitioner) by that other health practitioner of a health service, (ii) enters into a contract for services with another health practitioner for the provision (whether for, or on behalf of, the first-mentioned health practitioner) by that other health practitioner, of a health service, (iii) enters into an agency contract for the assignment, by an employment agency, of an agency health practitioner to provide a health service for, or on behalf of, the first-mentioned health practitioner, or (iv) insofar as it relates to the carrying on of the business of providing a health service— (I) employs one or more persons, (II) enters into a contract for services with one or more persons, (III) enters into an agency contract for the assignment of an agency worker, or (IV) enters into an arrangement with one or more persons, in respect of the carrying on of that business, (c) a partnership of 2 or more health practitioners who provide a health service in common which does not provide that health service for, or on behalf of, or through or in connection with (whether by reason of employment or otherwise), a person referred to in paragraph (a) and includes a partnership which— (i) employs another health practitioner for the provision (whether by or on behalf of, the partnership) by that other health practitioner of a health service, (ii) enters into a contract for services with another health practitioner for the provision (whether for, or on behalf of, the partnership) by that other health practitioner of a health service, (iii) enters into an agency contract for the assignment, by an employment agency, of an agency health practitioner to provide a health service for, or on behalf of, the partnership, or (iv) insofar as it relates to the carrying on of the business of providing a health service— (I) employs one or more persons, (II) enters into a contract for services with one or more persons, (III) enters into an agency contract for the assignment of an agency worker, or (IV) enters into an arrangement with one or more persons, in respect of the carrying on of that business, or (d) in the case of a cancer screening service, the Executive or, in respect of the cancer screening service referred to in paragraph (b) of the definition of “cancer screening service”, a provider referred to in paragraph (b) or (c) . (2) For the purposes of paragraphs (b) and (c) of the definition of “health services provider”, references in each such paragraph to “through or in connection with” do not include the use by a health services provider referred to in each such paragraph of a health service (or processes related to a health service) provided— (a) by a health services provider referred to in paragraph (a) of that definition, and (b) for the purpose of the provision, by a health services provider— (i) referred to in paragraph (b) of that definition, of a health service on its own behalf, or (ii) referred to in paragraph (c) of that definition, of a health service on behalf of a partnership. 4. The expenses incurred by the Minister in the administration of this Act shall, to such extent as may be sanctioned by the Minister for Public Expenditure, National Development Plan Delivery and Reform, be paid out of monies provided by the Oireachtas. PART 2 Open Disclosure of Notifiable Incident – Chapter 1 General 5. (1) Where a health services provider is satisfied that a notifiable incident has occurred in the course of the provision by it of a health service to a patient, (whether the notifiable incident occurred when that provider was providing that service or another health services provider was providing a health service to that patient) the health services provider shall, subject to sections 19 and 20 , hold a notifiable incident disclosure meeting in order to make the open disclosure of that notifiable incident to the patient or relevant person (or both of them) as specified in section 7 . (2) For the purposes of subsection (1) , where a health services provider is satisfied that a notifiable incident has occurred but— (a) none, or not all, of the likely consequences of the notifiable incident have presented or developed, or (b) not all of the information relating to the incident, including information relating to the cause of the incident, is available, the health services provider shall make the open disclosure of the notifiable incident under subsection (1) notwithstanding the absence of some or all of those consequences or that information. (3) For the purposes of subsection (1) , a health services provider may be satisfied that a notifiable incident has occurred as referred to in that subsection whether the provider has received information in respect of that notifiable incident pursuant to section 6 or otherwise. 6. (1) Without prejudice to section 5 , where, in the opinion of a health practitioner a notifiable incident has occurred in relation to a patient, the health practitioner shall, as soon as practicable, inform the health services provider which is, at the time he or she has formed the opinion, providing the health service to the patient. (2) A health practitioner shall inform the health services provider referred to in subsection (1) whether— (a) the notifiable incident may have occurred during the provision of a health service to the patient by— (i) that provider, or (ii) another health services provider, or (b) he or she is unsure when the notifiable incident occurred. 7. (1) A health services provider shall make the open disclosure of the notifiable incident to— (a) the patient concerned, (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 notifiable 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 notifiable incident has occurred, it is appropriate, having regard to section 5 , that 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 notifiable incident to a person whom the patient has nominated as a relevant person for the purposes of this Act and not the patient, or (c) both the patient and a relevant person where, before the notifiable incident 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 Act 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 notifiable incident to that relevant person. (2) For the purposes of subsection (1)(b)(i) , and making an open disclosure of a notifiable 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 has been 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. (3) For the purposes of a request referred to in— (a) subsection (1)(b)(iii) , and (b) subsection (1)(c) , without prejudice to subsection (2)(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 (2) ) as a person to whom clinical information may be disclosed in respect of information to be provided in an open disclosure of a notifiable incident. (4) For the purposes of subsection (1)(b)(ii) , and making an open disclosure a notifiable incident, the open disclosure shall be made to a person specified in subsection (2) . (5) Where an open disclosure of a notifiable incident is made pursuant to— (a) subsection (1)(b)(i) or (iii) , to a relevant person, or (b) subsection (1)(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 notifiable incident 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. (6) Where, after a health services provider has, in accordance with subsection (1)(b)(i) , held the notifiable incident 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. (7) In this section— “Act of 1991” means the Child Care Act 1991 ; “authorised person” in relation to a child referred to in subsection (2)(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. 8. (1) Subject to subsection (2) , the Minister may prescribe as a notifiable incident: (a) an incident which has occurred in the course of the provision of a health service; (b) an incident which, having regard to developments in clinical practice, healthcare and patient safety, may occur; (c) an incident which, having regard to such developments internationally, has occurred or may occur. (2) Regulations under this section shall only be made where the Minister is satisfied that— (a) the incident was or would be an unanticipated and unintended outcome of the health service provided, and would arise from the health service provided and not be attributable (in whole or in part) to the illness or underlying condition of the patient receiving the health service, (b) the consequence, for a patient, of an incident referred to in subsection (1) is one which has caused— (i) the death of the patient where the death was not wholly attributable to the illness of the patient or an underlying condition of that patient, (ii) a permanent lessening of bodily, sensory, motor, physical or intellectual functions, (iii) harm to that patient— (I) resulting in one or more permanent changes to the structure of the body of that patient, the effect of which is to shorten the life expectancy of that patient, or (II) the effect of which has impaired the sensory, motor or intellectual functions of that patient and the duration of the impairment has been, or is likely to be, for a continuous period of not less than 28 days, (c) the obtaining, provision and dissemination of information in respect of an incident referred to in subsection (1) , or a consequence referred to in paragraph (b) , is required to provide knowledge and an understanding of the causes of such incident or such consequence, (d) the application of such knowledge and understanding to the manner in which a health service is provided is required for the purposes of patient safety and avoiding, lessening or eradicating the repetition of such an incident, and (e) it is appropriate, in respect of any such incident and such information, knowledge, application and understanding that— (i) an open disclosure of an incident referred to in subsection (1) is made under this Act, and (ii) notification of that incident is made under section 27 , 28 or 29 . (3) Regulations under this section may make different provision for different incidents or classes of incidents referred to in subsection (1) and may make different provision for different patients and different classes of patients having regard to the different incidents and different classes of incidents and may, in respect of a consequence referred to in subsection (2) of an incident that is specified in those regulations, provide for different classes of consequences (including different classes of harm) referred to in subsection (2) . 9. Where a health services provider discloses, in accordance with this Act, at a notifiable incident disclosure meeting, to— (a) a patient that a notifiable incident has occurred in the course of the provision of a health service to him or her, (b) a relevant person that a notifiable incident has occurred in the course of the provision of a health service to the patient, or (c) a patient and a relevant person that a notifiable incident has occurred in the course of the provision of a health service to the patient, the disclosure shall be treated as an open disclosure by the health services provider of the notifiable incident and section 10 shall apply to— (i) the information in respect of the notifiable incident, provided to the patient or relevant person (or both of them) at the notifiable incident disclosure meeting, additional notifiable information provided at the additional notifiable information meeting and information provided in a clarification under section 23 , and (ii) an apology, in respect of the notifiable incident, where an apology is made at that meeting, or the additional notifiable information meeting as the case may be. 10. (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 notifiable incident disclosure meeting in respect of a notifiable incident, or pursuant to the provisions specified in subsection (3) , the statement referred to in section 18 (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 notifiable incident is, pursuant to section 5 (1) , made by the health services provider in respect of a notifiable incident 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 that notifiable incident or a clinical negligence action which arises (whether in whole or in part) from the consequences of that notifiable incident, (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 notifiable incident or a clinical negligence action which arises (whether in whole or in part) from the consequences of that notifiable incident, 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 notifiable incident concerned or any matter alleged which arises (whether in whole or in part) from that notifiable incident. (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 notifiable incident disclosure meeting in respect of a notifiable incident or pursuant to the provisions specified in subsection (3) , the statement referred to in section 18 (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 that notifiable incident, 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) . (3) This section shall— (a) in accordance with section 22 (7) , apply to— (i) additional notifiable information provided, and an apology where it is made, at the additional notifiable information meeting, and (ii) a statement referred to in section 22 (3) , and (b) in accordance with section 23 (8) , apply to information and statements provided in a clarification referred to in, and given under, that section. (4) Information provided by a health practitioner to a health services provider under section 6 — (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 notifiable incident concerned or any matter alleged which arises (whether in whole or in part) from that notifiable incident, (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 that notifiable incident, 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) . (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. (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). 11. (1) A health services provider shall prepare a statement in writing of— (a) its procedure for making an open disclosure of a notifiable incident pursuant to, and in accordance with this Part, and (b) the manner in which section 10 applies to the restrictions on the use, pursuant to this Act, of information provided, and any apology made, at the notifiable incident disclosure meeting, the additional notifiable information meeting, or the information provided in a clarification under section 23 and any statements in writing provided in respect of those meetings or that clarification. (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) . PART 2 Open Disclosure of Notifiable Incident – Chapter 2 Open disclosure: openness and transparency 12. (1) When making an open disclosure of a notifiable 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. (2) When making an open disclosure of a notifiable 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. (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. (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. (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. (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 (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 (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. (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 (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. PART 3 Procedure for making Open Disclosure of Notifiable Incident 13. (1) For the purposes of section 5 , the open disclosure of a notifiable incident 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 notifiable incident is to be made, or (b) where the conditions specified in subsection (2) are satisfied, a health practitioner referred to in that subsection. (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 notifiable incident, or (b) having had regard to the circumstances of the notifiable incident, the health services provider, or the principal health practitioner referred to in paragraph (a) of that subsection, is satisfied that the open disclosure of that incident should be made by another health practitioner, the open disclosure of that notifiable incident shall be made by a health practitioner whom the health services provider, having considered the incident concerned, considers appropriate. 14. (1) For the purposes of making an open disclosure of a notifiable incident pursuant to section 5 , the health services provider shall make the open disclosure of that notifiable incident 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 5 (2) , some, or all, of the likely consequences of the notifiable incident are not present or have not developed, (ii) as referred to in section 5 (2) , the health services provider does not have all of the information relating to the notifiable incident available to it when the open disclosure of the incident is made, or (iii) without prejudice to subparagraph (ii) , the health services provider does not have all, or any, of the information in respect of the cause of the incident available to it when the open disclosure of the incident is made, (b) all the circumstances of the patient and the nature, and consequences, of the notifiable incident concerned, and (c) the requirements of section 15 . (2) Having considered the appropriate time for making the open disclosure of the notifiable incident, the health services provider shall take all steps reasonably open to it to make the open disclosure as soon as practicable following that consideration. (3) Where an open disclosure of a notifiable incident 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 10 from having effect in respect of that open disclosure of that incident. 15. (1) Before making an open disclosure of a notifiable incident, 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 14 (1)(a) — (i) make an assessment of all the circumstances of the patient and the nature of the notifiable incident, 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 notifiable incident 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 notifiable incident, and (iii) consultations, if any, referred to in paragraph (a)(ii) , (c) determine whether, having regard to the nature and circumstances of the notifiable incident concerned, it is appropriate for an apology to be made to the patient or the relevant person (or both of them) at the notifiable incident disclosure meeting, (d) consider the information relating to the notifiable incident 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 16 , 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 notifiable incident and in respect of a request for clarification under section 23 , and (f) having regard to the information available, make arrangements for the preparation of the statement, referred to in section 18 (5) , that is to be provided, in accordance with section 18 (2)(c) to the patient or relevant person (or both of them). (2) Subsection (1)(b) shall not apply where an open disclosure of a notifiable incident is made to a relevant person pursuant to section 7 (1)(b)(ii) , (iii) or (1)(c) as the case may be. 16. (1) For the purpose of making a designation under section 15 (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 15 (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 15 (1)(e) , or (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 15 (1)(e) . (2) A designation under this section shall be in writing and shall be kept in the records, referred to in section 25 , relating to the open disclosure of the notifiable incident made under this Act. 17. (1) A notifiable incident disclosure meeting shall, subject to subsection (2) , be held in person with the patient or relevant person (or both of them). (2) A patient or a relevant person (or both of them) may, when contacted by a health services provider pursuant to section 18 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. (3) A request under subsection (2) may be made orally. (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 25 . 18. (1) A health services provider shall, subject to section 14 , 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 17 , to hold the meeting other than in person, for the purpose of making an open disclosure of a notifiable incident in respect of which the patient, or patient to whom the relevant person is connected, is the subject of the notifiable incident (in this Act referred to as an “notifiable incident disclosure meeting”). (2) When making an open disclosure of a notifiable incident at a notifiable incident 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 14 , the health services provider has in its possession, at the time the notifiable incident 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 notifiable incident concerned, (c) shall, in accordance with section 24 , 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 11 (1) to the patient or relevant person (or both of them) in accordance with section 24 . (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 notifiable incident disclosure meeting; (b) a description of the notifiable incident concerned; (c) the date on which— (i) the notifiable incident occurred (if known), and (ii) the notifiable incident came to the notice of the health services provider; (d) the manner in which the notifiable incident 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 notifiable incident which, at the time of the notifiable incident 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 of the notifiable incident 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 notifiable incident disclosure meeting, information in respect of those consequences, and (ii) physical or psychological consequences which, at the time of the notifiable incident 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 notifiable incident 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 notifiable incident, a statement to that effect; (h) where, at the time of the notifiable incident disclosure meeting— (i) any physical or psychological consequences arising from the notifiable incident 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 notifiable incident— (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 that incident and the circumstances giving rise to it. (4) Where, pursuant to section 15 (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 notifiable incident disclosure meeting, make the apology to the patient or the relevant person (or both of them) in respect of the notifiable incident. (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 notifiable incident was made pursuant to section 5 (1) , (e) specify the date on which the open disclosure of the notifiable incident was made, (f) state that the notifiable incident disclosure meeting was held in compliance with section 5 (1) , and (g) be signed in accordance with subsection (6) . (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 13 (2) , who made the open disclosure of the notifiable incident on behalf of the health services provider. (7) The health services provider shall keep, in the records referred to in section 25 , the statement referred to in subsection (5) . 19. (1) Nothing in this Act shall require a patient to engage with the health services provider in the open disclosure of a notifiable incident and— (a) a patient may authorise a relevant person not to attend the notifiable incident disclosure meeting, and (b) where a relevant person refuses to attend the notifiable incident 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. (2) Where a health services provider informs a patient or a relevant person that the provider proposes to hold a notifiable incident disclosure meeting in order to make an open disclosure of the notifiable incident and the patient or relevant person does not want to have the open disclosure made to him or her and refuses to attend that notifiable incident disclosure meeting, the patient, or a relevant person, shall inform the provider that he or she— (a) will not attend the notifiable incident 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 5 (2) and section 14 , any additional notifiable information that may be provided (or apology that may be made) pursuant to section 21 . (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 notifiable incident 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 25 , and (f) pursuant to that statement, not proceed to hold the notifiable incident disclosure meeting. (4) Where section 7 (1)(c) applies and a health services provider informs both a patient and a relevant person that the provider proposes to hold a notifiable incident disclosure meeting in order to make an open disclosure of the notifiable incident and both the patient and relevant person do not want to have the open disclosure made to them and refuse to attend that notifiable incident disclosure meeting, the patient and relevant person shall inform that provider that— (a) they will not attend the notifiable incident 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 5 (2) and section 14 , any additional notifiable information that may be provided (or apology that may be made) pursuant to section 21 . (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 notifiable incident 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 25 , and (f) pursuant to that statement, not proceed to hold the notifiable incident disclosure meeting. (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 incident to be disclosed and the date of the incident (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 25 , the note referred to in paragraph (a) , which has been signed in accordance with paragraph (c) . (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 noti