Legalize / Ireland / Act

Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

Type Act

Publication 2023-05-02

Last updated 2024-10-01

State In force

Source Irish Statute Book

articles 83

Reform history JSON API

(b) which is registered in accordance with section 49 of the Act of 2007 and includes—

(i) a designated centre whose registration has been cancelled under section 51 of that Act where an appeal against the cancellation has been made and has not been determined or withdrawn or in respect of which an appeal has been made under section 62 of that Act and that appeal has not been determined or withdrawn, and

(ii) a designated centre in respect of which an application was made to the District Court under section 59 of the Act of 2007 and the application has not been determined or withdrawn or in respect of which an appeal has been made under section 62 of that Act and that appeal has not been determined or withdrawn.

29. Notification to Commission of notifiable incident by certain health services providers

29. (1) Where a health services provider, which provides a health service in an approved centre, is satisfied that a notifiable incident, specified in subsection (2), has occurred in the course of the provision by it of a health service to a patient, it shall notify the Commission of that notifiable incident—

(a) as soon as practicable, and

(b) in any event, not later than 7 days from the day on which the provider was satisfied the incident had occurred.

(2) For the purposes of subsection (1), all of the following shall be notified in accordance with that subsection:

(a) each notifiable incident specified in Part 1 of Schedule 1;

(b) in the case of a notifiable incident specified in regulations made under section 8, each such incident specified in any regulations made under that section.

(3) A notification under this section shall include the information specified in section 27(3) for the notifiable incident concerned.

(4) The Commission shall acknowledge receipt, in writing, of a notification made to it under this section not later than 21 days from receipt of the notification.

(5) An acknowledgement made under subsection (4) may be made electronically.

(6) In this Part, “approved centre” shall be construed in accordance with section 63 of the Mental Health Act 2001 and, in accordance with section 65(4)(a) of that Act, or as the case may be, section 64(10)(a) of that Act, and references to an approved centre include a reference to an approved centre to which section 65(4)(a) of that Act, or as the case may be, section 64(10)(a)(iii) of that Act, refers.

30. Method of making notifications under sections 27, 28 and 29

30. For the purposes of making a notification under section 27, 28 or 29, the health services provider shall make the notification by means of the National Treasury Management Agency incident management system.

31. Provision of additional and further information by health services provider

31. (1) Where, following a notification under section 27, 28 or 29—

(a) the Authority,

(b) the chief inspector, or

has had regard to the notifiable incident concerned and requires additional information in respect of the notifiable incident concerned, it, or he or she, may request the health services provider concerned to furnish it, or him or her, with additional information that is additional to the information specified in the notification, and where it, or he or she, considers it appropriate with the further information referred to in subsection (2) (in this Part referred to as “additional Part 4 information”).

(2) The further information referred to in subsection (1) (in this Part referred to as “further Part 4 information”) is information which—

(a) arises from the consideration by the Authority, chief inspector or Commission of the nature of the notifiable incident concerned, and

(b) having had regard to the safety of patients, and the performance by the Authority, chief inspector or Commission, it, or him or her, of its, or his or her, functions the Authority, chief inspector or Commission considers necessary for the performance of those functions.

(3) Additional Part 4 information or further Part 4 information, provided pursuant to a request under this section shall be provided in such manner as the Authority, chief inspector or Commission specifies in the request.

32. (1) Where, in the opinion of the Authority, chief inspector or the Commission, having had regard to—

(a) the information, specified in section 27(3), 28(3) or as the case may be section 29(3), provided in respect of the notifiable incident, additional Part 4 information and further Part 4 information provided under section 31,

(b) the issues arising from that information in relation to the safety of patients, and

(c) the functions of a relevant body including functions relating to the provision, or regulation, of a health service or the regulation of a health practitioner,

it is necessary for the purposes of the safety of patients that such information be shared with one or more relevant bodies for the performance by any such relevant body of its functions, the Authority, the chief inspector or the Commission may share information (including additional Part 4 information and further Part 4 information referred to in paragraph (a)) provided to it, or as the case may be, to him or her under, and in accordance with, this Part with any such relevant body.

(2) A relevant body shall use any information provided to it under this section solely for the purpose of the performance by it of its functions.

(3) In this section—

“Act of 1962” means the Coroners Act 1962;

“relevant body” means all or any of the following:

(a) the coroner (within the meaning of the Act of 1962) for the coroner’s district (within the meaning of the Act of 1962) in which a notifiable incident has occurred;

(b) the Health Products Regulatory Authority;

(d) the Child and Family Agency;

(e) a body established by or under any enactment (other than the Companies Act 2014) whose functions include the regulation of any matter relating to a health service or the regulation of a health practitioner.

33. Notification under Part 4: information not to invalidate insurance; constitute admission of liability or fault; or not to be admissible in proceedings

33. (1) Information provided in a notification under this Part (including additional Part 4 information and further Part 4 information) and any such information that is, pursuant to section 32, shared under that section—

(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(1)(a),

in relation to the notifiable incident which is the subject of the notification 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, or

(ii) a person specified in subparagraphs (ii) to (ix) of section 10(1)(b),

in a court in relation to the notifiable incident which is the subject of the notification or a clinical negligence action which arises (whether in whole or in part) from the consequences of that notifiable incident, and

(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,

(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 which is the subject of the notification or any matter alleged which arises (whether in whole or in part) from that notifiable incident.

(2) Information provided in a notification under this Part—

(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(2)(a), or

(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 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.

(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.

34. Restriction of Act of 2014 in respect of notification made under this Part

34. (1) The Act of 2014 shall not apply to a record of, or relating to, a notification made under sections 27, 28 and 29, additional Part 4 information provided under section 31, further Part 4 information provided under section 31 or any other provision of this Part which is held—

(a) pursuant to section 27, by the Authority,

(b) pursuant to section 28, by the chief inspector,

(d) pursuant to section 30, by the State Claims Agency (within the meaning of section 8(6) of the Act of 2000).

(2) Where information obtained from a notification referred to in subsection (1) (including additional Part 4 information and further Part 4 information) is shared under section 32, the Act of 2014 shall not apply to a record of, or relating to, that notification (or that additional and further information) which is held by the relevant body referred to in section 32 with which it was shared.

PART 5 Open disclosure of Part 5 reviews

35. Part 5 review

35. (1) A patient may request a review (in this Act referred to as a “request for a Part 5 review”) of the results of a screening which has been carried out by a cancer screening service in relation to the patient.

(2) A request for a Part 5 review shall be made in writing to the health services provider who provided the cancer screening to the patient.

(3) Where a request for a Part 5 review has been received in accordance with subsection (2), the health services provider which received the request shall carry out the review, which review shall be carried out in such form and manner and subject to such requirements and conditions as may be reasonably specified by the provider for the purposes of carrying out Part 5 reviews under this Part.

36. Obligation to inform patient of right to make request for Part 5 review

36. (1) A health services provider shall, in relation to a patient in respect of whom a cancer screening is to be or is being carried out, inform the patient in writing, either before or at the time that it carries out the cancer screening on that patient, of his or her right to make a request under section 35 for a Part 5 review.

(2) Without prejudice to the generality of subsection (1), a health services provider shall, in relation to patients in respect of whom a cancer screening has, on or after the commencement of this section, been carried out by the health services provider establish and implement procedures for the further provision of the information given under subsection (1) to those patients in respect of their right to make a request for a Part 5 review under and in accordance with section 35.

(3) A health services provider shall publish the procedures referred to in subsection (2) on a website maintained by or on behalf of the health services provider.

37. Obligation to make an open disclosure of Part 5 review

37. (1) Where a Part 5 review has been carried out in respect of a patient, the health services provider shall, subject to sections 50 and 51, hold a Part 5 review disclosure meeting in order to make the open disclosure of the review to the patient or relevant person (or both of them) as specified in section 39.

(2) For the purposes of subsection (1), where a health services provider is satisfied that a Part 5 review has been carried out but not all of the information relating to the review is available, the health services provider shall make the open disclosure of the Part 5 review under subsection (1) notwithstanding the absence of some of that information.

38. Health practitioner to inform health services provider of Part 5 review

38. (1) Without prejudice to section 37, where, a health practitioner becomes aware that a Part 5 review has been carried out in relation to a patient, the health practitioner shall, as soon as practicable, inform the health services provider which is providing the health service to the patient of that fact.

(2) A health practitioner shall inform the health services provider referred to in subsection (1) whether or not the Part 5 review was carried out during the provision of a health service to the patient by—

(a) that provider, or

(b) another health services provider.

39. Persons to whom open disclosure of Part 5 review is made

39. (1) A health services provider shall make the open disclosure of the Part 5 review 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 Part 5 review, 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 Part 5 review has taken place, it is appropriate, having regard to section 37, that the open disclosure of that review 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 Part 5 review to a person whom the patient has nominated as a relevant person for the purposes of this Act and not the patient,

(c) both the patient and a relevant person where, before the Part 5 review 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 Part 5 review to that relevant person.

(2) For the purposes of subsection (1)(b)(i), and making an open disclosure of the Part 5 review 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,

(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 Part 5 review.

(4) For the purposes of subsection (1)(b)(ii), and making an open disclosure of a Part 5 review, the open disclosure shall be made to a person specified in subsection (2).

(5) Where an open disclosure of a Part 5 review 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 Part 5 review 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 Part 5 review 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 section 172(1) of 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.

40. Open disclosure of Part 5 review

40. Where a health services provider discloses, in accordance with this Act, at a Part 5 review disclosure meeting, to—

(a) a patient,

(b) a relevant person, or

the information specified in paragraphs (a) to (c) of the definition of a Part 5 review, the disclosure shall be treated as an open disclosure by the health services provider of the Part 5 review and section 41 shall apply to—

(i) the information in respect of the Part 5 review, provided to the patient or relevant person (or both of them) at the Part 5 review disclosure meeting, additional Part 5 review information provided at the additional Part 5 review information meeting and information provided in a clarification under section 54, and

(ii) an apology, in respect of the Part 5 review, where an apology is made at that meeting, or the additional Part 5 review information meeting as the case may be.

41. 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(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(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

(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,

(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.

(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(5) and the statements referred to in the provisions specified in subsection (3)—

(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

(3) This section shall—

(a) in accordance with section 53(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(3),

and

(b) in accordance with section 54(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 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),

(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,

(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

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).

42. 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.

(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).

43. 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.

(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.

(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,

(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,

(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.

44. 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.

(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.

45. 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(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

(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.

(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.

46. 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(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(5), that is to be provided, in accordance with section 49(2) to the patient or relevant person (or both of them).

(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(1)(b)(ii), (iii) or (1)(c) as the case may be.

47. Designated person

47. (1) For the purpose of making a designation under section 46(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(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(1)(e),

(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(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(1)(e).

(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.

48. Part 5 review disclosure meeting generally to be held in person

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).

(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.

(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 56.

49. Part 5 review disclosure meeting

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”).

(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(1) to the patient or relevant person (or both of them) in accordance with section 55.

(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;

(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—

(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.

(4) Where, pursuant to section 46(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.

(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),

(d) state that the open disclosure of the Part 5 review was made pursuant to section 37(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(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 44(2),

who made the open disclosure of the Part 5 review on behalf of the health services provider.

(7) The health services provider shall keep, in the records referred to in section 56, the statement referred to in subsection (5).

50. 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.

(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(2) and section 45, any additional Part 5 review information that may be provided (or apology that may be made) pursuant to section 52.

(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),

(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.

(4) Where section 39(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(2) and section 45, any additional Part 5 review information that may be provided (or apology that may be made) pursuant to section 52.

(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,

(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.

(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),

(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).

(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, F2[the patient or the relevant person (or both of them) may], within 5 years from the date of the refusal, request the health services provider to make the open disclosure.

(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.

(9) Where the health services provider receives a request under subsection (7), it shall hold a Part 5 review disclosure meeting.

(10) The health services provider shall keep, in the records referred to in section 56, the note referred to in subsection (8).

51. 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(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(1).

(2) Where for the purposes of section 37(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(1).

(3) Where for the purposes of section 37(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(1).

(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,

(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).

(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.

(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.

52. 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(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(2), and

(b) subparagraphs (i) and (ii) of section 45(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.

(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).

(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.

(4) A request under subsection (3) may be made orally.

(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”).

(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(1)(b), the open disclosure of the Part 5 review was made by a health practitioner referred to in section 44(2), by that health practitioner, or

(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.

(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.

(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.

53. 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

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).

(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(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(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(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.

(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,

(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).

(4) The statement referred to in subsection (3) shall be signed by—

(a) the principal health practitioner referred to in section 52(6)(a),

(b) the health practitioner referred to in section 52(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.

(5) The health services provider shall keep, in the records referred to in section 56, the statement referred to in subsection (3).

(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.

(7) Section 41 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(5).

54. 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.

(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

(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).

(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).

(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.

(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

(6) The statement referred to in subsection (5) shall be signed by the person who provided the clarification.

(7) The health services provider shall keep, in the records referred to in section 56, the statement referred to in subsection (5).

(8) Section 41 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(5).

55. 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(5) to a patient or relevant person (or both of them) in accordance with section 49(2) and the statement referred to in section 49(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(3) to a patient or relevant person (or both of them) in accordance with section 53(1), and

(c) a clarification provided under section 54 and the provision of the statement referred to in section 54(3)(b) to a patient or relevant person (or both of them) in accordance with that section.

(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.

(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(5) to a patient or relevant person (or both of them) in accordance with section 49(2) and the statement referred to in section 49(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(3) to a patient or relevant person (or both of them) in accordance with section 53(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(3)(b) to a patient or relevant person (or both of them) in accordance with that section.

(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.

56. 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(2),

(b) the statement referred to in section 49(7),

(d) the note referred to in section 50(6)(d),

(e) the note referred to in section 50(10),

(f) the statement referred to in section 51(4)(d),

(g) the statement referred to in section 53(5),

(h) the statement in writing—

(i) of a request referred to in section 54(2)(e), and

(ii) referred to in section 54(7),

and

(i) a record of a request (if any) referred to in section 48(4) or section 52(9).

(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.

PART 6 Clinical Audit

57. 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,

(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.

58. 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.

(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.

(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

shall be construed accordingly.

59. 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,

(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).

60. Restriction of Act of 2014

60. (1) A record referred to in subsection (2) shall not be disclosed under the Act of 2014.

(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.

(3) In this section, “record” has the meaning assigned to it by the Act of 2014.

61. 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(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(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

(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,

(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.

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Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

29. Notification to Commission of notifiable incident by certain health services providers

30. Method of making notifications under sections 27, 28 and 29

31. Provision of additional and further information by health services provider

32. Sharing information

33. Notification under Part 4: information not to invalidate insurance; constitute admission of liability or fault; or not to be admissible in proceedings

34. Restriction of Act of 2014 in respect of notification made under this Part

PART 5 Open disclosure of Part 5 reviews

35. Part 5 review

36. Obligation to inform patient of right to make request for Part 5 review

37. Obligation to make an open disclosure of Part 5 review

38. Health practitioner to inform health services provider of Part 5 review

39. Persons to whom open disclosure of Part 5 review is made

40. Open disclosure of Part 5 review

41. Open disclosure of Part 5 review: information and apology not to invalidate insurance,constitute admission of liability or fault or be admissible in proceedings

42. Statement in relation to procedure for open disclosure of Part 5 review and application of section 41 to information and apology

43. Disclosure of information by health services provider and health practitioner

44. Making of open disclosure of Part 5 review by health services provider

45. Time of making of open disclosure

46. Matters to be addressed by health services provider before making open disclosure of Part 5 review

47. Designated person

48. Part 5 review disclosure meeting generally to be held in person

49. Part 5 review disclosure meeting

50. Refusal, by patient or relevant person, to participate in open disclosure of Part 5 review

51. Failure to contact patient or relevant person (or both) for purpose of open disclosure of Part 5 review

52. Additional Part 5 review information

53. Additional Part 5 review information to be provided at additional Part 5 review information meeting

54. Clarification of information provided at Part 5 review disclosure meeting or additional Part 5 review information provided at additional Part 5 review information meeting

55. Statements specifying information given at certain meetings

56. Records relating to open disclosure of results of Part 5 review

PART 6 Clinical Audit

57. Interpretation for Part

58. Clinical audit and clinical guideline

59. Clinical audit to which Part applies

60. Restriction of Act of 2014

61. Clinical audit data: information not to invalidate insurance; constitute admission of liability or fault; or not to be admissible in proceedings