(LRC Revised)

Number 10 of 2023

PATIENT SAFETY (NOTIFIABLE INCIDENTS AND OPEN DISCLOSURE) ACT 2023

REVISED

Updated to 1 October 2024

Changes to legislation

as of 10 July 2026, this Act is up to date with all changes known to be in force.

This Revised Act is an administrative consolidation of the

Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

. It is prepared by the Law Reform Commission in accordance with its function under

the

Law Reform Commission Act 1975

(3/1975) to keep the law under review and to undertake revision and consolidation

of statute law.

All Acts up to and including the

Criminal Justice (Amendment) Act 2024

(31/2024), enacted 4 October 2024, and all statutory instruments up to and including

the

Patient Safety (Notifiable Incidents and Open Disclosure) Regulations 2024

(S.I. No. 501 of 2024), made 1 October 2024, were considered in the preparation of

this

Revised Act.

Disclaimer: While every care has been taken in the preparation of this Revised Act,

the Law Reform Commission can assume no responsibility for and give no guarantees,

undertakings or warranties concerning the accuracy, completeness or up to date nature

of the information provided and does not accept any liability whatsoever arising from

any errors or omissions. Please notify any errors, omissions and comments by email

to

revisedacts@lawreform.ie.

Number

10

of

2023

PATIENT SAFETY (NOTIFIABLE

INCIDENTS AND OPEN DISCLOSURE) ACT 2023

REVISED

Updated to 1 October

2024

CONTENTS

PART 1

Preliminary and General

Section

1. Short title and commencement

2. Interpretation

3. Health services provider

4. Expenses

PART 2

Open Disclosure of Notifiable Incident

Chapter 1

General

5. Obligation to make an open disclosure of notifiable incident

6. Health practitioner to inform health services provider of notifiable incident

7. Persons to whom open disclosure of notifiable incident is made

8. Regulations specifying notifiable incident

9. Open disclosure of notifiable incident

10. Open disclosure of notifiable incident: information and apology not to invalidate

insurance; constitute admission of liability or fault; or not to be admissible in

proceedings

11. Statement in relation to procedure for open disclosure of notifiable incident

and application of section 10 to information and apology

Chapter 2

Open disclosure: openness and transparency

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

PART 3

Procedure for making Open Disclosure of Notifiable Incident

13. Making of open disclosure of notifiable incident by health services provider

14. Time of making of open disclosure

15. Matters to be addressed by health services provider before making open disclosure

of notifiable incident

16. Designated person

17. Notifiable incident disclosure meeting generally to be held in person

18. Notifiable incident disclosure meeting

19. Refusal, by patient or relevant person, to participate in open disclosure of notifiable

incident

20. Failure to contact patient or relevant person (or both) for purpose of open disclosure

of notifiable incident

21. Additional notifiable information

22. Additional notifiable information to be provided at additional notifiable information

meeting

23. Clarification of information provided at notifiable incident disclosure meeting

or additional notifiable information provided at additional notifiable information

meeting

24. Statements specifying information given at certain meetings

25. Records relating to open disclosure of notifiable incident

PART 4

Notification to Certain Bodies of Notifiable Incidents

26. Interpretation for Part

27. Notification to Authority by health services providers of notifiable incident

28. Notification to chief inspector of notifiable incident by certain health services

providers

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

PART 7

Amendment of Act of 2007

62. Amendment of section 2 of Act of 2007

63. Amendment of section 8 of Act of 2007

64. Amendment of section 9 of Act of 2007

65. Standards set by Authority

66. Provision of information to Authority

67. Amendment of section 41 of Act of 2007

68. Review of specified incident by chief inspector

69. Amendment of section 72 of Act of 2007

70. Amendment of section 73 of Act of 2007

71. Amendment of section 74 of Act of 2007

72. Amendment of section 75 of Act of 2007

73. Reports of Authority or chief inspector

74. Amendment of section 78 of Act of 2007

75. Prescribed private health services

76. Repeal

PART 8

Offences and Penalties

77. Offences

PART 9

Miscellaneous and General

78. Guidelines

79. Regulations

80. Review of operation of Act

81. Amendment of Act of 2000

82. Amendment of Act of 2017

83. Savings and transitional provisions in respect of open disclosure under Part 4

of Act of 2017

SCHEDULE 1

Notifiable Incidents

PART 1

PART 2

SCHEDULE 2

Amendments of Act of 2017

Acts Referred to

Assisted Decision-Making (Capacity) Act 2015

(No. 64)

CervicalCheck Tribunal Act 2019

(No. 31)

Child and Family Agency Act 2013

(No. 40)

Child Care Act 1991

(No. 17)

Civil Liability (Amendment) Act 2017

(No. 30)

Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010

(No. 24)

Companies Act 2014

(No. 38)

Coroners Act 1962

(No. 9)

Dentists Act 1985

(No. 9)

Freedom of Information Act 2014

(No. 30)

Health Act 2004

(No. 42)

Health Act 2007

(No. 23)

Health and Social Care Professionals Act 2005

(No. 27)

Interpretation Act 2005

(No. 23)

Medical Practitioners Act 2007

(No. 25)

Mental Health Act 2001

(No. 25)

National Treasury Management Agency (Amendment) Act 2000

(No. 39)

Nurses and Midwives Act 2011

(No. 41)

Pharmacy Act 2007

(No. 20)

Powers of Attorney Act 1996

(No. 12)

Number

10

of

2023

PATIENT SAFETY (NOTIFIABLE

INCIDENTS AND OPEN DISCLOSURE) ACT 2023

REVISED

Updated to 1 October

2024

An Act to provide for the mandatory open disclosure, by health services providers

of certain incidents occurring in the course of the provision, to a person, of a health

service; to provide, in the interest of the common good, for certain restrictions

on the use of the information provided in such disclosures that are made in accordance

with this Act and of any apologies made in the course of such disclosures and the

use of any other information relating to the open disclosure provided, and apology

made, after the notifiable incident disclosure meeting; to provide for the mandatory

open disclosure, by health services providers, of

Part 5

reviews carried out in accordance with this Act; to provide, in the interest of the

common good, for certain restrictions on the use of the information provided in such

disclosures that are made in accordance with this Act and of any apologies made in

the course of such disclosures and the use of any other information relating to the

open disclosure provided, and apology made, after the

Part 5

review disclosure meeting; to make provision for procedures in respect of clinical

audit, and the data obtained in clinical audits; to provide for the notification of

certain incidents to certain persons; to amend the

National Treasury Management Agency (Amendment) Act 2000

; to amend Part 4 of the

Civil Liability (Amendment) Act 2017

; to amend the

Health Act 2007

to provide for the application of standards set by the Health Information and Quality

Authority to private hospitals, to provide for the review by the chief inspector of

certain incidents occurring in the course of the provision of a health service to

a person by certain entities and for the Minister to prescribe certain health services

as a prescribed private health service; and to provide for related matters.

[2

nd May

, 2023]

Be it enacted by the Oireachtas as follows

CONTENTS

PART 1

Preliminary and General

Section

1. Short title and commencement

2. Interpretation

3. Health services provider

4. Expenses

PART 2

Open Disclosure of Notifiable Incident

Chapter 1

General

5. Obligation to make an open disclosure of notifiable incident

6. Health practitioner to inform health services provider of notifiable incident

7. Persons to whom open disclosure of notifiable incident is made

8. Regulations specifying notifiable incident

9. Open disclosure of notifiable incident

10. Open disclosure of notifiable incident: information and apology not to invalidate

insurance; constitute admission of liability or fault; or not to be admissible in

proceedings

11. Statement in relation to procedure for open disclosure of notifiable incident

and application of section 10 to information and apology

Chapter 2

Open disclosure: openness and transparency

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

PART 3

Procedure for making Open Disclosure of Notifiable Incident

13. Making of open disclosure of notifiable incident by health services provider

14. Time of making of open disclosure

15. Matters to be addressed by health services provider before making open disclosure

of notifiable incident

16. Designated person

17. Notifiable incident disclosure meeting generally to be held in person

18. Notifiable incident disclosure meeting

19. Refusal, by patient or relevant person, to participate in open disclosure of notifiable

incident

20. Failure to contact patient or relevant person (or both) for purpose of open disclosure

of notifiable incident

21. Additional notifiable information

22. Additional notifiable information to be provided at additional notifiable information

meeting

23. Clarification of information provided at notifiable incident disclosure meeting

or additional notifiable information provided at additional notifiable information

meeting

24. Statements specifying information given at certain meetings

25. Records relating to open disclosure of notifiable incident

PART 4

Notification to Certain Bodies of Notifiable Incidents

26. Interpretation for Part

27. Notification to Authority by health services providers of notifiable incident

28. Notification to chief inspector of notifiable incident by certain health services

providers

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

PART 7

Amendment of Act of 2007

62. Amendment of section 2 of Act of 2007

63. Amendment of section 8 of Act of 2007

64. Amendment of section 9 of Act of 2007

65. Standards set by Authority

66. Provision of information to Authority

67. Amendment of section 41 of Act of 2007

68. Review of specified incident by chief inspector

69. Amendment of section 72 of Act of 2007

70. Amendment of section 73 of Act of 2007

71. Amendment of section 74 of Act of 2007

72. Amendment of section 75 of Act of 2007

73. Reports of Authority or chief inspector

74. Amendment of section 78 of Act of 2007

75. Prescribed private health services

76. Repeal

PART 8

Offences and Penalties

77. Offences

PART 9

Miscellaneous and General

78. Guidelines

79. Regulations

80. Review of operation of Act

81. Amendment of Act of 2000

82. Amendment of Act of 2017

83. Savings and transitional provisions in respect of open disclosure under Part 4

of Act of 2017

SCHEDULE 1

Notifiable Incidents

PART 1

PART 2

SCHEDULE 2

Amendments of Act of 2017

Number

10

of

2023