1. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Dr Kieran Doran, Solicitor Senior Healthcare Ethics Lecturer School of Medicine University College Cork 1

2. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Introduction Introduced by Minister for Health Leo Varadkar in November 2015; Sought to bring forward Health Information Legislation such as Health Information Bill 2009; Seeks to link into Patient Identifiers Act 2014; Was not passed by Houses of the Oireachtas prior to 2016 General Election. 2

3. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 1: Preliminary Matters S.1 Short Title and Commencement; S.2 Interpretation; S.3 Regulations; and S.4 Expenses. 3

4. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 2: Personal Data, Personal Health Data & Personal Health Information S.5 Processing of Personal Data and Personal Health Data; S.6 Copies of Medical Records at Patient’s Request; S.7 Notification of Cessation of Provision of Health Services; 4

5. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 2: Personal Data, Personal Health Data & Personal Health Information S.8 Maintenance of Records of Disclosure; S.9 Offence of Buying or Selling of Personal Health Information; S.10 Disclosure of Personal Data by Statutory Regulatory Bodies; 5

6. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 2: Personal Data, Personal Health Data & Personal Health Information S.11 Standards of Electronic Exchange of Health Information; S.12 Standards for Management of Health Data. 6

7. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 3: Research Ethics Approval S.13 Interpretation; S.14 Approval of Research Ethics Committee by Authority (Health Information Quality Authority, HIQA); S.15 Withdrawal of Approval for Approved Research Ethics Committee; S.16 Varying Removal or Attachment of New Condition to Approval; 7

8. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 3: Research Ethics Approval S.17 Applications by Appointing Authorities for Removal or Variation of Conditions; S.18 Guidelines for Appointing Authorities and Approved Research Ethics Committees; S.19 Monitoring by HIQA of Appointing Authorities; 8

9. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 3: Research Ethics Approval S.20 Monitoring by Approved Research Ethics Committees by Appointing Authority; S.21 Requests by HIQA for Information; S.22 Revocation of Approval of Approved Research Ethics Committees; S. 23 Arrangements for Withdrawal or Revocation of Approval of Research Ethics Committee; 9

10. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 3: Research Ethics Approval S.24 Approval of Membership of Approved Research Ethics Committees; S.25 Sub-Committees of Approved Research Ethics Committees; S.26 Annual Reports of Approved Research Ethics Committees; S.27 Provision of Information on Internet; 10

11. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 3: Research Ethics Approval S.28 Application to HIQA for Referral of a Research Proposal to an Approved Research Ethics Committee; S.29 Decision on Ethics of Proposed Research Project; S.30 Effect of Approval under S.29 or an Appeal under S.32; S. 31 Decision Making Procedure; 11

12. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 3: Research Ethics Approval S.32 Appeal of Decision under Ss 28, 29 and 38 of 2015 Bill; S.33 Processing of Personal Data without Consent; S.34 Appeal of Decision from the Data Protection Commissioner; S.35 Relationship with Data Protection Legislation; 12

13. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 3: Research Ethics Approval S.36 Non-requirement to provide Personal Data; S.37 Notification of Acceptance of Decision or Intention to Appeal a Decision; S.38 Monitoring of Health Research; S.39 Offence of False or Misleading Statements or Representations; 13

14. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 3: Research Ethics Approval S.40 Complaints to the HIQA; S.41 Complaints to an Approved Research Ethics Committee; S.42 Advice & Training; and S.43 Fees Chargeable. 14

15. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 4: Data Matching Programmes S.44 Interpretation; S.45 Requirement to Provide Data; S.46 Use of Data under S.45; S.47 Disclosure of Data under S.45; S.48 Use of Data under held by Data Matching Programme; 15

16. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 4: Data Matching Programmes S.49 Publication of Results from Data Matching Programmes; S.50 Prescribed Data Matching Programmes; S.51 Revocation of Amendment of Regulations; S.52 Standards for Prescribed Data Matching Programmes; 16

17. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 4: Data Matching Programmes S.53 Compliance with Operating Standards; S.54 Investigation by Data Protection Commissioner; and S.55 Co-operation between HIQA and the Data Protection Commissioner. 17

18. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 5: Health Information Resources S.56 Interpretation; S.57 Requirement to Provide Data; S.58 Use of Data under S.57; S.59 Disclosure of Data Sets under S.57; 18

19. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 5: Health Information Resources S.60 Use of Data held by Prescribed Health Information Resource; S.61 Publication of Data held by Prescribed Health Information Resource; S.62 Prescribed Health Information Resources; S.63 Revocation or Amendment of Regulations; 19

20. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 5: Health Information Resources S.64 Standards for Prescribed Health Information Resources; S.65 Compliance with Standards; S.66 Investigation by Data Protection Commissioner; and S.67 Co-operation between Data Protection Commissioner and HIQA. 20

21. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 6: Patient Safety Standards S.68 Interpretation; S.69 Standards set by HIQA and Data Protection Commissioner on Notification of Patient Safety Incidents; S.70 Reportable Incidents; S.71 Notification of Reportable Incidents; 21

22. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 6: Patient Safety Standards S.72 Notification of Other Patient Safety Incidents; S.73 Functions of State Claims Agency under Part 6 of 2015 Bill; S.74 Information on Functions of State Claims Agency under Part 6 of 2015 Bill; 22

23. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 6: Patient Safety Standards S.75 Application of Freedom of Information Acts 1997-2014; S.76 Non-admissibility of Notification of Patient Safety Incidents in Civil Proceedings; and S.77 Non-interference with Other Legislative Reporting Requirements to Mental Health Commission or Chief Inspector of Social Services. 23

24. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 7: Clinical Audit S.78 Interpretation; S.79 Ministerial Guidance for Part 7 of the 2015 Bill; S.80 Publication of Aggregate Clinical Audit Results; S.81 Application of Freedom of Information Legislation; 24

25. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 7: Clinical Audit S.82 Admissibility as Legal Evidence; S.83 Non-interference with Other Legislative Reporting Requirements to Coroner’s Court or Health & Safety Authority or State Claims Agency. 25

26. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 8: Amendment of Data Protection Act 1988 S.84 Amendment of S.2 B of 1988 Act; S.85 Amendment of S.2 C of 1988 Act; S.86 Amendment of S.14 of 1988 Act; and S.87 Amendment of S.26 of 1988 Act. 26

27. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 9: Amendment of Health Act 2007 (HIQA Remit Extension) S.88 Amendment of S.2 of 2007 Act (Interpretation); S.89 Amendment of S.8 of 2007 Act (Functions of Authority); S.90 Amendment of S.9 of 2007 Act (Investigations of Authority); 27

28. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 9: Amendment of Health Act 2007 (HIQA Remit Extension) S.91 Amendment of S.10 of 2007 Act (Standards Set by Authority); S.92 Amendment of S.12 of the 2007 Act (Provision of Information to Authority); S.93 Amendment of S.73 of the 2007 Act (Right of Entry and Inspection of Authorised Person or Chief Inspector); 28

29. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 9: Amendment of Health Act 2007 (HIQA Remit Extension) S.94 Amendment of S.74 of 2007 Act (Requirement of Occupier of Dwelling or District Court Warrant to Enter Dwelling); S.95 Amendment of S.78 of 2007 Act (Reports of Authorised Person, Chief Inspector or Insectors); and 29

30. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 9: Amendment of Health Act 2007 (HIQA Remit Extension) S.96 New S.98 A of 2007 Act (Provision for Prescribing of Privately Provided Services to come within Remit of HIQA Standard Setting, Monitoring and Investigative Remit). 30

31. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Part 10: Legal Enforcement S.97 Hearing of Legal Proceedings; S.98 Proceedings for Offences under 2015 Bill; S.99 Offences of Directors and Bodies Corporate; S.100 Forfeiture or Destruction of Data; and S.101 Costs in Legal Proceedings. 31

32. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 Conclusion Broad Piece of Legislation; Ambitious in Scope Affecting a number of pieces of Existing Legislation; Involvement of a Large Number of Organisations; Future Enactment subject to Negotiationson Formation of a new Government. 32

33. HEALTH INFORMATION & PATIENT SAFETY BILL 2015 THANK YOU! Dr Kieran Doran, Solicitor Senior Healthcare Ethics Lecturer School of Medicine University College Cork (021) 4901513 K.Doran@ucc.ie © Dr Kieran Doran, Solicitor 2016 33