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Health Data Governance D
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Chapter 1. Introducing high-value, privacy-protective health information systems S Health Data Governance
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Chapter 2. High-value health data supporting health care management, policy and innovation d
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Chapter 3. The legislative framework governing personal health data s
PRIVACY, MONITORING AND RESEARCH
Chapter 4. Open and transparent health information systems
Chapter 5. Concentrating and strengthening national health data processing
Chapter 6. Fair and transparent health project approval processes
Chapter 7. De-identifying personal health data
Chapter 8. Health data security and management practices
Chapter 9. The way forward for privacy-protective health information systems
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OECD Health Policy Studies
Health Data Governance
PRIVACY, MONITORING AND RESEARCH
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OECD (2015), Health Data Governance: Privacy, Monitoring and Research, OECD Health Policy Studies,
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3
FORWORD –
Foreword
Health data collected by national governments that can be linked and shared are a
valuable resource that can be used safely to improve the health outcomes of patients and
the quality and performance of the health care systems that serve them. Data allowing a
comprehensive view of health care services permit uncovering medical errors, adverse
drug reactions, fraud, adherence to clinical guidelines, effective treatments, optimal care
paths and optimal responders to treatment.
Health Ministry leadership is necessary to ensure that delivering the data to manage
this important sector is at the forefront of government policy and action. Previous OECD
work has found a high variability across OECD countries in data availability and use to
concerns about and uncertainty about how to protect patient’s rights to privacy and to
preserve the security of health data when data are shared, linked and analysed.
This study supports OECD countries in developing privacy-protective uses of
personal health data by examining current data availability, uses and governance
practices; and identifying key data governance mechanisms that maximise benefits to
patients and to societies and minimise risks to patients’ privacy and to public trust and
confidence in health care providers and governments.
International collaboration in this dynamic area is essential for information about best
practices and lessons learned in health data governance to circulate widely; and to support
movement toward common best practices so that multi-country statistical and research
projects are feasible.
HEALTH DATA GOVERNANCE: PRIVACY, MONITORING AND RESEARCH © OECD 2015
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– ACKNOWLEDGEMENTS
Acknowledgements
This OECD study was undertaken by the OECD HCQI (Health Care Quality Indicators)
Expert Group as part of the 2013/14 programme of work of the OECD Health Committee.
The OECD Working Party on Security and Privacy in a Digital Economy (SPDE) provided
input to the study. The authors would like to acknowledge the representatives from the
countries who make up the HCQI Expert Group and the SPDE Working Party who gave
generously of their time to provide input to this study; and to the experts from participating
countries that provided responses to surveys and participated in case study interviews (see
Annexes B and C).
Particular thanks and recognition is extended to the members of the HCQI Advisory
Panel of Experts on Health Information Infrastructure (APHII) for their contribution to all
aspects of this study from its design and conduct, to analysis and reporting, to the
development of tools and identification of key data governance mechanisms. Members of
the APHII are recognised in Annex A of this report.
The contributions of the staff of the OECD Secretariat, in particular Jillian Oderkirk,
Niek Klazinga, Anna Irvin Sigal and Duniya Dedeyn are also acknowledged. The authors
would also like to acknowledge Stefano Scarpetta, Mark Pearson and Francesca Colombo
for their support and directions provided on the study.
HEALTH DATA GOVERNANCE: PRIVACY, MONITORING AND RESEARCH © OECD 2015
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TABLE OF CONTENTS –
Table of contents
Acronyms and abbreviations ........................................................................................................... 9
Glossary ........................................................................................................................................ 11
Executive summary ....................................................................................................................... 17
Chapter 1. Introducing high-value, privacy-protective health information systems ............. 19
Data are essential to improving health care and health system performance ........................... 21
References ................................................................................................................................ 27
Chapter 2. High-value health data supporting health care management, policy
and innovation ............................................................................................................................. 29
Key national health and health care datasets ............................................................................ 32
Progress in national dataset availability since 2011 ................................................................. 35
Highest coverage of the target population in the key datasets of Denmark, Finland,
Sweden and Iceland ................................................................................................................. 36
Automatic extraction of electronic data is prevalent in 13 countries ....................................... 37
Twelve countries reported consistently coding health care data using a terminology
standard ................................................................................................................................ …37
Retention periods for personal health data ............................................................................... 38
Concerns with the quality of the data ....................................................................................... 39
Six countries use all of their national health care datasets to regularly report about the
quality and performance of health care .................................................................................... 40
Finland, Iceland, Singapore, Sweden, the United Kingdom (Scotland and Wales)
have the highest proportion of key national health datasets sharing the same unique patient
ID number ................................................................................................................................ 40
Finland, Iceland, the United Kingdom (England) and Singapore are regularly linking
most of their national health care datasets for statistics and research ...................................... 41
Little change in data linkage activities since 2011 ................................................................... 43
National projects advancing high-value data to promote health and improve health care ....... 44
Key international projects to improve health care outcomes, safety and performance ............ 56
Key features of high-value, privacy-protective health information systems ............................ 60
Notes ........................................................................................................................................ 61
References ................................................................................................................................ 62
Chapter 3. The legislative framework governing personal health data .................................. 65
Data accessibility across OECD countries ............................................................................... 66
Legislative frameworks for the protection of privacy .............................................................. 68
Personal health data can have inconsistent legislative protection ............................................ 72
National health datasets contain sensitive personal information ............................................. 73
Legislation may permit the secondary analysis of personal health data in cases
where patient consent is not possible or practicable ................................................................ 75
Protection of the privacy of health care providers ................................................................... 77
Consent to uses of data in the future that cannot be specified today ....................................... 78
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– TABLE OF CONTENTS
Data sharing for the purpose of research or statistics ............................................................... 81
Sharing and access to de-identified data .................................................................................. 84
Foreign applicants for access to data ....................................................................................... 87
Data sharing challenges among national health dataset custodians ......................................... 90
Legislative reforms that are needed or are underway .............................................................. 95
Key elements of legislative frameworks supporting privacy-protective uses of health data ... 97
References ................................................................................................................................ 99
Chapter 4. Open and transparent health information systems .............................................. 101
Open government health data ................................................................................................ 103
Aims of open health data initiatives vary ............................................................................... 104
Transparency about national health datasets .......................................................................... 106
Sharing information with the public about approved studies involving personal health
data processing ....................................................................................................................... 107
Transparency about researcher access to data ........................................................................ 107
Public opinion about data uses ............................................................................................... 110
Public communication: Lesson’s learned from the UK Health and Social Care
Information Centre ................................................................................................................. 111
Approaches to engaging with stakeholders and the public about the processing
of personal health data ........................................................................................................... 114
Key elements of data governance that promote openness and transparency ......................... 114
References .............................................................................................................................. 116
Chapter 5. Concentrating and strengthening national health data processing .................... 119
Concentration of national health datasets .............................................................................. 120
Data linkages are concentrated in many countries ................................................................. 120
Data processing centres .......................................................................................................... 122
Accreditation or certification of data processors ................................................................... 123
Processing data access requests and recovering their costs ................................................... 127
Strategies and techniques to improve timeliness and reduce costs ........................................ 131
Accreditation or certification of data processors promotes both data security
and access to data ................................................................................................................... 132
References .............................................................................................................................. 134
Chapter 6. Fair and transparent health project approval processes ..................................... 135
Project approval processes ..................................................................................................... 136
Research ethics committees ................................................................................................... 137
Approval by the Data Protection Regulator following input from research ethics boards .... 139
Independent advisors within internal committees or governing boards ................................. 139
Internal decision-making process with advice from the privacy regulator ............................ 140
Internal decision-making processes ....................................................................................... 141
Appeals process ...................................................................................................................... 142
Transparent processes for requests to process or access personal health data ....................... 142
Project review boards must evaluate the risks and benefits to society of a proposed use
of personal health data ........................................................................................................... 143
Transparent and fair project approval processes are needed .................................................. 145
References .............................................................................................................................. 146
Chapter 7. De-identifying personal health data ...................................................................... 147
Gap between legal requirements and data de-identification in practice ................................. 149
Data are de-identified prior to analysis? ................................................................................ 150
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TABLE OF CONTENTS –
The use of pseudonyms to replace direct identifiers .............................................................. 151
Evaluating and addressing data re-identification risk ............................................................ 152
Weighing data de-identification techniques against dataset utility for the intended purpose .... 155
Data de-identification practices that consider the “big picture”: data protection, security
and utility ............................................................................................................................... 157
References .............................................................................................................................. 159
Chapter 8. Health data security and management practices ................................................. 161
Guidelines and policies to protect data privacy and security ................................................. 164
Data security within data custodians ...................................................................................... 166
External data processors and cloud computing services ........................................................ 169
Protecting data during the transfer process ............................................................................ 169
Data sharing agreements or contracts .................................................................................... 170
Mechanisms to assure compliance with data sharing agreements ......................................... 172
Penalties for non-compliance with the law and data sharing agreements or contracts .......... 173
Data breach experiences ......................................................................................................... 174
Alternatives to transferring data to third parties .................................................................... 175
Data security practices are essential to meeting legal requirements and public expectations ... 178
References .............................................................................................................................. 179
Chapter 9. The way forward for privacy-protective health information systems ................ 181
Progress during the past five years ......................................................................................... 183
Outlook for the next five years .............................................................................................. 184
Policy and technical obstacles to progress over the next five years ....................................... 185
Governance mechanisms supporting privacy-protective monitoring and research
involving personal health data ................................................................................................ 186
Next steps ............................................................................................................................... 187
Note ........................................................................................................................................ 189
References .............................................................................................................................. 190
Annex A. Health Care Quality Indicators Expert Group. Advisory Panel of Experts on Health
Information Infrastructure ........................................................................................................... 191
Annex B. Health Care Quality Indicators Information Infrastructure Questionnaire .................. 193
Annex C. HCQI Expert Interviews on Health Information Infrastructure ................................... 195
Tables
Table 2.1. Key national health dataset availability, maturity and use ................................... 31
Table 2.2. Dataset is available at the national level ............................................................... 35
Table 2.3. Proportion of the population covered by the data ................................................. 36
Table 2.4. Number of countries reporting sources of variables within national datasets ...... 37
Table 2.5. Number of countries reporting coding clinical terminology ................................ 38
Table 2.6. Just over half of countries with national datasets are regularly linking
the data to monitor quality or health system performance .................................................... 42
Table 2.7. Thirteen countries are linking data across the pathway of care ............................ 42
Table 2.8. Seven countries are linking seven or more key datasets on a regular basis
for statistics or research ......................................................................................................... 43
Table 2.9. Number of countries1 reporting a data linkage project is taking place
on a regular basis involving national datasets in 2011 and 2013 .......................................... 44
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Table 3.1. Proportion of key national personal health datasets meeting six data
accessibility factors ............................................................................................................... 68
Table 3.2. Countries reporting a national law or regulation that speaks to the protection
of health information privacy and/or to the protection and use of electronic clinical
records ................................................................................................................................... 71
Table 3.3. Variables considered as being among the most sensitive within national
health datasets ........................................................................................................................ 74
Table 3.4. Number of custodians of national datasets ........................................................... 81
Table 4.1. Open government health data initiatives ............................................................ 104
Table 5.1. Proportion of national datasets in the custody of and linked by
the same organisation .......................................................................................................... 121
Table 5.2. Number of organisations and datasets involved in linkage of key national
health datasets ...................................................................................................................... 121
Table 6.1. Public communication regarding requests for access to and processing
of personal health data ......................................................................................................... 143
Table 6.2. Risk-benefit evaluation tool supporting decision making about the processing
of personal health data ......................................................................................................... 144
Table 7.1. Proportion of key national health datasets with five data de-identification
practices ................................................................................................................................ 150
Table 8.1. Percentage of key national datasets where data security practices to protect
data from re-identification were identified .......................................................................... 163
Table 9.1. Views about progress in and the future of health data use ................................. 184
Table A.1. Members of the Advisory Panel of Experts on Health Information
Infrastructure ....................................................................................................................... 192
Table B.1. Countries that responded to the 2013-14 HCQI Information Infrastructure
Questionnaire ........................................................................................................................ 194
Table C.1. Participants to the 2013-14 HCQI Expert Interviews on Health Information
Infrastructure ........................................................................................................................ 196
Figures
Figure 1.1. Data use decisions should be taken by weighing societal benefits and risks
within a data governance framework that maximises benefits and minimises risks ................ 25
Figure 2.1. Key health data availability, maturity and use ....................................................... 31
Figure 3.1. Sharing and accessibility of health data for approved statistical and research
uses ........................................................................................................................................ 67
HEALTH DATA GOVERNANCE: PRIVACY, MONITORING AND RESEARCH © OECD 2015
