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Privacy, Confidentiality, and Health Research

Privacy, Confidentiality, and Health Research

Author: William W. Lowrance
Publisher: Cambridge University Press
ISBN: 9781107020870
Published In: June 2012
Format: Hardback , 202 pages
Jurisdiction: International ? Disclaimer:
Countri(es) stated herein are used as reference only

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The potential of the e-health revolution, increased data sharing, database linking, biobanks and new techniques such as geolocation and genomics to advance human health is immense. For the full potential to be realized, though, privacy and confidentiality will have to be dealt with carefully. Problematically, many conventional approaches to such pivotal matters as consent, identifiability, and safeguarding and security are inadequate. In many places, research is impeded by an overgrown thicket of laws, regulations, guidance and governance. The challenges are being heightened by the increasing use of biospecimens, and by the globalization of research in a world that has not globalized privacy protection. Drawing on examples from many developed countries and legal jurisdictions, the book critiques the issues, summarizes various ethics, policy, and legal positions (and revisions underway), describes innovative solutions, provides extensive references and suggests ways forward.

• Analyzes current problems, reviews practical solutions and proposes new approaches

• Reviews and comments in a concise manner

• Discusses the intersections between privacy and research

Preface and acknowledgments	xiii
1 Introduction	1
Health research as a public-interest cause	1
Privacy protection as a public-interest cause	3
Health data vulnerability	4
The challenges	4
2 Data, biospecimens, and research	7
A few essential notions	7
The e-health revolution	10
Data and databases	11
Biospecimen collections	13
Public research resource platforms	18
Degrees of sensitivity	18
Data and biospecimen ownership	22
What is research, anyway?	24
3 Privacy, confidentiality, safeguards	29
Privacy	29
Confidentiality	33
Safeguards	34
4 Broad privacy and data protection regimes	35
The plethora of controls	35
Two sorts of regimes	36
Early concerns about computers and privacy	36
The OECD privacy principles	38
Council of Europe Convention 108	40
The European strategy	40
The US approach	47
The Canadian strategy	48
Australia, Japan, APEC	49
5 Healthcare, public health, and research regimes	52
Healthcare and payment regimes	52
Public health regimes	53
Human-subject protection regimes	54
Clinical trial and product postmarketing regimes	57
Other, specialized laws and regulations	59
Research ethics review systems	60
“Rules” thickets in four countries	62
6 Consent	67
Consent as it is applied now	69
Legitimately sought, meaningfully informed, willingly granted	71
The casting of consent	74
Right to withdraw	78
Community engagement	79
Searching for research candidates	80
Research without consent	81
Some reflections	84
7 Identifiability and person-specific data	87
“Personal data”	87
Identifiers	92
De-identification for research	93
Ways non-identified data can become identified	96
Retaining the possibility to re-identify	98
The HIPAA Privacy Rule approach	99
Key-coding	104
Identifiability terminology	105
Identifiable to whom?	107
No personal data: no human subject?	108
Some reflections	109
8 Genetics and genomics	111
Genetics/genomics	112
GWAS	114
EHR-driven genomic discovery	115
Genotype-driven recruitment	115
Notice and consent	116
Genetic and genomic identifiability	118
The Personal Genome Project	121
Some reflections	122
9 Safeguards and responsibilities	125
Operational safeguards	125
Formal responsibilities	126
Stewardship	129
Data and biospecimen retention	129
Security	130
Privacy risk assessment	131
Requests for non-research access	132
Enforcement and sanctions	135
10 Data sharing, access, and transfer	138
Data sharing	138
Access	140
The two basic modes of access	140
Access agreements	141
Terms of restricted access	142
Privacy-preserving data linkage	146
Extremely restricted access	149
Oversight and governance	151
International transfer	152
Some reflections	156
11 Ways forward	158
Bibliography	160
Index	176