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Privacy, Confidentiality, and Health Research

Privacy, Confidentiality, and Health Research

  • Author:
  • 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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  • Description 
  • Contents 
  • Details

    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

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