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  • Cited by 28
Publisher:
Cambridge University Press
Online publication date:
July 2012
Print publication year:
2012
Online ISBN:
9781139107969

Book description

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.

Reviews

"Privacy, Confidentiality and Health Research by William W. Lowrance has appeared like 'manna' from heaven... This book is a must not only for bioethics and legal scholars but for policymakers and politicians. It is accessible, reader-friendly and best of all a well-thought-out tool for much needed reform."
--Bartha Maria Knoppers, Director of the Centre of Genomics and Policy, McGill University

"Privacy, Confidentiality and Health Research by William W. Lowrance has appeared like ‘manna’ from heaven."- Bartha Maria Knoppers, International Journal of Epidemiology

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Contents

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Royal College of Physicians, Royal College of Pathologists and British Society for Human Genetics, “Consent and confidentiality in clinical genetic practice: Guidance on genetic testing and sharing genetic information,” Report of the Joint Committee on Medical Genetics, second edn. (2011): www.rcplondon.ac.uk/sites/default/files/consent_and_confidentiality_2011.pdf.
Sleeboom-Faulkner, Margaret (ed.), Human Genetic Biobanks in Asia: Politics of Trust and Scientific Advancement (London: Routledge, 2009).
Solove, Daniel J., Understanding Privacy (Cambridge, MA: Harvard University Press, 2008).
Steinmann, Michael, Peter Sýora, and Urban Wiesing (eds.), Altruism Reconsidered: Exploring New Approaches to Property in Human Tissue (Farnham: Ashgate, 2009).
Strom, Brian L., Stephen E. Kimmel, and Sean Hennessy (eds.), Pharmacoepidemiology, fifth edn. (Chichester: Wiley-Blackwel, 2012).
Taylor, Mark J., “Data protection: Too personal to protect?SCRIPT-ed, 3, #1 (2006): www.law.ed.ac.uk/ahrc/script-ed/vol3-1/taylor.asp.
Thomas, Richard and Mark Walport, Data Sharing Review Report (2008): www.justice.gov.uk/reviews/docs/data-sharing-review-report.pdf.
UK Biobank, “Ethics and Governance Framework”: www.ukbiobank.ac.uk/wp-content/uploads/2011/05/EGF20082.pdf.
UK Data Archive, Veerle Van den Eynden, Louise Corti, Matthew Woollard, et al., “Managing and sharing data: Best practice for researchers” (2011): www.data-archive.ac.uk/media/2894/managingsharing.pdf.
UK Health Departments, “Governance arrangements for research ethics committees: A harmonised edition” (2011): www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_126614.pdf.
UK House of Lords, Committee on Privacy, Report of the Committee on Privacy, Kenneth Younger, chair (Home Office, Cmnd 5012, H. M. Stationery Office, 1972).
UK House of Lords, Committee on Privacy, Session of June 6, 1973: http://hansard.millbanksystems.com/lords/1973/jun/06/privacy-younger-committees-report.
UK House of Lords, Select Committee on the Constitution, Surveillance: Citizens and the State, 2nd Report of Session 2008–09: www.publications.parliament.uk/pa/ld200809/ldselect/ldconst/18/1802.htm.
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UK Information Commissioner’s Office, “Determining what information is ‘data’ for the purposes of the DPA” (2009): www.ico.gov.uk/upload/documents/library/data_protection/detailed_specialist_guides/what_is_data_for_the_purposes_of_the_dpa.pdf.
UK Information Commissioner’s Office “Determining what is personal data” (2007): www.ico.gov.uk/upload/documents/library/data_protection/detailed_specialist_guides/personal_data_flowchart_v1_with_preface001.pdf.
UK Information Commissioner’s OfficePrivacy Impact Handbook, version 2.0 (2009): www.ico.gov.uk/upload/documents/pia_handbook_html_v2/index.html.
UK Information Commissioner’s Office “Privacy notices code of practice” (2009): www.ico.gov.uk/upload/documents/library/data_protection/detailed_specialist_guides/privacy_notices_cop_final.pdf.
UK Information Commissioner’s Office “Use and disclosure of health data” (2002): www.ico.gov.uk/upload/documents/library/data_protection/practical_application/health_data_-_use_and_disclosure001.pdf.
UK National Information Governance Board, “System level security policy,” template: www.nigb.nhs.uk/ecc/applications/SLSP.pdf.
UK National Research Ethics Service. “Defining research” (2008): www.nres.npsa.nhs.uk/news-and-publications/publications/general-publications.
UK Office for National Statistics, “Disclosure control of health statistics” (2006): www.ons.gov.uk/ons/guide-method/best-practice/disclosure-control-of-health-statistics/index.html.
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US Department of Health and Human Services, Federal Policy on Protection of Human Subjects (“Common Rule”), DHHS version, 45 Code of Federal Regulations 46: www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
US Department of Health and Human Services, Office of Civil Rights, “Guidance on risk analysis requirements under the HIPAA Security Rule” (2010): www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/rafinalguidancepdf.pdf.
US Department of Health and Human Services, Office of Civil Rights, Workshop on the HIPAA Privacy Rule’s De-Identification Standard (May 2010): www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/De-identification/deidentificationagenda.html.
US Department of Health and Human Services, Office for Human Research Protections, “Guidance on research involving coded private information or biological specimens” (2008): www.hhs.gov/ohrp/policy/cdebiol.html.
US Department of Health and Human Services, Office for Human Research Protections “Guidance on the Genetic Information Nondiscrimination Act: Implications for investigators and Institutional Review Boards” (2009): www.hhs.gov/ohrp/policy/gina.pdf.
US Department of Health and Human Services, Office for Human Research Protections “Guidance on withdrawal of subjects from research: data retention and other related issues” (2010): www.hhs.gov/ohrp/policy/subjectwithdrawal.html.
US Department of Health and Human Services, Office for Human Research Protections “International compilation of human research protections” (2012): www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html.
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US Department of Health and Human Services, Secretary’s Advisory Committee on Human Research Protections, letter of January 24, 2011 to the Secretary, attachment A: www.hhs.gov/ohrp/sachrp/20110124attachmentatosecletter.html.
US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects (1979): www.hhs.gov/ohrp/humansubjects/guidance/belmont.html.
US National Committee on Vital and Health Statistics, letter to the Secretary of Health and Human Services, “Recommendations regarding sensitive health information” (November 10, 2010): www.ncvhs.hhs.gov/101110lt.pdf.
US National Heart, Lung, and Blood Institute, “Guidelines for NHLBI data set preparation” (2005): www.nhlbi.nih.gov/funding/setpreparation.htm.
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US National Institutes of Health, “Points to consider when planning a genetic study that involves members of named populations” (2008): http://bioethics.od.nih.gov/named_populations.html.
US National Institutes of Health “Protecting personal health information in research: Understanding the HIPAA Privacy Rule”: http://privacyruleandresearch.nih.gov/pr_02.asp.
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US Veterans Health Administration, “Notice of privacy practices”: www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1090.
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General resources

Australia, Privacy Act 1988: www.comlaw.gov.au/Details/C2011C00157.
Australian Office of the Privacy Commissioner: www.privacy.gov.au.
Biobanking and Biomolecular Resources Research Infrastructure: www.bbmri.eu/index.php/home.
Canada, Office of the Privacy Commissioner: http://priv.ca.
Canada, Personal Information Protection and Electronic Documents Act: http://laws-lois.justice.gc.ca/eng/acts/P-8.6.
Clarke, Roger: www.rogerclarke.com.
Council of Europe, Convention for the Protection of Human Rights and Fundamental Freedoms, European Treaty Series No. 5: http://conventions.coe.int/treaty/en/Treaties/Html/005.htm.
Council of Europe Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data, European Treaty Series No. 108 (1981): http://conventions.coe.int/Treaty/EN/Treaties/Html/108.htm.
El Emam, Khaled and the Electronic Health Information Laboratory, University of Ottawa and Children’s Hospital of Eastern Ontario: www.ehealthinformation.ca.
Electronic Medical Records and Genomics project (eMERGE): www.mc.vanderbilt.edu/victr/dcc/projects/acc/index.php/Main_Page.
European Commission, Directorate-General for Justice, data protection portal: http://ec.europa.eu/justice/data-protection/index_en.htm.
European Union, Charter of Fundamental Rights: www.europarl.europa.eu/charter/pdf/text_en.pdf.
European Union Directive on Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use (2001/20/EC): http://eur-lex.europa.eu/LexUriServ/LexUriServ.do%3Furi=OJ:L:2001:121:0034:0044:en:PDF.
European Union Directive on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data (Directive 95/46/EC): http://eur-lex.europa.eu/LexUriServ/LexUriServ.do%3Furi=celex:31995L0046:en:html.
France, Loi relative à l’informatique, aux fichiers et aux libertés. English translation: www.cnil.fr/fileadmin/documents/en/Act78-17VA.pdf.
General Practice Research Database: www.gprd.com/home.
infoUSA: www.infoUSA.com.
International Association of Privacy Professionals: http://www.privacyassociation.org.
International Cancer Genome Consortium: http://icgc.org.
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: www.ich.org/home.html.
International Organization for Standardization: www.27000.org/index.htm.
Japan, Personal Information Protection Act, English translation: www.cas.go.jp/jp/seisaku/hourei/data/APPI.pdf.
Malin, Bradley and the Health Information Privacy Laboratory, School of Medicine, Vanderbilt University: www.hiplab.org.
Michael John Durant v. Financial Services Authority [2003] EWCA Civ 1746, para. 28: www.bailii.org/ew/cases/EWCA/Civ/2003/1746.html.
Online Mendelian inheritance in man: www.ncbi.nlm.nih.gov/omim.
Ontario, Personal Health Information Protection Act (PHIPA): www.e-laws.gov.on.ca/html/statutes/english/elaws_statutes_04p03_e.htm.
Personal Genome Project: www.personalgenomes.org.
Public Population Project in Genomics (P3G): www.p3g.org.
Statistics Canada, Research Data Centres Program: www.statcan.gc.ca/rdc-cdr/index-eng.htm.
UK Biobank: www.ukbiobank.ac.uk.
UK Biobank Ethics and Governance Council: www.egcukbiobank.org.uk.
UK Data Protection Act 1998: www.legislation.gov.uk/ukpga/1998/29/contents.
UK Department of Health, Caldicott Guardian system, portal: www.connectingforhealth.nhs.uk/systemsandservices/infogov/caldicott.
UK Human Tissue Act, Supplementary list of materials: www.hta.gov.uk/_db/_documents/Supplementary_list_of_materials_200811252407.pdf.
UK National Information Governance Board: www.nigb.nhs.uk.
UK National Patient Safety Agency: www.nres.npsa.nhs.uk.
UK National Patient Safety Agency, Proportionate Review Service: www.nres.npsa.nhs.uk/applications/proportionate-review.
UK National Research Ethics Committees, portal: www.nres.npsa.nhs.uk.
US Department of Commerce, Safe Harbor certification portal: http://export.gov/safeharbor/eu.
US Department of Health and Human Services, healthcare data-security breach notifications: www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/breachtool.html.
US Department of Health and Human Services, Office for Human Research Protections, policy and guidance portal: www.hhs.gov/ohrp/policy/index.html.
US Department of Health and Human Services, Standards for Privacy of Individually Identifiable Health Information (Privacy Rule): www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/index.html.
US Department of Justice, “Overview of the Privacy Act of 1974”: www.justice.gov/opcl/1974privacyact-overview.htm.
US Genetic Information Nondiscrimination Act: www.eeoc.gov/laws/statutes/gina.cfm.
US Health Information Technology Economic and Clinical Health Act: http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__home/1204.
US National Center for Health Statistics, Research Data Center: www.cdc.gov/rdc.
US National Institute of Standards and Technology, Computer Security Resource Center: http://csrc.nist.gov.
US National Institutes of Health, Certificates of Confidentiality Kiosk: http://grants.nih.gov/grants/policy/coc.
US National Institutes of Health, Certificates of Confidentiality Kiosk Data sharing portal: http://grants.nih.gov/grants/policy/data_sharing.
US Secretary of Health and Human Services, Healthcare data-security breach notifications: www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/breachtool.html.
Western Australian Data Linkage System: www.datalinkage-wa.org.
World Health Organization, International Clinical Trials Registry Platform: http://apps.who.int/trialsearch/Default.aspx.

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