메뉴 건너뛰기




Volumn 2, Issue 1, 2010, Pages 1-25

The body as data? Biobank regulation via the ‘back door’ of data protection law

Author keywords

[No Author keywords available]

Indexed keywords


EID: 84873967011     PISSN: 17579961     EISSN: 1757997X     Source Type: Journal    
DOI: 10.5235/175799610791935443     Document Type: Article
Times cited : (22)

References (148)
  • 1
    • 85026264242 scopus 로고    scopus 로고
    • The term ‘data protection’ is used here in its primarily European sense to denote a set of norms that specifically regulate the processing of data relating to persons (ie, personal data) in order to safeguard, at least partly, the privacy and related interests of those persons. Outside Europe, such norms tend rather to be described in terms of protecting ‘privacy’, ‘data privacy’ or ‘information privacy’
    • The term ‘data protection’ is used here in its primarily European sense to denote a set of norms that specifically regulate the processing of data relating to persons (ie, personal data) in order to safeguard, at least partly, the privacy and related interests of those persons. Outside Europe, such norms tend rather to be described in terms of protecting ‘privacy’, ‘data privacy’ or ‘information privacy’.
  • 7
    • 78649364012 scopus 로고    scopus 로고
    • Firm Brings Gene Tests to the Masses
    • See eg, 28 January
    • See eg A Pollack, ‘Firm Brings Gene Tests to the Masses’ New York Times, 28 January 2010, www.nytimes.com/2010/01/29/business/29gene.html
    • (2010) New York Times
    • Pollack, A.1
  • 10
    • 13844267507 scopus 로고    scopus 로고
    • Storing Newborn Bloodspots: Modern Controversies
    • See further, eg
    • See further, eg, Linda Kharaboyan, Denise Avard and Bartha Maria Knoppers, ‘Storing Newborn Bloodspots: Modern Controversies’ (2004) 32 Journal of Law, Medicine & Ethics 741.
    • (2004) Journal of Law, Medicine & Ethics , vol.32 , pp. 741
    • Kharaboyan, L.1    Avard, D.2    Knoppers, B.M.3
  • 11
    • 23944463149 scopus 로고    scopus 로고
    • An Empirical Survey on Biobanking of Human Genetic Material and Data in Six EU Countries
    • Bartha Maria Knoppers (ed), Martinus Nijhoff
    • Anne Cambon-Thomsen et al, ‘An Empirical Survey on Biobanking of Human Genetic Material and Data in Six EU Countries’ in Bartha Maria Knoppers (ed), Populations and Genetics: Legal and Socio-Ethical Perspectives (Martinus Nijhoff, 2003) 141-68;
    • (2003) Populations and Genetics: Legal and Socio-Ethical Perspectives , pp. 141-168
    • Cambon-Thomsen, A.1
  • 13
    • 79851508921 scopus 로고    scopus 로고
    • Biobanks in Action: New Strategies in the Governance of Life
    • For discussion of the catalysts for the proliferation of biobanks see eg, Herbert Gottweis and Alan Petersen (eds), Routledge, ch 2
    • For discussion of the catalysts for the proliferation of biobanks see eg Herbert Gottweis, ‘Biobanks in Action: New Strategies in the Governance of Life’ in Herbert Gottweis and Alan Petersen (eds), Biobanks: Governance in Comparative Perspective (Routledge, 2008) ch 2.
    • (2008) Biobanks: Governance in Comparative Perspective
    • Gottweis, H.1
  • 14
    • 33744953632 scopus 로고    scopus 로고
    • From Hype to Mothballs in Four Years: Troubles in the Development of Large-scale DNA Biobanks in Europe
    • Most notably the Icelandic Health Sector Database run by deCODE genetics, Inc. See further
    • Most notably the Icelandic Health Sector Database run by deCODE genetics, Inc. See further Hilary Rose, ‘From Hype to Mothballs in Four Years: Troubles in the Development of Large-scale DNA Biobanks in Europe’ (2006) 6 Community Genetics 184.
    • (2006) Community Genetics , vol.6 , pp. 184
    • Rose, H.1
  • 15
    • 85026200963 scopus 로고    scopus 로고
    • As exemplified by the UK Biobank initiative: see
    • As exemplified by the UK Biobank initiative: see www.ukbiobank.ac.uk.
  • 16
    • 4544258314 scopus 로고    scopus 로고
    • Introduction to Biometrics
    • See further, eg, in Anil K Jain, Patrick Flynn and Arun A Ross (eds), Springer, ch 1
    • See further, eg, Anil K Jain and Arun Ross, ‘Introduction to Biometrics’ in Anil K Jain, Patrick Flynn and Arun A Ross (eds), Handbook of Biometrics (Springer, 2008) ch 1.
    • (2008) Handbook of Biometrics
    • Jain, A.K.1    Ross, A.2
  • 17
    • 85026242616 scopus 로고    scopus 로고
    • The use of human characteristics to recognise people has always been an integral part of human interaction
    • The use of human characteristics to recognise people has always been an integral part of human interaction.
  • 19
    • 33645889328 scopus 로고    scopus 로고
    • Biometric Borders: Governing Mobilities in the War on Terror
    • see eg
    • see eg Louise Amoor, ‘Biometric Borders: Governing Mobilities in the War on Terror’ (2006) 25 Political Geography 336;
    • (2006) Political Geography , vol.25 , pp. 336
    • Amoor, L.1
  • 20
    • 27944490811 scopus 로고    scopus 로고
    • Complexity and Counterterrorism: Thinking about BiometricsM
    • Patrick H O’Neil, ‘Complexity and Counterterrorism: Thinking about BiometricsM’ (2005) 28 Studies in Conflict and Terrorism 547.
    • (2005) Studies in Conflict and Terrorism , vol.28 , pp. 547
    • O’Neil, P.H.1
  • 21
    • 85026267562 scopus 로고    scopus 로고
    • See further, eg
    • See further, eg, Jain and Ross (n 15) 12-14.
    • , Issue.15 , pp. 12-14
    • Jain1    Ross2
  • 22
    • 85026211346 scopus 로고    scopus 로고
    • The case particularly with genetic information which may relate to the biological kin of the person from whom the information is directly derived
    • The case particularly with genetic information which may relate to the biological kin of the person from whom the information is directly derived.
  • 24
    • 85026215252 scopus 로고    scopus 로고
    • With respect to biometrics, see eg European Union, Article 29 Working Party on the Protection of Individuals with regard to the Processing of Personal Data (hereinafter ‘Article 29 Working Party’), ‘Working Document on Biometrics’ (1 August, WP 80
    • With respect to biometrics, see eg European Union, Article 29 Working Party on the Protection of Individuals with regard to the Processing of Personal Data (hereinafter ‘Article 29 Working Party’), ‘Working Document on Biometrics’ (1 August 2003) WP 80, http://ec.europa.eu/justice_home/fsj/privacy/docs/wpdocs/2003/wp80_en.pdf;
    • (2003)
  • 25
    • 85026270174 scopus 로고    scopus 로고
    • Council of Europe, Consultative Committee of the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (T-PD), ‘Progress report on the application of the principles of Convention 108 to the collection and processing of biometric data’ (February
    • Council of Europe, Consultative Committee of the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (T-PD), ‘Progress report on the application of the principles of Convention 108 to the collection and processing of biometric data’ (February 2005), www.coe.int/t/e/legal_affairs/legal_co-operation/data_protection/documents/reports_and_studies_of_data_protection_committees/2Biometrics_2005_en.pdf;
    • (2005)
  • 26
  • 27
    • 85026204638 scopus 로고    scopus 로고
    • With respect to genetic information, see eg United Kingdom, Human Genetics Commission
    • With respect to genetic information, see eg United Kingdom, Human Genetics Commission, Inside Information: Balancing Interests 4
    • Inside Information: Balancing Interests , pp. 4
  • 29
    • 3042681436 scopus 로고    scopus 로고
    • Australian Law Reform Commission (ALRC) and Australian Health Ethics Committee (AHEC), Report No 96, ALRC/AHEC, Sydney
    • Australian Law Reform Commission (ALRC) and Australian Health Ethics Committee (AHEC), Essentially Yours: The Protection of Human Genetic Information in Australia, Report No 96 (ALRC/AHEC, Sydney 2003);
    • (2003) Essentially Yours: The Protection of Human Genetic Information in Australia
  • 30
    • 85026262659 scopus 로고    scopus 로고
    • Article 29 Working Party, ‘Working Document on Genetic Data’ (17 March, WP 91
    • Article 29 Working Party, ‘Working Document on Genetic Data’ (17 March 2004) WP 91, http://ec.europa.eu/justice_home/fsj/privacy/docs/wpdocs/2004/wp91_en.pdf;
    • (2004)
  • 32
    • 0346435024 scopus 로고    scopus 로고
    • Cambridge University Press
    • Graeme Laurie, Genetic Privacy (Cambridge University Press, 2002).
    • (2002) Genetic Privacy
    • Laurie, G.1
  • 34
    • 85026198905 scopus 로고    scopus 로고
    • Lyon (n 20) 15.
    • , Issue.20 , pp. 15
    • Lyon1
  • 35
    • 54049141308 scopus 로고    scopus 로고
    • Biometrics, Identification and SurveillanceM
    • Lyon is here referring specifically to an effect of biometrics but his characterisation is also pertinent to surveillance systems more generally
    • David Lyon, ‘Biometrics, Identification and SurveillanceM’ (2008) 22 Bioethics 507. Lyon is here referring specifically to an effect of biometrics but his characterisation is also pertinent to surveillance systems more generally.
    • (2008) Bioethics , vol.22 , pp. 507
    • Lyon, D.1
  • 37
    • 85026193353 scopus 로고    scopus 로고
    • Norwegian Supreme Court decision of 1 February 2006, reported in Norsk Retstidende (Norwegian Law Reports; abbreviated as ‘Rt’)
    • Norwegian Supreme Court decision of 1 February 2006, reported in Norsk Retstidende (Norwegian Law Reports; abbreviated as ‘Rt’) 2006 90 [29].
    • (2006) , vol.90 , pp. 29
  • 38
    • 34249038614 scopus 로고    scopus 로고
    • Genetic Exceptionalism and Legislative PragmatismM
    • See further, eg
    • See further, eg, Mark A Rothstein, ‘Genetic Exceptionalism and Legislative PragmatismM’ (2007) 35 Journal of Law, Medicine & Ethics 59;
    • (2007) Journal of Law, Medicine & Ethics , vol.35 , pp. 59
    • Rothstein, M.A.1
  • 39
    • 85026232877 scopus 로고    scopus 로고
    • ALRC and AHEC, [3.41]-[3.63] and references cited therein
    • ALRC and AHEC (n 21) [3.41]-[3.63] and references cited therein.
    • , Issue.21
  • 40
    • 0037811093 scopus 로고    scopus 로고
    • Biometrics and the Body as Information: Normative Issues of the Socio-Technical Coding of the Body
    • David Lyon (ed), Routledge, ch 3
    • Irma van der Ploeg, ‘Biometrics and the Body as Information: Normative Issues of the Socio-Technical Coding of the Body’ in David Lyon (ed), Surveillance as Social Sorting: Privacy, Risk, and Automated Discrimination (Routledge, 2002) ch 3;
    • (2002) Surveillance as Social Sorting: Privacy, Risk, and Automated Discrimination
    • van der Ploeg, I.1
  • 44
    • 34250628067 scopus 로고    scopus 로고
    • Genetics, Biometrics and the Informatization of the BodyM
    • See too
    • See too Irma van der Ploeg, ‘Genetics, Biometrics and the Informatization of the BodyM’ (2007) 43 Annali dell’ Istituto Superiore di Sanità 47.
    • (2007) Annali dell’ Istituto Superiore di Sanità , vol.43 , pp. 47
    • van der Ploeg, I.1
  • 45
    • 77950928973 scopus 로고    scopus 로고
    • App no 30562/04 and 30566/04) ECtHR, 4 December
    • S and Marper v United Kingdom (App no 30562/04 and 30566/04) ECtHR, 4 December 2008.
    • (2008) S and Marper v United Kingdom
  • 46
    • 85026270804 scopus 로고
    • Convention for the Protection of Human Rights and Fundamental Freedoms (opened for signature 4 November, in force 3 September 1953) European Treaty Series (ETS) 5
    • Convention for the Protection of Human Rights and Fundamental Freedoms (opened for signature 4 November 1950; in force 3 September 1953) European Treaty Series (ETS) 5.
    • (1950)
  • 47
    • 85026225113 scopus 로고
    • Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (opened for signature 28 January, in force 1 October 1985) ETS 108 (hereinafter ‘Data Protection Convention’)
    • Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (opened for signature 28 January 1981; in force 1 October 1985) ETS 108 (hereinafter ‘Data Protection Convention’).
    • (1981)
  • 48
    • 85026221003 scopus 로고    scopus 로고
    • Marper (n 30) [68].
    • Marper , Issue.30 , pp. 68
  • 49
    • 85026201405 scopus 로고    scopus 로고
    • See too [68] and [73] where samples are treated as ‘containing’ personal information-ie, they are regarded, in effect, as vessels of such information and, as such, constitute ‘personal data’. The Court uses the terms ‘data’ and ‘information’ interchangeably: see eg
    • See too [68] and [73] where samples are treated as ‘containing’ personal information-ie, they are regarded, in effect, as vessels of such information and, as such, constitute ‘personal data’. The Court uses the terms ‘data’ and ‘information’ interchangeably: see eg [75].
  • 50
    • 85026264075 scopus 로고    scopus 로고
    • See too [68] and [73] where samples are treated as ‘containing’ personal information-ie, they are regarded, in effect, as vessels of such information and, as such, constitute ‘personal data’. The Court uses the terms ‘data’ and ‘information’ interchangeably, See too
    • See too [68] and [73] where samples are treated as ‘containing’ personal information-ie, they are regarded, in effect, as vessels of such information and, as such, constitute ‘personal data’. The Court uses the terms ‘data’ and ‘information’ interchangeably. See too [63].
  • 52
    • 85026193695 scopus 로고    scopus 로고
    • EWCA Civ 1275, [2002] 1 WLR 3223, [72] (‘Bodily samples are also a source of identifying data’) [74] (‘DNA samples in themselves have no forensic or diagnostic value. Their value lies in the … data they yield’)
    • Marper, R v Chief Constable of South Yorkshire [2002] EWCA Civ 1275; [2002] 1 WLR 3223, [72] (‘Bodily samples are also a source of identifying data’) [74] (‘DNA samples in themselves have no forensic or diagnostic value. Their value lies in the … data they yield’).
    • (2002) Marper, R v Chief Constable of South Yorkshire
  • 54
    • 85026250806 scopus 로고
    • Explanatory Report on the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (Council of Europe
    • Explanatory Report on the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (Council of Europe, 1981).
    • (1981)
  • 55
    • 85026213240 scopus 로고    scopus 로고
    • Note, though, that the report does not provide ‘an authoritative interpretation of the text of the Convention, although it might be of such nature as to facilitate the understanding of the provisions contained therein’
    • Note, though, that the report does not provide ‘an authoritative interpretation of the text of the Convention, although it might be of such nature as to facilitate the understanding of the provisions contained therein’: Law of the European Convention on Human Rights [II].
    • Law of the European Convention on Human Rights
  • 57
    • 85026231072 scopus 로고
    • See Recommendation R (92) 1 on the Use of Analysis of Deoxyribonucleic Acid (DNA) within the Framework of the Criminal Justice System (adopted 10 February, (distinguishing generally between ‘samples’ and ‘information derived from them’)
    • See Recommendation R (92) 1 on the Use of Analysis of Deoxyribonucleic Acid (DNA) within the Framework of the Criminal Justice System (adopted 10 February 1992) (distinguishing generally between ‘samples’ and ‘information derived from them’);
    • (1992)
  • 58
    • 85026255108 scopus 로고
    • Recommendation R (92) 3 on Genetic Testing and Screening for Health Care Purposes (adopted 10 February, (also distinguishing between ‘substances’ and ‘samples’ on the one hand and, on the other, ‘information derived therefrom’)
    • Recommendation R (92) 3 on Genetic Testing and Screening for Health Care Purposes (adopted 10 February 1992) (also distinguishing between ‘substances’ and ‘samples’ on the one hand and, on the other, ‘information derived therefrom’);
    • (1992)
  • 59
    • 85026269964 scopus 로고    scopus 로고
    • Recommendation Rec(2006)4 on Research on Biological Materials of Human Origin (adopted 15 March, (distinguishing generally between ‘biological materials’ and ‘associated (personal) data’). See too Explanatory Memorandum to Recommendation R (97) 5 on the Protection of Medical Data (adopted 13 February 1997) [41] (distinguishing ‘genetic data’ from ‘blood, tissue, hair, sperm, and so forth’
    • Recommendation Rec(2006)4 on Research on Biological Materials of Human Origin (adopted 15 March 2006) (distinguishing generally between ‘biological materials’ and ‘associated (personal) data’). See too Explanatory Memorandum to Recommendation R (97) 5 on the Protection of Medical Data (adopted 13 February 1997) [41] distinguishing ‘genetic data’ from ‘blood, tissue, hair, sperm, and so forth’;
    • (2006)
  • 60
    • 85026253502 scopus 로고    scopus 로고
    • see too [42], [47], [52] and [55]). Cf Elisabeth Rynning, ‘Biobankerna-hög tid för bankinspektion?' [The Biobanks-High Time for Bank Inspection?]
    • see too [42], [47], [52] and [55]. Cf Elisabeth Rynning, ‘Biobankerna-hög tid för bankinspektion?' [The Biobanks-High Time for Bank Inspection?] (1998) Förvaltningsrättslig Tidskrift
    • (1998) Förvaltningsrättslig Tidskrift
  • 61
    • 85026266228 scopus 로고    scopus 로고
    • principle 8 of Recommendation R (92) 1 is headed ‘storage of samples and data’
    • principle 8 of Recommendation R (92) 1 is headed ‘storage of samples and data’;
  • 62
    • 85026198815 scopus 로고    scopus 로고
    • while principle 10 of Recommendation R (92) 3 deals only with ‘genetic data’ under the heading ‘separate storage of genetic information’
    • while principle 10 of Recommendation R (92) 3 deals only with ‘genetic data’ under the heading ‘separate storage of genetic information’.
  • 63
    • 85026205122 scopus 로고    scopus 로고
    • See further
    • See further Harris et al (n 37) 800-1.
    • , Issue.37 , pp. 800-801
    • Harris1
  • 64
    • 84555200048 scopus 로고    scopus 로고
    • Data Protection in the Case Law of Strasbourg and Luxembourg: Constitutionalisation in Action
    • Serge Gutwirth et al (eds), Springer Science
    • Paul de Hert and Serge Gutwirth, ‘Data Protection in the Case Law of Strasbourg and Luxembourg: Constitutionalisation in Action’ in Serge Gutwirth et al (eds), Reinventing Data Protection? (Springer Science, 2009) 14-29;
    • (2009) Reinventing Data Protection? , pp. 14-29
    • de Hert, P.1    Gutwirth, S.2
  • 65
    • 10944256095 scopus 로고    scopus 로고
    • Data Protection Pursuant to the Right to Privacy in Human Rights TreatiesM
    • Lee A Bygrave, ‘Data Protection Pursuant to the Right to Privacy in Human Rights TreatiesM’ (1998) 6 International Journal of Law and Information Technology 254-84.
    • (1998) International Journal of Law and Information Technology , vol.6 , pp. 254-284
    • Bygrave, L.A.1
  • 66
    • 85026207864 scopus 로고    scopus 로고
    • Convention between the Kingdom of Belgium, the Federal Republic of Germany, the Kingdom of Spain, the French Republic, the Grand Duchy of Luxembourg, the Kingdom of the Netherlands and the Republic of Austria on the stepping up of cross-border cooperation, particularly in combating terrorism, cross-border crime and illegal migration (opened for signature 27 May
    • Convention between the Kingdom of Belgium, the Federal Republic of Germany, the Kingdom of Spain, the French Republic, the Grand Duchy of Luxembourg, the Kingdom of the Netherlands and the Republic of Austria on the stepping up of cross-border cooperation, particularly in combating terrorism, cross-border crime and illegal migration opened for signature 27 May 2005;
    • (2005)
  • 68
    • 85026204667 scopus 로고    scopus 로고
    • ICO, ‘The Information Commissioner’s response to the Home Office consultation paper on the retention, use and destruction of DNA data and fingerprints’ (7 August, version 1.0; final) 5 (emphasis added; see too 3)
    • ICO, ‘The Information Commissioner’s response to the Home Office consultation paper on the retention, use and destruction of DNA data and fingerprints’ (7 August 2009; version 1.0; final) 5 (emphasis added; see too 3), www.ico.gov.uk/upload/documents/library/data_protection/notices/response_to_ho_consultation_may09.pdf.
    • (2009)
  • 69
    • 85026261488 scopus 로고    scopus 로고
    • ICO, ‘Data Protection Technical Guidance: Determining what is personal data’ (21 August 2007, version 1.0)
    • ICO, ‘Data Protection Technical Guidance: Determining what is personal data’ (21 August 2007, version 1.0);
  • 70
    • 85026224857 scopus 로고    scopus 로고
    • ICO, ‘Data Protection Technical Guidance: Determining what information is “data”
    • ICO, ‘Data Protection Technical Guidance: Determining what information is “data”
  • 71
    • 85026238114 scopus 로고    scopus 로고
    • for the purposes of the DPA’ (28 January 2009; version 1.0). Both guidance notes are available at
    • for the purposes of the DPA’ (28 January 2009; version 1.0). Both guidance notes are available at www.ico.gov.uk/what_we_cover/data_protection/guidance/technical_guidance_notes.aspx.
  • 75
    • 77949654893 scopus 로고    scopus 로고
    • Data Protection and Genetics: Medical Research and the Public GoodM
    • where, against the grain, it is argued that samples as such do constitute data
    • Deryck Beyleveld, ‘Data Protection and Genetics: Medical Research and the Public GoodM’ (2007) 18 King’s Law Journal 279, where, against the grain, it is argued that samples as such do constitute data.
    • (2007) King’s Law Journal , vol.18 , pp. 279
    • Beyleveld, D.1
  • 76
    • 85026245561 scopus 로고    scopus 로고
    • Writing in 2004, state that ‘[t]he official view from the IC [Information Commissioner] is that samples themselves are not treated as personal data, because it is physical material’
    • Writing in 2004, Beyleveld et al (n 51) 428 state that ‘[t]he official view from the IC [Information Commissioner] is that samples themselves are not treated as personal data, because it is physical material’.
    • , Issue.51 , pp. 428
    • Beyleveld1
  • 77
    • 85026237891 scopus 로고    scopus 로고
    • See eg Data Protection Convention, Art 2(a)
    • See eg Data Protection Convention, Art 2(a);
  • 78
    • 85026212944 scopus 로고    scopus 로고
    • UK Data Protection Act, s 1(1
    • UK Data Protection Act 1998, s 1(1);
    • (1998)
  • 79
    • 85026202369 scopus 로고
    • Australia’s federal Privacy Act, s
    • Australia’s federal Privacy Act 1988, s 6(1).
    • (1988) , vol.6 , Issue.1
  • 80
    • 85026201383 scopus 로고    scopus 로고
    • For further analysis of these and like definitions, see eg
    • For further analysis of these and like definitions, see eg Bygrave (n 2) 41-50, 210-15, 315-19.
    • , Issue.2
    • Bygrave1
  • 83
    • 85026201616 scopus 로고
    • Council Directive (EC) 95/46 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, OJ L281/31 (hereinafter ‘Data Protection Directive’)
    • Council Directive (EC) 95/46 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [1995] OJ L281/31 (hereinafter ‘Data Protection Directive’).
    • (1995)
  • 86
    • 85026226962 scopus 로고    scopus 로고
    • Council Directive (EC) 95/46 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [1995] OJ L281/31 (hereinafter ‘Data Protection Directive’)
    • Council Directive (EC) 95/46 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [1995] OJ L281/31 (hereinafter ‘Data Protection Directive’).
  • 87
    • 85026251976 scopus 로고    scopus 로고
    • See the Commission’s commentary with respect to its amended proposal for a data protection Directive of 15 October 1992: COM (92) 422 final-SYN 287, 9. See also its commentary with respect to the original Directive proposal of 24 September 1990: COM (90) 314 final-SYN 287
    • See the Commission’s commentary with respect to its amended proposal for a data protection Directive of 15 October 1992: COM (92) 422 final-SYN 287, 9. See also its commentary with respect to the original Directive proposal of 24 September 1990: COM (90) 314 final-SYN 287, 15.
  • 88
    • 85026262264 scopus 로고    scopus 로고
    • COM (92) 422 final-SYN 287, 9. See also 3 (‘the principles of protection laid down by the Directive are not dependent on a particular technology or form of organization’)
    • COM (92) 422 final-SYN 287, 9. See also 3 (‘the principles of protection laid down by the Directive are not dependent on a particular technology or form of organization’).
  • 89
    • 85026214027 scopus 로고    scopus 로고
    • Article 29 Working Party, ‘Working Document on Genetic Data’ (17 March 2004) WP 91, 5 (noting that the applicability of Directive 95/46/EC to ‘samples’ of DNA is uncertain, but that ‘such samples may constitute a source of personal data’ and that, accordingly, ‘in regulating genetic data, consideration should also be given to the legal status of DNA samples’)
    • Article 29 Working Party, ‘Working Document on Genetic Data’ (17 March 2004) WP 91, 5 (noting that the applicability of Directive 95/46/EC to ‘samples’ of DNA is uncertain, but that ‘such samples may constitute a source of personal data’ and that, accordingly, ‘in regulating genetic data, consideration should also be given to the legal status of DNA samples’).
  • 90
    • 85026208111 scopus 로고    scopus 로고
    • For more on the leeway accorded member states in their implementation of the Directive, see eg
    • For more on the leeway accorded member states in their implementation of the Directive, see eg Bygrave (n 2) 34.
    • , Issue.2 , pp. 34
    • Bygrave1
  • 93
    • 85026203220 scopus 로고    scopus 로고
    • See the following chapters of, Sylvia Tomova, ‘Implementation of Directive 95/46/EC in Relation to Medical Research in Bulgaria’
    • See the following chapters of Beyleveld et al (n 66): Sylvia Tomova, ‘Implementation of Directive 95/46/EC in Relation to Medical Research in Bulgaria’ 46;
    • , Issue.66 , pp. 46
    • Beyleveld1
  • 103
    • 85026231253 scopus 로고    scopus 로고
    • See too Datainspektionen [Data Inspectorate], [Biobanks and the Personal Data Act] (Stockholm
    • See too Datainspektionen [Data Inspectorate], Biobanker och personuppgiftslagen [Biobanks and the Personal Data Act] (Stockholm 2004) 8, www.datainspektionen.se/Documents/rapport-biobanker.pdf.
    • (2004) Biobanker och personuppgiftslagen , pp. 8
  • 105
    • 33645420577 scopus 로고    scopus 로고
    • Public Law Aspects on the Use of Biobank Samples-Privacy versus the Interests of Research
    • Mats G Hansson and Marianne Levin (eds), Uppsala University
    • Elisabeth Rynning, ‘Public Law Aspects on the Use of Biobank Samples-Privacy versus the Interests of Research’ in Mats G Hansson and Marianne Levin (eds), Biobanks as Resources for Health (Uppsala University, 2003) 91;
    • (2003) Biobanks as Resources for Health , pp. 91
    • Rynning, E.1
  • 106
    • 85026202259 scopus 로고    scopus 로고
    • Offentligrättslig reglering av biobankerna-en utmaning för lagstiftaren
    • Public law regulation of biobanks-a challenge for the legislator, in Sanna Wolk (ed), [Biobank Law] , Studentlitteratur
    • Elisabeth Rynning, ‘Offentligrättslig reglering av biobankerna-en utmaning för lagstiftaren’ [Public law regulation of biobanks-a challenge for the legislator] in Sanna Wolk (ed), Biobanksrätt [Biobank Law] (Studentlitteratur, 2003) 49;
    • (2003) Biobanksrätt , pp. 49
    • Rynning, E.1
  • 107
    • 85026193425 scopus 로고    scopus 로고
    • Rynning (n 43) 303.
    • , Issue.43 , pp. 303
    • Rynning1
  • 109
    • 45849122730 scopus 로고    scopus 로고
    • See eg, Akademisk, 3rd rev edn, 151 regarding the Public Authorities’ Registers Act of 1978 (Lov nr 294 af 8 juni 1978 om offentlig myndigheders register) (repealed)
    • See eg Peter Blume, Personregistrering (Akademisk, 3rd rev edn 1996) 151 regarding the Public Authorities’ Registers Act of 1978 (Lov nr 294 af 8 juni 1978 om offentlig myndigheders register) (repealed).
    • (1996) Personregistrering
    • Blume, P.1
  • 110
    • 85026251484 scopus 로고    scopus 로고
    • See too, Assessment of the Data Protection Tribunal’s Case Decisions] CompLex 3/09 (Senter for rettsinformatikk/Unipub
    • See too Peter Blume, Vurdering af personvernnemndas praksis 2001-2008 [Assessment of the Data Protection Tribunal’s Case Decisions] CompLex 3/09 (Senter for rettsinformatikk/Unipub, 2009) 17-18.
    • (2009) Vurdering af personvernnemndas praksis 2001-2008 , pp. 17-18
    • Blume, P.1
  • 111
    • 85026207170 scopus 로고    scopus 로고
    • ALRC and AHEC
    • ALRC and AHEC (n 21).
    • , Issue.21
  • 113
    • 85026244189 scopus 로고    scopus 로고
    • ALRC and AHEC, [8.7]-[8.9]
    • ALRC and AHEC (n 21) [8.7]-[8.9];
    • , Issue.21
  • 114
    • 85026241616 scopus 로고    scopus 로고
    • ALRC and AHEC, [7.54]
    • ALRC and AHEC (n 79) [7.54].
    • , Issue.79
  • 115
    • 85026250346 scopus 로고    scopus 로고
    • Government Response to Australian Law Reform Commission and Australian Health Ethics Committee Report
    • Australian Government Attorney-General’s Department, 9 December, The definition of ‘sensitive information’ in the Act was amended, though, to expressly cover ‘genetic information about an individual’ (s 6(1))
    • Australian Government Attorney-General’s Department, ‘Government Response to Australian Law Reform Commission and Australian Health Ethics Committee Report: Essentially Yours: The Protection of Human Genetic Information in Australia’ (9 December 2005), www.alrc.gov.au/inquiries/title/alrc96/agd.htm. The definition of ‘sensitive information’ in the Act was amended, though, to expressly cover ‘genetic information about an individual’ (s 6(1)).
    • (2005) Essentially Yours: The Protection of Human Genetic Information in Australia
  • 116
    • 85026203119 scopus 로고    scopus 로고
    • See, [A Better Protection of Privacy], NOU [Norwegian Official Reports], (describing ‘a sample of physical/biological material’ (‘en forekomst av et fysisk/biologisk materiale’)-exemplified in the form of a strand of hair (‘hårstrå')-as (i) ‘data that have not been subjected to a strong degree of formalisation’ (‘data som … ikke er undergitt noen sterk grad av formalisering’), (ii) an ‘information data carrier’ (‘informasjonsdatabærer’), and (iii) ‘data material’ (‘datamateriale’))
    • See Et bedre personvern [A Better Protection of Privacy], NOU [Norwegian Official Reports] 1997 no 19, 29 (describing ‘a sample of physical/biological material’ (‘en forekomst av et fysisk/biologisk materiale’)-exemplified in the form of a strand of hair (‘hårstrå')-as (i) ‘data that have not been subjected to a strong degree of formalisation’ (‘data som … ikke er undergitt noen sterk grad av formalisering’), (ii) an ‘information data carrier’ (‘informasjonsdatabærer’), and (iii) ‘data material’ (‘datamateriale’)).
    • (1997) Et bedre personvern , Issue.19 , pp. 29
  • 117
    • 85026223456 scopus 로고    scopus 로고
    • See appeal decision in case 8/2002
    • See appeal decision in case 8/2002, www.personvernnemnda.no/vedtak/2002_8.htm.
  • 118
    • 85026213174 scopus 로고    scopus 로고
    • The decision is also reproduced in Blume
    • The decision is also reproduced in Blume (n 77) 74.
    • , Issue.77 , pp. 74
  • 119
    • 85026231889 scopus 로고    scopus 로고
    • ALRC and AHEC, [8.32]
    • ALRC and AHEC (n 21) [8.32].
    • , Issue.21
  • 120
    • 85026216913 scopus 로고    scopus 로고
    • Indeed, this would seem to be the approach taken in Germany: see
    • Indeed, this would seem to be the approach taken in Germany: see Simitis (n 72).
    • , Issue.72
    • Simitis1
  • 121
    • 85026270463 scopus 로고    scopus 로고
    • Referenced at
    • Referenced at n 43.
    • , Issue.43
  • 122
    • 85026192630 scopus 로고    scopus 로고
    • Organization for Economic Cooperation and Development (OECD), Recommendation on Human Biobanks and Genetic Research Databases (adopted 22 October, with accompanying guidelines
    • Organization for Economic Cooperation and Development (OECD), Recommendation on Human Biobanks and Genetic Research Databases (adopted 22 October 2009) with accompanying guidelines, www.oecd.org/dataoecd/41/47/44054609.pdf.
    • (2009)
  • 123
    • 48349137285 scopus 로고    scopus 로고
    • Governing Genetic Databases: Collection, Storage and UseM
    • Susan MC Gibbons and Jane Kaye, ‘Governing Genetic Databases: Collection, Storage and UseM’ (2007) 18 King’s Law Journal 203.
    • (2007) King’s Law Journal , vol.18 , pp. 203
    • Gibbons, S.M.C.1    Kaye, J.2
  • 124
    • 85026249835 scopus 로고    scopus 로고
    • With respect to the Italian regime, see, SCRIPTed 71
    • With respect to the Italian regime, see Elisa Stefanini, ‘The Need for Italian Biobank Regulation’ (2010) 7 SCRIPTed 71, www.law.ed.ac.uk/ahrc/script-ed/vol7-1/stefanini.asp.
    • (2010) The Need for Italian Biobank Regulation , vol.7
    • Stefanini, E.1
  • 126
    • 85026231950 scopus 로고    scopus 로고
    • With respect to the Swedish regime, see eg
    • With respect to the Swedish regime, see eg Wolk (n 74);
    • , Issue.74
    • Wolk1
  • 127
    • 85026239367 scopus 로고    scopus 로고
    • Sweden, Ministry of Health and Social Affairs, 'Översyn av lagen (2002:297) om biobanker i hälso- och sjukvården mm’ [Study of Act (2002:297) on biobanks in health and medical treatment] (29 May 2008) Dir
    • Sweden, Ministry of Health and Social Affairs, 'Översyn av lagen (2002:297) om biobanker i hälso- och sjukvården mm’ [Study of Act (2002:297) on biobanks in health and medical treatment] (29 May 2008) Dir 2008:71, www.sou.gov.se/kommittedirektiv/2008/dir2008_71.pdf.
    • (2008) , pp. 71
  • 128
    • 85026227535 scopus 로고    scopus 로고
    • With respect to the Australian regime, see ALRC and AHEC
    • With respect to the Australian regime, see ALRC and AHEC (n 21);
    • , Issue.21
  • 129
    • 57149086867 scopus 로고    scopus 로고
    • Human Genetic Databanks in Australia: Indications of Inconsistency and Confusion
    • Mark Stranger et al, ‘Human Genetic Databanks in Australia: Indications of Inconsistency and Confusion (2008) 27 New Genetics and Society 311.
    • (2008) New Genetics and Society , vol.27 , pp. 311
    • Stranger, M.1
  • 130
    • 85026236663 scopus 로고    scopus 로고
    • See eg European Commission, First Report on the implementation of the Data Protection Directive (95/46/EC) (15 May 2003) COM, final, Brussels
    • See eg European Commission, First Report on the implementation of the Data Protection Directive (95/46/EC) (15 May 2003) COM (2003) 265 final, Brussels, http://ec.europa.eu/justice_home/fsj/privacy/lawreport/report_en.htm;
    • (2003) , pp. 265
  • 133
    • 77953559041 scopus 로고    scopus 로고
    • Designing and Formulating Data Protection LawsM
    • and references cited therein
    • Dag Wiese Schartum, ‘Designing and Formulating Data Protection LawsM’ (2010) 18 International Journal of Law and Information Technology 2 and references cited therein.
    • (2010) International Journal of Law and Information Technology , vol.18 , pp. 2
    • Schartum, D.W.1
  • 134
    • 85026205951 scopus 로고    scopus 로고
    • See eg Norway’s Personal Data Act §, (stating that ‘[i]f the document which contained the erased data gives a clearly misleading picture after the erasure, the entire document shall be erased’ (‘[h]vis dokumentet som inneholdt de slettede opplysningene gir et åpenbart misvisende bilde etter slettingen, skal hele dokumentet slettes’))
    • See eg Norway’s Personal Data Act § 28(5) (stating that ‘[i]f the document which contained the erased data gives a clearly misleading picture after the erasure, the entire document shall be erased’ (‘[h]vis dokumentet som inneholdt de slettede opplysningene gir et åpenbart misvisende bilde etter slettingen, skal hele dokumentet slettes’)).
    • , vol.28 , Issue.5
  • 135
    • 85026250966 scopus 로고    scopus 로고
    • See eg Directive 95/46/EC, Art, d
    • See eg Directive 95/46/EC, Art 6(1)(d).
    • , vol.6 , Issue.1
  • 136
    • 85026239149 scopus 로고    scopus 로고
    • See eg ALRC and AHEC, [8.48]-[8.54] (particularly recommendation 8-4 advancing a qualified right of access in this context-a recommendation later rejected by the government)
    • See eg ALRC and AHEC (n 21) [8.48]-[8.54] (particularly recommendation 8-4 advancing a qualified right of access in this context-a recommendation later rejected by the government).
    • , Issue.21
  • 137
    • 85026229461 scopus 로고    scopus 로고
    • Biobanker-Mellem Krop og Data
    • See too, [Biobanks-Between Body and Data]
    • See too Mette Hartlev, ‘Biobanker-Mellem Krop og Data’ [Biobanks-Between Body and Data] (2004) 14 Lov & Ret 11-13.
    • (2004) Lov & Ret , vol.14 , pp. 11-13
    • Hartlev, M.1
  • 138
    • 58149223088 scopus 로고    scopus 로고
    • The Ethical Challenges of Genetic Databases: Safeguarding Altruism and TrustM
    • Alastair V Campbell, ‘The Ethical Challenges of Genetic Databases: Safeguarding Altruism and TrustM’ (2007) 18 King’s Law Journal 227, 229.
    • (2007) King’s Law Journal , vol.18
    • Campbell, A.V.1
  • 140
    • 85026217205 scopus 로고    scopus 로고
    • See eg Data Protection Directive, Art 8 (listing health data as a type of sensitive data subject to a more stringent consent regime than is the case for ordinary personal data)
    • See eg Data Protection Directive, Art 8 (listing health data as a type of sensitive data subject to a more stringent consent regime than is the case for ordinary personal data).
  • 141
    • 85026195975 scopus 로고    scopus 로고
    • See further
    • See further Hartlev (n 75) 69-70;
    • , Issue.75 , pp. 69-70
    • Hartlev1
  • 142
    • 85026240050 scopus 로고    scopus 로고
    • Hartlev (n 95) 11-12;
    • , Issue.95 , pp. 11-12
    • Hartlev1
  • 143
    • 85026240082 scopus 로고    scopus 로고
    • Datatilsynets årsberetning, [Annual Report 2002] (November 2003)
    • Datatilsynets årsberetning 2002 [Annual Report 2002] (November 2003) 20-21.
    • (2002) , pp. 20-21
  • 144
    • 85026248713 scopus 로고    scopus 로고
    • For further general discussion of these sorts of challenges in structuring data protection law, see eg, 12ff
    • For further general discussion of these sorts of challenges in structuring data protection law, see eg Schartum (n 91) 12ff;
    • , Issue.91
    • Schartum1
  • 145
    • 85026264093 scopus 로고    scopus 로고
    • [Data Protection Law] (Jurist- og Økonomforbundets, 3rd rev edn
    • Peter Blume, Databeskyttelsesret [Data Protection Law] (Jurist- og Økonomforbundets, 3rd rev edn 2008) 72-80.
    • (2008) Databeskyttelsesret , pp. 72-80
    • Blume, P.1
  • 146
    • 85026223713 scopus 로고    scopus 로고
    • Gibbons and Kaye (n 89) 204.
    • , Issue.89 , pp. 204
    • Gibbons1    Kaye2
  • 147
    • 85026215973 scopus 로고    scopus 로고
    • See too, (attributing part of the weakness in Australian biobank regulation to confusion and inconsistencies regarding terminology)
    • See too Stranger et al (n 90) (attributing part of the weakness in Australian biobank regulation to confusion and inconsistencies regarding terminology).
    • , Issue.90
    • Stranger1
  • 148
    • 85026267603 scopus 로고    scopus 로고
    • Information Concepts in Law: Generic Dreams and Definitional DaylightM
    • See further, forthcoming
    • See further Lee A Bygrave, ‘Information Concepts in Law: Generic Dreams and Definitional Daylight’ (2011) 19 International Journal of Law and Information Technology (forthcoming).
    • (2011) International Journal of Law and Information Technology , vol.19
    • Bygrave, L.A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.