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Annate arretrate

Rivista Italiana di Medicina Legale e del Diritto in campo sanitario

Rivista: Rivista Italiana di Medicina Legale (e del Diritto in campo sanitario)
Anno: 2019
Fascicolo: n. 1
Editore: Giuffrè Francis Lefebvre
ISSN: 1124-3376
Autori: Comandé Giovanni
Titolo: RICERCA IN SANITÀ E DATA PROTECTION UN PUZZLE ... RISOLVIBILE
Pagine: pp. 189-207
Keywords: Ricerca (data intensive), dati sanitari, Big Data, protezione dei dati, GDPR

L’autore analizza le disposizioni del Reg. UE 679/2016 in materia di trattamento di dati per finalità di ricerca scientifica soffermandosi sulle basi giuridiche del trattamento al fine di commentare criticamente la normativa di adeguamento nazionale e le criticità emergenti dagli strumenti di soft law.

RICERCA IN SANITÀ E DATA PROTECTION UN PUZZLE ... RISOLVIBILE


1) Mostert M., Bredenoord A.L., Biesaart M.C.I.H., van Delden J.J.M., Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach. Eur J Hum Genet. 2016; 24: 956-960.
2) Schneider G., Disentangling Health Data Networks: a Critical Analysis of art. 9.2 and art, 89 GDPR. Forthcoming.
3) Jensen P.B., Jensen LJ, Brunak S.Mining electronic health records: towards better research applications and clinical care. Nat Rev Genet, 2012; 13: 395-405.
4) Currie J. ‘Big Data’ versus ‘big brother’: on the appropriate use of large-scale data collections in pediatrics. Pediatrics 2013; 131: S127-S132; Comandè G., Nocco L., Peigné V., Il Fascicolo sanitario elettronico: uno studio multidisciplinare, in Riv. it. med. leg., anno XXXIV, 01/2012, p.105-121.
5) Marx V.Biology: the big challenges of Big Data. Nature 2013; 498: 255-60.; Costa FF. Big Data in biomedicine. Drug Discov Today 2014; 19: 433-40.
6) Comandé G.; Schneider G. Regulatory Challenges of Data Mining Practices: The Case of the Never-ending Lifecycles of ‘Health Data, Eur. Jour. Health Law, 2018; Vol. 25, Issue 3, pages 284-307.
7) Apple’s Research. Kit frees medical research. Nat Biotechnol 2015; 33: 322.
8) Costa F.F.Social networks, web-based tools and diseases: implications for biomedical research. Drug Discov Today 2013; 18: 272-81.
9) Comandé G. The Rotting Meat Error: From Galileo to Aristotle in Data Mining?, Eur. Data Protection L. R., 2018; Vol. 4, Issue 3, pages 270-277.
10) Mayer-Schonberger V., Ingelsson E.Big Data and medicine: a big deal? J Intern Med 2018; 283: 418-29; Weber G.M., Mandl K.D., Kohane I.S. Finding the Missing Link for Big Biomedical Data. JAMA 2014; 311: 2479-80.
11) Academy of Medical Sciences. Personal Data for Public Good: Using Health Information in Medical Research, 2006. Available at http://www.acmedsci.ac.uk/download. php?f=file&i=13206.8. Sethi N., Laurie G. Delivering proportionate governance in the era of eHealth: making linkage and privacy work together. Med Law Int 2013; 13: 168-204.
12) Heeney C., Hawkins N., de Vries J., Boddington P., Kaye J. Assessing the privacy risks of data sharing in genomics. Public Health Genomics 2011; 14: 17-25; Mascalzoni D, Dove ES, Rubinstein Y et al.International Charter of principles for sharing bio-specimens and data. Eur J Hum Genet 2014; 23: 721-8; McGuire A.L., Caulfield T., Cho M.K. Research ethics and the challenge of whole-genome sequencing. Nat Rev Genet 2008; 9: 152-6. Heeney C., Hawkins N., de Vries J, Boddington P, Kaye J.Assessing the privacy risks of data sharing in genomics. Public Health Genomics 2011; 14: 17-25; Mascalzoni D.; Dove E.S., Rubinstein Y. et al. International Charter of principles for sharing bio-specimens and data. Eur J Hum Genet 2014; 23: 721-8; McGuire A.L., Caulfield T., Cho M.K. Research ethics and the challenge of whole-genome sequencing. Nat Rev Genet 2008; 9: 152–6.
13) O’Brien S.J.Stewardship of human biospecimens, DNA, genotype, and clinical data in the GWAS era. Annu Rev Genomics Hum Genet 2009; 10: 193–209; Knoppers B.M., Zawati M.H., Kirby E.S. Sampling populations of humans across the world: ELSI issues. Annu Rev Genomics Hum Genet 2012; 13: 395-413; Tene O., Polonetsky J.Privacy in the age of Big Data: a time for big decisions. Stanford Law Rev Online 2012; 64: 63-9.
14) Laurie G. Genetic privacy: A Challenge to Medico-Legal Norms. Oxford University Press: New York, 2002; Mittelstadt B.D., Floridi L. The ethics of Big Data: current and foreseeable issues in biomedical contexts. Sci Eng Ethics 2015, e-pub ahead of print 23 May 2015 doi:10.1007/s11948-015-9652-2.
15) Greely H.T.The uneasy ethical and legal underpinnings of large-scale genomic biobanks. Annu Rev Genomics Hum Genet 2007; 8: 343-64.
16) Sul punto si vedano le conclusioni dell’E.D.P.B. sul rapporto tra Regolamento 679/2016 e il regolamento (EU) No 536/2014 del 16 Aprile 2014 sui on clinical trials per i prodotti medicinali ad uso umano.
17) Ploem M.C., Essink-Bot M.L., Stronks K. Proposed EU data protection regulation is a threat to medical research. BMJ 2013; 346: f3534.6. Dove E.S., Thompson B., Knoppers B.M. A step forward for data protection and biomedical research. Lancet (London, England) 2016; 387: 1374–5.
18) The Wellcome Trust.Analysis: Research and the General Data Protection Regulation- 2012/0011(COD), 2016. Available at https://wellcome.ac.uk/sites/default/files/newdata-protection-regulation-key-clauses-wellcome-jul16.pdf.
19) Fuster G.G.The Emergence of Personal Data Protection as a Fundamental Right of the EU Springer: Dordrecht, 2014. Sul dibattito si veda anche Tzanou M.Data protection as a fundamental right next to privacy? ‘Reconstructing’ a not so new right, International Data Privacy Law 2013; 3: 88-99; Lynskey O.Deconstructing data protection: the ‘Added-value’ of a right to data protection in the EU legal order. Int. and Comp. Law Quart. 2014; 63: 569-97.
20) Kokott J., Sobotta C.The distinction between privacy and data protection in the jurisprudence of the CJEU and the ECtHR. Int. Data Privacy Law 2013; 3: 222-8.
21) Fuster G.G.The Emergence of Personal Data Protection as a Fundamental Right of the EU, cit.; Hustinx P. EU Data Protection Law: The Review of Directive 95/46/EC and the Proposed General Data Protection Regulation 2014; Available at https://secure.edps.europa.eu/EDPSWEB/webdav/site/mySite/shared/Documents/EDPS/Publications/Speeches/2014/14-09-15_Article_EUI_EN.pdf; Kokott J, Sobotta C.The distinction between privacy and data protection in the jurisprudence of the CJEU and the ECtHR, cit.; Convention Praesidium. Explanations Relating to the Charter of Fundamental Rights of the European Union. Brussels, 11 October 2000, Charte 4473/00, Convent 49; Gellert R, Gutwirth S. The legal construction of privacy and data protection. Computer Law & Security Review 2013; 29: 522-30.
22) de Hert P., Gutwirth S.Data Protection in the Case Law of Strasbourg and Luxembourg: Constitutionalism in Action. In: S. Gutwirth et al. (eds.), Reinventing Data Protection? Springer: New York, 2009, pp. 3-43.
23) Regolamento (EU) No 536/2014, cit.
24) Boddington P., Curren L., Kaye J. et al.Consent forms in genomics: the difference between law and practice. Eur. Jour. Health Law, 2011; 18: 491–519; Laurie G., Postan E. Rhetoric or reality: what is the legal status of the consent form in health-related research? Med Law Rev 2013; 21: 371–414; Master Z., Nelson E., Murdoch B., Caulfield T.Biobanks Consent and Claims of Consensus. Nat Methods 2012; 9: 885–8; Kaye J. The tension between data sharing and the protection of privacy in genomics research. Annu Rev Genomics Hum Genet 2012; 13: 415–31.41. Kaye J.The tension between data sharing and the protection of privacy in genomics research. Annu Rev Genomics Hum Genet 2012; 13: 415–31. Per voci fvorevoli nonostante le perplessità cfr. Steinsbekk K.S., Kåre Myskja B., Solberg B. Broad consent versus dynamic consent in biobank research: is passive participation an ethical problem? Eur J Hum Genet 2013; 21: 897-902. Helgesson G.In defense of broad consent. Camb Q Healthc Ethics 2012; 21: 40-50.
25) Cioè “è soggetto a garanzie adeguate per i diritti e le libertà dell’interessato, in conformità del presente regolamento. Tali garanzie assicurano che siano state predisposte misure tecniche e organizzative, in particolare al fine di garantire il rispetto del principio della minimizzazione dei dati. Tali misure possono includere la pseudonimizzazione, purché le finalità in questione possano essere conseguite in tal modo. Qualora possano essere conseguite attraverso il trattamento ulteriore che non consenta o non consenta più di identificare l’interessato, tali finalità devono essere conseguite in tal modo.”
26) Se si guardano alcune fonti recenti la necessità sarebbe legata, per esempio, ad un rischio serio e concreto per la salute pubblica ed il superamento del consenso è condizonato all’approvazione di un comitato etico. È il caso per esempi della liea guida 12 del Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Health-related Research Involving Humans. 2016.
27) Ruyter K.W., Louk K., Jorqui M., Kvalheim V., Cekanauskaite A., Townend D. From research exemption to research norm: recognising an alternative to consent for large scale biobank research. Med Law Int 2010; 10: 287–313.
28) Prainsack B., Buyx A. A solidarity-based approach to the governance of research biobanks. Med Law Rev 2013; 21: 71–91.
29) Opinion 3/2019 concerning the Questions and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection regulation (GDPR) (art. 70.1.b)) adottata il 23 gennaio 2019.
30) Article 29 Working Party Guidelines on consent under Regulation 2016/679 of 10 April 2018, as endorsed by the EDPB on 25 May 2018.
31) Barocas S.; Nissenbaum H.Big data’s end run around anonymity and consen. In Privacy, big data, and the public good: Frameworks for Engagement. Cambridge University Press: Cambridge 2014, pp. 44-75.
32) Quinn P.The Anonymisation of Research Data – A Pyric Victory for Privacy that Should Not Be Pushed Too Hard by the EU Data Protection Framework? Eur. Jour. Health Law, 2016; 24: 1-24; Knoppers B.M., Zawati M.H., Kirby E.S.Sampling populations of humans across the world: ELSI issues, Annu Rev Genomics Hum Genet 2012; 13: 395-413; Mostert M., Bredenoord A.L., Biesaart M.C.I.H., van Delden J.J.M.Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach. cit.
33) The Nuffield Council on Bioethics. The collection, linking and use of data in biomedical research and health care: ethical issues. 2015.
34) Nuffield Council on Bioethics. The collection, linking and use of data in biomedical research and health care: ethical issues, 2015. Available at http://nuffieldbioethics.org/wp-content/uploads/Biological_and_health_data_web.pdf; Mittelstadt B.D., Floridi L. The ethics of Big Data: current and foreseeable issues in biomedical contexts. Sci Eng Ethics 2015; e-pub ahead of print 23 May 2015 doi:10.1007/s11948-015-9652-2.
35) Steinsbekk K.S., Kåre Myskja B., Solberg B.Broad consent versus dynamic consent in biobank research: is passive participation an ethical problem? Eur J Hum Genet 2013;21: 897-902; Casali P.G.Risks of the new EU Data protection regulation: an ESMO position paper endorsed by the European oncology community. Ann Oncol 2014; 25: 1458-61; Petrini C. ‘Broad’ consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose. Soc Sci Med 2010; 70: 217-20.
36) Hirsch D. D.In Search of the Holy Grail: Achieving Global Privacy Rules Through Sector-Based Codes of Conduct. Ohio State L. J. 2013; 74: 6, 1031-1045.
37) For an overview of these derogations see: The Wellcome Trust.Analysis. Research and the General Data Protection Regulation, 2016, cit.
1) Mostert M., Bredenoord A.L., Biesaart M.C.I.H., van Delden J.J.M., Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach. Eur J Hum Genet. 2016; 24: 956-960.
2) Schneider G., Disentangling Health Data Networks: a Critical Analysis of art. 9.2 and art, 89 GDPR. Forthcoming.
3) Jensen P.B., Jensen LJ, Brunak S.Mining electronic health records: towards better research applications and clinical care. Nat Rev Genet, 2012; 13: 395-405.
4) Currie J. ‘Big Data’ versus ‘big brother’: on the appropriate use of large-scale data collections in pediatrics. Pediatrics 2013; 131: S127-S132; Comandè G., Nocco L., Peigné V., Il Fascicolo sanitario elettronico: uno studio multidisciplinare, in Riv. it. med. leg., anno XXXIV, 01/2012, p.105-121.
5) Marx V.Biology: the big challenges of Big Data. Nature 2013; 498: 255-60.; Costa FF. Big Data in biomedicine. Drug Discov Today 2014; 19: 433-40.
6) Comandé G.; Schneider G. Regulatory Challenges of Data Mining Practices: The Case of the Never-ending Lifecycles of ‘Health Data, Eur. Jour. Health Law, 2018; Vol. 25, Issue 3, pages 284-307.
7) Apple’s Research. Kit frees medical research. Nat Biotechnol 2015; 33: 322.
8) Costa F.F.Social networks, web-based tools and diseases: implications for biomedical research. Drug Discov Today 2013; 18: 272-81.
9) Comandé G. The Rotting Meat Error: From Galileo to Aristotle in Data Mining?, Eur. Data Protection L. R., 2018; Vol. 4, Issue 3, pages 270-277.
10) Mayer-Schonberger V., Ingelsson E.Big Data and medicine: a big deal? J Intern Med 2018; 283: 418-29; Weber G.M., Mandl K.D., Kohane I.S. Finding the Missing Link for Big Biomedical Data. JAMA 2014; 311: 2479-80.
11) Academy of Medical Sciences. Personal Data for Public Good: Using Health Information in Medical Research, 2006. Available at http://www.acmedsci.ac.uk/download. php?f=file&i=13206.8. Sethi N., Laurie G. Delivering proportionate governance in the era of eHealth: making linkage and privacy work together. Med Law Int 2013; 13: 168-204.
12) Heeney C., Hawkins N., de Vries J., Boddington P., Kaye J. Assessing the privacy risks of data sharing in genomics. Public Health Genomics 2011; 14: 17-25; Mascalzoni D, Dove ES, Rubinstein Y et al.International Charter of principles for sharing bio-specimens and data. Eur J Hum Genet 2014; 23: 721-8; McGuire A.L., Caulfield T., Cho M.K. Research ethics and the challenge of whole-genome sequencing. Nat Rev Genet 2008; 9: 152-6. Heeney C., Hawkins N., de Vries J, Boddington P, Kaye J.Assessing the privacy risks of data sharing in genomics. Public Health Genomics 2011; 14: 17-25; Mascalzoni D.; Dove E.S., Rubinstein Y. et al. International Charter of principles for sharing bio-specimens and data. Eur J Hum Genet 2014; 23: 721-8; McGuire A.L., Caulfield T., Cho M.K. Research ethics and the challenge of whole-genome sequencing. Nat Rev Genet 2008; 9: 152–6.
13) O’Brien S.J.Stewardship of human biospecimens, DNA, genotype, and clinical data in the GWAS era. Annu Rev Genomics Hum Genet 2009; 10: 193–209; Knoppers B.M., Zawati M.H., Kirby E.S. Sampling populations of humans across the world: ELSI issues. Annu Rev Genomics Hum Genet 2012; 13: 395-413; Tene O., Polonetsky J.Privacy in the age of Big Data: a time for big decisions. Stanford Law Rev Online 2012; 64: 63-9.
14) Laurie G. Genetic privacy: A Challenge to Medico-Legal Norms. Oxford University Press: New York, 2002; Mittelstadt B.D., Floridi L. The ethics of Big Data: current and foreseeable issues in biomedical contexts. Sci Eng Ethics 2015, e-pub ahead of print 23 May 2015 doi:10.1007/s11948-015-9652-2.
15) Greely H.T.The uneasy ethical and legal underpinnings of large-scale genomic biobanks. Annu Rev Genomics Hum Genet 2007; 8: 343-64.
16) Sul punto si vedano le conclusioni dell’E.D.P.B. sul rapporto tra Regolamento 679/2016 e il regolamento (EU) No 536/2014 del 16 Aprile 2014 sui on clinical trials per i prodotti medicinali ad uso umano.
17) Ploem M.C., Essink-Bot M.L., Stronks K. Proposed EU data protection regulation is a threat to medical research. BMJ 2013; 346: f3534.6. Dove E.S., Thompson B., Knoppers B.M. A step forward for data protection and biomedical research. Lancet (London, England) 2016; 387: 1374–5.
18) The Wellcome Trust.Analysis: Research and the General Data Protection Regulation- 2012/0011(COD), 2016. Available at https://wellcome.ac.uk/sites/default/files/newdata-protection-regulation-key-clauses-wellcome-jul16.pdf.
19) Fuster G.G.The Emergence of Personal Data Protection as a Fundamental Right of the EU Springer: Dordrecht, 2014. Sul dibattito si veda anche Tzanou M.Data protection as a fundamental right next to privacy? ‘Reconstructing’ a not so new right, International Data Privacy Law 2013; 3: 88-99; Lynskey O.Deconstructing data protection: the ‘Added-value’ of a right to data protection in the EU legal order. Int. and Comp. Law Quart. 2014; 63: 569-97.
20) Kokott J., Sobotta C.The distinction between privacy and data protection in the jurisprudence of the CJEU and the ECtHR. Int. Data Privacy Law 2013; 3: 222-8.
21) Fuster G.G.The Emergence of Personal Data Protection as a Fundamental Right of the EU, cit.; Hustinx P. EU Data Protection Law: The Review of Directive 95/46/EC and the Proposed General Data Protection Regulation 2014; Available at https://secure.edps.europa.eu/EDPSWEB/webdav/site/mySite/shared/Documents/EDPS/Publications/Speeches/2014/14-09-15_Article_EUI_EN.pdf; Kokott J, Sobotta C.The distinction between privacy and data protection in the jurisprudence of the CJEU and the ECtHR, cit.; Convention Praesidium. Explanations Relating to the Charter of Fundamental Rights of the European Union. Brussels, 11 October 2000, Charte 4473/00, Convent 49; Gellert R, Gutwirth S. The legal construction of privacy and data protection. Computer Law & Security Review 2013; 29: 522-30.
22) de Hert P., Gutwirth S.Data Protection in the Case Law of Strasbourg and Luxembourg: Constitutionalism in Action. In: S. Gutwirth et al. (eds.), Reinventing Data Protection? Springer: New York, 2009, pp. 3-43.
23) Regolamento (EU) No 536/2014, cit.
24) Boddington P., Curren L., Kaye J. et al.Consent forms in genomics: the difference between law and practice. Eur. Jour. Health Law, 2011; 18: 491–519; Laurie G., Postan E. Rhetoric or reality: what is the legal status of the consent form in health-related research? Med Law Rev 2013; 21: 371–414; Master Z., Nelson E., Murdoch B., Caulfield T.Biobanks Consent and Claims of Consensus. Nat Methods 2012; 9: 885–8; Kaye J. The tension between data sharing and the protection of privacy in genomics research. Annu Rev Genomics Hum Genet 2012; 13: 415–31.41. Kaye J.The tension between data sharing and the protection of privacy in genomics research. Annu Rev Genomics Hum Genet 2012; 13: 415–31. Per voci fvorevoli nonostante le perplessità cfr. Steinsbekk K.S., Kåre Myskja B., Solberg B. Broad consent versus dynamic consent in biobank research: is passive participation an ethical problem? Eur J Hum Genet 2013; 21: 897-902. Helgesson G.In defense of broad consent. Camb Q Healthc Ethics 2012; 21: 40-50.
25) Cioè “è soggetto a garanzie adeguate per i diritti e le libertà dell’interessato, in conformità del presente regolamento. Tali garanzie assicurano che siano state predisposte misure tecniche e organizzative, in particolare al fine di garantire il rispetto del principio della minimizzazione dei dati. Tali misure possono includere la pseudonimizzazione, purché le finalità in questione possano essere conseguite in tal modo. Qualora possano essere conseguite attraverso il trattamento ulteriore che non consenta o non consenta più di identificare l’interessato, tali finalità devono essere conseguite in tal modo.”
26) Se si guardano alcune fonti recenti la necessità sarebbe legata, per esempio, ad un rischio serio e concreto per la salute pubblica ed il superamento del consenso è condizonato all’approvazione di un comitato etico. È il caso per esempi della liea guida 12 del Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Health-related Research Involving Humans. 2016.
27) Ruyter K.W., Louk K., Jorqui M., Kvalheim V., Cekanauskaite A., Townend D. From research exemption to research norm: recognising an alternative to consent for large scale biobank research. Med Law Int 2010; 10: 287–313.
28) Prainsack B., Buyx A. A solidarity-based approach to the governance of research biobanks. Med Law Rev 2013; 21: 71–91.
29) Opinion 3/2019 concerning the Questions and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection regulation (GDPR) (art. 70.1.b)) adottata il 23 gennaio 2019.
30) Article 29 Working Party Guidelines on consent under Regulation 2016/679 of 10 April 2018, as endorsed by the EDPB on 25 May 2018.
31) Barocas S.; Nissenbaum H.Big data’s end run around anonymity and consen. In Privacy, big data, and the public good: Frameworks for Engagement. Cambridge University Press: Cambridge 2014, pp. 44-75.
32) Quinn P.The Anonymisation of Research Data – A Pyric Victory for Privacy that Should Not Be Pushed Too Hard by the EU Data Protection Framework? Eur. Jour. Health Law, 2016; 24: 1-24; Knoppers B.M., Zawati M.H., Kirby E.S.Sampling populations of humans across the world: ELSI issues, Annu Rev Genomics Hum Genet 2012; 13: 395-413; Mostert M., Bredenoord A.L., Biesaart M.C.I.H., van Delden J.J.M.Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach. cit.
33) The Nuffield Council on Bioethics. The collection, linking and use of data in biomedical research and health care: ethical issues. 2015.
34) Nuffield Council on Bioethics. The collection, linking and use of data in biomedical research and health care: ethical issues, 2015. Available at http://nuffieldbioethics.org/wp-content/uploads/Biological_and_health_data_web.pdf; Mittelstadt B.D., Floridi L. The ethics of Big Data: current and foreseeable issues in biomedical contexts. Sci Eng Ethics 2015; e-pub ahead of print 23 May 2015 doi:10.1007/s11948-015-9652-2.
35) Steinsbekk K.S., Kåre Myskja B., Solberg B.Broad consent versus dynamic consent in biobank research: is passive participation an ethical problem? Eur J Hum Genet 2013;21: 897-902; Casali P.G.Risks of the new EU Data protection regulation: an ESMO position paper endorsed by the European oncology community. Ann Oncol 2014; 25: 1458-61; Petrini C. ‘Broad’ consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose. Soc Sci Med 2010; 70: 217-20.
36) Hirsch D. D.In Search of the Holy Grail: Achieving Global Privacy Rules Through Sector-Based Codes of Conduct. Ohio State L. J. 2013; 74: 6, 1031-1045.
37) For an overview of these derogations see: The Wellcome Trust.Analysis. Research and the General Data Protection Regulation, 2016, cit.
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