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Biobanks and Electronic Health Records: Open Issues

Chapter

Abstract

This paper provides the description of possible, desirable interactions between biobanks and the genetic data they process on the one side, and a regulatory concept that is becoming crucial in the European and Italian privacy law context, namely Electronic Health Records (EHR) on the other. The computerized processing of personal health data via digital platforms has received by the Italian Data Protection Authority a regulatory definition which appears to be quite narrowly constructed around the idea that this kind of data treatment will be authorized only if carried on for the purpose of providing a medical service for the therapeutic or diagnostic benefit of the patient.

The interactive treatment of genetic data combining health data providing a follow up of the health conditions of the original donor is crucial in the so called post-genomic era. Bioinformatics itself is characterized by a series of activities taking place at the informational level, like acquisition, storage, distribution, analysis and interpretation. Providing health services based also on individual genetic identities and on the knowledge of genomic risks of patients will enhance the efficacy of health care.

References

  1. Barbareschi M, Cotrupi S, Guarrera GM (2008) Biobanca: strumentazione, personale, analisi dei costi. Pathologica 100:139–143Google Scholar
  2. Comitato Nazionale per la biosicurezza e le biotecnologie – Gruppo di lavoro Bioinformatica (2005) Linee guida per la definizione di una strategia per lo sviluppo del settore della bioinformatica in Italia con particolare attenzione all’ambito biomedico. http://www.governo.it/biotecnologie/documenti/2.bioinformatica.pdf. Accessed 5 Mar 2012
  3. Bregman-Eschete Y (2006) Genetic databases and biobanks: who controls our genetic privacy? Santa Clara Comput High Technol Law J 23:1–54Google Scholar
  4. Brownsword R (2009) Consent in the Data Protection Law: Privacy, Confidentiality and Fair Processing. In: Gutwirth S, Poullet Y, De Hert P, De Terwangne C, Nouwt S (eds) Reinventing data protection? Springer, Dordrecht, pp 83–110CrossRefGoogle Scholar
  5. Buttarelli G (1997) Banche dati e tutela della riservatezza. La privacy nella Società dell’Informazione. Giuffré, MilanoGoogle Scholar
  6. Bygrave LA (2002) Data protection law. Approaching its rationale, logic and limits. Springer, The Hague/London/New YorkGoogle Scholar
  7. Caggia F (2007) Il trattamento dei dati sulla salute, con particolare riferimento all’ambito sanitario. In: Cuffaro V, D’Orazio R, Ricciuto V (eds) Il codice del trattamento dei dati personali. Giapichelli, Torino, p 405Google Scholar
  8. Cangelosi G (2007) I servizi pubblici sanitari: prospettive e problematiche della telemedicina. In: Il Diritto di famiglia e delle persone, fasc. 1, pt 2, pp 431–481Google Scholar
  9. Caplan L (2006) Consent and anonymization in research involving biobanks. EMBO Rep 7(7):661–666CrossRefGoogle Scholar
  10. Casini M, Sartea C (2009) La consulenza genetica in Italia: problemi, regole di consenso informato, trattamento dei dati genetici e privacy. In: Medicina e morale, fasc. 6, pp 1121–1151Google Scholar
  11. Casonato C (2009) Il consenso informato. Profili di diritto comparato. In: Casonato C, Frosini TE, Groppi T (eds) Diritto pubblico comparato ed europeo. Giapichelli, Torino, pp 1052–1073Google Scholar
  12. Casonato C, Piciocchi C, Veronesi P (2011) Forum BioDiritto—I dati genetici nel biodiritto. Cedam, PadovaGoogle Scholar
  13. Cushman R (2008) PHRs and the next HIPAA. http://www.projecthealthdesign.org/media/file/PHR_HIPAA2.pdf. Accessed 5 Mar 2012
  14. Cunha de Azevedo MV, Andrade N, Doneda D (2010) La re-identificazione dei dati anonimi e il trattamento dei dati personali per ulteriore finalità: sfide alla privacy. In: Ciberspazio e Diritto, fasc. 4, pp 641–655Google Scholar
  15. Den Besten M (2003) The rise of bionformatics. http://ssrn.com/abstract=1521649. Accessed 5 Mar 2012
  16. Finocchiaro G (2008) Il trattamento dei dati sanitari: alcune riflessioni critiche a dieci anni dall’entrata in vigore del Codice in materia di protezione dei dati personali. In: Ferrari GF (ed) La legge sulla privacy dieci anni dopo. Egea, Milano, pp 207–220Google Scholar
  17. Froomkin AM (2008a) Forced sharing of patient-controlled health records. Working paper. http://www.projecthealthdesign.org/media/file/Forced-sharing.pdf. Accessed 5 Mar 2012
  18. Froomkin AM (2008b) The new health information architecture: coping with the privacy implications of the personal health records revolution. UM ELSI Group for Project HealthDesign. http://www.projecthealthdesign.org/media/file/social-life-info-15.pdf. Accessed 5 Mar 2012
  19. Garante per la protezione dei dati personali (2009) Linee guida in tema di referti. http://www.garanteprivacy.it/garante/doc.jsp?ID=1630271. Accessed 5 Mar 2012
  20. Godard B, Schmidtke J, Cassiman JJ, Ayme S (2003) Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective. Eur J Hum Genet 11(Suppl 2):S88–S122Google Scholar
  21. Green AJ (2009) Chains of duty and trust in health information management. Stud Ethics Law Tech 3(1):Art 7Google Scholar
  22. Guarda P (2008) Data protection, information privacy, and security measures: an essay on the European and the Italian legal frameworks. Ciberspazio e Dir 65. http://eprints.biblio.unitn.it/archive/00001524. Accessed 5 Mar 2012
  23. Guarda P (2011) Fascicolo sanitario elettronico e protezione dei dati personali. Università degli Studi di Trento, Trento. http://eprints.biblio.unitn.it/archive/00002212. Accessed 5 Mar 2012
  24. Guarda P, Zannone N (2009) Towards the development of privacy-aware systems. Inform Softw Technol 51:337–350CrossRefGoogle Scholar
  25. Hall MA (2009) Property, privacy and the pursuit of integrated electronic medical records. http://ssrn.com/abstract=1334963. Accessed 5 Mar 2012
  26. Häyry M, Chadwick R, Arnason V, Arnason G (eds) (2007) The ethics and governance of human genetic databases, European perspectives. Cambridge University Press, CambridgeGoogle Scholar
  27. Helgesson G, Johnsson L (2005) The right to withdraw consent to research on biobank samples in medicine. Health Care Philos 8(3):315–321CrossRefGoogle Scholar
  28. Hoffman S, Podgurski A (2006) In sickness, health, and cyberspace: protecting the security of electronic private health information. http://papers.ssrn.com/sol3/papers.cfm?abstract_id=931069. Accessed 5 March 2012
  29. Izzo U (2000) Medicina e diritto nell’era digitale: i problemi giuridici della cibermedicina. In: Danno e responsabilità, fasc. 8–9, pp 807–818Google Scholar
  30. Jacobson PD (2002) Medical records and HIPAA: is it too late to protect privacy? Minn Law Rev 86:1497–1514Google Scholar
  31. Juso R (2004) Dati sensibili e consenso informato: profili costituzionali e legislativi. Ragiusan 237:6Google Scholar
  32. Kaye J, Stranger M (eds) (2009) Principles and practice in biobank governance. Ashgate, FarnhamGoogle Scholar
  33. Macilotti M (2008) Proprietà, informazione ed interessi nella disciplina delle biobanche a fini di ricerca. Nuova giur Civ VII:222–235Google Scholar
  34. Macilotti M (2009) Consenso informato e biobanche di ricerca. Nuova Giur Civ II:153–165Google Scholar
  35. Macilotti M (2012) Biobanche. In: Digest Civ. Utet, TorinoGoogle Scholar
  36. Macilotti M, Izzo U, Pascuzzi G, Barbareschi M (2008) La discipina giuridica delle biobanche. Pathologica 100:86–101Google Scholar
  37. Maliapen M (2009) Clinical genomic data use: privacy protecting patients rights. Stud Ethics Law Technol 3(1): Art. 1, 3Google Scholar
  38. Monti A (2006) Bioninformatica e diritto d’autore. La conoscenza ha bisogno di codici aperti. Ciberspazio e Diritto 511–534Google Scholar
  39. Palmerini E (2007) Commento all’art. 84. In: Bianca CM, Busnelli FD (eds) La protezione dei dati personali. Commentario al D. Lgs. 30 giugno 2003, n. 196 (“Codice Privacy”). Cedam, Padova, II, p 1303Google Scholar
  40. Roden DM, Pulley JM, Basford MA, Bernard GR, Clayton EW, Balser JR, Masys DR (2008) Development of a large-scale de-identified DNA biobank to enable personalized medicine. Clin Pharmacol Therap 84(3):362–369CrossRefGoogle Scholar
  41. Rodota’ S (2000) Tra diritto e società. Informazioni genetiche e tecniche di tutela. In: Rivista critica del diritto privato, fasc. 4, pp 571–604Google Scholar
  42. Schwartz PM (1997) Privacy and the economics of health care information. Tex Law Rev 76:1Google Scholar
  43. Sinha A (2000) An overview of telemedicine: the virtual gaze of health care in the next century. Med Anthropol Q New Ser 14(3):291–309. http://www.jstor.org/stable/649500. Accessed 5 Mar 2012
  44. Skene L (2009) Feeding back relatives and significant findings to participants. In: Kaye J, Stranger M (eds) Principles and practice in biobank governance. Ashgate, Farnham, pp 161–175Google Scholar
  45. Terry NP (2008) Personal health records: directing more costs and risks to consumer. http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1248768. Accessed 5 Mar 2012
  46. Terry NP, Francis LP (2007) Ensuring the privacy and confidentiality of electronic health records. Univ Illinois Law Rev 681–735Google Scholar
  47. Townend D, Taylor MJ, Wrights J, Wickins-Drazilova D (2009) Privacy interests in biobanking: a preliminary view on a European perspective. In: Kaye J, Stranger M (eds) Principles and practice in biobank governance. Ashgate, Farnham, pp 137–159Google Scholar
  48. Viciani S (1996) L’autodeterminazione “informata” del soggetto e gli interessi rilevanti (a proposito dell’informazione sul trattamento sanitario). In: Rassegna di diritto civile, fasc. 2, pp 272–308Google Scholar
  49. Viciani S (2007) Brevi osservazioni sul trattamento dei dati interenti la salute e la vita sessuale in ambito sanitario. In: Rivista critica del diritto privato, fasc. 2, pp 315–323Google Scholar
  50. Willison DJ (2009) Use of data from the electronic health record for health research—current and potential governance challenges approaches. http://www.priv.gc.ca/information/pub/ehr_200903_e.pdf. Accessed 5 Mar 2012
  51. Zarabzadeh A, Bradley RWG, Grimson J (2009) Participant ensuring privacy in networked biobanks. In: Kaye J, Stranger M (eds) (2009) Principles and practice in biobank governance. Ashgate, Farnham, pp 177–189Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.Trento Law and Technology Research Group, Faculty of LawUniversity of TrentoTrentoItaly

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