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Biobanks and Electronic Health Records: Open Issues

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Comparative Issues in the Governance of Research Biobanks

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.

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Notes

  1. 1.

    For further information on research biobanks see: Kaye and Stranger (2009); Macilotti (2012); Id. (2009), p. 153; Id. (2008), p. 222; Barbareschi et al. (2008), p. 139; Macilotti et al. (2008), p. 86; Bregman-Eschete (2006).

  2. 2.

    The European legislator—with the famous Directives 95/46/ECand 2002/58/EC—intervened, devoting to the problem of health data processing an ad hoc regulation, thus highlighting the specificity and the dangers that operations relating to this particular category of data may show. Regarding data protection regulation in general, see: Bygrave (2002); Guarda (2008), p. 65. At the national level, Italian legislator (at art. 4, co. 1, lett. d) of Legislative Decree 30 June 2003, n. 196 (Code for protection of personal data; hereinafter: Privacy Code) defines so-called “sensitive data” as follows: “personal data allowing the disclosure of racial or ethnic origin, religious, philosophical or other beliefs, political opinions, membership of parties, trade unions, associations or organizations of a religious, philosophical, political or trade-unionist character, as well as personal data disclosing health and sex life”. In order to process this kind of information a stricter and more protective discipline has been provided, since their collection, communication and dissemination may present the data subject to which they pertain with several serious risks of discrimination. With respect to health data processing in the Italian legal system, see: Buttarelli (1997); Caggia (2007), p. 405; Finocchiaro (2008), p. 207; Palmerini (2007), p. 1303; Viciani (2007), p. 315. An old, but very interesting, essay on health data and privacy by an economic analysis perspective in Schwartz 1997, p. 1.

  3. 3.

    For further information see a recent study on the relationship between genetic data and biolaw: Casonato et al. (2011).

  4. 4.

    With respect to telemedicine issues, see: Izzo (2000), p. 807; Cangelosi (2007), p. 431; Sinha (2000).

  5. 5.

    See in general Guarda, Fascicolo (2011); Froomkin (2008a, b); Terry and Francis (2007); Hall (2009); Hoffman and Podgurski (2006); Jacobson (2002); Terry (2008). For a further analysis with respect to the incorporation of legal principles of privacy into digital architecture see: Guarda and Zannone (2009), p. 337.

  6. 6.

    See Cushman (2008).

  7. 7.

    This document proposes the following definition of this new instrument: “A comprehensive medical record or similar documentation of the past and present physical and mental state of health of an individual in electronic form, and providing ready availability of these data for medical treatment and other closely related purposes”.

  8. 8.

    It is also worth mentioning another General Provision that provides some guidelines on online medical reporting: Garante per la protezione dei dati personali (2009).

  9. 9.

    Digital technologies and, in particular, the so-called Web 2.0 encourage and, in some ways determine, this need-to-know that distinguishes the user of the network and, more generally, individuals of this beginning of the third millennium.

  10. 10.

    See the interesting document of Comitato Nazionale per la biosicurezza e le biotecnologie 2005, see also Rodotà (2005), p. 571.

  11. 11.

    See Monti (2006), p. 511; Den Besten (2003).

  12. 12.

    LG FSE, p. 2.9.

  13. 13.

    LG FSE, p. 2.11. On the use of information from EHR systems for purposes of medical research see Willison (2009).

  14. 14.

    Roden et al. (2008), p. 362, with specific reference to the relationship between biobanks and Electronic Medical Records (EMR): “Coupling these biobanks to electronic medical record (EMR) systems has the potential to enable investigators in the field of genomics to search, record and analyze phenotypic information pertaining to large numbers of patients in a “real word” context”. On the desirable return to the donor of the results of research conducted in biobank research see Skene (2009).

  15. 15.

    The expression is taken, with special reference to the techniques of de-identification, by Maliapen (2009), p. 3.

  16. 16.

    Townend et al. (2009), p. 137: “the new genetic data processing possibilities are in potential conflict with these fundamental rights, because the real value of research and biobanking research using genetic data will be in the ITS relation to the medical and environmental life-story of the data subject”.

  17. 17.

    Zarabzadeh et al. (2009), p. 177, the aspects that should be taken to protect the confidentiality of those who undergo the genetic testing are investigated, spec. p. 179: “ensuring the confidentiality of participant data at all times is an essential aspect of biobank operation”.

  18. 18.

    Rivers of ink have been spilled on this issue, in which the doctrine has never stopped being interested: see, among many, Macilotti (2009); Juso (2004), p. 6; Casini and Sartea (2009), p. 1121; Casonato (2009), p. 1052; Brownsword (2009), p. 83; Viciani (2007), p. 315; Godard et al. (2003), p. S88; Viciani (1996), p. 272.

  19. 19.

    The effect of withdrawal of consent is the immediate destruction of the sample and the data associated with it or its complete anonymisation, preventing their traceability to the donor, with all the concerns already expressed above. This is also appointed by the Authorisation of the processing of genetic data by the Italian Privacy Authority, February 22, 2007, which, in paragraph 6, states that: “[…] In accordance with art. 23 of the Code, the consent shall be valid only if the person is free from any conditioning or coercion and is freely revocable at any time. In the case where a person withdraws consent to the processing of data for research purposes, the biological sample is also destroyed if it has been taken for such purposes, except that, by the beginning or following treatment, the sample can no longer be referred to an identified or identifiable person” (this authorisation has been recently re-extended until 30 June 2011 by the deliberation of Privacy Authority of 23 December 2010). See in general Helgesson and Johnsson (2005), p. 315.

  20. 20.

    See Caplan (2006), p. 661.

  21. 21.

    With regard to the governance of research biobanks, see Häyry et al. (2007) and Kaye and Stranger (2009).

  22. 22.

    See Zarabzadeh et al. (2009), p. 180. See also Maliapen (2009), p. 3.

  23. 23.

    Maliapen (2009), p. 2, which splits in two the de-identification techniques: those that allow the re-identification (Patient De-identification System), and those that prevent it a priori (Toolkit based Encryption System).

  24. 24.

    A further study on the general theme of the re-identification of anonymised data can be read in Cunha de Azevedo et al. (2011), p. 641.

  25. 25.

    Maliapen (2009), pp. 4–5; Townend et al. (2009), p. 137.

  26. 26.

    For further information see Green (2009), part 8.

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  1. Trento Law and Technology Research Group, Faculty of Law, University of Trento, Trento, Italy

    Paolo Guarda

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  1. Paolo Guarda
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  1. University of Trento, via Verdi 73, Trento, 38122, Italy

    Giovanni Pascuzzi

  2. , Faculty of Law, University of Trento, Via Verdi 53, Trento, 38122, Italy

    Umberto Izzo

  3. University of Trento, Via Verdi 53, Trento, 38122, Italy

    Matteo Macilotti

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Guarda, P. (2013). Biobanks and Electronic Health Records: Open Issues. In: Pascuzzi, G., Izzo, U., Macilotti, M. (eds) Comparative Issues in the Governance of Research Biobanks. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-33116-9_8

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