Abstract
This chapter provides an overview of the most important issues surrounding the data protection in the context of personalised medicine. It analyses the existing regulatory framework at EU level and interpretations provided in the relevant judgments of the Court of Justice of the EU. It proceeds with identifying the potential gaps and challenges, especially concerning the application of eHealth system.
In order to be able to offer each of our patients a course of treatment perfectly adapted to his illness and to himself, we try to obtain a complete, objective idea of his case; we gather together in a file of his own all the information we have about him.
(Sournia 1962)
Author “Nada Bodiroga Vukobrat” is deceased at the time of publication.
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Notes
- 1.
Joined cases C-92/09 (Volker und Markus Schecke GbR) and C-93/09 (Hartmut Eifert) v Land Hessen, EU:C:2010:662.
- 2.
Joined cases C-293/12 and C-594/12, Digital Rights Ireland Ltd v Minister for Communications, Marine and Natural Resources and Others and Kärntner Landesregierung and Others, EU:C:2014:238.
- 3.
Case C-362/14, Maximillian Schrems v Data Protection Commissioner, EU:C:2015:650.
- 4.
Case C-212/13, František Ryneš v Úřad pro ochranu osobních údajů, EU:C:2014:2428.
- 5.
Case C-212/13, Ryneš, para. 29.
- 6.
Case T-343/13, CN v European Parliament, T-343/13, EU:C:2015:926.
- 7.
S. and Marper v. the United Kingdom, ECHR App. No. 30562/04 and 30566/04, Judgment of 4.12.2008; see more in Horak and Bodiroga-Vukobrat (2017).
- 8.
Treaty of Lisbon amending the Treaty on the European Union and the Treaty Establishing the European Community, OJ C 306 of 17 December 2007, for the latest consolidated version thereof see Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the European Union, OJ C 202, 7.6.2016; Charter of Fundamental Rights of the European Union, OJ C 202, 7.6.2016.
- 9.
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, OJ L 281, 23.11.1995, p. 31 and Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications), OJ L 201, 31.7.2002, p. 37.
- 10.
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), OJ L 119, 4.5.2016.
- 11.
Article 29 Data Protection Working Party (2017) Guidelines on Data Protection Impact Assessment (DPIA) and determining whether processing is “likely to result in a high risk” for the purposes of Regulation 2016/679 (wp248rev.01) (hereinafter: DPIA Guidelines), adopted on 4 April 2017, http://ec.europa.eu/newsroom/article29/item-detail.cfm?item_id=611236, pp. 10–18.
- 12.
DPIA Guidelines (2017), pp. 10–18.
- 13.
Cases C-158/96, Raymond Kohll v Union des caisses de maladie, EU:C:1998:171; C-120/95, Nicolas Decker v Caisse de maladie des employés privés, EU:C:1998:167; C-368/98, Abdon Vanbraekel and Others v Alliance nationale des mutualités chrétiennes (ANMC), EU:C:2001:400; C-157/99, B.S.M. Geraets-Smits v Stichting Ziekenfonds VGZ and H.T.M. Peerbooms v Stichting CZ Groep Zorgverzekeringen, EU:C:2001:404; C-385/99, V.G. Müller-Fauré v Onderlinge Waarborgmaatschappij OZ Zorgverzekeringen UA and E.E.M. van Riet v Onderlinge Waarborgmaatschappij ZAO Zorgverzekeringen, EU:C:2003:270; C-372/04, The Queen, on the application of Yvonne Watts v Bedford Primary Care Trust and Secretary of State for Health, EU:C:2006:325; C-173/09, Georgi Ivanov Elchinov v Natsionalna zdravnoosiguritelna kasa, EU:C:2010:581.
- 14.
Mileu Ltd. – Time.lex (2014) Overview of the national laws on electronic health records in the EU Member States and their interaction with the provision of cross-border eHealth services. Final report and recommendations, http://ec.europa.eu/health/ehealth/docs/laws_report_recommendations_en.pdf.
- 15.
Commission Implementing Decision of 22 December 2011 providing the rules for the establishment, the management and the functioning of the network of national responsible authorities on eHealth (2011/890/EU), OJ L 344, 28.12.2011.
- 16.
The 2008 Commission recommendation on cross-border interoperability of electronic health record systems defines the terms ‘electronic health record’ as “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 for ready availability of these data for medical treatment and other closely related purposes”;
‘electronic health record system’ as a system for recording, retrieving and manipulating information in electronic health records; and
‘patient’s summary, emergency data set, medication record’ as subsets of electronic health records that contain information for a particular application and particular purpose of use, such as an unscheduled care event or ePrescription. See European Commission (2008).
- 17.
Under the 2008 Commission recommendation on cross-border interoperability of electronic health record systems stakeholders include patients, defined as any natural person who receives or wishes to receive health care in a Member State; and
health professionals, a term which includes a doctor of medicine or a nurse responsible for general care or a dental practitioner or a midwife or a pharmacist within the meaning of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC; and medical service too. See more about stakeholders in Hartlev (2007, p. 167).
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Vukobrat, N.B., Horak, H. (2019). Patient–Doctor Relationship: Data Protection in the Context of Personalised Medicine. In: Bodiroga-Vukobrat, N., Rukavina, D., Pavelić, K., Sander, G.G. (eds) Personalized Medicine in Healthcare Systems. Europeanization and Globalization, vol 5. Springer, Cham. https://doi.org/10.1007/978-3-030-16465-2_5
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