PL EN


Preferencje help
Widoczny [Schowaj] Abstrakt
Liczba wyników
Powiadomienia systemowe
  • Sesja wygasła!
  • Sesja wygasła!
Tytuł artykułu

Connecting for Surgery: The Belgian Use Case on the Legal Aspects of the Digital Operating Room

Treść / Zawartość
Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
Telecommunications technology is making its way into operating rooms by new developments in e-health. However, conflicts arise with existing legal principles regarding data protection. This paper deals with key elements of the interactions between data protection and evolution in e-health. The scope will be the digital operating room, where different health services and activities converge through networked technology, raising a number of privacy-related issues. For instance, the patient's health records and tools for recording surgical procedures could be integrated within the same platform, potentially leading to sensitive personal data linkage. Also the possible duration and reason of storage of surgical recordings, is a matter that remains largely unresolved in current practice. First, this paper will analyze the data exchanges of the digital operating room. As these will include personal patient data, it must be assessed whether and how the European framework on data protection can apply. Second, the regulatory regime of the manufacturers of the devices of the digital operating room will be analyzed. Can the current legal framework relating to e-health provide for suitable regulation for such devices? Drawing from experience gained in research projects, this paper aims to provide practical answers to often theoretical questions.
Słowa kluczowe
Rocznik
Tom
Strony
11--19
Opis fizyczny
Bibliogr. 20 poz.
Twórcy
autor
Bibliografia
  • [1] L. Atzori, A. Iera, and G. Morabito, “The Internet of Things: A survey”, Comp. Netwo., vol. 54, pp. 2787–2805, 2010.
  • [2] R. Weber, “Internet of things – Need for a new legal environment?”, Comp. Law Secur. Rev., vol. 25, pp. 522–527, 2009.
  • [3] 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, Official Journal L 281 of 23 November 1995, pp. 31–50. In Belgium, this directive has been implemented as: Act of 8 December 1992 on the protection of the privacy against the processing of personal data, Belgian State Gazette, 18 March 1993 (Data Protection Act).
  • [4] C. Kuner, European Data Protection Law. Oxford: University Press, 2007.
  • [5] D. De Bot, Verwerking van Persoonsgegevens. Antwerpen: Kluwer, 2001.
  • [6] Article 2(h) Directive 95/46/EC.
  • [7] Academy of Medical Sciences, Personal data for public good: using health information in medical research, London, Academy of Medical Sciences, 11–12, 2006.
  • [8] T. Caulfield, R. Brown, and E. M. Meslin, “Challenging a Well Established Consent Norm?: One Time Consent for Biobank Re- search”, J. Inte. Biotechnol. Law, vol. 4, pp. 69–74, 2007.
  • [9] V. Arnason, “Coding and Consent: Moral Challenges of the Database Project in Iceland”, Bioethics, vol. 18, pp. 41–42, 2004.
  • [10] S. Elprama, P. Duysburgh, and A. Jacobs, “TeleSurgery D1.3.1 – Draft Desk and Key Observational Informant Research on Everyday Surgical Practices”, IBBT, 2011.
  • [11] Article 1, 3 Royal Decree of 3 May 1999 defining the minimum requirements of the medical record, as defined in article 15 of the Act on hospitals coordinated on 7 August 1987, Belgian State Gazette, 30 July 1999.
  • [12] B. Van Alsenoy et al., “GINI D3.1 – Legal Provisions for Deploying INDI services”, pp. 29–30, 2011 [Online]. Available: www.gini-sa.eu
  • [13] S. Pearson and A. Charlesworth, “Accountability as a way forward for Privacy Protection in the Cloud”, in Proc. First Int. Conf. Cloud Computing, Beijing, China, Dec. 2009, pp. 131–144.
  • [14] X. Huysmans, “Identity Management for eGovernment – Deliverable 1.2 Conceptual Framework”, IBBT, 2005.
  • [15] Royal Decree of 13 February 2001 executing the Act of 8 December 1992 on the protection of the privacy regarding the processing of personal data, Belgian State Gazette, 13 March 2001.
  • [16] J. Vandendriessche, “De verwerking van persoonsgegevens voor historische, statistische en wetenschappelijke doeleinden”, TBBR, vol. 9, pp. 534–543, 2006.
  • [17] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Official Journal L 169 of 12 July 1993, pp. 36–40.
  • [18] Act of 25 March 1964 on medicines, Belgian State Gazette, 17 April 1964.
  • [19] Act of 7 May 2004 concerning Experiments on the Human Person, Belgian State Gazette, 18 May 2004.
  • [20] Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, Official Journal L 121 of 1 May 2001, pp. 34–44.
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-article-BATA-0019-0012
JavaScript jest wyłączony w Twojej przeglądarce internetowej. Włącz go, a następnie odśwież stronę, aby móc w pełni z niej korzystać.