Legal Guidelines regarding the Use of Electronic Patient Data. Do we need new Rules of the Game?
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Legal Guidelines regarding the Use of Electronic Patient Data. Do we need new Rules of the Game?

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Legal Guidelines regarding the Use of Electronic Patient Data. Do we need new Rules of the Game?. Van Overstraeten T. eHealth week 2010 (Barcelona: CCIB Convention Centre; 2010)

Legal Guidelines regarding the Use of Electronic Patient Data. Do we need new Rules of the Game?. Van Overstraeten T. eHealth week 2010 (Barcelona: CCIB Convention Centre; 2010)

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  • 1. Legal Guidelines on the Use of Electronic Patient Data Do we need new rules of the game?
  • 2. Introduction • Health informatics increase ability to collect and process patient data • Positive effects on patient care • Help reduce medical errors • Promote evidence-based medicine by increasing clinical data for research and enhancing scientific knowledge (secondary use) • Limitation: privacy and secrecy of patient data
  • 3. EU Legal Framework • EU Directive 95/46 of 24 October 1995 • Privacy and personal data protection recognised as fundamental rights (Article 16 Lisbon TFEU 2009) • Other Directives re. electronic data • Directive 2002/58/EC of 12 July 2002 • Modified by Directive 2009/136/EC of 25 November 2009
  • 4. EU Directive 95/46 • Main purposes • Freedom of circulation of personal data within the EU • Protection of personal data • Personal data = data related to an identified or identifiable individual • Processing broadly defined as any type of use • Specific category for electronic patient data • Health-related data (“sensitive”, additional protection)
  • 5. EU Directive 95/46 • Main principles • Fair and lawful processing • For limited purposes (no further incompatible processing) • Adequate, relevant and not excessive • Accurate and up to date • Not kept for longer than is necessary • Data subjects’ rights (information and access) • Secured processing (technically and organisationally) • No transfer to third countries without adequate protection • Notification to relevant regulator
  • 6. Health-related data • Relevant legal ground for processing (Article 8) • Explicit consent of the data subject • Protection of data subject’s vital interests • For preventive medicine, medical diagnosis, treatment or healthcare services, with supervision by a health professional bound by professional secrecy
  • 7. Secondary use • Hierarchy for the further processing of personal data for scientific purposes (WP 29 No. 136 of 2007): • Anonymous data • If impossible to achieve the scientific purpose with the latter: pseudonymised data (key-coded data) • If impossible to achieve the scientific purpose: non pseudonymised data (= personal data) • Issue of (ir)reversibility of data
  • 8. Secondary use • Directive flexible for scientific research and public health interest (with local implementation issues): • Further data processing not incompatible with initial purpose (Article 6.1 b and Recital 29) • Data may be stored for longer period (Article 6.1, e) • Member States may derogate from the prohibition to process sensitive data (Recital 34) • No obligation of information when impossible or disproportionate (Article 11.2 and Recital 40)
  • 9. Guidelines re. secondary processing 1. Prepare inventory of candidate sources (e.g. database of clinical trials, routine healthcare) 2. Review extent of anonymisation/codification and perform risk assessment re. identifiability of data subjects 3. Pay particular attention to potential identifiers, including presence of rare disorders, key coded data Source: Association of the British Pharmaceutical Industry (ABPI) - 2007
  • 10. Guidelines re. secondary processing 4. Review information provided to data subjects and their consents upon data collection for primary purpose • Statement re. potential future uses or planned duration or storage of data? • Compatibility of proposed processing with original consent (i.e. not truly a secondary use)? 5. Generate a risk statement with • Evaluation of likelihood of data subject’s identification • Compatibility with original stated purpose • Justification for proposed secondary use of the data
  • 11. Guidelines re. secondary processing 6. Determine if • Tracking down and re-consenting of data subject is needed OR • The data should be anonymised OR • Other legal grounds enabling processing for secondary use
  • 12. New Rules? • Existing legal framework in the EU under review • Two main developments since 1995 • Digital technology (telemedicine, electronic health records, eHealth platform, etc.) • Globalisation of medical research
  • 13. New Rules? • Need for a single legal framework to respond to globalisation • Need for harmonisation and standardisation of approach (e.g. template consent forms) • Same protection to all health-related data irrespective of geographic location of data subjects • ⇒ International Convention (WHO)
  • 14. Questions? Tanguy Van Overstraeten Linklaters LLP Rue Brederode 13 1000 Brussels Belgium Tel: +32 2 501 94 05 tvanover@linklaters.com