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)

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