1. EHR stakeholder workshop – 11th October 2007 1 EHR integration for clinical research: Legal & Privacy issues Mats Sundgren – AstraZeneca Petra Wilson - Cisco

2. EHR stakeholder workshop – 11th October 2007 2 The transitional environment  EHR technology is becoming more mature  Pace of standardisations & nomenclature models are moving forward  Adoption of EHR in both hospitals & private practice is on a steady incline  Increasing engagement (in EU & US) to leverage eHealth issues Trends have created a transitional environment (Health care, Governmental, Patients, Vendors, and Bio- pharma), which bring different opportunities & challenges

3. EHR stakeholder workshop – 11th October 2007 3 The adoption of EHRs

4. EHR stakeholder workshop – 11th October 2007 4 The Potential of EHRs  Primary use of EHRs is and remains the treatment of patients within and across healthcare providers  The data in EHRs is rich and versatile – could it be a useful source of data for research?  ….. Questions for this meeting:  1) what secondary use could the pharmaceutical industry like to make of EHR data?  2) In how far are such uses legally acceptable?  3) what technical challenges exist for such use?  4) what technical tools exists to facilitate such use?

5. EHR stakeholder workshop – 11th October 2007 5 The pharma perspective  Secondary use of EHRs in the context of pharmaceutical research, –given appropriate measures & considerations to protect the privacy and confidentiality of individuals  Means utilising health care information with the purpose of improving clinical science & research  Adequate & proper management of EHRs for secondary have impact not only on: quality, speed, cost in new drug development –but also on the innovation capability of the industry which in the end will have benefits for patients and societies

6. EHR stakeholder workshop – 11th October 2007 6 Pathways for pharma industry  The industry might take two positions –Reactive scenario the industry waits and see……. –Proactive scenario The industry needs to promote collaboration & interaction with all stakeholders to enhance progress and create momentum and value for all actors

7. EHR stakeholder workshop – 11th October 2007 7 Challenges Primary & Secondary use  Interoperability, standards, governance  But bring also new legal & privacy issues –The human right of privacy Anonymisation Pseudonymistaion –The duty of Security and Control –Quality of data –Ownership of data Physical ownership Legal ownership Moral ownership Intellectual property –Governance arrangements –Collaboration models –Transparency and openness –Etc.

8. EHR stakeholder workshop – 11th October 2007 8 The Legal Basics  Directive 95/46/EC on Data Protection  ‘Personal data’ means all personal identifiable date, not just name and address!  ‘Processing’ means more than collection – it includes any operation on the data  The position on medical data:  “Member States shall prohibit the processing of personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, trade-union membership, and the processing of data concerning health or sex life.” Article 8 (1)  Exceptions:  Consent  Processing of (medical) data by health professionals  Substantial public interest exemptions

9. EHR stakeholder workshop – 11th October 2007 9 Potential solutions  Patient consent  Who, how, when and what for  Collection and processing by medical professionals  Public Interest  Privacy Enhancing Technologies  Research Guidelines  Ethics Committees

10. EHR stakeholder workshop – 11th October 2007 10 Objectives  Discussion bringing together different perspectives –Pharamceutical and research industry needs –Legal framework –Technical tools  Enhance understanding & provide new thinking  Build shared recommendations for on the way forward