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EHR stakeholder workshop – 11th October 2007 1
EHR integration for clinical research: Legal & Privacy issues
Mats Sundgren – AstraZenecaPetra Wilson - Cisco
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
EHR stakeholder workshop – 11th October 2007 3
The adoption of EHRs
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?
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
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
Health careindustry
EU
Pharma industry
Vendors
Regulatoryagencies
Patien
Patientgroups
Govermental
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.
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
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
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
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