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?

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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

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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.

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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

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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

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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