ENSURING THE TRUSTWORTHY REUSE OF HEALTH DATA FOR RESEARCH Dipak - - PowerPoint PPT Presentation

Electronic Health Records for Clinical Research

ENSURING THE TRUSTWORTHY REUSE OF HEALTH DATA FOR RESEARCH

Dipak Kalra President

Ensuring the trustworthy reuse of health data for research

▪ Compliance with data protection legislation, at a European level and across all European Member States ▪ Consistent information governance practices and expectations across Europe

▪ Societally acceptable codes of good practice for governing many uses of health data ▪ Reflect state of the art in privacy protection and information security ▪ Greater confidence and reduced risk for those providing data for research use e.g. hospitals, GPs, patients ▪ Greater confidence and reduced risk for those performing the research, managing the data or sponsoring the research

▪ Greater societal endorsement of public health and research uses of health data ▪ A scaling up of learning from health data, leading to more rapid innovation in treatments, and accelerated health system transformation towards better health outcomes

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Some key principles for trustworthy reuse of health data: the EHR4CR example

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Segregation…

• f the research data

warehouse from the EHR

De-identification…

individual patient data are de-identifed (anonymised, pseudonymised, to best practice standards)

Control…

lock/unlock access by hospital

• r GP practice

Consolidation…

• nly aggregated patient numbers

leave the healthcare site

Governance…

independent institute ensures data are accessed in a trustworthy way

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Need to remove the bottlenecks to accessing and combining health data from diverse sources across Europe

• Only patient counts leave a hospital
• Platform never stores or communicates

data about single data subjects

• Only treating physicians can re-identify

candidate patients

• Standard operating rules
• Robust identify management,

information security and audit

• Transient data pools per specific

research question and team

• Ethical code of practice
• Limited to (pre-agreed) bona fide

research

• Pre-agreed purposes of use
• Requirement for data sharing

agreements

There is a need for harmonised best practices & sustainability

• Provenance metadata captured throughout

the architecture

• Strong separation between zones for

clinical use and research use

• Pseudo-identification and linkage managed

by a trusted “middle” zone

• allows flexibility as to where the 'linkage

zone' is provided

i~HD information governance services

▪ Quality labelling criteria for the platform and services, including components deployed at hospitals, and in other data sources ▪ Codes of Practice for feasibility studies and for remote data access and sharing ▪ Standard Operating Rules

▪ Legal requirements and their implementation through specific technical safeguards and specified duties, to ensure proper use of the platform

▪ Standard Operating Procedures

▪ Access Controls, Incident Management, Audit & Monitoring, Study Management, Organisation Management

▪ Staff competence checklist and training resources about data management and privacy protection when using the platform

▪ for hospital staff, pharma and academic research staff, for platform service providers

▪ i~HD Information Governance Board, providing oversight

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Staff competence

▪ Staff using the platform services and applications, in pharma, hospitals, and the service providers must

▪ meet defined standards of knowledge and competence ▪ work to an agreed Code of Conduct and Ethics

▪ a high-level catalogue of rights and duties concerning privacy while conducting clinical trials and reusing clinical data for research

▪ Main areas covered

▪ Work To high professional standards

▪ Personal behaviour, processes, Good practices, Data and systems, Outcomes, Mitigating risk

▪ Respect the rights and professional interests of others (staff and colleagues) ▪ Protect and promote the interests of patients and the public ▪ Promote the standards and status of clinical research professionals

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ECRIN, infrastructure for multinational trials in Europe

• ESFRI-roadmap infrastructure
• „ERIC“ status
• Coordinating centre (Paris)
• National partners / national hubs
• European Correspondent hosted in

national hub

• Develop tools for multinational trials
• Support trial preparation and conduct
• Including data managemeent services

through ECRIN-certified data centres

▪ Coordinating services provided by national partners

i~HD Information Governance Board: activities

▪ Confirms the suitability of the i~HD governance instruments ▪ Confirms that all deployed platform components and services have been certified, and all connected organisations have a staff accreditation programme ▪ Reviews activity and incident logs on a regular basis ▪ Receives and investigates all incidents and apply escalation and remediation as appropriate ▪ Provides regular reports for the i~HD Executive Board, key stakeholders and for the public ▪ Monitors the evolving legislative and regulatory landscape, and make recommendations for updates to the governance instruments as needed

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i~HD Information Governance Board: proposed constitution

▪ Patient association representatives ▪ Privacy protection legal experts, EU and some national ▪ Hospital privacy protection officers ▪ Medicines regulatory experts ▪ Information security experts ▪ Service Provider representative as an observer ▪ i~HD appointed representative as an observer ▪ Other expertise may be co-opted as needed

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Enriching knowledge and enhancing care through health data