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Making the Most of the Electronic Age

Widespread use of electronic health record systems (EHRs), which provide timely and secure access to comprehensive patient data, delivers significant individual, social and economic benefits in the areas of patient healthcare, public health and clinical research. However, the optimum use of EHRs for clinical research depends upon two key factors: interoperability and the re-use of data for research purposes. This paper focuses particularly on the challenges of the re-use of data, which could have a radical impact on the business of the pharmaceutical industry by opening possibilities for novel approaches in personalised medicine, safety and efficacy of new treatments. Examples of the benefits for clinical research include more efficient management and organisation of clinical trials, and easier validation of disease models and simulators (in silico drug testing), leading to better assessment of efficacy and safety of drugs and faster, more affordable development of therapies targeted at specific patient populations. Specific shorter-term benefits could also be seen in patient recruitment, adverse event reporting, pharmacovigilance and pharmacogenomics. Recently, the European Commission has undertaken efforts to raise awareness among EU Member States and within the healthcare, life sciences and IT industries, of the remarkable potential of EHRs. Results from cross-disciplinary workshops have highlighted the formidable challenges of reconciling privacy regulations, technical compatibility and cooperative processes. None of this will be easy, but the alternative of doing nothing could have a marked, negative impact across the EU.

The positive benefits of timely and secure access to patient data have been recognised by health providers across the EU. The widespread use of EHRs, when combined with the proper organisation, regulatory framework and skills, should lead to improved health care, patient safety and efficiency. However, the potential contribution of EHRs to a wider public health agenda has not, to date, been fully recognised by all stakeholders. Aggregated and anonymised EHR data (at local, regional and national levels) has the potential to bring great benefits to public health, clinical research, evidence-based knowledge translation and pharmacovigilance. This added value of EHR implementation could enable ‘eHealth’ applications that can modernise healthcare and vastly improve clinical research. The interoperability of EHRs will also provide a range of tangible and far-reaching benefits for the patient, the public health sector, and the life sciences and IT industries, and provide EU member states with an important innovation tool.


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Mats Sundgren, PhD, is a Principal Scientist within Global Clinical Development at AstraZeneca R&D. He has worked in the field of pharmaceutical R&D for more than 22 years. He is currently working with clinical information strategy and medical informatics aspects, and is part of the AstraZeneca Health Information Technology (HIT) network. Mats is also a member of the European Federation of Pharmaceutical Associations (EFPIA) EHR task force and the EU Innovative Medicine Initiative (IMI) Knowledge Management project group.

Petra Wilson, PhD, is Director for Health in Cisco’s Internet Business Solutions Group. She works extensively with a large number of health sector players, both in clinical care and policy-making positions on the integration of ICT tools in healthcare. Petra currently holds the Chair of HIMSS Europe Governing Council and the Chair of the Continua Health Alliance European Policy Group.

Isabelle de Zegher, MD, MSc, is an independent consultant. She worked in the field of pharmaceutical development for 11 years at Novartis, UCB and Cap Gemini Life Sciences consulting, after working for 10 years in the field of healthcare IT at Cap Gemini and in a Belgium SME. She has extensive experience in health IT, data standards, data integration and semantic interoperability in clinical research. She previously chaired the EFPIA task force on EHR integration, and is also a member of the HL7 Regulated Clinical Research Information Management Committee and a member of the CDISC Board of Directors.

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Mats Sundgren
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Petra Wilson
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Isabelle de Zegher
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