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home > epc > spring 2003 > clinical research and data privacy: a comparison of us and european approaches and philosophies
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European Pharmaceutical Contractor

Clinical Research and Data Privacy: A Comparison of US and European Approaches and Philosophies

There exists a multitude of different health care concepts and practices worldwide, depending on regional law and culture/tradition. Health care encompasses many associated activities that can occur within organisations besides the health care provider. Adequate protection for all primary and secondary uses of personal health information is greatly dependent on whether the jurisdiction has a comprehensive data protection law. The adequacy of protection for clinical trial records is heavily dependent on local practices and particularly on the transfer of personal data in an almost unidentifiable form.

Like many other policy challenges posed by the Internet, today's privacy concerns were not as compelling a decade ago because this technology is very powerful and seemingly doesn't stop changing. More than ever, the speed of innovation and attendant social change deprives lawmakers and regulators around the world of time for thorough consideration of the implications of new technology. This dilemma is exacerbated by the international character of globe-spanning technologies, which increases the number of stakeholders as well as the complexity of policy-making.

Despite these sub-optimal conditions for creating rules of the game, the modern proliferation of the media, largely fuelled by Internet technology, heightens the pressures placed on lawmakers to respond more quickly than ever before. No one has responded more quickly or more vigorously to modern privacy challenges than the European Union. In the following we describe the philosophical differences between the European and US approaches to contemporary privacy challenges.


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By Dr Thomas Bart, Managing Director of eCR e-Clinical Research GmbH
 
Dr Thomas Bart is Managing Director of eCR e-Clinical Research GmbH in Zurich. He studied Communication Science and National Economy at the Technical University of Berlin and Medicine at the University of Tьbingen. His clinical experience is primarily in cardiology, with a specialisation in ECG and ABPM (ambulatory blood pressure monitoring).

Thomas has over 14 years' experience in pharmaceutical communication and clinical research. In addition to his engagement at eCR, Thomas is an Independent Consultant to the pharmaceutical industry.


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