1. Balancing the Interests of Patient Data Protection and Medication Safety Monitoring in a Public-Private Partnership
- Author
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Jonathan Richardson, Valerie Hliva, Stella Blackburn, Nancy A Dreyer, Anna Jamry-Dziurla, Shahrul Mt-Isa, Rebecca Johnson, and Alison Bourke
- Subjects
020205 medical informatics ,Population ,Computer applications to medicine. Medical informatics ,R858-859.7 ,Health Informatics ,02 engineering and technology ,03 medical and health sciences ,Viewpoint ,0302 clinical medicine ,Health Information Management ,Nursing ,Informed consent ,pharmacovgilance ,0202 electrical engineering, electronic engineering, information engineering ,Data Protection Act 1998 ,Medicine ,030212 general & internal medicine ,education ,Internet ,data protection ,education.field_of_study ,Data collection ,business.industry ,ethics ,3. Good health ,Clinical trial ,Public–private partnership ,General partnership ,public-private partnerships ,pregnancy ,Willingness to accept ,business - Abstract
Obtaining data without the intervention of a health care provider represents an opportunity to expand understanding of the safety of medications used in difficult-to-study situations, like the first trimester of pregnancy when women may not present for medical care. While it is widely agreed that personal data, and in particular medical data, needs to be protected from unauthorized use, data protection requirements for population-based studies vary substantially by country. For public-private partnerships, the complexities are enhanced. The objective of this viewpoint paper is to illustrate the challenges related to data protection based on our experiences when performing relatively straightforward direct-to-patient noninterventional research via the Internet or telephone in four European countries. Pregnant women were invited to participate via the Internet or using an automated telephone response system in Denmark, the Netherlands, Poland, and the United Kingdom. Information was sought on medications, other factors that may cause birth defects, and pregnancy outcome. Issues relating to legal controllership of data were most problematic; assuring compliance with data protection requirements took about two years. There were also inconsistencies in the willingness to accept nonwritten informed consent. Nonetheless, enrollment and data collection have been completed, and analysis is in progress. Using direct reporting from consumers to study the safety of medicinal products allows researchers to address a myriad of research questions relating to everyday clinical practice, including treatment heterogeneity in population subgroups not traditionally included in clinical trials, like pregnant women, children, and the elderly. Nonetheless, there are a variety of administrative barriers relating to data protection and informed consent, particularly within the structure of a public-private partnership.
- Published
- 2015