Linked health data for pharmacovigilance in children: Perceived legal and ethical issues for stakeholders and data guardians

Abstract

Objective: The inclusion of the Community Health Index in the recording of National Health Service (NHS) contacts in Scotland facilitates national linkage of data such as prescribing and healthcare utilisation. This linkage could be the basis for identification of adverse drug reactions. The aim of this article is to report the views of healthcare professionals on data sharing, ownership and the legal and other applicable frameworks relevant to linkage of routinely collected paediatric healthcare data. Design: Qualitative study using semistructured face-to-face interviews addressing the study aims. Participants: Purposive sample of professional stakeholders (n=25) including experts on ethics..