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, data protection, pharmacovigilance, data linkage, legal issues and prescribing.

SUBMITTER: Hopf YM 

PROVIDER: S-EPMC3927931 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature