Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes.

Aims: During the global H1N1 influenza A (swine flu) pandemic 2009-2010, swine flu vaccines were expeditiously licensed and a mass vaccination programme for high risk groups, including pregnant women, was introduced in the UK. This pilot active safety surveillance study was performed to establish the feasibility of rapidly monitoring the new swine flu vaccines in large patient numbers receiving or offered the vaccination under normal conditions of use within a short time frame.

Methods: A cohort design with safety data capture through modern technologies was carried out in Scotland, UK during the winter swine flu vaccination programme 2009-2010 in individuals receiving or offered the swine flu vaccination.

Managing security and privacy concerns over data storage in healthcare research.

Purpose: Issues surrounding data security and privacy are of great importance when handling sensitive health-related data for research. The emphasis in the past has been on balancing the risks to individuals with the benefit to society of the use of databases for research. However, a new way of looking at such issues is that by optimising procedures and policies regarding security and privacy of data to the extent that there is no appreciable risk to the privacy of individuals, we can create a 'win-win' situation in which everyone benefits, and pharmacoepidemiological research can flourish with public support.