Legal issues of data anonymisation in research

Abstract

In this paper Donnan et al expertly demonstrate the value of anonymised individual data in medical research, showing that effects masked in aggregated data are clearly visible when individual data are used. However, the use of anonymised data raises interesting legal questions. The MEMO researchers paid careful attention to protecting patient confidentiality for the 166 000 files they used in the study, with the data being anonymised with purpose made software that was used by named staff whose employment contracts could be revoked in the event of breaches of patient confidentiality. Given the large amount of data involved, patients' individual consent could not be sought, but efforts were made to inform patients of the possible use of their medical data and their rights of privacy through the publication of a patient information leaflet. One should not assume, however, that anonymising data for medical research is …