Challenges with the characterisation of genomic data under Australian privacy law and implications for genomic data sharing
Margaret Otlowski1, Lisa Eckstein2, Center for Law and Genetics, Faculty of Law, University Of Tasmania Hobart2, Eastwood South Australia 1Center for Law and Genetics, Faculty of Law, University Of Tasmania, Hobart, Tas, Australia2Bellberry Ltd, Eastwood, South Australia, Australia
Abstract
Genomic data sharing (GDS) is regarded as essential in order to facilitate understanding of how genes affect human health. A key ELSI issue for GDS is protecting the privacy of donors. Typically, privacy protection is addressed by only sharing ‘de-identified’ data. However, as capacity for re-identification advances, the very concept of ‘de-identification’ of genomic data is coming under intense scrutiny with significant implications for established practices for collection of biospecimens and their subsequent sharing. In turn, the touchstone of ‘reasonable identifiability’ for determining whether information is ‘personal’ and therefore coming within Privacy Act protection is becoming unworkable.
This presentation explores the privacy implications of this phenomenon of the changing status of genomic data and implications for GDS. It critiques the binary approach to the issue of what information warrants protection- identifiable data is the subject of protection but de-identified data is not. The difficulties in determining the status of genomic data creates uncertainty leading to unpredictability of whether privacy protection applies. Additional challenges arise from standard language in participant information sheets and consent form language, which often seeks consent for sharing de-identified data coupled with reassuring language that the sharing practices mean that the individual will not be identifiable in the future.
The presentation will argue for a more realistic and transparent approach to genomic data in the research setting to facilitate both protection of donor interests and appropriate GDS. It also evaluates national reform proposals from the Attorney General’s Department which would strengthen privacy protection for genomic data.
Biography
Margaret is Professor of Law at University of Tasmania and Director of the Center for Law and Genetics. Her research expertise is in health law focusing on law and genetics/genomics including issues of regulation, privacy, consent, discrimination and data sharing. She is a Fellow of the Australian Academy of Law.
(Bio for Lisa to come)