Background: As evidence to inform clinical care and regulatory decision making is increasingly based on health data from individual patients and citizens/people, there is a growing tension between the need for privacy/confidentiality and the ability to facilitate research into the effective and safe use of medicines.
Objectives: • To explore the benefits and privacy/confidentiality risks of utilising individual level health data, from the viewpoint of several stakeholders including Pharma, Regulators, Payers, Academics, Individuals & Society. • To discuss the confidentiality barriers, eg technical, ethical and legal, to sharing individual level RWD for research and to inform both clinical and regulatory decision making, and explore if there are ways to balance the risks and benefits. This symposium will be valuable for researchers, data providers, regulators, digital health system developers (including apps), payers, clinicians, and patients, to inform and help plan future research and operations with regard to utilising individual level RWD while maintaining privacy/confidentiality.
Description: The symposium will set out why regard for privacy/confidentiality is important, and how it can impact on the use and availability of data for pharmaceutical and medical research for regulatory and clinical decision making. A privacy design expert will join industry and service provider speakers to debate how to anticipate and prepare for the privacy/confidentiality issues of person level data. The differences in legal environment across geographies will also be discussed. Following the talks, the Chair will facilitate an interactive discussion between the audience, and the speakers to answer queries and explore further discussion on finding the right balance between sharing data and safe use. Alison Bourke will introduce the topic and the speakers. David Miller will further talk about issues within the use of data in the development of pharmaceuticals and the impact of the need for confidentiality/privacy. Amanda Culley and Alison Bourke will provide brief examples of systems which allow both cancer and genomics data to be utilised for research while still ensuring anonymity. Finally, Georgina Bourke will explain the latest thinking in designing systems to enable data sharing while ensuring people are fully “informed”.