Session details:

Chair: Robin Mitra, Lancaster University

Speaker: Nicola Stingelin, University of Basel
Title: ‘Data confidentiality’: a moribund construction?

Abstract:

The increase in access to ‘real world’, big data regarding the physical, economic, societal, genomic and environmental ‘determinants’ of health on an individual and population level has many implications for medical research and medical practice in both the private and public sector. Many established aspects of ‘data confidentiality’ need increasingly to be revisited.

The presentation will consider the following issues:

- Does the classical central distinction made in data ethics analysis and data legislation between personal and non-personal data, with personal data been seen as demanding a higher level of ethics oversight and regulation compared to non-personal data require revision?

- Should the ethics focus on individual data rights be revisited in the light of big data being increasingly the starting point from which the personal is derived – with predictive big data becoming also the individual?

- The implications for ‘data confidentiality’ coming from the ongoing discussions surrounding what (big) data is, and how it should be classified: as an asset, a resource, a public or common good? Flowing from this, can or should we speak of owning or controlling data; or are concepts such as stewardship appropriate?

- Does the social contract with the commercial sector need remodelling? Corporations who drive their R&D processes based on real world data could conceivably and not unreasonably be required to apply new benefit sharing models to their profit (especially during the life of IP)?
 

Speaker: Katherine Tucker, Roche
Title: Data privacy and secondary use of clinical trial data – challenges and opportunities

Abstract:

There is a long-standing practice in the pharma industry of re-using clinical trial data to inform scientific research. The aim is to improve our understanding of diseases, medicines and patient populations and ultimately deliver benefit to patients. In fact one could argue it could be unethical not to utilise data to its maximum extent. But with the advent of relatively new data protection laws such as the EU General Data Protection Regulation, how does clinical trial data re-use interplay with data protection requirements? This talk will outline of how data privacy laws relate to clinical trials, the role of anonymization, the challenges and practical implementation and finally how Roche are approaching these issues. In addition, the speaker will talk about work Roche has been conducting with UKAN relating to EMA policy 0070, relating to public access to clinical data (via documents).
 

Speaker: Mark Elliot, University of Manchester
Title: The revised Anonymisation Decision-making Framework

Abstract:

The original Anonymisation Decision-making Framework book was published in the middle of 2016. At the time were aware that a review would be needed fairly soon afterwards due to the advent of the General Data Protection Regulation (GDPR). In 2017, an adaptation for Australian law – the De-identification Decision-making Framework (DFF) – was produced, leading to refinements of the basic idea. In all the two publications have been downloaded over 15,000 times and have a large base of users.

At the beginning of 2018, we (the UK Anoymisation Network) started the review project, with funding from Higher Education Funding Council for England (HEFCE). This consisted of a series of one-day workshops starting with a legal experts’ workshop followed by a user community workshop and finally an international experts’ group. Following these workshops and various other forms of feedback that we have received, we decided on a more extensive revision of the framework than was originally envisaged. In this talk, I will outline the new framework and discuss the implications of the changes for those handling data.

Panel discussion