Webinar: If you can't help, get out of the way: data protection & other legal hurdles in health data sharing for Covid-19 vaccine research - Law SG

BCS Law "in conversation with" the Pharmaceutical research sector: an online panel chaired by Chiara Rustici

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Speakers:

Nigel Hughes has a thirty-five-year career spanning the NHS in the UK (16 years), NGOs and patient organisations (10 years) and within the pharmaceutical industry (17 years). He has worked clinically in HIV and viral hepatitis, liver disease, and in sales & marketing, medical affairs, market access and health economics, R&D, precision medicine, advanced diagnostics, health IT and Real World Data/Real World Medicine. His experience covers clinical, education, as an advisor, consulting, communications and lobbying over the years. He is currently the Project Lead for the IMI2 European Health Data & Evidence Network (EHDEN), and was Platform Co-Lead for the IMI1 European Medical Information Framework (EMIF), as well as consulting on numerous projects and programmes in the domain of RWD/RWE.

Barry Moult has been an RAF-trained nurse since the early 1970, and a data protection officer at West Suffolk Hospital since 2000. More recently, Barry became the head of information governance and health records at 2 Acute Trusts in Suffolk and Essex. Formerly a Chair of the National Health Service national strategical information governance network (SIGN) group (2015 – 2018), and member of the NHS GDPR working group for health and social care, Barry sits on its records management code of practice consultation panel and is an active participant in the information governance toolkit (DSPT) restructure.

A key note speaker, data protection/information governance chair for "excellence in health care conferences", data protection consultant and DPO for a number of organisations, Barry is used to providing information governance support, DSPT submission, gap analysis, audit and training on topics key to data sharing in primary care such as understanding modern government healthcare, the role of a Caldicott guardian and of the senior information risk owner.

Between September 2017 and July 2018 Barry was seconded to the local STP, looking at information sharing and GDPR for health and social care.

In March 2020 Barry was awarded the Practitioner Award for Excellence in Data by the U.K.'s Information Commissioner Office.

Kurt Cagle is a well-known futurist, data scientist, author, blogger, and technical advisor to several companies with specific expertise in data modeling, ETL, semantic web technologies, data analytics (primarily R), XML and NoSQL databases, data governance and data lifecycle. What is less known is Kurt's specific knowledge of health data and metadata: developing taxonomies and ontologies for large, USA and international healthcare providers has given him a cross-jurisdictional insight into the state of health datasets standardisation. Kurt is the founder of Semantical LLC, a consulting company specializing in digital transformations and the move towards knowledge-based organizations. He is also the principal developer of Kaleidoscope, a personal editable, cloud-based knowledge graph that will be debuting later this year. When not writing books on technology, in his spare time Kurt authors science fiction and fantasy novels.

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Agenda:

Our next webinar, on May 14 will look specifically at the hurdles the pharmaceutical sector is encountering in accessing health data sets for Covid-19 vaccine and other pharma research. Our speakers, industry insiders highly engaged in policy-making at UK and EU level, will highlight to policy-makers round the world which legal issues the industry finds harder to navigate.

Questions raised will be:

1) What makes access to the health data sets of the deceased for research purposes so hard both within a state and across EU member states?
2) What makes re-purposing towards Covid-19 research of Real World Data, i.e. legacy health datasets, originally collected for unrelated primary care purposes, so hard?
3) The GDPR allows us to handle health data without patient consent for a public health public interest according EU or member state law. Covid-19 is an obvious case of public health public interest but what are we to do if no primary legislation at member state level has been put in place in time? What EU-wide protocol or WHO accepted guidance can we rely on instead?
4) What is the correct way of thinking about consent in the era of COVID-19?
5) How can we lawfully access and blend 3rd party health data, or Real World Evidence, from commercial entities (fitbit data streams, insulin pump glucose readings, oxymeter readings etc.) with electronic patients records when it's clearly beneficial for their own diagnosis and personalised treatment?
6) How to exchange patients' health data in case studies with researchers outside the EU: are legal difficulties real or perceived?
7) Do we need pandemic preparedness for the legislative process, i.e. ensure we have legal frameworks and procedures that will be operational specifically in the event of future epidemics/pandemics?
8) Are there mandatory health data standardisation rules?
9) COVID-19 illustrates how data collection for defined periods of time only is also dangerous: can deletion be a crime?
10) Does the law of intellectual property applied to health data sets address both the public interest of research for the public good and patenting rights of the pharma sector?

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