This program offers an exclusive insight into the General Data Protection Regulation’s impact on health data driven research and innovation as experienced by experts from across the health innovation sector. The speakers, working in the legal, ethical, ICT, data management and patient representative professions, will share their knowledge and experience on key aspects of data protection in the field of healthcare innovation. They will discuss and explore practical experience and solutions, best practices and approaches for compliance, data breach management, failures and prosecutions, meaningful public engagement, security, novel technologies and forthcoming regulation (including the AI Regulation and Data Governance Act) and  more.

How does the GDPR apply to health data?

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Course code: 2001

1. The why, what, who and how of the GDPR - providing a quick review of the GDPR and its implications for the health and research sector by Petra Wilson
2. GDPR - three years on by Brendan Barnes
3. GDPR and the hospital experience by Diego Fornaciari

Duration: ~70 minutes

Setting up a GDPR-compliant data collection and processing pipeline

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Course code: 2002

1. Reviewing GDPR and what we are learning in the pandemic by Maria Christofidou
2. Navigating research governance for data-driven studies by Dr. Nathan Lea
3. GDPR compliance: a hands-on researcher perspective by Liesbet Peeters
4. GDPR for data-driven research: understanding the challenges in defining roles and responsibilities by Evelyn Fox

Duration: ~95 minutes

Patient and participant consent, transparency notices and data subject rights

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Course code: 2003

1. The ethics of informed consent - why we need it and why it is problematic for health data research by Heide Mertes
2. Legal bases for processing health data: consent and beyond by Mahsa Shabani
3. Consent, transparency and all that jazz - the patient perspective by Julie Power

Duration: ~90 minutes

Data protection, safeguards, threats and breaches

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Course code: 2004

1. A practical perspective at the intersection between data protection and information security by Ruben Roex
2. How to make your company quality compliant? by Anke Verheyen
3. Putting data protection safeguards into practice by Dr. Nathan Lea

Duration: ~90 minutes

Anonymisation and pseudonymisation

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Course code: 2005

1. Anonymisation and pseudonymisation - the legal position and some practical approaches by Peter Singleton
2. Registries and biobanks in the GDPR era: Experience from the field of rare autoimmune disease by Prof. Mark Little
3. Technical methods for privacy by Dr. Louis Aslett

Duration: ~70 minutes

Regulatory compliance for AI development

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Course code: 2006

1. The draft AI Act and its potential impact in healthcare by Petra Wilson
2. How can we trust AI? by Prof. Dipak Kalra
3. Ethics, regulation and AI by Dr. Nathan Lea
4. Discussion on tackling AI challenges with Peter Singleton, Dr. Nathan Lea and Maria Christofidou

Duration: ~90 minutes