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Semester 1

Confidentiality and Data Protection in Biomedicine (LAWS10232)

Subject

Law

College

CAHSS

Credits

20

Normal Year Taken

3

Delivery Session Year

2023/2024

Pre-requisites

Visiting students must have completed 3 Law courses at grade B or above. We will only consider University/College level courses. This course is only open to visiting students who are nominated to study with us on a Law exchange agreement. Exchange students outside of Law and study abroad students are not eligible to enrol on this course before teaching begins, with no exceptions, and spaces cannot be guaranteed to those students at any time. **Please see Additional Restrictions**

Course Summary

This course provides a detailed exploration of two legal regimes in the biomedical context (comprising both health care and health research, broadly defined) that are of increasing importance: data protection/privacy law and the common law duty of confidentiality. Both of these legal regimes have experienced rapid development in the 21st century. New medical innovations, greater international research collaborations, and the push for Big Data research and digitisation of society generate pertinent, complex questions about what ought to be done (if anything) with our personal (and patient) data, and under what legal and ethical conditions. As part of this exploration, brief consideration will also be given to a third related and emerging legal regime, namely a right of privacy in terms of the common law and the tort of misuse of private information. This course will enable students to explore some of the key concepts, rules, and functions of confidentiality and data protection/privacy laws as they operate in biomedicine. The central focus of the course is the interplay between UK data protection law, the common law duty of confidentiality, and wider frameworks in Europe and at the international level (including the Data Protection Act 2018, General Data Protection Regulation, European Court of Human Rights jurisprudence concerning Art. 8 ECHR, and Council of Europe and OECD data privacy frameworks). We will analyse and evaluate this interaction drawing on a range of sources, including case law, statute, policy, academic literature, advisory opinions, and domestic and international laws and practices.

Course Description

This course will consist of 10 seminars organised into three parts, covering 'Foundations', 'Core Elements' and exploration of 'Contemporary Issues': **Part 1: Foundations of the legal regimes: *1. The common law duty of confidentiality - history and legal development through case studies; *2. The common law duty of confidentiality - modern context and interface with ethics and practice (e.g. General Medical Council, National Data Guardian, Confidentiality Advisory Group); *3. From confidentiality to privacy (including the tort of misuse of private information) to data protection law (focusing on Art 8 ECHR and ECtHR jurisprudence). **Part 2: Core elements of data protection law in biomedicine: *4. Data protection terminology and underlying principles: introduction to the GDPR and Data Protection Act 2018 (including focus on privacy notices and DPIAs); *5. The legal grounds for lawful processing of personal data in the biomedical context: a focus on consent (versus) the public interest; *6. Challenges arises from Big Data and large-scale biomedical initiatives: a focus on the data minimisation principle; *7. Rights of the data subject qua patient and research participant. **Part 3: Contemporary issues in the biomedical context: *8. International data transfers and specific challenges in the biomedical research context; *9. Making data protection law work for biomedical research: is reform needed?; *10. Bringing the legal regimes together in biomedicine: how might the common law duty of confidentiality, tort of misuse of private information, and data protection law work better together, if at all?

Assessment Information

Written Exam 0%, Coursework 100%, Practical Exam 0%

Additional Restrictions

**All 3rd year Law courses are ONLY open to visiting students nominated on an exchange agreement within the School of Law (including Erasmus students on a Law-specific exchange). Exchange students outside of Law, and independent study abroad students, are not eligible to enrol in these courses, with no exceptions.** Please note that 3rd year Law courses are high-demand, meaning that they have a very high number of students wishing to enrol in a very limited number of spaces. These enrolments are managed strictly by the CAHSS Visiting Student Office, in line with the quotas allocated by the department, and all enquiries to enrol in these courses must be made through the CAHSS Visiting Student Office. It is not appropriate for students to contact the Law School directly to request additional spaces. If there is sufficient space for other visiting students to enrol at the start of the semester (which cannot be guaranteed at all), visiting students must meet the pre-requisites listed above.

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