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Information & Data Protection Law
CPD Points:
Up to 1 point. details »

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Regulated by the Solicitors Regulation Authority:
Listen and pass the quiz: Gain 1 CPD point (60 minutes)
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Regulated by the Bar Standards Board:
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Regulated by ILEX:
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  • FREE
30 minutes of audio
(+ optional 5 minute online quiz)
Plays on Computer:
Yes Downloadable as MP3:    Yes
Course Aims:

This podcast aims to analyse the relationship between medical research and the legal and regulatory protection of personal data in the EU. Particular problems in relation to the definition of key coded data and the distinctions between subjective and objective conceptions of personal data are discussed, and the practice of some Member States compared. The definition of and protection issues arising out of pharmacovigilance requirements are considered, and consideration is made of the competing interests of individuals in gaining access to their health data, and the research companies in withholding that data, and using it for secondary research. Future prospects in this field, both as regards medical research and legal regulation are examined in conclusion.

After completing the course you will:
  • Understand key principles relating to the regulation of medical research, such as key coded data, pharmacovigilance and secondary research;
  • Be able to distinguish subjective and objective notions of personal data;
  • Be aware of key pharmacovigilance requirements;
  • Understand the difficulties inherent in individuals’ rights of access to data and companies’ right to undertake secondary research;
  • Appreciate possible future directions in medical research and legal regulation.
Complex Difficulty: 4 of 5
Legal Principles
Sources and References:
  • Working Paper 136;
  • E2B(M): Data Elements for Transmission of Individual Case Safety;
  • EU-US Safe Harbor Agreement.

In this podcast Dan Cooper of Covington and Burling examines the interaction between medical research and data protection regulation, in particular in the EU. A number of issues are covered, including key coded data, pharmacovigilance and the rights of access of subjects to medical research relating to their health. Particular difficulties are discussed in relation to the variation of data protection regulation among the EU Member States, the transfer of health data outside the EU and the obstacles to using personal data in secondary research. Finally, the speaker analyses some important public and private sector initiatives on medical research and looks at possible future directions for medical research and legal regulation in this field.

Podcast last reviewed: 2011-03-28

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