The European Medicines Agency (EMA) has established an expert group in data anonymisation known as the technical anonymisation group (TAG) to help further develop best practices for the anonymisation of clinical reports, in the context of the Agency's policy on the publication of clinical data.
The group includes members from academia, industry, patients and healthcare professionals with expertise in areas such as data protection, developing standards and guidance for anonymisation and re-analysis of clinical data. EMA established the group following a public call for applications launched in March 2017.
As part of its responsibilities, the group will consider experience to date with EMA's publication of clinical reports. In particular, it will assess:
- patient re-identification and any privacy risks in the light of new technological developments;
- the scientific utility of the published clinical data as a function of the anonymisation methodology used;
- whether it is possible to successfully conduct a secondary analysis of the anonymised clinical data.
More information on the TAG's responsibilities is available in this document:
EMA publishes the agendas and minutes of the TAG meetings on the meeting pages, as well as the relevant presentations. For information on meetings of the TAG:
Members
The table below lists (in alphabetical order of surname) the current members of the TAG, together with their curriculum vitae and declaration of interests.
Name | Curriculum vitae (CV) | Declaration of interests (DoI) |
Khaled El Emam | Khaled El Emam (CV) | Khaled El Emam (DoI) |
Jean-Marc Ferran | Jean-Marc Ferran (CV) | Jean-Marc Ferran (DoI) |
Uwe Fiedler | Uwe Fiedler (CV) | Uwe Fiedler (DoI) |
Christine Fletcher | Christine Fletcher (CV) | Christine Fletcher (DoI) |
Cathal Gallagher | Cathal Gallagher (CV) | Cathal Gallagher (DoI) |
Lukasz Kniola | Lukasz Kniola (CV) | Lukasz Kniola (DoI) |
Bradley Malin | Bradley Malin (CV) | Bradley Malin (DoI) |
Sarah Nevitt | Sarah Nevitt (CV) | Sarah Nevitt (DoI) |
Nicola Orlandi | Nicola Orlandi (CV) | Nicola Orlandi (DoI) |
Lee Parker | Lee Parker (CV) | Lee Parker (DoI) |
Frank Rockhold | Frank W. Rockhold (CV) | Frank W. Rockhold (DoI) |
Kristian Svendsen | Kristian Svendsen (CV) | Kristian Svendsen (DoI) |
Rafal Swierzewski | Rafal Swierzewski (CV) | Rafal Swierzewski (DoI) |
The following individuals are also members of the TAG:
- Monica Dias (chair, EMA)
- João Francisco Ferreira (EMA)
- Anna Gross (EMA)
- Anne-Sophie Henry-Eude (EMA)
- Frank Pétavy (EMA)
- Karen Quigley (EMA)
- Giuseppe d'Acquisto (Italian data protection authority)
- Dina Kampouraki (observer, European data protection supervisor)