Balancing Data Anonymization with Data Utility
Focus Area: Transparency
The regulatory landscape of clinical trials data sharing continues to evolve. In October 2014, the European Medicines Agency (EMA) released its policy on the publication of clinical data—referred to as Policy 0070—that crystallized the EU regulatory shift toward transparency in data sharing. EMA Policy 0070 called for proactive publication by the EMA of clinical data from clinical reports submitted to the agency, available to the public for general information, academic use, and non-commercial purposes. In April 2016, the General Data Protection Regulation (GDPR) was published with an enforcement date of May, 2018.
Efforts to facilitate and promote clinical trials data and document sharing rely, in part, on the effective anonymization of clinical study reports. Although existing policy guidelines acknowledge a range of methods to prevent identification of subjects after publication of study documents, concrete standards and recommendations for data anonymization are largely absent.
Clearly, standards of data anonymization that maintain scientific utility of the data are needed.
Current Status: Active Workgroup
Impact: Development of a roadmap toward harmonized standards and recommendations for data anonymization.
- Define key principles of data protection and anonymization to enable data sharing in the public interest
- Develop anonymization approaches and standards that ensure privacy protection and meet the standards required to maintain accessibility and scientific utility of the data
- Consider how the principles of consent, data anonymization, and data protection may be implemented to facilitate medical research
- Examine opportunities for international harmonization of standards to enable clinical data sharing
- November 2017: Workshop with European Medicines Agency on Data Anonymization: A Key Enabler for Healthcare Clinical Data Sharing
- December 2018: Joint report released on proceedings from November 2017 Workshop.
Project Manager: Emily Statham