United-States (US) Food and Drug Administration (FDA) - Derived Adverse Event Reporting System and Database

Privacy Impact Assessment:
US FDA-Derived Adverse Event Reporting System & Database

March 22, 2004

Heather Sutcliffe
Manager, Marketed Health Products
Safety and Information Division

Program/Service Web Site:

Brief Program/Service Description:

The Marketed Health Products Directorate (MHPD) of Health Canada (HC) is responsible for the coordination of consistency of post-market surveillance and assessment of signals and safety trends concerning all Canadian marketed health products.

MHPD intends to establish a US AERS database by acquiring the AERS application from the US FDA that will be updated periodically with a copy of FDA AERS-derived. The data will be received on physical media and will be uploaded into the US AERS database. Only data fields containing non-identifiable personal information will be extracted from the media.

This project is important to strengthen the analysis of information and the existing public health protection cooperative activities with foreign regulatory agencies for marketed health products. The US AERS-derived data will provide for a larger data pool and is highly comparable to the foreign adverse event data received at MHPD. The data received electronically will alleviate MHPD from the burden of performing data entry and medically coding text.

Scope of the PIA:

The scope of the PIA covers the collection, use, disclosure, retention and disposal of information for the US AERS Database as it existed on January 13, 2004.

The report should be considered in conjunction with the PIA Report on the Canadian Adverse Drug Reaction Monitoring Program and the Threat and Risk Assessment (TRA) for the US AERS Database Project.

Privacy Risks and Mitigation Strategies:

The privacy impact assessment uncovered a number of privacy risks. Appropriate mitigation for these risks were recommended and accepted by program management. The implementation of these mitigation strategies are ongoing.

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