Drug Industry Gets FDA Guidance on Electronic Health Data Usage

Sponsors of drug and biological products should address potential limitations of data sources and study design elements when proposing to use electronic health records or medical claims data in clinical studies, the FDA says.

The Food and Drug Administration on Wednesday finalized guidance on its industry recommendations for selecting data sources “to maximize the completeness and accuracy” of data derived from electronic health records and medical claims for clinical studies.

Electronic health records and medical claims are types of data that contain patient health information, which have become widely used in safety studies and are increasingly being proposed for use ...