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Industry Questions Legality Of FDA Proposal To Release Masked Data

Device firms claim FDA does not have the legal authority to release masked and/or de-identified clinical trial data to researchers, as proposed in June. They also underscore the challenges in effectively masking device data, the risks to patient privacy and the hazards of analysis based on partial data.

Device companies say FDA is venturing beyond its legal authority in a recent proposal to release data derived from marketing applications to researchers.

FDA issued its proposal in a Federal Register notice in June, which called for public comments on the concept of making masked and/or de-identified pre-clinical and clinical data from marketing applications available to third parties for independent research. The goal, FDA says, would be to allow outside experts to access data with research value in a way that would protect patient privacy and the commercial investments of product sponsors

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