The U.S. Food and Drug Administration (FDA) has issued a notice seeking comments on “the proposed availability of de-identified and masked data derived from medical product applications.” Calling for improved efficiencies and effectiveness in medical product development, the agency stated that making available “de-identified and masked clinical and preclinical data,” could provide “scientific data that may be of value in the generation of new knowledge to facilitate innovation in the development and evaluation of critically needed medical products.”

FDA has specifically requested comments on the following: (i) what factors should be considered in masking study data; (ii) what limitations, if any, should be placed on the agency’s ability to make masked data available; (iii) are there additional factors FDA should consider in de-identifying data aside from removing names and other information that identify patients or research subjects; (iv) would regulatory changes facilitate implementation of such a proposal, and if so, what changes would be most useful; and (v) in what situations would disclosing masked data be most useful to advance public health. FDA will accept comments until August 5, 2013. See Federal Register, June 4, 2013.