Defined in Title III, section 3001 of the 21st Century Cures Act, as amended by section 605 of the FDA Reauthorization Act of 2017 (FDARA)1, and includes data that are collected by any persons and are intended to provide information about patients’ experiences with a disease or condition. Patient experience data can be interpreted as information that captures patients’ experiences, perspectives, needs, and priorities related to (but not limited to): 1) the symptoms of their condition and its natural history; 2) the impact of the conditions on their functioning and quality of life; 3) their experience with treatments; 4) input on which outcomes are important to them; 5) patient preferences for outcomes and treatments; and 6) the relative importance of any issue as defined by patients.

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