patient experience data

Defined in 1 dictionary — U.S. Code

United States Code

21 U.S.C. § 360bbb-8c — for purposes of this section (2 versions over time)

For purposes of this section, the term “patient experience data” includes data that—

(1) are collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers); and

(2) are intended to provide information about patients’ experiences with a disease or condition, including—

(A) the impact (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation on patients’ lives; and

(B) patient preferences with respect to treatment of such disease or condition.