Sec. 506. Decentralized clinical studies
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The Secretary of Health and Human Services shall— not later than 12 months after the date of enactment of this Act, issue draft guidance that addresses considerations for decentralized clinical studies, including considerations regarding the engagement, enrollment, and retention of a meaningfully diverse clinical population, with respect to race, ethnicity, age, sex, and geographic location, when appropriate; and not later than 1 year after closing the comment period on such draft guidance, finalize such guidance. The guidance under subsection
(a)shall address the following: Recommendations for how digital health technology or other remote assessment options, such as telehealth, could support decentralized clinical studies, including guidance on considerations for selecting technological platforms and mediums, data collection and use, data integrity and security, and communication to study participants through digital technology. Recommendations for subject recruitment and retention, including considerations for sponsors to minimize or reduce burdens for clinical study participants through the use of digital health technology, telehealth, local health care providers and laboratories, or other means. Recommendations with respect to the evaluation of data collected within a decentralized clinical study setting. In this section, the term decentralized clinical study means a clinical study in which some or all of the study-related activities occur at a location separate from the investigator’s location.