Sec. 301. Report on collaboration and alignment in regulating digital health technologies
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/bill/117/hr/6000/ih/section-301·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall submit a report to the Congress on the efforts to ensure collaboration and alignment across the centers and offices of the Food and Drug Administration with respect to the regulation of digital health technologies. The report under subsection
(a)shall include a description of the following: How the Commissioner of Food and Drugs and the heads of the centers and offices of the Food and Drug Administration collaborate in regulating digital health technologies, including recommendations with respect to— the use of digital endpoints for regulatory review, including the validation and qualification of digital endpoints and digital biomarkers; the acceptance of decentralized trials; the use of digital health technologies in patient-focused development of products; and the use and validation of digital health technology tools; How the Food and Drug Administration coordinates with foreign regulators to ensure harmonization on the regulation and use of digital health technologies. In this section, the term digital health technologies includes those technologies in health care or society that help deliver or provide access to health care products and services such as hardware (for example, wearable sensors, virtual reality headsets, and digitally-enabled drug delivery devices), advanced analytics (for example, artificial intelligence, machine learning, and sophisticated computation), cloud services (for example, storage, computing, and data processing), and software (for example, mobile medical applications, and software as a medical device).