Physiological Signal Dataset Development for AI/ML Wearable Device Research

The Food and Drug Administration Office of Acquisition and Grant Services seeks development of a physiological signal dataset for AI/ML wearable device research, with quotes due August 7 and questions due July 31. This is a Firm Fixed Price commercial acquisition (FAR Part 12) with no set-aside.

Place of performance requires a hospital affiliation within ten miles of the study site. The two-phase effort spans 365 days from contract award. Phase 1 (90 days) requires systematic review and synthesis of publicly available cardiac physiological signal datasets—including ECG, PPG, accelerometry, blood pressure, and activity label data—with manuscript submission to a high-impact peer-reviewed journal. Phase 2 involves prospective clinical study recruiting 50 healthy adults (25 male, 25 female, ages 22–60) across four weekly data collection sessions capturing synchronized ECG, PPG, three-axis accelerometry, and blood pressure during postural transitions, quiet standing, treadmill walking at 2 and 3.5 mph, and stair climbing. Raw sensor signal access is mandatory; processed-only output is unacceptable. Contractor must deliver the complete de-identified dataset with full documentation within 365 days. Optional Year 1 provides manuscript preparation and publication support for Phase 2 outcomes and public dataset release.

The contractor must demonstrate ten-plus years of AI/ML experience in biomedical data, seven-plus years of wearable dataset analysis experience, successful execution of at least five clinical studies, federal collaboration experience, access to at least three distinct ECG/PPG wearable device brands with raw signal download capability, and authorized laboratory space with qualified medical personnel. All work requires close FDA/CDRH collaboration with regular technical engagement and FDA written concurrence required before public dissemination or publication. NAICS 541715, PSC R425. Evaluation emphasizes Relevant Experience and Relevant Past Performance equally as primary factors, with Technical Capability as secondary. Quotes submitted via email must remain valid through September 30.