Physiological Signal Dataset Development for AI/ML Wearable Device Research

The FDA Office of Acquisition Grant Services, under the Department of Health and Human Services, has issued a solicitation for the development of a physiological signal dataset to support artificial intelligence and machine learning research for wearable medical devices. The project requires the collection, processing, and annotation of high-quality physiological data from human subjects using wearable sensors, with the goal of creating a standardized, de-identified dataset usable for training and validating AI algorithms. The solicitation, identified by RFQ134632, was posted on July 28, 2026, with a response deadline of August 7, 2026, and carries a NAICS code of 541715 for research and development in the physical, engineering, and life sciences. The work is expected to be conducted in coordination with FDA standards for data privacy, quality, and ethical sourcing, and must comply with all applicable regulations governing human subject research and biomedical data handling. The primary point of contact for inquiries is Telisha Wilson, reachable via phone or email, and the office is located in Rockville, Maryland. There is no set-aside designation, meaning any eligible entity may respond regardless of size or ownership status. The place of performance is not specified, implying flexibility in where the data collection and processing may occur, provided all regulatory, ethical, and technical requirements are met. All proposals must demonstrate expertise in physiological signal acquisition, data annotation, AI/ML readiness, and compliance with federal guidelines for health data management. Successful bidders will be expected to deliver a fully documented, validated dataset with metadata and usage protocols suitable for integration into FDA-regulated AI/ML research pipelines.