Smart Health (SH) The need for a significant healthcare transformation has been recognized by numerous organizations, including the President's Council of Advisors on Science and Technology (PCAST), National Research Council (NRC), Institute of Medicine (IOM), Computing Community Consortium (CCC), the National Academy of Engineering and the Office of the National Coordinator for Health Information Technology (ONC). The Smart Health subtopics aim to support the early stage development of novel devices, components, systems, algorithms, networks, applications, or services that will enable the much needed transformation of healthcare from reactive, hospital-centered, and indemnity-based to proactive, person-centered, preventive, and cost-efficient. The SH subtopics are not aimed at supporting clinical trials, the clinical validation of information technologies, or medical devices or studies performed primarily for regulatory purposes. Limited studies with human subjects may be acceptable to the extent that they are performed in support of feasibility, proof-of-concept studies of early-stage technologies. Proposals that request support for clinical studies will be deemed non-compliant with the SBIR/STTR solicitations.