Purpose

The purpose of this Notice of Special Interest (NOSI) is to encourage grant applications to support the evaluation of the utility and validity of digital health and artificial intelligence/machine learning (AI/ML) tools and technologies in biomedical and behavioral research. The intent is to support the addition of new measurement modalities to evaluate existing and recently developed but not yet validated digital health and AI tools such as sensor technologies, smartphone applications, software as a medical device (SaMD), and AI/ML algorithms.

Background

Digital health and AI/ML technologies have grown exponentially in the past two decades. Digital health technologies include mobile devices, health information technology, wearable devices, sensors, telehealth and telemedicine, and internet of things (IoT). AI/ML tools include computational technology integrated within devices or platforms as well as stand-alone AI/ML technologies such as SaMD, risk assessment and prognosis algorithms, and software for informing health care used in the cure, mitigation, treatment, recovery, or prevention of health conditions without being part of a hardware medical device.

The range of health research and practice affected by the technological revolution is quite broad, including use in disease surveillance and public health research as well as for medical screening and diagnostic purposes where they can provide tools that can reach diverse users including individuals living in rural and underserved areas and low- and middle-income countries. However, many of these recently released tools are unregulated and their analytical validity, clinical validity, and/or reliability, utility for research, practice, and clinical care have not been examined. Widespread use and adoption of these technologies requires more rigorous evaluation across research and clinical settings, diverse populations, and health contexts including an understanding of how to optimize the implementation of these tools and technologies. Through this NOSI, NIH strives to capitalize on current research projects that collect outcomes to validate digital health and AI/ML tools.

This is a reissue of NOT-CA-22-037, with modified scientific priorities.

Research Objectives

Research supported by this NOSI is expected to provide support for analytical and/or clinical validation of recently developed digital health and AI/ML technologies. Digital health and AI/ML technologies are defined broadly to include any health technology leveraging mobile health, health information technology, wearable devices, sensors, telehealth and telemedicine, internet of things (IoT), SaMD and/or related AI/ML algorithms and tools to monitor and manage health across the life course. As noted previously, the purpose of this NOSI is not to support the development of new tools or technologies.

Applicants should clearly justify the importance and implications of validating digital health and AI/ML tools and technologies. Studies should apply rigorous research methods to evaluate the analytical and/or clinical validity of any proposed digital health and AI/ML applications including the use of gold-standard comparators. Projects that validate digital health or AI/ML tools for a new context of use, including another disease area or specific populations (e.g., low income, minority group), and research projects that evaluate the reliability of the tool and its sensitivity are encouraged.

Studies proposing secondary analysis should address the sufficiency of existing datasets to validate technologies and deepen the evidence base of digital health and AI/ML applications while also addressing potential bias, including plans for risk mitigation that ensure safety, privacy, and effectiveness among diverse individuals and populations.  For Food and Drug Administration (FDA) regulated devices, activities included under this notice should follow FDA guidance and support appropriate activities leading to a future marketing submission to the FDA.

Investigators must carefully review the specific research interests of NIH Institutes and Centers (ICs) that are participating in this NOSI.