The National Institutes of Health (NIH) is offering grant funding for the validation of digital health and artificial intelligence/machine learning (AI/ML) tools for improving public health care. This presents a significant commercial opportunity for companies developing these technologies. This funding aims to support research that rigorously assesses the validity and utility of these tools in real-world settings.
NIH Grant Focus: Validation of Digital Health Technologies
This Notice of Special Interest (NOSI), NOT-CA-24-031, underscores the growing need for validated digital health and AI/ML tools in biomedical and behavioral research. The NIH recognizes the potential of these technologies to revolutionize health care delivery and seeks to ensure their effectiveness and reliability through rigorous scientific evaluation. The emphasis is on validating existing tools, not developing new ones.
Key Research Objectives for Grant Applications
Proposed research should focus on the analytical and clinical validation of existing digital health and AI/ML technologies. This includes:
- Validation across diverse contexts: Research should demonstrate the effectiveness of these tools in various settings, including different disease areas and diverse populations.
- Rigorous methodology: Studies must employ robust research methods, including gold-standard comparators, to ensure accurate and reliable results.
- Addressing bias and equity: Applications should address potential biases within the tools and ensure their safety, privacy, and effectiveness across different populations. Projects aiming to reduce health disparities are particularly encouraged.
- Secondary data analysis: Projects utilizing existing datasets should demonstrate the sufficiency of the data for validation purposes and address potential biases.
Specific Areas of Interest for Different NIH Institutes
Various NIH Institutes and Centers (ICs) have expressed specific interests within this broad funding opportunity. For example:
- National Cancer Institute (NCI): Focuses on tools for cancer risk assessment, screening, early detection, diagnosis, treatment, and survivorship.
- National Heart, Lung, and Blood Institute (NHLBI): Interested in tools for managing cardiovascular and respiratory diseases, including AI/ML for image analysis and remote monitoring.
- National Institute on Aging (NIA): Seeks tools to improve care for older adults, including those with Alzheimer’s disease and related dementias, focusing on remote monitoring and data analysis from wearables.
Application and Submission Information
This NOSI applies to due dates starting April 5, 2024, and extends through July 6, 2025. Applicants must adhere to the guidelines outlined in the chosen Funding Opportunity Announcement (FOA) and include “NOT-CA-24-031” in the Agency Routing Identifier field.
Commercial Implications of NIH Funding
This grant opportunity offers a substantial commercial advantage for companies working in the digital health and AI/ML space. Successful validation through NIH-funded research can:
- Enhance credibility and market positioning: Demonstrated effectiveness through rigorous research builds trust with potential customers and strengthens market competitiveness.
- Accelerate adoption: Validation studies can provide the evidence needed to drive wider adoption of these technologies by healthcare providers and patients.
- Attract further investment: Successful grant funding and positive research outcomes can attract further investment for product development and commercialization.
- Pave the way for regulatory approval: Data generated from these studies may support future FDA submissions for regulated devices.
Conclusion: A Strategic Opportunity
This NIH grant presents a strategic opportunity for companies to validate their digital health and AI/ML technologies, enhance their commercial viability, and ultimately contribute to improving public health outcomes. Companies are strongly encouraged to consult the specific requirements of each participating NIH Institute and contact the relevant program officers to discuss their proposed research.
