NIH Highlighted Topic: Data Science and Artificial Intelligence Approaches for Biomedical, Biobehavioral and Social Science Research
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
The National Institutes of Health (NIH) is encouraging innovative research focused on developing and validating AI and data science approaches that harmonize, decipher, and extract complex patterns from the massive multimodal, high-dimensional data generated by biomedical research and electronic health records. This highlighted topic aims to advance interpretable, reproducible, and scalable AI methods that improve modeling of risk and resilience trajectories, disease mechanisms, and integrated prevention and treatment services.
Data science and AI hold significant promise for addressing complex biomedical problems, yet NIH notes that heterogeneous, fragmented data lacking uniform standards remains a major barrier to widespread adoption in research and clinical practice. This topic is issued as part of the Make America Healthy Again initiative, aligning with NIH's expanded focus on mental health and addiction research, screentime effects in children and adolescents, and an AI-driven approach to pediatric cancer research and clinical trials. NIH is particularly interested in projects that make large-scale biomedical data AI-ready and integrate disparate systems, such as EHRs, surveillance, and community services, for coordinated longitudinal care.
Areas of interest include interpretable and explainable AI for mechanistic insight, AI modeling of longitudinal risk and disease trajectories across substance use, HIV, and comorbidities, generative AI applications for chronic recurrent eye disorders and precision diagnostics, multimodal data integration for Alzheimer's disease and aging biology, AI/ML models for alcohol use disorder prevention using real-world environmental and social data, computational tools for complementary and integrative health approaches, AI applications across hearing, balance, taste, smell, voice, speech, and language disorders, and sex-based biology modeling for chronic disease risk, relapse, and treatment response in women.
Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.
This highlighted topic is supported by an especially broad coalition of ICOs, including the National Institute on Drug Abuse (NIDA), National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI), National Eye Institute (NEI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Mental Health (NIMH), National Institute of Nursing Research (NINR), National Library of Medicine (NLM), Office of Data Science Strategy (ODSS), and Office of Research on Women's Health (ORWH), reflecting how foundational AI and data science approaches have become across nearly every corner of NIH's research mission.
How much funding would I receive?
Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.
What could I use the funding for?
Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).
Eligible activities may include:
Development of speech-generating devices and AAC communication platforms
AI and machine learning tools for adaptive communication support
Personalized AAC assessment and recommendation systems
Precision measurement tools for tracking communication outcomes
Digital health platforms supporting AAC users and caregivers
Literacy instruction technologies for AAC users
Mobile applications supporting non-speaking and minimally verbal individuals
Predictive analytics and communication profiling systems
User-centered design and accessibility research for AAC technologies
Tools supporting communication partner engagement and training
Clinical software for AAC implementation and therapy management
Mixed-methods research platforms for communication needs analysis
Technologies supporting lifelong AAC adaptation and personalization
Remote monitoring and telehealth solutions for speech and communication therapy
Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions
Research evaluating quality-of-life and well-being outcomes for AAC users
Prototype development, validation studies, and usability testing
Commercialization planning and implementation strategy development
Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.
Are there any additional benefits I would receive?
Beyond the formal funding award, awardees gain several strategic advantages:
Government Validation and Credibility:
Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.Enhanced Visibility and Market Recognition:
Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.Access to the Federal Innovation Ecosystem:
Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.Stronger Commercial and Exit Potential:
By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.
What is the timeline to apply and when would I receive funding?
Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.
Where does this funding come from?
Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.
Who is eligible to apply?
Applicants must be U.S. small business concerns (SBCs) that:
Are organized for profit with a U.S. place of business.
Have ≤ 500 employees including affiliates.
Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.
What companies and projects are likely to win?
Projects that demonstrate:
A clear unmet medical or public-health need,
Strong scientific rationale and feasibility,
High commercialization potential, supported by a realistic market and regulatory strategy, and
Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).
Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.
Are there any restrictions I should know about?
Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.
Foreign entities are not eligible.
Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.
How long will it take me to prepare an application?
For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.
How can BW&CO help?
Our team specializes in complex federal R&D proposals and can:
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