RFA-RM-27-012-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Strategic Coordination (Common Fund)

This Notice of Funding (NOFO) is developed as a Common Fund initiative (https://commonfund.nih.gov/) through the Office of the NIH Director, Office of Strategic Coordination (https://commonfund.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. The NOFO will be administered by the National Cancer Institute on behalf of the NIH.

Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.

Funding Opportunity Title

PRIMED-AI: Data-to-Model Academic-Industrial Partnerships (D2M-AIP) for Precision Medicine with AI: Integrating Imaging with Multimodal Data (UG3/UH3 Clinical Trial Optional)

Activity Code

UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

Announcement Type

New

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-RM-27-012

Companion Funding Opportunity

RFA-RM-27-011

, U01 Research Project (Cooperative Agreements)

RFA-RM-27-013

UG3/

UH3

Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II

RFA-RM-27-014

, U54 Specialized Center (Cooperative Agreements)

RFA-RM-27-015

, U24 Resource-Related Research Project (Cooperative Agreements)

Number of Applications

See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.310

Funding Opportunity Purpose

The overarching goal of this notice of funding opportunity (NOFO) and its companion opportunities is to establish the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program to support development of innovative, reliable, cost-effective, and sustainable multimodal AI-based clinical decision support (CDS) tools. PRIMED-AI CDS tools are based on the integration of clinical imaging with other types of multimodal health data to enhance care for patients with a wide range of health conditions. The PRIMED-AI Program seeks to catalyze the adoption of AI-based CDS tools into clinical workflows to enable novel personalized medicine strategies that address significant health challenges.

The purpose of this Notice of Funding Opportunity (NOFO) is to catalyze the development and testing of Artificial Intelligence (AI)-enabled, image-centered, multimodal Clinical Decision Support (CDS) tools, developed in pursuance as Software as a Medical Device (SaMD). These projects are expected to have high potential for demonstrable, positive impact on patient outcomes and/or healthcare processes.

Funding Opportunity Goal(s)

The Office of Strategic Coordination (Common Fund) supports research and other projects that will accelerate fundamental biomedical discovery and translation of that knowledge into effective prevention strategies and new treatments.

Key Dates

Posted Date

June 30, 2026

Open Date (Earliest Submission Date)

September 19, 2026

October 19, 2026

Not Applicable

Not Applicable

July 2027

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Due Dates for E.O. 12372

Not Applicable

Expiration Date

October 20, 2026

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) NOFOs seek to spur on the development of innovative, reliable, cost-effective, and sustainable multimodal AI-based clinical decision support (CDS) tools with the potential for transformational impact. The PRIMED-AI Program is based on the integration of clinical imaging with other types of multimodal health data that form the basis for CDS tool development and testing, which serve to enhance patient care for a wide range of health conditions.

The purpose of the Data-to-Model Academic-Industrial Partnership (D2M-AIP) NOFO is to support multi-sector and multi-disciplinary research teams, including investigators from both academia and industry, to create mutually beneficial opportunities for partners in the pre-competitive development stage. D2M-AIP projects are primarily focused on the integration and harmonization of novel multiscale, multimodal data with clinical imaging data and the development and testing of truly novel AI-enabled, image-centered, multimodal CDS tools, developed in pursuance as Software as a Medical Device (SaMD). D2M-AIP projects will leverage existing resources across the partnership, such as high-performance computing capabilities and access to clinical data, to generate robust validation data and engage with regulators, positioning the technology for rapid post-award translation into a viable and impactful clinical product.

Key Terms used in PRIMED-AI Program

Background Clinical imaging plays a pivotal role in disease diagnosis, treatment planning and monitoring, and assessment of health and treatment outcomes; however, current developments of artificial intelligence (AI) for clinical imaging-based clinical decision support (CDS) tools typically leverage data of a single imaging modality from radiological or ophthalmological sources, while health is shaped by a variety of interconnected factors–clinical, biological, genetic, environmental, and social. The Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program seeks to integrate clinical imaging with relevant, complementary multimodal data (MMD). The overarching goal of the PRIMED-AI Program is to catalyze the development and adoption of innovative AI-based CDS tools into clinical workflows. The PRIMED-AI Program initiatives collectively aim to tackle complex clinical challenges by fostering cross-disciplinary collaboration to create innovative, reliable, cost-effective, and sustainable AI solutions that enable new precision medicine strategies and improve patient outcomes.

Prior to applying, applicants are encouraged to check the PRIMED-AI Program website for updates to relevant FAQs and informational webinars, and are also encouraged to read all companion NOFOs to ensure they are aware of the goals and responsibilities of all PRIMED-AI award recipients, including methods PRIMED-AI intends to utilize to address error mitigation and technical management. Familiarity with the companion NOFOs may better inform proposed D2M-AIP interconnections with other aspects of the PRIMED-AI Program.

D2M-AIP PRIMED-AI CDS tools aim to enhance diagnostic accuracy, optimize treatment, improve prognostic prediction, and streamline workflows for clinical decision-making through processing and integration of complex, multimodal data streams to ultimately improve patient outcomes and/or lower patient care costs. This initiative and its companion Model-to-Clinic (M2C), directly address a critical translational gap in AI research–the gap between promising AI prototypes developed in controlled research environments and robustly validated, clinically deployable PRIMED-AI CDS tools that function reliably in real-world healthcare settings. For the purpose of this NOFO, applicants must demonstrate sufficient access to verified, comprehensive, and complex multimodal datasets as well as integration and harmonization of these data to address a target clinical application. Applicants to the D2M-AIP NOFO will produce a "validated AI prototype," defined as a model that has undergone sufficient technical validation to demonstrate robust performance and technical feasibility. Projects must move beyond single-site studies to ensure broad clinical applicability through comprehensive analytic validation (required) and clinical validation (where appropriate). Ultimately, the D2M-AIP NOFO aims to catalyze a new generation of AI-augmented healthcare delivery approaches that enhance diagnosis, prognosis, and/or treatment within a precision medicine framework.

The value of any PRIMED-AI CDS tool developed under this program is contingent upon its relevance, reliability, and broad clinical adoption to improve patient care and reduce patient care costs.

Distinction Between Data-to-Model Academic-Industrial Partnership (D2M-AIP) and Model-to-Clinic (M2C) NOFOs The PRIMED-AI Program includes two parallel NOFOs designed with distinct primary foci along the data-to-model-to-clinic continuum. To help applicants select the appropriate funding opportunity, the essential differences are summarized here:

The D2M-AIP NOFO outlines a partnership structure designed to bridge gaps in knowledge and expertise by combining the strengths of academic, industry, and other investigators. Each application should establish an interdisciplinary, multi-institutional research team that collaborates strategically to develop and translate a solution to a defined problem. Teams are expected to plan, design, and validate the solution to ensure it meets the needs of end users. At a minimum, each partnership must include one academic and one industry organization. This NOFO particularly encourages applications that focus on enhancing commercialization potential and facilitating the translation of AI innovations into commercially viable products.

These teams have the potential to create mutually beneficial opportunities for partners in the pre-competitive development stage. Partnerships are expected to synergistically leverage their existing resources such as high-performance computing capabilities and access to clinical data to create added value. While the development of a market-ready product is not required, projects must significantly reduce risks to enable future commercialization. A primary goal of D2M-AIPs is to leverage the partnership to generate robust validation data and engage with regulators, positioning the technology for rapid post-award translation into a viable and impactful clinical product.

Proposals should take FDA guidance for CDS tools and AI-based SaMD into account (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software, https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-software-medical-device).

Examples of responsive D2M-AIP research projects include, but are not limited to:

(Focus: Novel data integration, new AI model development, and de-risking for commercialization)

Key Requirements D2M-AIP projects supported by this NOFO will involve two distinct, milestone-driven phases of innovation research and development. In the UG3 phase, D2M-AIP award recipients will integrate comprehensive clinical imaging and multimodal data streams for AI model building and conduct initial pilot studies with a novel AI-enabled CDS tool. In the UH3 phase, award recipients will refine, further develop, and systematically validate the performance of these tools, providing evidence of their potential for transformative impact on real-world challenges in precision medicine. Applications must be built upon the following five pillars (further specified in Section IV):

Applications Not Responsive to this NOFO.

To be considered responsive, applications must align with the central goal of the PRIMED-AI Program.

The following types of applications will be considered non-responsive and will not be reviewed:

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed

New

The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The NIH Common Fund intends to commit funds for approximately 6-8 UG3/UH3 awards. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Applicants should request a budget appropriate for the proposed scope of work, not to exceed $450,000 in direct costs per year for UG3 and $800,000 for UH3 phases.

Award Project Period

The total project period for a UG3/UH3 award may not exceed 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations)

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide.

Investigators from U.S. Federal Government Agencies (see eligibility statement above) may participate in this program as unpaid collaborators, co-Is, or unpaid consultants in accord with the Terms and Conditions provided in this NOFO. While their expertise and resources are highly valued, NIH intramural scientists cannot receive salary support or any other direct financial compensation from funds awarded through this extramural NOFO. Their involvement should be clearly outlined in the application, including a description of their scientific contribution, the number of person months devoted to the project, and a formal letter of collaboration from their Institute/Center Scientific Director or equivalent, confirming their commitment to the project and that no grant funds will be used for their support or the operational costs of NIH intramural facilities. Any use of NIH intramural resources should be fully justified and approved by the relevant NIH Institute/Center. The grant applicant is responsible for writing the section of the grant that describes the proposed collaboration within the grant, which the NIH investigator should see and approve. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide.

Specific Eligibility for Federally Funded Research and Development Centers (FFRDCs) and University Affiliated Research Centers (UARCs): FFRDCs and UARCs may not apply to this Research Opportunity Announcement as a prime performer/lead institution; however, subject to any restrictions (i.e., direct competition limitations as determined by the entity or potential limiting organizational conflicts of interest, agency sponsor related requirements and policies, etc.), FFRDCs and UARCs may be included as part the prime performer's proposal, as a sub-awardee. As with all prime/sub-awardee teaming arrangements, the Government will only have privity of contract with the prime performer, and all payments will be made through the prime awardee.

Foreign applicants

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

SF424(R&R) Senior/Key Person Profile

R&R Budget

All instructions in the How to Apply- Application Guide must be followed.

The budget request for this NOFO must distinguish between extramural costs, and the NIH intramural investigator costs. Extramural costs are associated with the extramural investigator and the applicant organization. NIH intramural investigator costs are those required by the intramural investigator for carrying out the proposed work and which are specifically identified with the project.

Cost of NIH Intramural work Please note that the NIH Intramural Research program (IRP) costs and participation will not be included in the award paid to the grantee. However, cost of IRP reagents, consumables and data analysis (e.g. software licenses) should be submitted as a separate budget page in the budget section. IRP budgets may not include any salary and related fringe benefits for career, career conditional or other federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project. The IRP budget may also include consultant costs, equipment, supplies, travel, and other items typically listed under other expenses. Funds can be requested for services by an external investigator or contractor as a subcontract/consortium including the applicable indirect (F&A) Extramural Grantee Costs Extramural costs may include such items as salary support for the extramural PD/PI and staff at the applicant organization, supplies, laboratory animals, data analysis, and other allowable costs for work performed at the (extramural) applicant organization, as well as travel costs for the extramural investigator(s).

The PD/PI and up to two other key personnel with complementary expertise are required to attend an annual in person Consortium meeting in Bethesda, MD, as well as virtual Consortium-led tutorials and open innovation meetings, as appropriate. Funds to attend these in person meetings should be budgeted in the application.

R&R Subaward Budget

PHS 398 Cover Page Supplement

PHS 398 Research Plan All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Applications must be built upon five core pillars, with a robust strategy for each. The first four pillars should be detailed within the 12-page application limit, while Pillar 5 must be submitted as a separate, required attachment (3 pages maximum). The entire strategy should be tailored to the specific aims of the project.

1. Data Quality and Governance for Model Development

2. Clinically Grounded AI Technology

3. Pathway to Implementation and Adoption

4. Integrated Multidisciplinary Team 1 - Collaborative Structure: Applications may use a multiple PD/PI mechanism. D2M-AIP applications must include

Industry participation from the outset is expected to facilitate the efficient translation and future commercialization of project outputs. It is strongly encouraged that the MPI Leadership plan addresses communication plans, processes for making decisions on scientific direction, data rights, inventions and intellectual property, and procedures for resolving conflicts.

Note: Non-profit organizations, such as foundations or research institutes, may be included as additional partners in a D2M-AIP consortium but do not fulfill the requirement for the primary industrial partner focused on commercialization.

2 - Core Multidisciplinary Expertise: Applicants must establish an inter-disciplinary, multi-institutional research team with the combined expertise necessary to address the proposed translational challenge. The academic-industrial partnership may include any number of participants and organizations necessary to assemble a critical mass of expertise and know-how for effective execution. The level of participation may vary among partners, based on the translational goals of the project. The team must possess the necessary expertise for the project's scope. Required expertise includes:

Expertise in regulatory science is also encouraged, either on the team or through consultation. For projects proposing clinical validation, expertise in clinical workflow is mandatory. Additionally, NIH encourages proposed projects to include:

3 - Investigator(s) and Environment Leadership Plan: All applications must include a comprehensive Leadership Plan. The arrangements for collaborations must allow administration of the joint effort as a single project. An organizational structure that clearly defines the partnership and relationships among the various components must be described in the Leadership Plan and illustrated in an organizational chart. This plan should also describe:

4 - Resource Allocation: Under terms and procedures to be defined in the Leadership Plan, the partnership has the responsibility and authority to use D2M-AIP funds in the most productive way to achieve the goals defined at the time that the award is made. To accomplish these tasks, the PD(s)/PI(s) can adjust funding among D2M-AIP participants to support new partners or to reduce support to existing partners as needed.

5. Error Mitigation and Technical Management Applicants must submit a required Error Mitigation and Technical Management Plan as a separate attachment, up to three pages in length, that addresses all components listed in the linked guidance. The filename "Error Mitigation and Technical Management Plan.pdf" should be used for this attachment. This file name will be reflected in the final image bookmarking for easy access to reviewers. The Error Mitigation and Technical Management Plan may be revised during the award period in accordance with Consortium policies and updated NIH guidance.

Key Components of Phased Innovation Projects D2M-AIP projects are phased innovation awards consisting of linked awards (UG3/UH3) for each phase. Approach is divided into two distinct parts corresponding to the UG3 and UH3 phases. The total duration of the UG3 and UH3 phases cannot exceed 5 years. At the end of the Approach section for the UG3 and UH3 subsections, milestones and timelines should be provided under separate headings.

Phase 1 (UG3) – Novel Data Integration for AI Model Building (Up to 2 Years) focusing on systematic PRIMED-AI CDS tool development and comprehensive technical validation (will generally rely on retrospective or de-identified, curated datasets for technical validation).

UG3 Implementation Activities must include, but are not limited to:

Phase 2 (UH3) - Model Refinement/Analytical and Performance Testing following successful transition, focusing on further development of the PRIMED-AI CDS tool and validation of the tool's potential for delivering future clinical value.

UH3 Implementation Activities must include, but are not limited to:

Projects may consider leveraging existing high-performance computing (HPC) hardware and/or cloud infrastructure, where appropriate, in model development and analytical performance testing.

Continuous Monitoring Framework (Optional): If clinical deployment occurs as part of the UH3 research plan, develop a plan to implement robust methodologies for ongoing surveillance of model performance and reliability post-deployment, utilizing tools such as AI run charts or equivalent statistical monitoring methods. This framework should align with the FDA's guidance on post market surveillance, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-surveillance-under-section-522-federal-food-drug-and-cosmetic-act.

Clinical Trial Design (Optional): While they are not required, applicants may propose to conduct clinical trials if appropriate and feasible within the project period. If a trial is proposed, the applicant must describe the trial thoroughly and provide strong justification for their chosen design. If a trial is proposed as part of a D2M-AIP project, it is anticipated that such trials will focus primarily on the efficacy of the developed CDS tools and be evaluated within de novo dedicated prospective trials or evaluated leveraging ongoing or planned trials to assess CDS performance as secondary…