Funding Opportunity Purpose

The purpose of this NOFO is to invite grant applications that support healthcare safety by determining (1) whether and how certain breakthrough uses of Artificial Intelligence (AI) systems can affect patient safety; and (2) how AI systems can be safely implemented and used. AI has the potential to improve the safety, effectiveness, efficiency, accessibility, and affordability of healthcare. However, as with most technologies, this potential must be balanced by identifying and mitigating potential risks for patient harm and user burden.

Research Objectives

As noted above, this NOFO is focused on two research areas of interest:

• Whether and how certain breakthrough uses of AI systems can affect patient safety and

• How AI systems can be safely implemented and used.

It is acceptable for applicants to propose research that crosses these research categories of interest. For example, an applicant may propose to study how a breakthrough AI system can positively affect patient safety when it's implemented or used in a certain manner.

This NOFO is not intended to support the development of new AI systems, instead it focuses on assessing the impact, both positive and negative, of actual AI deployments in healthcare delivery systems and how that impact can be affected by implementation and use strategies.

Examples of applied research projects responsive to this NOFO include but are not limited to those described below. Mixed methods research projects are encouraged where applicable.

• Research to demonstrate the clinician time saved through implementation of AI systems to reduce documentation or inbox burdens

• Research to determine if AI systems to reduce documentation or inbox burdens create new patient safety issues and, if so, how might they be mitigated or eliminated

• Research to determine how best to integrate AI systems that alleviate clinician burden into clinician workflows

• Research to determine how to safely implement and use an LLM-based system, which has been shown to expedite accurate responses to patient or clinician queries

• Research to determine how best to ensure the usability of AI systems that address patient safety challenges

• Research to develop an evaluation tool or approach to assess the safe implementation of AI systems

• Research to determine how best to integrate AI systems into clinician workflows to maximize their effect on enhancing patient safety and identifying and mitigating patient safety hazards.

• Research to determine how to enhance clinician-AI teaming to improve patient safety

• Research to determine how AI can be implemented to mitigate and not exacerbate inequities in care, particularly in the area of patient safety

All projects must:

• Describe the healthcare practice setting(s) for the research: outpatient, inpatient, emergency department, ambulatory surgery center, post-acute care settings, home, etc.;

• Describe the patient population(s) impacted by the research;

• Describe how the research considers the guidance released by the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) in its Artificial Intelligence Risk Management Framework

• Describe how AI hazards, harms, benefits, and process improvements will be identified, harms prevented or mitigated, and processes implemented and/or improved;

• Evaluate and report (as applicable):

• Improvement in the safety and effectiveness of care and reduction in adverse events;

• Improvement in patient and/or clinician experience;

• Reduction in provider burden; and

• Unintended adverse clinician impact or patient safety events and mitigating actions taken.

Special requirements and information

• Grantees awarded through this NOFO will have external collaboration with each other via two virtual meetings to address learning and dissemination. PD/PI and any key personnel are encouraged to participate in the learning and dissemination meetings.

• Key personnel on the research team must include individuals having expertise in AI or the implementation of AI systems as well as expertise in patient safety, quality assurance, or human factors engineering.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon AHRQ appropriations and the submission of a sufficient number of meritorious applications.

Future year funding is contingent upon the availability of funds for each year of support.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Award Budget

The total costs (direct and indirect costs) awarded to a grant under this NOFO will not exceed $500,000 in any given year and $1 million for the entire project period. An application with a budget that exceeds $500,000 total costs in any given year will not be reviewed.

Application budgets should reflect actual needs of the proposed project, within the total costs cap.

Funds may be used only for those expenses that are directly related and necessary to the project and must be expended in compliance with applicable Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards (45 CFR Part 75) and the HHS Grants Policy Statement.

Award Project Period

The scope of the proposed project should determine the project period. The project period may not exceed 2 years.