[Federal Register Volume 90, Number 192 (Tuesday, October 7, 2025)]
[Presidential Documents]
[Pages 48153-48155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-19495]



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Vol. 90

Tuesday,

No. 192

October 7, 2025

Part II





The President





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Executive Order 14355--Unlocking Cures for Pediatric Cancer With 
Artificial Intelligence


                        Presidential Documents 



Federal Register / Vol. 90 , No. 192 / Tuesday, October 7, 2025 / 
Presidential Documents

___________________________________________________________________

Title 3--
The President

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                Executive Order 14355 of September 30, 2025

                
Unlocking Cures for Pediatric Cancer With 
                Artificial Intelligence

                By the authority vested in me as President by the 
                Constitution and the laws of the United States of 
                America, it is hereby ordered:

                Section 1. Purpose and Policy. My Administration is 
                committed to driving innovation to prevent and treat 
                childhood diseases, including through the use of 
                artificial intelligence (AI). Pediatric cancer remains 
                the leading cause of disease-related death for children 
                in the United States aged 1-19 years, and its incidence 
                has increased by more than 40 percent since 1975.

                As outlined in my joint address to the Congress in 
                March, reversing this trend is one of the top 
                priorities for the Make America Healthy Again (MAHA) 
                Commission established in Executive Order 14212 of 
                February 13, 2025 (Establishing the President's Make 
                America Healthy Again Commission). AI presents an 
                opportunity to more quickly achieve this aim.

                In 2019, my Administration created the Childhood Cancer 
                Data Initiative (CCDI), a Federal investment in 
                childhood cancer research of $50 million in funding 
                every year for 10 years to address the critical need to 
                collect, generate, and analyze childhood cancer data. 
                The CCDI is building a foundational data 
                infrastructure, aggregating and generating new data, 
                and using this data to make new discoveries.

                AI can be used to build upon this data initiative to 
                produce meaningful solutions to pediatric, adolescent, 
                and young adulthood cancer. This application of AI has 
                the potential to transform the Nation's current care 
                and research approach for pediatric cancer--as well as 
                our healthcare and research infrastructure more 
                broadly--through use of the rich and multimodal data, 
                secured with appropriate individual privacy 
                protections, to develop early and superior diagnostics, 
                identify cures and optimize treatments, and advance 
                medicine that will save lives.

                For too long, we have watched our children and their 
                families battle cancer and its long-term chronic 
                effects while healthcare systems often rely on outdated 
                technologies and can be slow to adopt certain 
                innovations. We must prioritize investment in AI-
                enabled science, build world-class scientific datasets, 
                and empower researchers and clinicians with the tools 
                needed to translate data and AI capabilities into 
                improved care.

                Sec. 2. Harnessing American AI Innovation. The MAHA 
                Commission, in coordination with the Secretary of 
                Health and Human Services (Secretary), the Assistant to 
                the President for Science and Technology (APST), and 
                the Special Advisor for AI and Crypto, and in alignment 
                with the implementation of America's AI Action Plan, 
                shall work to develop innovative ways to utilize 
                advanced technologies such as AI to unlock improved 
                diagnoses, treatments, cures, and prevention strategies 
                for pediatric cancer. The initial focus shall be on 
                identifying opportunities to accelerate the progress of 
                AI-driven solutions at the CCDI, including by making 
                data platforms and tools available as part of the CCDI 
                Data Ecosystem and funding research projects at 
                National Cancer Institute-Designated Cancer Centers 
                that prioritize:

                    (a) improving data infrastructure by consolidating 
                data from multiple sources for AI-ready analysis and 
                utilizing AI to better select participants for clinical 
                trials;

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                    (b) enhancing data analysis of complex biologic 
                systems with AI tools to radically improve predictive 
                modeling of patient response, disease progression, and 
                treatment toxicity and to turn multi-omics data and 
                imaging data into novel diagnostic, prognostic, and 
                therapeutic biomarkers; and
                    (c) improving clinical trial design, access, and 
                outcomes for patients by incorporating multimodal data 
                and using AI approaches to maximize utilization of the 
                information from clinical trials and improve 
                accessibility, recruitment, administration, conduct, 
                and interpretation of clinical trial results.

                Sec. 3. Increasing Investment and Engagement in 
                Pediatric Cancer Research and Care Infrastructure. The 
                MAHA Commission, in coordination with the Secretary, 
                the Director of the Office of Management and Budget, 
                the Director of the National Institutes of Health, and 
                the APST, shall prioritize expanding pediatric cancer 
                research and advancements in care by identifying and 
                implementing strategies for:

                    (a) increasing investment from existing Federal 
                funds for the CCDI and other Federal Government 
                initiatives that address pediatric cancer; and
                    (b) encouraging the private sector to make use of 
                the most advanced technologies to unlock cures for 
                pediatric cancer, including those based on AI, to the 
                maximum possible extent.

                Sec. 4. Improving Data Sharing and Empowering Patients. 
                The Secretary, in consultation with the APST, shall 
                work to ensure that AI innovation is appropriately 
                integrated into current work on interoperability to 
                maximize the potential for electronic health record and 
                claims data to inform private sector and academic 
                research and clinical trial design, while ensuring that 
                patients and parents control their health information. 
                In addition, the Secretary shall work to finalize 
                interoperability standards for patient data to be used 
                with AI that appropriately account for structured and 
                unstructured data and enable safe and privacy-compliant 
                exchanges of data.

                Sec. 5. Definition. For the purposes of this order, 
                ``artificial intelligence'' or ``AI'' has the meaning 
                set forth in 15 U.S.C. 9401(3).

                Sec. 6. General Provisions. (a) Nothing in this order 
                shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or 
the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget 
relating to budgetary, administrative, or legislative proposals.

                    (b) This order shall be implemented consistent with 
                applicable law and subject to the availability of 
                appropriations.
                    (c) This order is not intended to, and does not, 
                create any right or benefit, substantive or procedural, 
                enforceable at law or in equity by any party against 
                the United States, its departments, agencies, or 
                entities, its officers, employees, or agents, or any 
                other person.

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                    (d) The costs for publication of this order shall 
                be borne by the Department of Health and Human 
                Services.
                
                
                    (Presidential Sig.)

                THE WHITE HOUSE,

                    September 30, 2025.

[FR Doc. 2025-19495
Filed 10-6-25; 11:15 am]
Billing code 4150-28-P