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President Trump launches Genesis Mission to unleash AI innovation & discovery

DigiCure: Legal insights at the intersection of Technology and Life Sciences and Health Care

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The White House released an Executive Order (EO) on November 24th launching the “Genesis Mission,” a national effort to “unleash a new age of AI‑accelerated innovation and discovery that can solve the most challenging problems of this century.” The EO directs a whole-of-government effort — with opportunities for involvement by the private sector — to leverage the power of AI to accelerate scientific research in several key domains.

The Genesis Mission

The EO directs the mobilization of resources from across government, the private sector, and research institutions to dramatically bolster AI development and use. The EO explains that the benefits of the Genesis mission will be myriad, as it will “dramatically accelerate scientific discovery, strengthen national security, secure energy dominance, enhance workforce productivity, and multiply the return on taxpayer investment into research and development, thereby furthering America’s technological dominance and global strategic leadership.” The Genesis Mission’s goal is to build an integrated AI platform to harness federal scientific datasets to train scientific foundation models and create AI agents to test new hypotheses, automate research workflows, and accelerate scientific breakthroughs.

The Secretary of Energy (Secretary) will be responsible for implementing the Genesis Mission within the Department of Energy. The Assistant to the President for Science and Technology (APST) will provide general leadership of the Mission, including coordination of participating agencies through the National Science and Technology Council (NSTC) and the issuance of guidance to ensure that the Mission is aligned with national objectives.

Opportunities for private sector engagement

The EO contemplates several opportunities for private sector engagement to further the Mission.

  • Agencies can launch funding opportunities or prize competitions to incentivize private-sector participation in AI-driven scientific research.
  • The Secretary is directed to establish mechanisms for agency collaboration with external partners possessing advanced AI, data, or computing capabilities or scientific domain expertise, including through cooperative research and development agreements, user facility partnerships, or other appropriate arrangements with external entities to support and enhance the activities of the Mission.
  • To facilitate these collaborations, the Secretary will:
    • develop standardized partnership frameworks,
    • establish policies for ownership, licensing, trade-secret protections, and commercialization of intellectual property,
    • implement uniform and stringent data access and management processes and cybersecurity standards for non-Federal collaborators accessing datasets, models, and computing environments, and
    • establish procedures for vetting and authorization of users.
  • The APST will identify opportunities for international scientific collaboration.

The White House Office of Science and Technology Policy (OSTP) also has issued a Request for Information (RFI) from stakeholders, including the private sector, on a range of questions related to the Genesis Mission. Questions include what policy changes would enable better public-private collaboration, what changes to commercial incentives would accelerate and support the translation of discoveries into practical applications, and how the government can strengthen research security while minimizing compliance burdens on researchers. Interested parties can file comments on these issues through December 26, 2025.

Implications for the Life Sciences sector

The White House’s Genesis Mission EO has the potential to significantly accelerate scientific discovery and research and leverage significant federal resources and data to support research, drug and device approvals, and AI model training. The EO and OSTP are particularly focused on federal data sets being used to accelerate scientific findings from health-related data sets and the Secretary of Energy is required to identify science and technology challenges that could be addressed through the Genesis Mission, including in biotechnology. Use of vast federal data sets to train AI models and support development and discovery, while lessening potential barriers to public-private collaboration could utterly transform research and vastly accelerate advances in discovery, development, and approval of new technologies, treatments, products, and tests in the health and life sciences sector.

  • AI-Enabled Research and Development. The initiative calls for deployment of AI agents to automate research workflows and hypothesis testing, supported by high-performance computing infrastructure. For pharmaceutical or medical device manufacturers, these capabilities represent a potentially transformative shift in how AI-driven medical technologies are developed and validated. The initiative could facilitate rapid development and validation of AI-driven algorithms for diagnostic imaging, clinical decision support, and predictive analytics.
  • Access to Federally Curated Data. The initiative envisions integration of large-scale, standardized datasets across scientific domains. The EO emphasizes cybersecurity standards and intellectual property protections for collaborative research and requires the implementation of uniform and stringent data access and management processes and cybersecurity standards for non-Federal collaborators accessing datasets, models, and computing environments, including measures requiring compliance with classification, and privacy requirements. These requirements will be key to protecting datasets but also will impose uniform and strict requirements on entities hoping to leverage and access such datasets or collaborate on research initiatives involving the Genesis platform.

Actions for companies

  • Consider Commenting – Consider whether to respond to the RFI to identify policy changes to help foster public-private collaboration and an accelerated path to market.
  • Monitor Implementation – Track agency guidance and interagency collaborations under Genesis to identify opportunities for participation in AI research initiatives.
  • Evaluate Data Strategy – Assess whether access to federally curated datasets could strengthen algorithm development while maintaining compliance with privacy and data integrity requirements.
  • Align with Agency Expectations – Incorporate cybersecurity controls, and algorithm transparency into design controls and documentation now, anticipating future regulatory scrutiny.
  • Explore Partnerships – Consider cooperative research agreements or consortia participation to leverage advanced computing resources and modeling frameworks.
  • Update Risk Management Plans – Integrate Genesis-related developments into risk analysis for AI-enabled devices, including cybersecurity and IP considerations.

The Genesis Mission signals a federal commitment to AI-centric innovation that will intersect with drug and medical device development. Manufacturers should act now to position themselves for emerging opportunities and evolving regulatory expectations.

Key dates

  • December 26, 2025: the comment period closes for the OSTP RFI on the American scientific enterprise.
  • 60 Days / January 23, 2026: the Secretary must identify and submit to the APST a detailed list of at least 20 science and technology challenges of national importance that the Secretary assesses to have potential to be addressed through the Mission.
  • 90 Days / February 22, 2026: the Secretary must identify federal computing, storage, and networking resources to support the Mission and identify additional partnerships or infrastructure enhancements to support the computational foundation for the AI platform.
  • 120 Days / March 24, 2026: the Secretary must identify a set of initial data and model assets for use in the Mission and develop a plan for incorporating datasets from federally funded research, other agencies, academic institutions, and approved private-sector partners.
  • 240 Days / July 22, 2026: the Secretary must review capabilities across the DOE labs and federal research facilities to identify facilities with the ability to engage in AI-directed experimentation and manufacturing.
  • 270 Days / August 21, 2026: the Secretary will seek to demonstrate an initial operating capability of the AI platform for at least one national science and technology challenge.

 

 

Authored by Mark Brennan, Katy Milner, Jodi Scott, Melissa Levine, and Ellen Jin.

This article is the ninth in our new thought leadership series, “DigiCure: Legal insights at the intersection of Technology and Life Sciences and Health Care,” which aims to help you stay informed about the broad array of legal and regulatory issues affecting companies operating at the intersection of the technology and life sciences & health care sectors. From using AI in clinical studies, to evolving patient data concerns, to the entire digital health product lifecycle, our team will discuss novel issues arising in all parts of the world, including unique deal-making, litigation, and compliance concerns. Ensure you are subscribed to Our Thinking to receive these new insights!

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