The Department of Health and Human Services (HHS) released its AI Strategic Plan in January 2025, establishing a comprehensive approach to artificial intelligence. The Plan’s Overview states that it “provides a framework and roadmap to ensure that HHS fulfills its obligation to the Nation and pioneers the responsible use of AI to improve people’s lives” in order to achieve “unparalleled advances in the health and well-being of all Americans.”

Noting that current trends “indicate that the innovative use of AI in healthcare delivery is rapidly evolving” and that investment in AI is “large and growing,” the Plan identifies four key goals that are applied to multiple areas as follows:

1. Catalyzing health AI innovation and adoption to unlock new ways to improve people’s lives.
2. Promoting trustworthy AI development and ethical and responsible use to avoid potential harm.
3. Democratizing AI technologies and resources to promote access; and
4. Cultivating AI-empowered workforces and organization cultures to effectively and safely use AI.

In the Plan, HHS states that its actions will “span a variety of levers available to [it] and its divisions, including regulations, policies and guidance, grants, funding programs, public education and outreach, and internal infrastructure, procurement, and operations.”

The plan acknowledges the need for ongoing adaptation and improvement in implementing AI. This includes addressing emerging concerns and ensuring continued regulatory compliance, stating that “existing approaches may be updated to address emerging concerns while ensuring that AI use remains compliant with current regulations (e.g., patient privacy).”

HHS is striving to create a unified and effective approach to leveraging the power of AI. This involves ensuring that all parts of the department, as well as its wider network of partners, are working together seamlessly. This is reflected in the Plan’s statement that it aims to “maximize coordination and strategically align its divisions and the rest of the health and human services ecosystem towards the achievement of [its] strategic vision and the realization of the opportunities of AI to improve people’s lives.”

MEDICAL RESEARCH AND DISCOVERY

In medical research and discovery, HHS plays an “active role in spurring activity and promoting safety and quality,” with “nearly 83% of NIH’s funding awarded for extramural research and research support.” The Plan outlines several key initiatives to advance AI in this field:

• “Expanding the breadth of medical research and discovery AI use across disease areas and steps of the value chain.”
• “Fostering AI-ready data standards and datasets to bolster their usability for AI-empowered medical research and discovery.”
• “Increasing accessibility to responsibly curated AI-ready data, models and algorithms, and tooling and infrastructure for all.”
• “Developing and retaining a robust AI talent pipeline in medical research and discovery.”

MEDICAL PRODUCT DEVELOPMENT

The impact of AI on medical product development is already significant, as “FDA has authorized approximately 1,000 AI-enabled medical devices, and FDA has received over 550 submissions for drug and biological products with AI components,” while “NIH alone makes an approximately $3B annual investment in clinical trials.” 

The role of AI varies across medical products, with the Plan stating that in drugs and biological products, it is “generally helpful in producing information or data to support decision-making across the product development life cycle, from development to manufacturing and postmarket surveillance and monitoring.” 

Meanwhile, the Plan states that it may play three roles in devices: “in the development or maintenance of the device, as a stand-alone product that can perform one or more device purposes without being part of a traditional hardware device, or as part of or integral to a device.” 

To address these developments, the Plan outlines several key actions, which include:

• Clarifying regulatory oversight of medical products
• Aligning standards and information-sharing mechanisms across research and healthcare delivery; and
• Improving training in the governance and management of AI in medical products.

HEALTHCARE DELIVERY

Healthcare delivery, which the Plan defines as “financing, direct provision of patient care, related administrative services and research,” represents a significant portion of the U.S. economy. According to the Plan, national health expenditures in the U.S. were $4.5T in 2022, representing 17% of the U.S. economy. 

Given that AI has the potential to enhance a wide range of activities in healthcare delivery, the Plan outlines several key actions:

• Providing guidelines and resources on oversight, medical liability, and privacy and security protections to increase confidence for organizations to develop AI
• Enhancing enforcement and clarifying guidelines relating to existing requirements; and
• Providing support for healthcare delivery organizations to address core infrastructure and deployment challenges that improve AI readiness.

Additional areas addressed in the Plan consist of:

• Human Services Delivery
• Public Health
• Cybersecurity and Critical Infrastructure Protection; and
• Internal Operations

Looking ahead, HHS says that it recognizes that the Plan will “require revisions over time as technologies evolve and is committed to providing structure and flexibility to ensure longstanding impact.” As part of its long-term commitment, HHS states that it will “iteratively monitor and reevaluate regulatory oversight mechanisms of AI in medical and health technologies outside of FDA’s jurisdiction as the field rapidly evolves.”

Categories: AI, Uncategorized

Tags: healthcare ai, healthcare cybersecurity