Healthy Technology Act of 2025

Bill Number

H.R. 238

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-01-07: Referred to the House Committee on Energy and Commerce.

Last Updated

2025-02-20T21:19:39Z

AI-Generated Summary

Purpose

The Healthy Technology Act of 2025 aims to update federal law to explicitly allow artificial intelligence (AI) and machine learning (ML) technologies to prescribe drugs under specific conditions. This clarification seeks to integrate advanced technologies into healthcare while ensuring oversight from both state and federal regulators.

Key Provisions

• Definition Expansion: Amends Section 503(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding a new subsection (6). This defines a "practitioner licensed by law to administer such drug" to include AI and ML technologies that meet two criteria:
• Authorized by a state law to prescribe the specific drug.
• Approved, cleared, or authorized by the Food and Drug Administration (FDA) through established processes, such as:
• Section 510(k): Premarket notification for devices substantially equivalent to existing ones.
• Section 513: Classification procedures for medical devices.
• Section 515: Premarket approval for high-risk devices.
• Section 564: Emergency use authorization for devices during public health emergencies.
• Scope: Applies only to drug prescriptions, focusing on technologies that function like licensed practitioners.

Significant Changes to Existing Law

• Broadened Definition of Practitioner: Previously, the FD&C Act limited drug prescriptions to human practitioners (e.g., doctors, nurses) licensed by law. This bill expands that to include qualifying AI/ML systems, marking a shift from human-only to technology-inclusive prescribing.
• Dual Oversight Requirement: Introduces a requirement for both state authorization and FDA validation, ensuring technologies cannot prescribe without regulatory checks. No other major alterations to the FD&C Act are made.

Potential Impacts

• On Government Agencies: The FDA may see increased workload in reviewing and authorizing AI/ML for prescribing, potentially requiring new guidelines or resources. State health departments could need to enact or update laws to authorize such technologies.
• On Citizens (Patients): Could improve access to faster, more efficient drug prescriptions, especially in underserved areas, but raises concerns about accuracy, accountability, and privacy if AI errors occur.
• On International Relations: Minimal direct impact, though it may influence global standards for AI in healthcare by positioning the U.S. as a leader in tech-enabled medicine.
• Broader Healthcare System: Encourages innovation in telemedicine and automated care, potentially reducing costs and human error, but could disrupt traditional prescribing roles.

Main Stakeholders Affected

• AI and ML Developers/Tech Companies: Gain legal clarity to market prescribing tools, but must navigate FDA approvals.
• Healthcare Providers and Facilities: May integrate AI for efficiency, but need to ensure compliance with state and federal rules.
• Patients and Consumers: Benefit from potential advancements in care delivery, but face new risks related to technology reliability.
• State Governments: Responsible for passing authorizing statutes, affecting local healthcare policies.
• FDA and Federal Regulators: Tasked with evaluating and authorizing technologies, influencing national drug safety standards.

Notable Legal, Constitutional, or Political Implications

• Legal Implications: Establishes precedent for treating AI/ML as quasi-legal entities in regulated fields like medicine, potentially leading to future lawsuits over liability (e.g., who is responsible for AI-prescribed drug errors— the developer, state, or FDA?). It reinforces the FD&C Act's focus on safety without overriding state authority.
• Constitutional Implications: None directly evident; the bill respects federalism by requiring state authorization, avoiding conflicts with states' rights under the 10th Amendment.
• Political Implications: Supports bipartisan interest in technological innovation and healthcare modernization, but could spark debates on ethics, job displacement for human practitioners, and equitable access to AI-driven care. As an introduced bill (H.R. 238, 119th Congress), its passage would signal growing acceptance of AI in public policy.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Schweikert, David [R-AZ-1]

Recent Actions

• 2025-01-07: Referred to the House Committee on Energy and Commerce.
• 2025-01-07: Introduced in House
• 2025-01-07: Introduced in House

Bill Versions

• Healthy Technology Act of 2025 — issued 2025-01-07 — PDF (2 pages)