Overview
Title
To amend the Federal Food, Drug, and Cosmetic Act to clarify that artificial intelligence and machine learning technologies can qualify as a practitioner eligible to prescribe drugs if authorized by the State involved and approved, cleared, or authorized by the Food and Drug Administration, and for other purposes.
ELI5 AI
In the Healthy Technology Act of 2025, there is a new idea that smart computers could help doctors by prescribing medicine, but only if the state and a big group like the FDA think it's okay.
Summary AI
H.R. 238, also known as the “Healthy Technology Act of 2025,” proposes changes to the Federal Food, Drug, and Cosmetic Act. The bill aims to make it clear that artificial intelligence and machine learning technologies can be considered qualified to prescribe drugs. However, these technologies must be authorized by the relevant State and approved by the Food and Drug Administration (FDA). This means that AI and machine learning can potentially join human practitioners in prescribing medications if they meet these specific conditions.
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Keywords AI
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AnalysisAI
H.R. 238, titled the "Healthy Technology Act of 2025," is a legislative proposal aimed at updating the Federal Food, Drug, and Cosmetic Act. The primary goal of this bill is to include artificial intelligence (AI) and machine learning technologies among entities that can legally prescribe drugs, provided these technologies are authorized by state law and approved by the Food and Drug Administration (FDA). Such an update seeks to recognize advanced technological systems as potential participants in the healthcare landscape, thereby acknowledging their growing capabilities in medical diagnostics and decision-making.
Significant Issues
The inclusion of AI and machine learning technologies as eligible "practitioners" comes with a set of controversial and challenging issues. Firstly, introducing non-human entities into roles traditionally held by licensed medical professionals sparks debate over oversight, accountability, and liability. Unlike human practitioners, the accountability mechanisms for AI systems are not well-established, which raises concerns about who bears responsibility for errors or adverse outcomes.
Moreover, the bill specifies that AI systems need state authorization and FDA approval to qualify as practitioners. However, these criteria might not fully encompass the ethical and competency standards typically required in healthcare settings. This potential gap in addressing the full scope of responsibilities and skills required could undermine patient safety and the integrity of healthcare delivery.
The bill allows individual states to decide whether to authorize these technologies, leading to potential inconsistencies across the nation. Such variability might result in fragmented medical practice regulations, complicating interstate healthcare practices and potentially affecting the uniformity of patient care nationwide.
Additionally, the bill relies on referencing complex legal provisions, such as FDA sections where AI technologies might be approved. This reliance forces policymakers and the public to engage in cross-referencing, making the legislative proposal less transparent and harder to understand for those not well-versed in legal particulars.
Broad Public Impact
From a broad perspective, this bill could usher in a new era where technology increasingly aids in healthcare delivery. It could pave the way for more rapid and data-driven therapeutic decisions, potentially enhancing efficiency and access to healthcare services. However, these benefits must be weighed against the risks, chiefly concerning safety and accountability.
If enacted, the bill could accelerate innovation and technological integration in medical fields. AI-driven solutions might become more prevalent, offering support in underserved or remote areas where human practitioners may be sparse. Nevertheless, this shift also risks marginalizing the role and judgement of traditional healthcare providers, possibly undermining trust in medical practice should errors attributable to AI arise.
Impact on Stakeholders
For healthcare providers, this legislation presents both opportunities and challenges. While it could offer valuable tools that augment decision-making capabilities, it also introduces competition for diagnostic and prescription tasks traditionally performed by human practitioners.
State governments and regulatory bodies would face increased pressure to develop frameworks ensuring these technologies are safe and effective. This responsibility might entail establishing new standards and oversight mechanisms, which could be resource-intensive.
Technology companies involved in AI healthcare solutions stand to benefit
Issues
The inclusion of artificial intelligence and machine learning technologies as 'practitioners' eligible to prescribe drugs (Section 2) is highly controversial, as it raises significant questions about oversight, accountability, and liability in medical practice. This change challenges existing norms and frameworks in healthcare law and regulation.
The criteria for AI and machine learning technologies to qualify as practitioners (Section 2), which are based on state authorization and FDA approval, may be inadequate in addressing ethical and functional competencies required in healthcare, potentially compromising patient safety.
The amendment may lead to inconsistencies in medical practice regulation across states (Section 2), as each state has the discretion to authorize AI technologies differently. This lack of uniformity could complicate interstate healthcare practices and patient care.
The reference to legal provisions such as 'authorized under section 510(k), 513, 515, or 564' in Section 2 requires readers to cross-reference other laws, which can be burdensome and inaccessible for the general public, making the policy less transparent and understandable.
There is insufficient detail regarding the specific requirements for AI and machine learning technologies to qualify as 'practitioners' beyond statutory and regulatory approvals (Section 2). This lack of detail could lead to unclear standards and create loopholes in the regulation of such technologies.
Sections
Sections are presented as they are annotated in the original legislative text. Any missing headers, numbers, or non-consecutive order is due to the original text.
1. Short title Read Opens in new tab
Summary AI
The first section of this act gives it the official name “Healthy Technology Act of 2025.”
2. Prescription of drugs by artificial intelligence or machine learning technologies Read Opens in new tab
Summary AI
The section adds a provision to the Federal Food, Drug, and Cosmetic Act allowing artificial intelligence and machine learning technologies to be considered as "practitioners" authorized to prescribe drugs, as long as they are permitted by state law and have received necessary federal approvals.