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  • 1Southern Methodist University (SMU) Dedman School of Law, Dallas, TX, USA.

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Summary
This summary is machine-generated.

Large language models (LLMs) require robust legal frameworks for safe medical use. This study proposes treating AI like medical professionals and products, ensuring competence, safety, and performance standards for patient protection.

Keywords:
FDAartificial intelligencechatbotsliabilitymedicineregulation

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Area of Science:

  • Artificial Intelligence in Medicine
  • Legal and Ethical AI Governance
  • Healthcare Quality Assurance

Background:

  • Large language models (LLMs) show potential in healthcare but exhibit unreliability and safety concerns.
  • Existing AI guidelines lack clear pathways for legal implementation in medical applications.
  • Current focus is on AI model standards, not their translation into enforceable law.

Purpose of the Study:

  • To propose a legal and regulatory framework for governing LLMs in medical diagnosis and treatment.
  • To evaluate the applicability of existing medical quality assurance frameworks to AI governance.
  • To establish measurable standards for AI safety, performance, and accountability in healthcare.

Main Methods:

  • Analysis of current AI guidelines and their limitations for legal application.
  • Evaluation of existing medical quality frameworks for potential adaptation to AI.
  • Exploration of legal and economic incentives (reimbursement, liability) for AI compliance.

Main Results:

  • Identifies gaps in current AI standards and the need for legal transmutation.
  • Suggests adapting medical quality frameworks for AI governance.
  • Proposes a dual approach: treating LLMs as professionals and products with measurable standards.

Conclusions:

  • LLMs in medicine need oversight comparable to human professionals and products.
  • Measurable safety and performance standards, coupled with legal liability and incentives, are crucial.
  • This approach offers a path toward genuine oversight and safe integration of LLMs in US healthcare.