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Integrating Ethical Principles Into the Regulation of AI-Driven Medical Software.

Filzah Faheem1, Mahdi Haq1, Mohamed Derhab2

  • 1Neurology, NeuroCare.AI, Dallas, USA.

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|March 26, 2025
PubMed
Summary

Artificial intelligence (AI) in medical devices offers significant benefits but faces slow adoption due to ethical concerns. A structured regulatory framework integrating medical ethics is recommended to build trust and promote AI in healthcare.

Keywords:
artificial intelligencedeep learningethicsmachine learningmedical devicesregulations

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Area of Science:

  • Medical Ethics
  • Health Informatics
  • Regulatory Science

Background:

  • A notable rise in artificial intelligence (AI)-based software as medical devices (SaMD) is observed in the US and EU.
  • Clinical adoption of AI SaMD is hindered by ethical considerations, despite their potential for early intervention and improved patient outcomes.
  • Existing regulatory frameworks lack a unified, structured approach for AI SaMD approval, with varying focuses on technical versus ethical aspects.

Purpose of the Study:

  • To examine the ethical principles governing AI-based medical devices.
  • To analyze current regulatory guidelines in the context of medical ethics.
  • To propose recommendations for a comprehensive regulatory framework for AI SaMD.

Main Methods:

  • Review of medical ethics principles (autonomy, beneficence, justice).
  • Analysis of existing regulatory guidelines for AI-based software as medical devices.
  • Synthesis of ethical principles and regulatory requirements.

Main Results:

  • AI SaMD presents ethical challenges related to patient autonomy, beneficence, and equitable healthcare distribution.
  • Current regulatory bodies' principles, while similar, lack a standardized, structured approval process.
  • The International Medical Device Regulators Forum's SaMD Working Group has outlined essential controls but a comprehensive approach is missing.

Conclusions:

  • A universally accepted framework for AI SaMD approval is currently unavailable.
  • Integrating medical ethics principles into a comprehensive regulatory framework is crucial for AI adoption.
  • Focusing on quality management, risk assessment, and data privacy can foster trust in AI healthcare solutions.