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Artificial Intelligence-Based Software as a Medical Device (AI-SaMD): A Systematic Review.

Shouki A Ebad1, Asma Alhashmi2, Marwa Amara2

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Summary
This summary is machine-generated.

Artificial intelligence-based software as a medical device (AI-SaMD) research is limited. This review identifies challenges and emphasizes practical, experimental studies for AI-SaMD

Keywords:
AIAI-SaMDSaMDregulatorysystematic review

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Area of Science:

  • Medical Technology
  • Artificial Intelligence
  • Healthcare Informatics

Background:

  • Artificial intelligence-based software as a medical device (AI-SaMD) is a growing field with increasing regulatory approvals.
  • Research in AI-SaMD, spanning technology, healthcare, and national security, remains limited.
  • A knowledge gap exists regarding the technological, clinical, and regulatory aspects of AI-SaMD.

Purpose of the Study:

  • To systematically review AI-SaMD literature from the past decade (2015-2024).
  • To classify key findings, identify critical challenges, and synthesize insights on AI-SaMD.
  • To bridge the research gap by analyzing technological, clinical, and regulatory dimensions.

Main Methods:

  • Systematic literature review adhering to the PRISMA framework.
  • Selection of AI-SaMD studies published between 2015 and 2024.
  • Analysis of publication venues, geographical trends, challenges, and research gaps.

Main Results:

  • AI-SaMD research predominantly focuses on specialized areas like radiology and ophthalmology, not general practice.
  • Key implementation challenges include regulatory frameworks, AI malpractice (explainability, oversight), and data governance (privacy, sharing).
  • Effective AI-SaMD implementation requires addressing regulatory issues, fostering interdisciplinary collaboration, clinician training, EHR integration, and rigorous model validation.

Conclusions:

  • The study provides insights for stakeholders, advocating for practical, experimental research over theoretical analyses.
  • Prioritizing real-world application necessitates moving beyond theoretical discussions.
  • Future research directions are outlined, highlighting limitations in current theoretical approaches.