AIMC Topic: Government Regulation

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Regulation of artificial intelligence in healthcare: Clinical Laboratory Improvement Amendments (CLIA) as a model.

Journal of the American Medical Informatics Association : JAMIA
OBJECTIVES: To assess the potential to adapt an existing technology regulatory model, namely the Clinical Laboratory Improvement Amendments (CLIA), for clinical artificial intelligence (AI).

FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine.

JAMA
IMPORTANCE: Advances in artificial intelligence (AI) must be matched by efforts to better understand and evaluate how AI performs across health care and biomedicine as well as develop appropriate regulatory frameworks. This Special Communication revi...

Implications of An Evolving Regulatory Landscape on the Development of AI and ML in Medicine.

Pacific Symposium on Biocomputing. Pacific Symposium on Biocomputing
The rapid advancement of artificial intelligence and machine learning (AI/ML) technologies in healthcare presents significant opportunities for enhancing patient care through innovative diagnostic tools, monitoring systems, and personalized treatment...

Addressing health disparities in the Food and Drug Administration's artificial intelligence and machine learning regulatory framework.

Journal of the American Medical Informatics Association : JAMIA
The exponential growth of health data from devices, health applications, and electronic health records coupled with the development of data analysis tools such as machine learning offer opportunities to leverage these data to mitigate health disparit...

Patient safety and quality improvement: Ethical principles for a regulatory approach to bias in healthcare machine learning.

Journal of the American Medical Informatics Association : JAMIA
Accumulating evidence demonstrates the impact of bias that reflects social inequality on the performance of machine learning (ML) models in health care. Given their intended placement within healthcare decision making more broadly, ML tools require a...

A governance model for the application of AI in health care.

Journal of the American Medical Informatics Association : JAMIA
As the efficacy of artificial intelligence (AI) in improving aspects of healthcare delivery is increasingly becoming evident, it becomes likely that AI will be incorporated in routine clinical care in the near future. This promise has led to growing ...