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Learning to Regulate Learning Healthcare Systems.

Jan Piasecki, Vilius Dranseika

    Cambridge Quarterly of Healthcare Ethics : CQ : the International Journal of Healthcare Ethics Committees
    |May 23, 2019
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    Summary
    This summary is machine-generated.

    Learning Healthcare Systems (LHS) do not blur research and clinical practice lines. LHS activities resemble public health surveillance and should adopt its ethical principles for accountability.

    Keywords:
    ethics reviewinformed consentlearning healthcare systempublic accountabilitypublic health ethicspublic health surveillanceresearch ethics

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    Area of Science:

    • Bioethics
    • Health Services Research
    • Regulatory Science

    Background:

    • Science often advances faster than societal oversight and regulation.
    • Learning Healthcare Systems (LHS) collect clinical data for hypothesis testing, raising regulatory questions.
    • Existing regulations may hinder low-risk research within LHS.

    Purpose of the Study:

    • To evaluate the claim that LHS blur the lines between research and clinical practice.
    • To propose an appropriate ethical and regulatory framework for LHS activities.
    • To determine if a new ethical framework is needed for LHS research.

    Main Methods:

    • Analysis of the nature of Learning Healthcare System activities.
    • Comparison of LHS operations with existing research and public health surveillance models.
    • Ethical framework evaluation based on established principles.

    Main Results:

    • Learning Healthcare Systems do not fundamentally blur the distinction between research and clinical practice.
    • A significant portion of LHS activities align closely with public health surveillance.
    • A single regulatory framework for all biomedical research is not necessitated by LHS.

    Conclusions:

    • Learning Healthcare Systems should adopt the ethical principles of public health surveillance.
    • Key principles for LHS include comprehensiveness, transparency, and public accountability.
    • Existing regulatory frameworks may be adapted rather than replaced for LHS.