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· 368 · Journal of Nanjing Medical University（Social Sciences）of Nanjing Medical University（Social Sciences） 2024年8月
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An analysis of the ethical governance path of medical artificial
intelligence under the paradigm of“hard law soft law”

XU Hui，WANG Yi
School of Law，Xiangtan University，Xiangtan 411105，China
Abstract：The traditional legal and technological ethical rules which based on hard law norms have
inevitable objective limitations when governing medical artificial intelligence ethics with risk characteristics
such as lack of trust in human⁃computer interaction，uncontrollable decision⁃making，unreliable security，and
unfair distribution of medical resources，which make it impossible to provide the necessary for good governance.
Therefore，the dualistic legal model of“hard law soft law”that emphasizes the integrated theoretical structure
of“openness⁃control”can provide a new governance framework for the ethical governance of medical artificial
intelligence. Theoretically，the“hard law soft law”paradigm can demonstrate the legitimacy of ethical risk
regulation in medical artificial intelligence and ensure the responsiveness of medical artificial intelligence
ethical risk decision⁃making. In practice，the“hard law soft law”paradigm has become a common governance
framework for ethical risk management in medical artificial intelligence abroad. In the future，under the
paradigm of “hard law soft law”， the ethical governance path of medical artificial intelligence should
continuously regulate the generation mechanism of soft law，and enhance the benign interaction mechanism of
“hard law soft law”. We also recommend giving full play to the governance advantages of hard law and soft law
to achieve institutional complementarity，intending to construct a safe，trustworthy，and responsible ethical
governance framework for medical artificial intelligence.
Key words：medical artificial intelligence；artificial intelligence ethics；artificial general intelligence；
soft law；hard law