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Regulatory Responses to AI in Healthcare and Medical Diagnostics

Regulatory Responses to AI in Healthcare and Medical Diagnostics
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Author(s): Naresh Tiwari (Cap Tech, USA)
Copyright: 2025
Pages: 34
Source title: Navigating Law and Policy in STM Enterprises: Ethical Governance, Regulation, and Innovation Strategy
Source Author(s)/Editor(s): Hewa Majeed Zangana (Duhok Polytechnic University, Iraq), Jamal Al-Karaki (Zayed University, UAE)and Marwan Omar (Illinois Institute of Technology, USA)
DOI: 10.4018/979-8-3373-4862-9.ch003

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Abstract

The integration of AI in healthcare offers transformative possibilities for precision medicine, early disease detection, and clinical decision support. However, these advancements come with significant legal, ethical, and regulatory challenges. This chapter explores global regulatory responses to AI in healthcare, analyzing approaches from the EU, US, and select Asian countries. It examines medical device regulations, data protection laws, and liability frameworks in addressing AI-enabled system risks. The chapter discusses transparency, accountability, and patient autonomy in AI deployment, providing insights for policymakers, healthcare professionals, and technology developers to balance innovation with public trust and patient safety. By identifying best practices and emerging trends, the chapter aims to foster innovation while safeguarding patient safety.

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