AI in healthcare raises complex legal issues, particularly in data privacy, intellectual property, and regulatory compliance. Compliance with laws such as the Health Insurance Portability and Accountability Act (HIPAA) in the U.S. and the General Data Protection Regulation (GDPR) in Europe is crucial to protect patient data. These laws require stringent measures for handling electronic health records, ensuring that AI-driven technologies do not violate patient confidentiality or expose sensitive data to unauthorized access. Additionally, liability concerns arise when AI-driven diagnostic tools provide incorrect recommendations, leading to potential malpractice claims (Computer, 2024). If an AI system misdiagnoses a patient, determining who is legally responsible—the physician, hospital, or AI developer—can be challenging. Intellectual property (IP) rights also present a major challenge in AI-driven healthcare. Companies investing in AI models for disease diagnosis or treatment recommendations seek to patent their innovations. However, legal frameworks struggle to define ownership over AI-generated insights, especially when multiple stakeholders contribute to AI model development. Furthermore, cross-border regulations complicate AI deployment in international healthcare markets. A system trained in one country may not comply with another's data protection laws, limiting AI’s scalability across different jurisdictions. Another legal concern is informed consent. Traditional medical procedures require patients to understand potential risks and benefits before receiving treatment. However, AI decision-making can be opaque, making it difficult for patients to fully grasp how AI influences their care. If a treatment plan is suggested by AI, should patients have the right to decline AI-based recommendations? Addressing these legal challenges requires updates to existing healthcare regulations and the creation of new laws that specifically govern AI-driven medical applications. Future policies should focus on liability distribution, data protection, and transparency to foster trust in AI-powered healthcare solutions.
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