The rise of AI in healthcare offers transformative possibilities but poses significant legal and regulatory risks. Stakeholders must actively navigate this complex landscape by implementing robust AI compliance programs. Key opportunities in AI include advancements in predictive analytics, enhancing patient safety and operational efficiency. However, misuse or lack of monitoring may lead to significant patient care and liability issues, including violations of the False Claims Act (FCA). AI diagnostics, while innovative, require human oversight to mitigate risks of misdiagnosis and coding errors. Privacy and data security remain critical concerns, especially given the increasing number of data breaches. Recent state and federal legislation, such as California’s SB 1120 and Virginia H 2154, aims for transparency and bias mitigation in AI use. To ensure compliance, healthcare organizations should establish governance committees, create comprehensive policies, and conduct regular audits and training. Staying ahead of regulatory changes is essential for leveraging AI while managing risks effectively.
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Navigating Opportunities, Enforcement Risks, and False Claims: The Imperative for AI-Specific Compliance

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