Legal Readiness for AI in Healthcare: A Provider’s Quick Guide

Artificial Intelligence (AI) continues to revolutionize industries and is poised to bring transformative change in healthcare delivery, drug discovery, diagnostics, and data analysis and communication. This technology is exciting and offers tremendous possibilities for both patients and providers. With new technologies, however, there are new risks and rewards to consider. Healthcare providers must carefully consider the legal implications of incorporating AI tools into their operations and clinical practices. A few key areas stand out at present:

• Patient data privacy and security remain paramount. Healthcare providers are subject to stringent federal and state regulations, such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Any AI system with access to Protected Health Information (PHI) must meet rigorous standards for data protection. As part of compliance with the Security Rule and the Privacy Rule, AI tools that process PHI should be designed and/or implemented in a manner that follows HIPAA use and disclosure rules, and employs robust encryption, access controls, and compliance checks to avoid potential breaches and costly penalties.
• The adoption of AI raises important questions about malpractice liability and accountability. The accuracy and reliability of AI-powered diagnostic tools, treatment recommendations, or patient monitoring systems are critical to patient outcomes. Institutional-level providers, group practices, and individual practitioners must carefully assess the risk of error and ensure that appropriate safeguards are in place, such as human oversight and ongoing validation, to minimize the likelihood of errors. Additionally, healthcare providers may need to revise their malpractice insurance policies to address potential legal liability if AI tools contribute to adverse patient outcomes. Providers and insurers will need to reach a consensus as to which responsibilities lie with the AI software developers, the healthcare providers, or both.
• Healthcare providers must also be mindful of regulatory approvals and ethical considerations when integrating AI into clinical practice. AI-based medical devices or software may require approval from regulatory bodies such as the U.S. Food and Drug Administration (FDA) before being used in patient care. Additionally, healthcare providers must ensure that AI algorithms are unbiased and transparent in their decision-making processes. This may require ensuring that regular audits are conducted, using true random samples of patient populations in training data, and implementing safeguards to prevent algorithmic discrimination or other outcomes that violate established and accepted provider standards regarding the rights, informed consent, and well-being of patients. Navigating these complex legal and ethical considerations is essential for healthcare stakeholders and businesses of all kinds to successfully and safely adopt AI technologies.

For more information and legal insights as to how AI may affect your business, please contact Andrew A. Ferrer in Verrill’s Boston office or another member of our Artificial Intelligence & Emerging Technologies group.