Compliance Strategies for Mitigating AI Risk in Healthcare

Artificial intelligence (AI) is poised to transform healthcare, particularly in oncology, by supporting diagnostics, predictive analytics, and administrative tasks. However, according to an article by Foley, AI’s rapid development surpasses the creation of a regulatory framework to govern its use. This gap in regulation and the resulting AI risk in healthcare was a key topic at the September 2024 Cancer Care Business Exchange, where stakeholders discussed practical steps for implementing AI solutions responsibly.

Key considerations include ensuring compliance with privacy and security standards, as AI systems require vast amounts of data, often sourced from electronic medical records and patient portals. Providers must understand how AI solutions operate and verify vendor agreements comply with privacy laws, including HIPAA. State laws may also mandate patient notifications if AI uses personal data.

As regulatory oversight increases, the article suggests that healthcare organizations should actively monitor new AI-related laws, like those passed in Utah and Colorado, and ensure AI-driven medical devices receive necessary approvals. The FDA is working on evaluating AI medical devices but may need congressional guidance.

Healthcare providers should conduct due diligence and establish robust contracts with AI vendors to mitigate risks such as cybersecurity breaches or missed diagnoses. Contracts should cover performance expectations, confidentiality, indemnification, and liability limits. Providers should also develop strong governance frameworks to manage AI implementation, ensuring ongoing compliance and employee training.

Finally, healthcare organizations should prioritize AI solutions that enhance efficiency and improve patient care while exploring whether these solutions qualify for reimbursement from programs like Medicare and Medicaid. These steps can help mitigate AI risk in healthcare while fostering its responsible use.