The healthcare industry is undergoing a rapid transformation as artificial intelligence (AI) emerges as a powerful tool for improving patient care and administrative functions. While AI holds immense promise, it also introduces significant legal and regulatory complexities. Given this complex landscape, healthcare organizations will want a rigorous due diligence process when selecting AI vendors. This due diligence process should address the intersection of the vendor and the organization's roles related to:
- Data privacy and security: Protecting patient data and compliance with regulations like HIPAA, GDPR, and CCPA.
- Regulatory compliance: Adherence to HHS, CMS, FDA, and other relevant regulatory bodies.
- Algorithmic bias and fairness: Ensuring AI models are unbiased and equitable.
- Patient safety and efficacy: Verifying the AI system's accuracy and reliability.
- Liability and indemnification: Understanding responsibility for AI-related errors or harm.
In the event of a legal dispute or claim, a well-crafted vendor contract with clear terms and conditions can provide a strong defense for your organization. Additionally, documentation of the due diligence process, including vendor assessments and evaluation criteria, can be invaluable in demonstrating your organization's commitment to responsible AI implementation.
By investing time and resources in AI vendor due diligence, healthcare organizations can significantly reduce their legal exposure. In subsequent posts, we will delve deeper into the specific steps involved in assessing AI vendors, including evaluating vendor expertise, assessing AI technology, prioritizing data privacy and security, and negotiating robust contractual protections. By following these best practices, healthcare executives can make informed decisions and reduce legal risks.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.