Recent developments suggest that major health care and life sciences organizations are expanding their use of AI beyond trial initiatives and targeted applications, while federal and state policymakers struggle to develop clear and consistent rules. As a result, health care providers must address growing AI-related risk through existing compliance, contracting, and operational controls.
Despite AI's rapid integration into health care, however, federal policy concerning AI remains largely unsettled. On
The practical takeaway for health care providers, health tech companies, and life sciences organizations is that they should not wait for comprehensive AI-specific regulation before strengthening internal AI controls. In our view, organizations should assume that AI-related risk may already be present in technology contracts and operational workflows, even where the contracts or workflows do not expressly reference AI. Existing agreements also may not clearly address vendor use of customer data, whether vendors can introduce new or expanded AI-enabled functionality through updates, or responsibility for AI-generated outputs. Likewise, these agreements may not clearly align with HIPAA-related obligations where protected health information is involved.
What Health Care Providers Should Do Now:
While health care providers should work toward the development of a formal AI policy, they should first consider conducting a targeted review of current vendor contracts, governance processes, and operational workflows through an AI lens. That review should assess data-use rights, whether vendors can introduce new or expanded AI-enabled functionality through updates, allocation of responsibility for AI-assisted outputs, audit and termination rights if AI-related use exceeds permissible parameters, and consistency with HIPAA-related obligations where protected health information is involved.
Providers should also identify where AI is already being used internally, what data supports these tools, how outputs are validated before operational or clinical reliance, and whether personnel understand the limits of AI-assisted tools in documentation, reimbursement, and patient-facing settings. Taking those steps now could significantly reduce the likelihood that unresolved AI issues will emerge later in negotiations, implementations, audits, or enforcement activity.
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Footnotes
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2. The White House, President Donald J. Trump Unveils National AI Legislative Framework (
3. See, e.g., FDA, FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices (
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