DOJ Targets AI Tools and Third-Party Risks in Healthcare Enforcement
The Department of Justice recovered a record $6.5 billion in False Claims Act settlements during 2025, with 83% tied to healthcare cases. The enforcement surge signals that compliance scrutiny remains a top priority regardless of administration changes, according to legal experts who discussed 2026 enforcement trends at the Access USA conference.
Whistleblowers are driving the enforcement wave. Of the $6.5 billion recovery, 75% came from qui tam filings-lawsuits brought by current or former employees. These cases often trigger DOJ healthcare fraud investigations and reveal internal noncompliance that companies missed.
Third-Party Exposure
Patient support programs frequently rely on external entities like hubs, foundations, and vendors. These third parties introduce compliance risks that companies cannot fully control.
A manufacturer may maintain a compliant program internally while third-party partners operate with minimal oversight. Regulators hold companies accountable for partner behavior regardless of contractual disclaimers. Third parties have sometimes acted as conduits for kickback schemes, allowing manufacturers to mask activities they could not undertake directly.
The DOJ's compliance guidance recommends clear communication of expectations to third parties and ongoing monitoring of their activities. Companies cannot transfer their compliance responsibility to outside vendors.
AI Tools Present Hidden Risks
Half of healthcare professionals surveyed at the conference identified AI for Healthcare tools as the greatest enforcement risk in patient support programs for 2026. The concern centers on opacity-companies may not fully understand how their AI systems influence provider and patient decisions.
AI tools can subtly nudge decisions through modeling that even developers don't fully grasp. When regulators examine these systems, they may find anti-kickback violations or healthcare fraud risks that the company never intended. A provider decision influenced by an AI algorithm in ways no one can fully explain raises immediate red flags.
Companies should thoroughly understand their AI tools before deployment. Testing against AI for Legal and compliance principles before market release prevents costly enforcement actions later.
More than 40% of conference attendees said their organizations feel very prepared for DOJ scrutiny. The remainder reported moderate or limited readiness, suggesting many healthcare companies still have work to do on compliance infrastructure.
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