Summary: Kodiak Solutions’ annual Top Risks list reveals generative AI oversight, cybersecurity threats, and regulatory compliance as key challenges for health systems in 2025. Robust internal auditing helps prevent small problems from escalating, guiding improvements in training, policies, and processes. Ensuring data security and adhering to federal guidelines are essential priorities.

Key Takeaways:

  • Evolving technologies like generative AI demand proactive, strategic oversight to maintain data integrity and patient safety.
  • Comprehensive internal auditing and vigilant compliance with federal regulations help healthcare organizations mitigate risk, prevent costly penalties, and maintain operational stability.

Kodiak Solutions released its annual Top Risks list, finding that overseeing the use of generative artificial intelligence, enhancing cybersecurity, and ensuring compliance with a host of federal healthcare regulations as some of the lead issues facing health systems in 2025.

Kodiak Solutions developed its annual Top Risks list based on discussions with leaders of many of the largest U.S. hospitals and health systems, and risk assessments or audits at hundreds of hospitals, health systems, medical practices and other provider organizations.

“Our annual Top Risks report illustrates the wide range of risks that are keeping leaders of hospitals and health systems awake at night,” said Dan Yunker, senior vice president, risk and compliance, at Kodiak Solutions. “The ripple effects these risks can cause across a provider organization underscore the need for vigilance to keep problems from becoming entrenched in processes and systems.”

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Generative AI, machine learning, and other forms of AI offer great promise to health systems to enhance efficiency, offer greater convenience to patients and reduce burdens on clinicians. But Kodiak found that the growing use of AI comes with many significant potential risks that must be avoided or mitigated. The report suggests that internal auditors should consider audits in several areas to gauge their preparedness, including:

  • Quality and integrity of existing data sets
  • Cross-functional process development and oversight
  • Testing, governance, policies and legal frameworks for the use and fairness of generative AI
  • Resource training and support of AI-driven processes for adoption of safe and responsible use to ensure patient safety and security

Kodiak’s risk management experts also identified revenue cycle and workforce challenges as other financial/operational challenges that deserve heightened oversight.

Rising Cybersecurity Threats

Hospitals, health systems and medical providers face rising cybersecurity risks directly to their own information systems and, increasingly, from their exposure to attacks made on their vendors, according to the company. The Change Healthcare data breach, and resulting shutdown of payments for many healthcare providers, illustrated the significant financial losses that provider organizations can sustain during a third-party cyberattack.

Other information technology top risks identified by Kodiak Solutions also are related to cyberattacks. Business continuity capabilities are needed to aid in recovery from cybersecurity incidents. System access management and biomed device security are both aspects of preventing attacks.

Compliance Challenges

Kodiak’s audits and discussions with leaders over the past year highlighted the growing, fast-changing compliance risks with the No Surprises Act, the 340B drug discount program and price transparency regulations. Failing to maintain compliance in any of these areas can lead to significant monetary penalties. In the case of the 340B program, poor compliance can lead to repaying discounts to drug makers and even expulsion from the program.

“Robust internal auditing serves as the last line of defense before small issues grow into large problems that can threaten the health of the enterprise,” Yunker said. “Internal auditing also provides the road map for enhancing training, policies and processes to ensure greater compliance going forward.”