Our inaugural survey of healthcare compliance and life sciences professionals reveals an industry on the brink of crisis. As rapid technological change and mounting cyberattacks collide with limited budgets and complex regulatory frameworks, leaders are left scrambling to maintain patient data security — and quality of care. Barnes & Thornburg surveyed 120 healthcare compliance, risk and legal leaders across U.S.-based healthcare and life sciences organizations, including hospital systems, physicians’ practices, and pharmaceutical, biotech and medical device manufacturers. Their answers reveal how those leading or supporting compliance and risk matters – CEOs, chief compliance officers, chief risk officers and in-house counsel – are meeting this particular moment.

What are healthcare compliance leaders facing in 2025?

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Key Findings From Barnes & Thornburg’s Healthcare Compliance Outlook

More than half of healthcare compliance and risk leaders say they struggle to allocate appropriate resources to keep up with security risks. 56 percent say they anticipate more challenges in the future than they already have.

Less than half of survey respondents are “very confident” about maintaining a high quality of care given compliance demands. A further 54 percent of respondents are seeking or considering private equity investments to provide their organizations with the necessary resources to maintain a high quality of care.

AI’s promise to speed up the internal legal compliance function is of particular interest, with most AI applications targeting data analysis, risk assessments and/or administrative tasks. And while the gains have potential to be huge, the costs are adding up. Of the 75 percent of survey respondents who are using or exploring AI, 60 percent expect it to add more than 10 percent to their budget in 2025.

Cybersecurity threats like ransomware attacks and patient data breaches are a big concern. Maintaining regulatory compliance is also necessary. Adding AI to those tech issues could have unforeseen consequences.

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AI, Budgets and Evolving Risk: Healthcare Regulations and Compliance in 2025

Healthcare organizations have difficulty keeping up with regulations and security risks amid rising labor and technology costs.

Resource constraints are causing respondents to question whether they can continue to deliver quality of patient care.

Generative and predictive AI are being adopted across the industry.

While AI could help to alleviate some labor costs, there is no consensus on the ethical use of the technology.

Partner and Chair of Barnes & Thornburg’s Healthcare Department and Healthcare Industry Practice

John E. Kelly

Healthcare compliance professionals are dealing with expanding areas of risk, even as many report resource constraints that could limit their ability to meet challenges. These pressures underscore the need for organizations to adopt a robust compliance strategy to stay ahead of the curve.

Report resource restraints

Feel very prepared to meet compliance and risk challenges

3/4 of survey respondents are using or considering AI

Of respondents say developing an AI governance structure is difficult

Partner and Co-Chair of Barnes & Thornburg’s Data Security and Privacy Practice

Brian J. McGinnis

The rapid expansion of AI and digital health offers ample opportunities to enhance patient care and access. But organizations must establish guardrails to protect against associated risks, including cybersecurity and data threats, and ensure secure and ethical use of this powerful technology.

2025 Healthcare Compliance Outlook