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2 MIN READ

What Behavioral Health Providers Need to Know About Regulatory Changes In 2025

From HIPAA and 42 CFR Part 2 to the ONC’s Cures Act and CMS interoperability rules, providers face increasing pressure to stay compliant in a world that’s becoming more connected, data-driven, and digitally vulnerable.

Here’s what behavioral health organizations need to know now, what to watch for in the future, and how Sigmund Software’s EHR solutions can help you keep pace.

Navigating the Shifting Landscape of Compliance

Behavioral health providers operate under a unique set of regulatory demands, especially when it comes to patient privacy. HIPAA has long set the foundation for protecting health information, but 42 CFR Part 2 adds another layer of complexity for organizations dealing with substance use disorder treatment.

Recent updates from the Department of Health and Human Services (HHS) aim to better align HIPAA with 42 CFR Part 2, particularly around patient consent and redisclosure rules. The goal is to make it easier to share information across care teams while still protecting the sensitive nature of behavioral health records. These changes mean providers must ensure their systems can clearly identify and manage data protected under both sets of rules, especially as more care becomes collaborative and cross-disciplinary.

At the same time, the Office of the National Coordinator’s (ONC) Cures Act Final Rule continues to reshape expectations for information access. Behavioral health providers are now required to make clinical information, such as progress notes and assessments, accessible to patients unless there is a compelling reason to withhold it. This shift reinforces the importance of transparency and patient empowerment, but it also raises questions around clinical documentation, patient portals, and API-enabled access. With AI and algorithms becoming bigger proponents of EHR tools, the ethics behind data usage raise even more questions

Organizations participating in Medicare or Medicaid programs also need to keep pace with CMS interoperability rules, which emphasize real-time data sharing, standardized formats like FHIR (Fast Healthcare Interoperability Resources), and improved patient access. Behavioral health providers must ensure their EHR systems are equipped to meet these evolving expectations.

What to Expect in 2025

Looking ahead, several key developments are likely to shape how behavioral health organizations approach compliance in the coming year.

One major area of focus will be cybersecurity. With healthcare data breaches on the rise, and behavioral health records among the most sensitive, there’s growing momentum for new mandates around cyber resilience. Providers should prepare for increased scrutiny around risk assessments, data encryption, and employee cybersecurity training.

Artificial intelligence will also be under the microscope. As more providers adopt AI-powered tools for documentation, clinical decision support, and predictive analytics, regulators are expected to implement oversight mechanisms to ensure transparency, accuracy, and fairness. 

Behavioral health providers may soon need to document how AI tools influence care decisions and demonstrate that those tools are free from bias.

Interoperability expectations will continue to rise as the technology and platforms become more nuanced and expansive.

How Sigmund Software Supports Compliance

In this shifting environment, having the right EHR partner can make all the difference. Sigmund Software is purpose-built for behavioral health and addiction treatment providers, with compliance woven into every layer of the platform.

Sigmund is designed to help providers meet today’s regulations and adapt quickly when those rules evolve. 

Just as importantly, Sigmund’s team is committed to keeping clients informed with our 24/7 support. As new rules and policies emerge, the platform evolves to ensure your organization remains compliant without disruption to patient care.

Ready to future-proof your organization?
Contact us today to see how Sigmund can support your team.