2025 Regulatory Outlook: Key Legislation Set to Shape Healthcare

As the year moves ahead, I expect the healthcare regulatory landscape to rapidly evolve, shaped by new policies and a changing administration. These shifts will bring challenges and opportunities as organizations navigate legislation impacting everything from public health and cybersecurity to artificial intelligence (AI) and data access. Here’s a look at some of the key regulatory trends to watch this year.

1. Public Health Initiatives: A Healthier Future

A renewed focus on public health, spurred by vocal advocacy over the past year, is expected to bring significant policy changes. These may include updated nutritional standards in schools, greater transparency in food labeling, and initiatives aimed at combating chronic health conditions.

These measures not only promote healthier lifestyles but also have long-term implications for healthcare costs and outcomes. By addressing the root causes of poor health through education and regulation, we hope to see a healthier population and reduced strain on healthcare systems.

2. Cybersecurity: Securing Patient Data in a Digital Age

The rise in healthcare data breaches—up 264% in large incidents since 2018—underscores the urgent need for enhanced cybersecurity measures. In 2025, the industry should expect to see regulations aimed at:

• Strengthening data protection standards.
• Embedding security protocols within software.
• Mandating more rigorous employee training to mitigate human error, a leading cause of breaches.

Healthcare organizations must also embrace proactive measures, such as phishing simulations and ongoing staff education, to build a robust defense against evolving threats. These initiatives reflect a broader trend of protecting patient data while enhancing access and interoperability.

3. AI in Healthcare: Balancing Innovation and Risk

Artificial intelligence continues to transform healthcare by streamlining diagnostics and identifying anomalies faster than ever. However, the unregulated growth of AI also introduces risks, such as deepfakes and AI-enabled cyberattacks.

In 2025, expect clearer guidelines on:

• Where AI can be deployed in healthcare workflows.
• The need for human oversight in critical decision-making.
• Standards for AI transparency and accountability.

Striking a balance between harnessing AI’s potential and mitigating its risks will be a pivotal challenge for regulators and healthcare organizations alike.

4. Interoperability: Driving Industry-Wide Collaboration

Interoperability standards like FHIR remain central to improving data exchange across the healthcare ecosystem. However, achieving widespread adoption will require inclusivity, bringing smaller players and diverse voices to the table.

By involving a broader range of stakeholders, regulators can ensure that new standards are not only functional but also widely accepted. This collaborative approach will help build trust, drive adoption, and unlock the full potential of interoperability.

Opportunities Amid Change

While regulatory changes can be daunting, they also open doors for innovation and collaboration. For example:

• The push for cybersecurity enhancements creates opportunities for technology companies to develop advanced security solutions.
• AI regulations will spark discussions on ethical usage, paving the way for new tools that prioritize patient safety.
• Inclusive interoperability efforts will foster partnerships between established players and emerging innovators.

Preparing for the Future

As healthcare professionals, we must stay informed about these regulatory shifts and proactively adapt to new requirements. By embracing change, prioritizing education, and leveraging technology, we can drive meaningful improvements in patient care and system efficiency.

2025 promises to be a year of transformation for healthcare. Let’s seize the opportunity to innovate and collaborate, ensuring a brighter, healthier future for all.?

To hear more from Kel on this topic, tune in to her appearance on a recent episode of Health Now’s Walking the Talk podcast.

Kel Pults, DHA, MSN, RN, NI-BC, NREMT is the Chief Clinical Officer & VP, Government Strategy at MediQuant, where she leads efforts to build the most effective health information technology to support clinical data management solutions.