Healthcare Compliance Trends & Statistics

What Are Healthcare Compliance Trends?

Healthcare compliance trends refer to the evolving regulations and standards that guide patient information protection, ethical practices, and high-quality care. Non-compliance can lead to legal issues, reputational damage, and financial penalties. 

Because the Department of HHS regularly updates its guidelines, professionals must stay current on any changes affecting their practice. Below are the top compliance trends to help you remain informed.

Top Healthcare Compliance Trends To Watch Out For

If you want to stay on top of things in healthcare compliance, it’s important to focus on the trends shaping the industry. These trends highlight where changes are happening, helping you make smart decisions while avoiding risks. Let’s take a look at what’s coming up. 

1. Regulatory Changes and Updates

To start, healthcare regulations are constantly evolving, and professionals should keep a close eye on directives from the Department of HHS. 

Recent revisions include adjustments to Medicare Advantage rules and expanded recommendations for establishing compliance programs, especially important for providers entering the field. 

Some of the other key changes are:

• Healthcare transaction review laws. Several U.S. states have implemented healthcare transaction review laws (also known as “mini-HSR” laws) to regulate consolidation in the industry. In early 2024, more states introduced rules requiring notice and, in some cases, approval for pending healthcare deals.
• California’s new healthcare regulations. AB 853 (effective January 1, 2024) mandated a 180-day notice for transactions involving retail drug firms. AB 3129 (introduced February 16, 2024) proposed restrictions on management-services models and would require 90 days’ notice to the California Attorney General for transactions involving private equity and healthcare providers.
• Federal actions on data protection and privacy. On February 28, 2024, President Biden issued an Executive Order to safeguard sensitive personal data from foreign exploitation.
• Confidentiality of Substance Use Disorder (SUD) Records. On February 8, 2024, the HHS finalized changes to the Confidentiality of Substance Use Disorder Records, aligning them more closely with HIPAA rules, introducing civil and criminal enforcement, and simplifying consent processes.
• Final HIPAA Privacy Rule. On April 22, 2024, the HHS Office for Civil Rights released the final HIPAA Privacy Rule to protect reproductive healthcare privacy, limiting how covered entities can use and disclose protected health information.
• State-level consumer health privacy laws. On March 31, 2024, Washington and Nevada’s health privacy laws took effect, requiring consumer consent for certain data collection, sharing, or selling. These laws also ban geofencing-based marketing around healthcare facilities. While they don’t apply to HIPAA-regulated PHI, covered entities may still be impacted.

2. Focus on Proactive Compliance

Moving forward, there is a growing shift from reactive strategies toward proactive measures. This change emphasizes identifying potential legal or regulatory issues before they escalate. 

As part of this approach, organizations often conduct periodic internal audits, review and refine their policies, and train staff on emerging requirements.

3. Interoperability Redefines Healthcare Connectivity

Interoperability has become a focal point in healthcare, where siloed health information often limits providers’ ability to anticipate member needs and offer timely interventions. In recent years, there has been a marked increase in the use of digital health tools and their integration into care management.
Looking ahead, 2025 is shaping up as a key year for assessing progress in interoperability and payer technology adoption, driven by evolving regulatory requirements. 

By January 2027, real-time data exchange through Application Programming Interfaces (APIs) will become enforceable, setting a new benchmark for seamless communication among patients, providers, and payers.

4. Corporate Social Responsibility and Ethical Practices

Alongside the push for better connectivity, there is a growing emphasis on CSR and ethical decision-making. 

Healthcare organizations are examining how their operations affect patient care and overall organizational ethics. 

As scrutiny increases, maintaining transparency and responsible conduct will remain essential for fostering trust and meeting regulatory obligations.

5. Modernizing Prior Authorization Processes

Another major focus for regulatory developments in 2025 is the overhaul of prior authorization processes, which are currently paper-heavy and prone to delays. These inefficiencies not only prolong patient wait times but also strain resources for both payers and providers.

Important milestones include 2025 as a preparation year, during which health organizations will observe progress and identify areas needing further improvement ahead of final enforcement in 2027. 

Meanwhile, 2026 will emphasize building APIs that align with advanced Explanation of Benefits (EOB) requirements, paving the way for more streamlined and efficient prior authorization workflows.

6. Whistleblower Protection and Anti-Retaliation

Organizations need a clear anti-retaliation policy backed by regular training on internal procedures and relevant external laws. Employees should understand how to use both internal reporting systems and external whistleblower programs. 

It’s also critical to ensure those who report issues are not treated differently from others involved in the situation, reinforcing trust and transparency within the organization.

7. Artificial Intelligence (AI)

Due to the expanding use of different technology systems, the risk of data privacy and security breaches grows. In response, AI in healthcare is transforming how the healthcare sector detects Fraud, Waste, Abuse (FWA), and early spending patterns. 

Patient Compliance Trends

The way patients interact with healthcare systems has changed drastically, and a big part of that can be credited due to digitization. Doctors, nurses, and patients now communicate faster, access records instantly, and benefit from more accurate diagnoses thanks to digital healthcare advancements. 

But as much as this has improved patient care, it also means data security has to be stronger than ever. Hence, these are the trends we will be observing in 2025 regarding patient compliance:

1. Multi-Factor Authentication (MFA)

Passwords alone are no longer enough to protect sensitive healthcare data. Hackers are getting smarter, and stolen passwords are one of the easiest ways they gain access. That’s where MFA comes in.

As it requires at least two factors, MFA makes it much harder for unauthorized users to get into medical systems. Healthcare providers must apply different MFA methods to protect patient records, billing information, and internal systems from attacks.

2. Biometric Security and Secure Access Service Edge Solutions

With so much patient information stored digitally, security has to go beyond passwords and PINs.

This means using fingerprints, facial recognition, iris scans, or even voice authentication to verify identity. Only authorized personnel can access patient data, significantly reducing the risk of leaks or breaches.

As for SASE (Secure Access Service Edge) solutions is an advanced security network that ensures only approved users and devices can access healthcare systems.

Biometric security combined with SASE solutions is helping hospitals, clinics, and medical professionals keep patient data secure, both from external hackers and unauthorized internal access.

3. Medical Device Security and Regulations

Modern healthcare relies heavily on connected medical devices, from heart monitors to insulin pumps to remote diagnostic tools. While this improves patient care, it also introduces cybersecurity risks.

For example, strict regulations in Australia and New Zealand now govern medical device security, ensuring manufacturers design medical devices with cybersecurity in mind.
Also, they have standardized security protocols to protect patient data.

If a connected medical device is compromised, it’s not just a data breach, it’s a patient’s health at risk. That’s why regulations ensure devices remain safe, private, and secure.

4. Digital Health Monitoring

Mobile applications and cloud-based platforms are giving patients and healthcare providers real-time data on medication use, side effects, and outcomes. This type of tracking fosters accountability and helps practitioners adjust treatments swiftly.

5. Wearable or Smart Devices

New wearable technologies provide timely reminders, measure physiological parameters, and even deliver medications automatically. This continual feedback loop allows individuals to remain on schedule without manual prompts.

6. Personalized Dosage Forms

Tailoring medication strengths, formulations, and delivery mechanisms based on genetic or lifestyle factors supports more precise therapies. Personalization can address individual barriers to compliance, such as tolerance issues, leading to greater treatment success.

7. AI in Medical Devices

With AI becoming a key player in healthcare, regulatory bodies are stepping in to ensure its safe and effective use. The FDA has introduced a framework specifically for AI/ML-based medical devices, focusing on transparency, patient safety, and continuous learning. 

On a global level, the EU’s Medical Device Regulation (MDR) has also set strict standards to ensure AI-driven devices are both safe and effective.

8. Tougher Post-Market Surveillance Requirements

Regulations around post-market surveillance have become stricter. Once a medical device hits the market, companies must actively monitor its performance and report any safety concerns. 

Regulatory bodies like the FDA, the EU MDR, and the EMA now require more detailed data collection, adverse event reporting, and proactive risk management. This ensures that any potential device issues are addressed quickly to protect patient safety.

9. Global Regulatory Harmonization

Medical device manufacturers often deal with multiple regulatory frameworks across different countries. 

To simplify this, organizations like the International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Program (MDSAP) are working on global harmonization. 

Standardized regulations make it easier for companies to get approvals across multiple markets while maintaining high safety standards.

10. The Rise of Software as a Medical Device (SaMD)

Software as a Medical Device (SaMD) is gaining traction, thanks to the growth of digital health. It plays a crucial role in the form of diagnostic tools, remote monitoring apps, or AI-powered treatment solutions. 

Regulatory agencies recognize the unique challenges of software-based medical devices and have introduced specific guidelines to ensure their safety, effectiveness, and compliance. 

The FDA and EU MDR have both laid out clear frameworks to regulate SaMD, ensuring these digital tools meet the same rigorous standards as traditional medical devices.

Healthcare Compliance Statistics

As of 2025, healthcare compliance is going through a spiral of improvements shaped by technological advancements, evolving regulations, and persistent security challenges. Key trends include:

Escalating Data Breaches and Cyberattacks

1. More than half of surveyed healthcare professionals cite external data breaches as a top risk (56%), closely followed by ransomware threats (52%) and HIPAA violations (49%).
2. One major breach reported earlier this year affected around 100 million individuals, highlighting the sheer scale of potential harm to patient data. [1]
3. In just the first half of the year, over 31 million people were impacted by the ten largest breaches in healthcare. This figure may rise as major events like the Change Healthcare ransomware attack unfold. [1]
4. Healthcare organizations encounter an average of 1,426 breach attempts every week. [2]
5. Around 68% of healthcare entities experienced a supply chain attack in 2024. Of those, 82% reported disruptions in patient care. [3]

Gaps in Risk Auditing

6. Only 48% of healthcare organizations audit high-risk areas, and even fewer partner with external experts or industry peers to enhance their compliance strategies. [1]
7. Without regular audits, organizations leave themselves vulnerable to data breaches, fraud, and potential regulatory fines. [1]

AI Adoption in Healthcare

8. Although AI has garnered attention across many industries, its effects in healthcare remain relatively modest. Unlike sectors such as finance or retail, healthcare’s focus on patient care often slows the adoption of new tech. [1]
9. This trend is expected to continue into the coming years, as many healthcare organizations prioritize clinical outcomes over the latest technological innovations. [1]

Phishing: A Persistent Threat

10. More than 90% of cyberattacks in healthcare are phishing attempts. In many cases, these incidents lead to severe data breaches or system compromises. [4]
11. Attacks include standard phishing emails (71%), spear-phishing (67%), and less common tactics such as vishing (27%), whaling (27%), and deepfakes (2%). [5]

Under-Resourced Cybersecurity Efforts

12. Over half (56%) of healthcare providers allocate less than 10% of their IT budget to cybersecurity. Nearly 41% believe they don’t have enough funding to establish an effective security strategy. [5]
13. More than half (53%) of organizations say they lack sufficient in-house cybersecurity expertise, and nearly half (46%) face limited overall IT staffing. [5]

Legacy Systems and Medical Device Security

14. Outdated operating systems or unsupported software were the initial access points in nearly a quarter (24%) of severe security breaches. [5]
15. Around 39% of healthcare cybersecurity professionals are deeply worried about legacy technology, with about half reporting that over 10% of their infrastructure is outdated. [5]
16. Only about half (51%) of organizations explicitly address medical device security in their broader cybersecurity plans. [5]

Ransomware and Insurance Challenges

17. Not all ransom payments are covered by cybersecurity policies; only 47% of healthcare entities report that their insurance pays out in these scenarios. [5]
18. Ninety percent of private healthcare organizations say ransomware attacks have directly affected their business and revenue. [5]
19. Recovery costs are twice as high for organizations lacking reliable backups. [6]
20. The average ransom payment grew by 10% in 2024, reaching $4.88 million. [7]
21. Data loss or exfiltration in 2024 had a harsher effect compared to 2023, increasing mortality rates by 4% and treatment delays by 3%. [8]

Backup and Incident Response

22. Over one-third (37%) of IT and security professionals note that their organizations don’t consistently back up sensitive information. [5]
23. Only half of the healthcare institutions perform regular cybersecurity audits and just 37% run annual incident response exercises. [5]

Employee Awareness and Insider Risks

24. Even though three-quarters of healthcare staff have some form of cybersecurity awareness training, one in four still believes they need additional instruction but haven’t been offered any. [5]
25. Nearly a third of healthcare employees do not know if their workplace has a formal cybersecurity policy. [5]
26. About 20% of breaches in healthcare settings involve insiders who aren’t even direct employees, underscoring the need for rigorous vendor and contractor oversight. [5]
27. Healthcare is projected to spend more than $125 billion on cybersecurity between 2020 and 2025, with an estimated annual growth of around 15%. [5]

Protect Your Organization, Collaborate with IS Partners Today!

The healthcare sector experiences more security breaches than any other industry, according to the HIPAA Journal. These breaches often involve protected health information (PHI) or personal health information (commonly referred to as ePHI when in electronic form). 

PHI includes patient and doctor records, test outcomes, prescriptions, and personally identifiable information (PII) such as names, addresses, or social security numbers.

Regulatory frameworks like HIPAA, HITRUST, SOC Healthcare, and HITECH guide healthcare entities in upholding strict security and privacy standards. IS Partners supports organizations by creating tailored compliance strategies, strengthening data controls, and embedding patient-oriented safeguards. 

This enables healthcare providers like you to pursue AI innovations without compromising on vital regulatory commitments.

Ready to bolster your healthcare cybersecurity strategy? Contact IS Partners today to get started.

References

1. https://www.ajmc.com/view/2025-outlook-tackling-ai-cybersecurity-and-regulatory-challenges 
2. https://www.hipaajournal.com/healthcare-data-breach-statistics/ 
3. https://www.securitymagazine.com/articles/101118-68-of-healthcare-workers-experienced-a-supply-chain-attack 
4. https://www.techmagic.co/blog/cyber-attacks-in-healthcare 
5. https://www.hipaajournal.com/healthcare-cybersecurity/ 
6. https://news.sophos.com/en-us/2024/03/26/the-impact-of-compromised-backups-on-ransomware-outcomes/ 
7. https://blog.barracuda.com/2025/01/09/2024-by-the-numbers 
8. https://www.businesswire.com/news/home/20241008377345/en/Third-Annual-Ponemon-Institute-Report-Nearly-Seven-in-10-Healthcare-Organizations-Experienced-Disruption-to-Patient-Care-Due-to-Cyber-Attacks