How to Become HIPAA Compliant: 2025 Steps

HIPAA compliance is mandatory for any organization that handles protected health information (PHI)—from healthcare providers and insurers to their vendors and service partners. In 2025, stricter enforcement, evolving cyber threats, and changes in how ePHI is stored and shared make compliance more complex—and more critical—than ever.

Compliance is not optional—it’s the only way to avoid serious financial penalties.

Unintentional violations can cost between $100 and $50,000 per incident, with a yearly cap of $25,000 for repeat offenses. If the violation is due to reasonable cause, fines can escalate to $50,000 per violation, up to $100,000 annually—even without malicious intent.

To meet these expectations, organizations must go beyond basic documentation. They need thorough risk assessments, defined security policies, continuous staff training, and technical safeguards that align with the HIPAA Privacy, Security, Breach Notification, and Omnibus Rules.

In this blog, we’ll walk through the essential 2025 steps to become HIPAA compliant—from identifying risks and training employees to managing third-party exposure and preparing for potential incidents.

Understanding HIPAA in 2025

The Health Insurance Portability and Accountability Act (HIPAA) sets national standards for protecting health data and applies to both covered entities (like healthcare providers and insurers) and their business associates.

In 2025, HIPAA enforcement is shifting toward stricter, more actionable requirements (Source). Proposed updates focus on how organizations protect electronic protected health information (ePHI)—with new mandates around:

• Annual risk assessments
• Multi-factor authentication and encryption for all ePHI
• Vendor oversight, including 24-hour breach notifications
• Asset inventories and tested incident response plans

These changes reflect a move from flexible guidelines to clear, enforceable standards—making ongoing security action, not just documentation, central to compliance.

Who Must Comply with HIPAA?

HIPAA applies to two main types of organizations:

• Covered Entities: These are healthcare providers like hospitals, clinics, doctors, dentists, pharmacies, and health insurance companies. If they create, store, or transmit patient health information, they must follow HIPAA rules.
• Business Associates: These are vendors or service providers that work with covered entities and have access to protected health information (PHI). Examples include IT support companies, billing services, cloud storage providers, and legal consultants.

As of 2025, both groups are required to follow the same security, privacy, and breach notification rules. That means every organization that touches PHI—even indirectly—must ensure it’s protected.

If you handle health data, HIPAA compliance is your legal responsibility.

The 2025 Steps to Become HIPAA Compliant

Becoming HIPAA compliant in 2025 requires more than just having policies in place—it means taking ongoing, measurable actions to protect health information.

The steps outlined below reflect the latest HIPAA expectations, including updates to the Security Rule that focus on securing electronic protected health information (ePHI), managing vendor risk, and preparing for breaches.

Each step helps ensure your organization meets legal requirements and is prepared to respond quickly to threats or audits.

Step 1 – Conduct a Comprehensive HIPAA Risk Assessment

A HIPAA risk assessment is the starting point for identifying and addressing vulnerabilities in how your organization handles electronic protected health information (ePHI).

In 2025, regulators expect risk assessments to be detailed, up to date, and specific to your systems and operations. To comply, you should:

• Map where and how ePHI is stored, accessed, and transmitted
• Identify technical, physical, and administrative weaknesses
• Analyze the likelihood and impact of each risk
• Define mitigation steps and track their implementation

Your findings must be documented and reviewed regularly. This ensures your risk profile reflects current threats and system changes—and provides required evidence during an audit or investigation.

A strong risk assessment gives you a clear view of your security gaps and a plan to fix them.

Step 2 – Develop Strong HIPAA Policies and Procedures

Every organization subject to HIPAA must have documented policies and procedures that reflect how it protects protected health information (PHI). These are not optional—they are required under the HIPAA Security Rule.

Your policies must cover:

• Access control: Who can access electronic PHI (ePHI), and under what conditions
• Data handling: How ePHI is stored, transmitted, and disposed of
• Incident response: What to do if a breach or security event occurs
• Workforce training: How staff are trained on HIPAA requirements and their roles
• Vendor management: How you evaluate and manage business associates with access to PHI

These policies must be reviewed regularly, especially after any changes to your systems, processes, or workforce.

Under HIPAA regulation 45 CFR §164.316(b)(2), you are legally required to retain all documentation related to policies, procedures, risk assessments, and related activities for at least 6 years.

Creating strong, specific policies ensures you're not only compliant—but ready to act if an incident occurs or an audit takes place.

Step 3 – Implement Required Administrative, Physical, and Technical Safeguards

The HIPAA Security Rule requires all covered entities and business associates to implement three specific categories of safeguards to protect electronic protected health information (ePHI): administrative, physical, and technical.

These safeguards must be tailored to your organization’s size, complexity, and risk exposure—not taken from generic templates.

Administrative Safeguards (45 CFR §164.308)

These define how your organization manages security internally. They include:

• Appointing a security official responsible for HIPAA compliance
• Performing regular risk assessments and addressing identified gaps
• Establishing role-based access policies
• Training staff on HIPAA responsibilities and sanctions for violations
• Developing clear procedures for responding to security incidents

Physical Safeguards (45 CFR §164.310)

These address the physical protection of systems and locations where ePHI is accessed or stored:

• Limiting facility access to authorized personnel
• Securing devices and workstations used to access ePHI
• Implementing protocols for the secure disposal or reuse of hardware

Technical Safeguards (45 CFR §164.312)

These involve the systems and controls used to restrict and monitor access to ePHI:

• Assigning unique user IDs and enforcing strong access controls
• Logging and auditing all access to ePHI systems
• Encrypting ePHI during transmission and storage
• Automatically terminating sessions after inactivity

Each safeguard must be implemented with documented policies and reviewed periodically to ensure effectiveness. These are not optional—they form the backbone of HIPAA compliance and are commonly audited by regulators.

Step 4 – Train Employees on HIPAA Requirements

Employee security training is a core requirement under the HIPAA Privacy and Security Rules. All workforce members who handle protected health information (PHI) must be trained on how to protect it—both during normal operations and in response to incidents.

Training must cover:

• What counts as PHI and ePHI
• How to identify and report potential privacy or security issues
• Proper use of email, mobile devices, and systems that access PHI
• Organization-specific privacy and security policies
• Breach response procedures and consequences of non-compliance

Training should be delivered during onboarding and repeated annually or when policies change. It must also be documented to demonstrate compliance during audits.

Failure to train staff is a common root cause of HIPAA violations—especially when human error leads to data exposure.

HIPAA doesn’t mandate exact training formats, but expects content to be relevant to job roles and updated regularly. The requirement is outlined in 45 CFR §164.308(a)(5).

Step 5 – Execute Business Associate Agreements (BAAs)

Any third-party that accesses, stores, or transmits protected health information (PHI) on your behalf is considered a business associate under HIPAA. This includes IT vendors, billing services, cloud providers, and consultants.

Before sharing PHI, you must have a signed Business Associate Agreement (BAA). This legally required contract outlines:

• Permitted uses and disclosures of PHI
• Security obligations and breach reporting requirements
• Subcontractor responsibilities
• Steps for returning or destroying PHI when the contract ends

BAAs are required under 45 CFR §164.502(e) and must be reviewed regularly. Without one, your organization may be liable for any HIPAA violations caused by the vendor.

Always ensure that every partner handling PHI has a valid, up-to-date BAA in place.

Step 6 – Establish a Breach Notification Process

HIPAA requires all covered entities and business associates to have a clear, documented process for identifying, evaluating, and reporting data breaches involving protected health information (PHI).

Under the HIPAA Breach Notification Rule (45 CFR §164.400–414), organizations must:

• Assess any unauthorized access, use, or disclosure of PHI to determine if it qualifies as a breach
• Notify affected individuals within 60 days of discovering the breach
• Report breaches to the U.S. Department of Health and Human Services (HHS); immediately if it affects 500+ individuals, or annually for smaller breaches
• Notify the media if the breach affects more than 500 residents in a single state or jurisdiction
• Document the incident, risk assessment, decisions made, and actions taken

Business associates must notify the covered entity within 60 days of discovering a breach, allowing the covered entity to fulfill its own notification obligations.

Having a well-defined and tested breach response plan is critical, not just for compliance, but for minimizing impact and maintaining trust.

Step 7 – Document and Audit Compliance Activities

HIPAA requires covered entities and business associates to maintain detailed records of their compliance efforts and regularly assess the effectiveness of their security measures.

Key documentation should include:

• Risk assessments and mitigation actions
• Security and privacy policies
• Employee training logs
• Business Associate Agreements
• Breach reports and incident responses

Per 45 CFR §164.316(b), this documentation must be retained for at least six years.

Organizations are also expected to conduct internal audits to verify that policies are being followed and to identify potential gaps.

Clear records and regular reviews are essential for demonstrating HIPAA compliance—especially during investigations or audits.

Common HIPAA Violations to Avoid in 2025

HIPAA enforcement in 2025 focuses on whether organizations are actively maintaining compliance—not just having policies on paper. The most common violations stem from overlooked procedures and unmanaged risks:

• Outdated Risk Assessments: Conducting a risk analysis once, then failing to update it after system or vendor changes, remains a top compliance failure.
• Incomplete Business Associate Oversight: Having a signed BAA isn’t enough. HHS expects ongoing vendor evaluations and updated agreements as relationships evolve.
• Inadequate or Generic Training: One-size-fits-all training misses real risks. Regulators now expect role-based, up-to-date training that prepares staff to handle PHI securely.
• Excessive Access to PHI: Failing to adjust access as roles change can lead to unauthorized use—often flagged in internal audits or breach reports.
• Unencrypted ePHI on Devices or Cloud Platforms: Not encrypting ePHI significantly increases liability in a breach, especially for mobile or cloud-based systems.
• Late or Incomplete Breach Notifications: Missing the 60-day notification window, or underreporting affected individuals, often leads to escalated penalties.

Most violations result from operational gaps—not technical failures. Staying compliant means integrating privacy and security into day-to-day processes, not just relying on IT controls.

To support this shift, explore Keepnet’s guide on building a security-conscious corporate culture.

How Keepnet Helps Achieve HIPAA Compliance

HIPAA compliance requires reducing human risk across your workforce. Keepnet’s Extended Human Risk Management platform empowers organizations to build a security-aware culture with AI-driven phishing simulations, role-based training, and automated phishing response.

The platform helps organizations:

• Simulate real-world phishing threats using over 6,000 templates, including email, SMS, voice, QR code, MFA, and callback phishing
• Identify risky user behavior and deliver instant micro-training to reinforce secure actions
• Educate staff with role-specific security awareness programs, tailored to job functions and threat exposure

Keepnet’s AI-Powered Phishing Simulator and Adaptive Security Awareness Training align with HIPAA’s requirements for workforce security, breach prevention, and ongoing risk management. With targeted simulations and continuous learning, your team becomes a resilient line of defense against social engineering and insider threats.

Stay HIPAA Compliant in 2025

HIPAA compliance in 2025 means demonstrating that your safeguards, training, and policies are not only documented—but actively working.

That includes up-to-date risk assessments, role-based employee training, secured third-party relationships, and a tested breach response process.

With rising enforcement and evolving risks, organizations must stay proactive and audit-ready. The steps in this guide provide a clear path to meet HIPAA standards and reduce exposure.

Check out Keepnet’s Free Phishing Simulation Test to assess how well your employees recognize threats—and take the first step toward a stronger, HIPAA-aligned security posture.