How to Become HIPAA Compliant: Complete 2026 Guide

Becoming HIPAA compliant means more than adding security software or asking employees to complete annual training. Organizations that handle protected health information need to understand where that information exists, assess the risks around it, put appropriate safeguards in place, manage vendors, prepare for incidents, and keep records showing that those steps are being followed.

The work also does not end after the first assessment. New employees, systems, vendors, locations, and security threats can change how protected health information is handled. HIPAA compliance needs to remain part of normal business operations.

This guide explains the main steps organizations should take to build and maintain a HIPAA compliance program in 2026.

Who Needs to Become HIPAA Compliant?

HIPAA primarily applies to covered entities and business associates. HHS states that organizations that do not meet either definition generally do not have to comply with the HIPAA Rules.

Covered Entities

Covered entities generally include:

• Health plans
• Health care clearinghouses
• Healthcare providers that conduct certain healthcare transactions electronically

Hospitals, medical practices, pharmacies, health insurers, and other healthcare organizations may fall into this category depending on how they operate.

Covered entities need to follow applicable requirements under the HIPAA Privacy, Security, and Breach Notification Rules.

Business Associates and Subcontractors

A business associate is generally a company or individual that performs certain services for a covered entity and creates, receives, maintains, or transmits protected health information as part of that work. This can include cloud providers, IT companies, billing services, consultants, data processors, and record storage providers.

Business associates may also work with subcontractors that fall under HIPAA when those subcontractors handle PHI on their behalf. Understanding the broader HIPAA compliance requirements is important because the obligations can extend beyond the healthcare provider to outside organizations that support its operations.

How to Become HIPAA Compliant in 10 Steps

There is no single document or software product that makes an organization HIPAA compliant. A practical compliance program brings risk management, security, privacy, employee processes, vendors, and documentation together.

Step 1: Identify PHI, ePHI, Systems, and Data Flows

Start by identifying the protected health information your organization handles.

Document where PHI and electronic protected health information, or ePHI, are:

• Created
• Received
• Stored
• Accessed
• Transmitted
• Backed up
• Shared with third parties

Look beyond the main electronic health record or application. PHI may also appear in email, cloud storage, laptops, mobile devices, backup systems, shared drives, support platforms, and vendor environments.

A simple data-flow map can make it easier to see how sensitive information moves through the organization and where security gaps may exist.

Step 2: Conduct a HIPAA Security Risk Analysis

The HIPAA Security Rule requires covered entities and business associates to conduct an accurate and thorough assessment of potential risks and vulnerabilities affecting ePHI.

The analysis should look at threats, vulnerabilities, existing safeguards, likelihood, and potential impact.

A broader cybersecurity risk assessment can also help identify weaknesses across systems, processes, and third-party relationships.

The goal is not to complete a template. The organization needs a clear picture of where its real security risks are.

Step 3: Create a Risk Management and Remediation Plan

Once risks are identified, decide how they will be addressed.

A remediation plan should usually include:

• The issue or risk
• Its priority
• Required corrective action
• Responsible owner
• Target completion date
• Current status
• Remaining risk after remediation

Not every weakness can be fixed at once. Prioritization should focus first on issues that create the greatest risk to the confidentiality, integrity, or availability of ePHI.

Step 4: Develop HIPAA Policies and Procedures

Policies should explain how the organization handles HIPAA requirements in everyday operations. They should cover areas such as privacy practices, information access, passwords and authentication, security incidents, device security, vendor management, data disposal, contingency planning, workforce onboarding and termination, and breach notification.

These policies should match the way employees actually work. A policy copied from another organization will have limited value if it does not reflect the systems, responsibilities, and processes used in the business.

Step 5: Implement Administrative, Physical, and Technical Safeguards

The HIPAA Security Rule organizes safeguards into three main groups: administrative, physical, and technical.

Organizations should select reasonable and appropriate protections based on their risks and operating environment.

Controls may include access management, training, facility protections, authentication, audit logging, backups, security monitoring, and protection of data during transmission.

HHS makes clear that the Security Rule requires regulated entities to protect the confidentiality, integrity, and availability of ePHI.

Step 6: Assign Privacy and Security Responsibilities

HIPAA compliance needs clear ownership.

HIPAA requires covered entities and business associates to designate a Security Official responsible for the Security Rule program, and covered entities must also designate a Privacy Official. Beyond those required roles, organizations should make clear who manages policies, incidents, training, access decisions, vendor issues, and risk management.

Smaller organizations may combine responsibilities, while larger organizations may have separate privacy, security, compliance, and IT teams.

The important point is that responsibility should be clearly assigned rather than assumed.

Step 7: Train Employees and Manage PHI Access

Employees need training that matches their responsibilities and the information they handle.

Training should cover practical issues such as:

• Appropriate PHI use
• Secure passwords
• Phishing
• Email and messaging
• Lost devices
• Unauthorized disclosure
• Incident reporting
• Privacy procedures

HHS guidance confirms that workforce security awareness and training are part of HIPAA Security Rule responsibilities.

Access should also be based on job duties. When an employee changes roles or leaves the organization, permissions should be reviewed and removed when no longer needed.

HIPAA also requires organizations to establish and enforce a sanctions policy. Organizations must apply appropriate sanctions to workforce members who fail to follow established privacy and security policies and procedures.

Step 8: Review Vendors and Sign Business Associate Agreements

Any vendor that handles PHI on behalf of a covered entity or business associate should be reviewed to determine whether a business associate agreement, or BAA, is required.

A BAA documents how PHI may be used and what responsibilities the vendor has for protecting it.

However, signing a BAA does not replace security due diligence. HHS notes that customers may seek additional assurances about a vendor’s safeguards based on their own risk management needs.

Regular vendor security assessments can help identify weaknesses before a third-party problem becomes a larger compliance issue.

Step 9: Create Incident and Breach Response Procedures

Organizations should know what to do when PHI may have been exposed, lost, accessed improperly, or involved in a cyberattack.

A response process should cover:

• Reporting the incident
• Containment
• Investigation
• Evidence preservation
• Risk assessment
• Mitigation
• Documentation
• Breach notification decisions

Under the Breach Notification Rule, covered entities and business associates have notification obligations when certain breaches of unsecured PHI occur.

Documented incident response planning helps teams make decisions faster when an actual event happens.

Step 10: Monitor Compliance and Maintain Documentation

HIPAA compliance should continue after remediation work is completed. Organizations should regularly review user access, security events, risk findings, vendors, policies, employee training, system changes, incidents, and corrective actions to make sure controls remain effective.

Keeping this information documented also provides evidence that required compliance work has been completed and makes future assessments, audits, and internal reviews easier to manage.

What HIPAA Safeguards Must Be Implemented?

The Security Rule groups safeguards into administrative, physical, and technical categories.

Administrative Safeguards

Administrative safeguards cover how security is managed.

They include areas such as:

• Risk analysis
• Risk management
• Workforce security
• Access management
• Security training
• Incident procedures
• Contingency planning
• Periodic evaluation

These controls provide the management structure behind the security program.

Physical Safeguards

Physical safeguards protect facilities, devices, workstations, and media that may contain or provide access to sensitive information. This can include facility access controls, workstation security, device handling procedures, media controls, secure disposal practices, and protections for portable equipment.

Organizations should also consider remote and hybrid work environments when evaluating physical risks, since employees may access PHI from locations outside the traditional workplace.

Technical Safeguards

Technical safeguards protect ePHI within electronic systems.

The HIPAA Security Rule requires organizations to implement technical safeguards that address the following standards:

• Access controls
• Unique user identification
• Person or entity authentication
• Audit controls
• Integrity measures
• Transmission security

Organizations must meet the Security Rule’s applicable technical safeguard requirements, with specific implementation measures determined by the rule and the organization’s risk assessment.

What HIPAA Documentation Should You Maintain?

Good documentation helps show how the compliance program works and what actions the organization has taken.

Risk Assessments, Policies, and Training Records

Keep records of risk analyses, remediation activities, policies, procedures, security evaluations, and employee training.

These records help demonstrate that compliance work is ongoing rather than limited to a one-time project.

Business Associate Agreements and Vendor Records

Maintain current BAAs as well as records showing which vendors handle PHI, what services they provide, and how their security has been reviewed.

Vendor records should be updated when services, contracts, or data access change.

Incident, Breach, and Security Documentation

Keep records of security incidents, investigations, breach assessments, mitigation activities, and notification decisions.

HHS specifically expects organizations to retain documentation showing that required breach notifications were made or why notification was not required.

How Often Should HIPAA Compliance Be Reviewed?

HIPAA does not work well as an annual checklist completed once a year. Reviews should also happen when meaningful changes occur.

When Should the Risk Analysis Be Updated?

Risk analysis should be reviewed when changes affect the organization’s security environment.

Examples include:

• New technology
• New locations
• Major software changes
• Cloud migrations
• New vendors
• Mergers
• Significant security incidents
• Changes in how ePHI is handled

HHS guidance recommends integrating risk analysis into the planning of new technologies and business operations rather than waiting until after changes are made.

When Should Training and Policies Be Updated?

Training should be provided when employees join and when their responsibilities or policies change.

Policies should also be reviewed when systems, risks, regulations, or business processes change.

Training should reflect current risks instead of repeating the same material year after year without considering how employees actually work.

Is There an Official HIPAA Certification?

Businesses often advertise themselves as “HIPAA certified,” but this wording can create confusion.

Can an Organization Become Officially HIPAA Certified?

HHS does not offer, endorse, or recognize any HIPAA certification program.

Private organizations may offer assessments, certificates, or training credentials, but these do not replace the organization’s legal responsibility to comply with HIPAA.

HIPAA compliance depends on how the organization operates and maintains its privacy and security practices over time.

How Can an Organization Demonstrate HIPAA Compliance?

Organizations can demonstrate HIPAA compliance by maintaining clear evidence of their security and privacy practices. This may include current risk analyses, risk remediation records, security policies, training records, access reviews, business associate agreements, vendor assessments, incident records, contingency plans, security monitoring, and internal review documentation.

The strongest evidence shows that policies and controls are not only documented but are also being followed consistently in day-to-day operations.

What HIPAA Changes Should Organizations Know About in 2026?

Healthcare cybersecurity remains an active regulatory area, so organizations need to distinguish between existing requirements and proposed changes.

Are the Proposed HIPAA Security Rule Changes in Effect?

As of September 2026, HHS continues to describe the cybersecurity update as a proposed modification to the HIPAA Security Rule rather than a final replacement for the existing rule.

Organizations should therefore avoid treating every proposed requirement as if it were already mandatory.

What HIPAA Requirements Apply Today?

Covered entities and business associates still need to comply with the HIPAA requirements currently in force.

That includes applicable requirements involving:

• Risk analysis
• Risk management
• Administrative safeguards
• Physical safeguards
• Technical safeguards
• Workforce security
• Incident procedures
• Business associate arrangements
• Documentation

Recent OCR enforcement also shows that existing Security Rule requirements remain active. In April 2026, OCR announced four settlements connected to ransomware investigations under the current HIPAA Security Rule.

What Are the Most Common HIPAA Compliance Mistakes?

Many compliance problems begin with gaps in basic processes rather than unusual technical failures.

Treating Risk Analysis as a One-Time Task

Completing one risk analysis and never revisiting it can leave new systems, vendors, and threats outside the compliance program.

Risk analysis should evolve with the organization.

Missing PHI Locations or Third-Party Risks

Organizations sometimes focus only on their main healthcare platform and overlook PHI stored in email, cloud applications, backups, laptops, support tools, or vendor systems.

Those overlooked environments can create significant exposure.

Using Outdated Policies or Incomplete Documentation

Policies that no longer match actual operations can make compliance harder to demonstrate.

Documentation should reflect current systems, responsibilities, vendors, and procedures.

How Nexeris Helps Organizations Become HIPAA Compliant

Building a HIPAA compliance program can be difficult when security, vendors, documentation, policies, and employee responsibilities are handled separately.

Nexeris helps organizations identify where ePHI is stored, review risks, find control gaps, organize policies, prepare documentation, and create a practical remediation plan.

Working with a HIPAA compliance consultant can also help teams understand what work needs to happen first and build a compliance process that can be maintained as the organization grows.

FAQs

How Do You Become HIPAA Compliant?

Start by determining whether HIPAA applies, identifying PHI and ePHI, completing a risk analysis, fixing security and privacy gaps, creating policies, training employees, reviewing vendors, signing required BAAs, preparing for incidents, and maintaining ongoing records.

How Long Does It Take to Become HIPAA Compliant?

There is no fixed HIPAA compliance timeline. A smaller organization with mature security controls may need less remediation, while a larger organization with multiple systems, vendors, and documentation gaps may require significantly more work.

Is a HIPAA Risk Analysis Required?

Yes. Covered entities and business associates subject to the Security Rule must assess potential risks and vulnerabilities affecting ePHI.

Does HIPAA Require Employee Training?

Yes. HIPAA includes workforce training and security awareness requirements. Training should reflect employee responsibilities and the risks they may encounter.

Do Business Associates Need to Be HIPAA Compliant?

Yes. Business associates have direct responsibilities under certain HIPAA requirements and can be held responsible for violations involving PHI.

Is There an Official HIPAA Certification?

No. HHS does not offer or recognize any HIPAA certification, and a private “HIPAA certified” credential does not establish compliance.

How Long Must HIPAA Documentation Be Retained?

Required Security Rule documentation generally must be kept for six years from the later of the date it was created or the date it was last in effect.

This applies to HIPAA compliance documentation such as policies, risk analyses, and training records. It is not a medical records retention requirement, which is generally set by state law.