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The Health Insurance Portability and Accountability Act (HIPAA) is a multilayered framework that establishes federal standards for protecting and preventing disclosure of protected health information (PHI) without a patient’s consent. Compliance with HIPAA is mandatory, and organizations must implement and manage various policies and procedures to meet its requirements.
Due to its broad scope, HIPAA was designed to be flexible and scalable. While it sets clear requirements for protecting PHI, it doesn’t provide clear guidance on how to comply with them. Instead, it allows organizations to determine appropriate policies and procedures based on their risk environment and needs.
This guide will help you effectively develop and manage HIPAA policies and procedures. We’ll outline:
- Why HIPAA policies and procedures matter
- How to create them
- Best ongoing policy and procedure management practices
What are HIPAA’s policies and procedures?
HIPAA policies and procedures are formal, documented guidelines and practices that outline how an organization complies with HIPAA requirements. Both covered entities and business associates must implement, update, and manage policies and procedures to ensure the safety and integrity of PHI.
While policies and procedures are often referenced together, they serve slightly different purposes:
- Policies set high-level expectations for how PHI must be handled
- Procedures provide actionable steps that employees must follow when processing PHI
To fully comply with HIPAA, you must follow its “Rules,” which are standards added to HIPAA over time that outline the policies and procedures for handling PHI. Each rule plays a key role in PHI management, but the three core ones are the Privacy Rule, the Security Rule, and the Breach Notification Rule.
See examples of policies and procedures from each of these three rules below:
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
Why do HIPAA policies and procedures matter?
While implementing policies and procedures is mandatory for HIPAA compliance, this isn’t the only reason to implement them. When properly developed, policies offer several operational benefits, including:
- Clarity: Policies and procedures simplify HIPAA requirements, allowing stakeholders to understand how to apply them to daily workflows
- Uniformity: Once implemented, policies and procedures can ensure top-down alignment across departments, enabling stakeholders to use consistent methods to achieve organizational goals
- Simplicity: Policies set clear expectations for stakeholders, and procedures break them down into actionable steps that are repeatable
“
Having clearly defined policies and procedures ensures consistent, compliant, and accountable behavior across the workforce, especially when handling sensitive data like PHI. Specifically for HIPAA, clearly defined policies don’t just satisfy regulatory requirements—they serve as a shared blueprint that empowers every employee and contractor to understand their role in protecting patient privacy.”
4 steps to create HIPAA policies and procedures
The four steps for developing effective HIPAA policies are:
- Determine the policy purpose
- Establish the scope
- Assess existing policies
- Develop policies and procedures to address gaps
Step 1: Determine the policy purpose
The first step before drafting HIPAA policies is evaluating your organization’s specific needs and risk landscape. HIPAA’s requirements are designed to be adaptable, allowing organizations to determine how their size, industry, and risk level shape implementation needs.
Communicate with key stakeholders of the organization to ensure your evaluation addresses all risk areas and includes the considerations across departments. Each team interacts with sensitive information differently, and their insights can reveal risks and inefficiencies that may otherwise go unnoticed. Multiple departments raising the same concerns provides a clear signal to prioritize those areas when developing your policies.
The findings you gain from this step shape the rest of your policy-building process, giving you an organization-wide perspective.
Step 2: Establish the scope
Once you’ve defined clear goals for your HIPAA policies, determine which people, processes, and assets they cover. To do this, you should conduct an internal audit that accounts for all assets interacting with PHI.
Establishing a precise scope is essential, as your initial assessment must account for all PHI assets. If you overlook one, you’ll have to conduct the internal audit again, which can lead to costly delays in your compliance process.
When performing the evaluation, ensure that all assets that store and transmit PHI are accounted for, not only electronic systems and devices. While those assets are the most common threat vectors, you should also account for personnel and physical environments, since HIPAA requires safeguards for all potential risk sources.
{{cta_withimage39="/cta-blocks"}} | The Healthcare compliance checklist
Step 3: Assess existing policies
Before developing new policies and procedures within your defined scope, evaluate existing ones to identify any that already meet HIPAA requirements. This is especially useful if your organization pursues other industry-leading frameworks and standards, such as:
Many of these standards have requirements that overlap with HIPAA, so you won’t have to develop as many new policies. This can save significant resources and expedite your HIPAA compliance process.
Your gap assessment should revisit foundational audit workflows. Focus on reviewing your access controls, business associate agreements (BAAs), and auditing your incident and breach reporting plans to ensure they align with HIPAA standards.
Step 4: Develop policies and procedures to address gaps
Once you’ve completed the gap assessments, you can leverage the findings to create a clear roadmap for developing new policies and updating existing ones to ensure they meet HIPAA requirements.
When reviewing policies, mind the addressable and required specifications of the Security Rule. While you may not have to adapt the addressable specifications, the required specifications must exactly match the Security Rule guidance—you might have to update them even if they meet HIPAA standards.
Break down each finalized policy into clearly defined procedures that outline the step-by-step processes for handling PHI within HIPAA requirements. This ensures employees understand their responsibilities and allows for consistency across teams and departments, reducing the risk of errors and making it easier to demonstrate compliance during audits.
Each policy should also include defined processes for ongoing monitoring and reviews to ensure continued effectiveness and alignment as your organization’s threat landscape and regulatory requirements change.
Best practices for managing HIPAA policies and procedures
Developing and implementing your HIPAA policies and procedures isn’t a one-time effort—continuous compliance requires regular monitoring to ensure they remain effective. Maintaining and updating these policies and procedures is essential to avoid non-compliance and potential civil or criminal penalties.
You should also prepare for unscheduled audits as part of ongoing HIPAA compliance. The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) conducts them if you’re a covered entity, while contracting entities may audit business associates, if the BAA prescribes it. To stay proactive and audit-ready, implement these practices:
- Perform regular staff training: According to Vanta’s HIPAA violation survey, 49% of HIPAA-related incidents happen because of an internal employee error. That’s why you should consider frequent staff training to ensure your stakeholders understand and follow the most up-to-date procedures for safeguarding PHI. Schedule sessions regularly and after any policy updates to familiarize your employees with changes.
- Monitor and review your posture: Your risk landscape and regulatory obligations change as your operations evolve. At a minimum, review your policies annually to ensure they address current risks, technologies, and operations.
- Maintain documentation: HIPAA requires organizations to maintain detailed records such as PHI access logs, policy revisions, and breach reports for at least six years. Thorough documentation streamlines audits and offers insights into the effectiveness of your policies and procedures.
- Ensure leadership buy-in: If leaders are not pushing policies across the organization, it becomes difficult to motivate adoption and therefore policy acceptance.
Monitoring and documenting HIPAA compliance requires considerable time and resources, especially when performed manually. Continuously monitoring and documenting policies can put pressure on busy teams, leading to bottlenecks, delays, inefficiencies, and even human error.
You can mitigate these issues by implementing a dedicated automation solution to streamline procedure management.
Streamline HIPAA policy and procedure management with Vanta
Vanta is a leading trust management platform that streamlines HIPAA compliance through built-in resources, prescriptive guidance, and automation across documentation, policies, and controls.
The platform can automate several tedious compliance workflows, helping organizations become HIPAA compliant more efficiently by reducing manual effort and saving time and resources.
Vanta offers a dedicated HIPAA product with many helpful features, such as:
- Policy templates and a built-in editor
- Ready-to-use document templates
- Automated evidence collection through 375+ integrations
- Built-in governance and training solution
- A unified dashboard to streamline control tracking
- HIPAA training videos developed by Vanta’s security and compliance experts, including:
- HIPAA overview
- Key HIPAA definitions
- HIPAA patient rights
- HIPAA Privacy Rule
- Securing patient data and sensitive information
If your organization already complies with other industry-leading frameworks such as SOC 2, HITRUST, NIST, or ISO 27001, you can cross-map your existing controls to HIPAA and save time.
Schedule a custom demo to see how Vanta can benefit organizations pursuing HIPAA.
{{cta_simple18="/cta-blocks"}} | HIPAA product page
A note from Vanta: Vanta is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
Preparing for HIPAA compliance
How to create and manage HIPAA policies and procedures
Preparing for HIPAA compliance
Looking to streamline the work for HIPAA compliance?
The Health Insurance Portability and Accountability Act (HIPAA) is a multilayered framework that establishes federal standards for protecting and preventing disclosure of protected health information (PHI) without a patient’s consent. Compliance with HIPAA is mandatory, and organizations must implement and manage various policies and procedures to meet its requirements.
Due to its broad scope, HIPAA was designed to be flexible and scalable. While it sets clear requirements for protecting PHI, it doesn’t provide clear guidance on how to comply with them. Instead, it allows organizations to determine appropriate policies and procedures based on their risk environment and needs.
This guide will help you effectively develop and manage HIPAA policies and procedures. We’ll outline:
- Why HIPAA policies and procedures matter
- How to create them
- Best ongoing policy and procedure management practices
What are HIPAA’s policies and procedures?
HIPAA policies and procedures are formal, documented guidelines and practices that outline how an organization complies with HIPAA requirements. Both covered entities and business associates must implement, update, and manage policies and procedures to ensure the safety and integrity of PHI.
While policies and procedures are often referenced together, they serve slightly different purposes:
- Policies set high-level expectations for how PHI must be handled
- Procedures provide actionable steps that employees must follow when processing PHI
To fully comply with HIPAA, you must follow its “Rules,” which are standards added to HIPAA over time that outline the policies and procedures for handling PHI. Each rule plays a key role in PHI management, but the three core ones are the Privacy Rule, the Security Rule, and the Breach Notification Rule.
See examples of policies and procedures from each of these three rules below:
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
Why do HIPAA policies and procedures matter?
While implementing policies and procedures is mandatory for HIPAA compliance, this isn’t the only reason to implement them. When properly developed, policies offer several operational benefits, including:
- Clarity: Policies and procedures simplify HIPAA requirements, allowing stakeholders to understand how to apply them to daily workflows
- Uniformity: Once implemented, policies and procedures can ensure top-down alignment across departments, enabling stakeholders to use consistent methods to achieve organizational goals
- Simplicity: Policies set clear expectations for stakeholders, and procedures break them down into actionable steps that are repeatable
“
Having clearly defined policies and procedures ensures consistent, compliant, and accountable behavior across the workforce, especially when handling sensitive data like PHI. Specifically for HIPAA, clearly defined policies don’t just satisfy regulatory requirements—they serve as a shared blueprint that empowers every employee and contractor to understand their role in protecting patient privacy.”
4 steps to create HIPAA policies and procedures
The four steps for developing effective HIPAA policies are:
- Determine the policy purpose
- Establish the scope
- Assess existing policies
- Develop policies and procedures to address gaps
Step 1: Determine the policy purpose
The first step before drafting HIPAA policies is evaluating your organization’s specific needs and risk landscape. HIPAA’s requirements are designed to be adaptable, allowing organizations to determine how their size, industry, and risk level shape implementation needs.
Communicate with key stakeholders of the organization to ensure your evaluation addresses all risk areas and includes the considerations across departments. Each team interacts with sensitive information differently, and their insights can reveal risks and inefficiencies that may otherwise go unnoticed. Multiple departments raising the same concerns provides a clear signal to prioritize those areas when developing your policies.
The findings you gain from this step shape the rest of your policy-building process, giving you an organization-wide perspective.
Step 2: Establish the scope
Once you’ve defined clear goals for your HIPAA policies, determine which people, processes, and assets they cover. To do this, you should conduct an internal audit that accounts for all assets interacting with PHI.
Establishing a precise scope is essential, as your initial assessment must account for all PHI assets. If you overlook one, you’ll have to conduct the internal audit again, which can lead to costly delays in your compliance process.
When performing the evaluation, ensure that all assets that store and transmit PHI are accounted for, not only electronic systems and devices. While those assets are the most common threat vectors, you should also account for personnel and physical environments, since HIPAA requires safeguards for all potential risk sources.
{{cta_withimage39="/cta-blocks"}} | The Healthcare compliance checklist
Step 3: Assess existing policies
Before developing new policies and procedures within your defined scope, evaluate existing ones to identify any that already meet HIPAA requirements. This is especially useful if your organization pursues other industry-leading frameworks and standards, such as:
Many of these standards have requirements that overlap with HIPAA, so you won’t have to develop as many new policies. This can save significant resources and expedite your HIPAA compliance process.
Your gap assessment should revisit foundational audit workflows. Focus on reviewing your access controls, business associate agreements (BAAs), and auditing your incident and breach reporting plans to ensure they align with HIPAA standards.
Step 4: Develop policies and procedures to address gaps
Once you’ve completed the gap assessments, you can leverage the findings to create a clear roadmap for developing new policies and updating existing ones to ensure they meet HIPAA requirements.
When reviewing policies, mind the addressable and required specifications of the Security Rule. While you may not have to adapt the addressable specifications, the required specifications must exactly match the Security Rule guidance—you might have to update them even if they meet HIPAA standards.
Break down each finalized policy into clearly defined procedures that outline the step-by-step processes for handling PHI within HIPAA requirements. This ensures employees understand their responsibilities and allows for consistency across teams and departments, reducing the risk of errors and making it easier to demonstrate compliance during audits.
Each policy should also include defined processes for ongoing monitoring and reviews to ensure continued effectiveness and alignment as your organization’s threat landscape and regulatory requirements change.
Best practices for managing HIPAA policies and procedures
Developing and implementing your HIPAA policies and procedures isn’t a one-time effort—continuous compliance requires regular monitoring to ensure they remain effective. Maintaining and updating these policies and procedures is essential to avoid non-compliance and potential civil or criminal penalties.
You should also prepare for unscheduled audits as part of ongoing HIPAA compliance. The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) conducts them if you’re a covered entity, while contracting entities may audit business associates, if the BAA prescribes it. To stay proactive and audit-ready, implement these practices:
- Perform regular staff training: According to Vanta’s HIPAA violation survey, 49% of HIPAA-related incidents happen because of an internal employee error. That’s why you should consider frequent staff training to ensure your stakeholders understand and follow the most up-to-date procedures for safeguarding PHI. Schedule sessions regularly and after any policy updates to familiarize your employees with changes.
- Monitor and review your posture: Your risk landscape and regulatory obligations change as your operations evolve. At a minimum, review your policies annually to ensure they address current risks, technologies, and operations.
- Maintain documentation: HIPAA requires organizations to maintain detailed records such as PHI access logs, policy revisions, and breach reports for at least six years. Thorough documentation streamlines audits and offers insights into the effectiveness of your policies and procedures.
- Ensure leadership buy-in: If leaders are not pushing policies across the organization, it becomes difficult to motivate adoption and therefore policy acceptance.
Monitoring and documenting HIPAA compliance requires considerable time and resources, especially when performed manually. Continuously monitoring and documenting policies can put pressure on busy teams, leading to bottlenecks, delays, inefficiencies, and even human error.
You can mitigate these issues by implementing a dedicated automation solution to streamline procedure management.
Streamline HIPAA policy and procedure management with Vanta
Vanta is a leading trust management platform that streamlines HIPAA compliance through built-in resources, prescriptive guidance, and automation across documentation, policies, and controls.
The platform can automate several tedious compliance workflows, helping organizations become HIPAA compliant more efficiently by reducing manual effort and saving time and resources.
Vanta offers a dedicated HIPAA product with many helpful features, such as:
- Policy templates and a built-in editor
- Ready-to-use document templates
- Automated evidence collection through 375+ integrations
- Built-in governance and training solution
- A unified dashboard to streamline control tracking
- HIPAA training videos developed by Vanta’s security and compliance experts, including:
- HIPAA overview
- Key HIPAA definitions
- HIPAA patient rights
- HIPAA Privacy Rule
- Securing patient data and sensitive information
If your organization already complies with other industry-leading frameworks such as SOC 2, HITRUST, NIST, or ISO 27001, you can cross-map your existing controls to HIPAA and save time.
Schedule a custom demo to see how Vanta can benefit organizations pursuing HIPAA.
{{cta_simple18="/cta-blocks"}} | HIPAA product page
A note from Vanta: Vanta is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
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