

HIPAA is a federal regulation that became law in 1996. Its main purpose is to ensure that individually identifying health information can’t be disclosed or shared without patients’ knowledge or consent.
To keep up with technological changes and the compliance environment, HIPAA received updates in the form of Rules—frameworks that outline specific aspects of securing protected health information (PHI).
One of these updates is the Minimum Necessary Rule, which limits the amount of patient information that can be used, accessed, or disclosed. While the Rule outlines key requirements, it does not prescribe clear criteria on how to meet them, making compliance challenging.
This article will break down everything you need to know about the Minimum Necessary Rule, including:
- Who needs to comply
- Exceptions to the rule
- Best compliance practices
What is the HIPAA Minimum Necessary Rule?
The HIPAA Minimum Necessary Rule is a part of the Privacy Rule, which aims to reduce the risk to PHI by limiting access to it. According to the Rule, covered entities and business associates should take reasonable steps to ensure that only the minimal amount of PHI needed for a given purpose is used or disclosed.
PHI includes information created, maintained, or transmitted by a covered entity related to an individual's treatment, healthcare services, or payment for those services. The Minimum Necessary Rule applies to both physical and electronic PHI, and must be implemented to comply with the Privacy as well as the Security Rule.
One of the common challenges of implementing the Minimum Necessary Rule is its lack of specificity. While the rule states only the minimum necessary information should be used or disclosed, it doesn’t clarify what constitutes that “minimum.” Instead, it requires organizations to determine the minimum based on context, which can result in uneven application across teams or departments.
Who needs to comply?
Compliance with the Minimum Necessary Rule is essential for HIPAA compliance—all covered entities that handle PHI have to meet its requirements. This includes:
- Health plans
- Healthcare clearinghouses
- Healthcare providers
Since the 2013 updates in the form of the Omnibus Rule, this requirement now also extends to business associates—organizations that have entered into a business associate agreement (BAA) with a covered entity and handle, store, or transmit PHI on their behalf. Common examples include:
- Collection agencies
- Billing services
- Cloud service providers
The primary enforcer of the rule (and HIPAA in general) is the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). If a breach occurs as a result of non-compliance, the OCR may issue corrective measures and financial penalties, while the Department of Justice (DoJ) may issue criminal charges in more severe cases.
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
Exceptions to the Minimum Necessary Rule
Aside from prescribing limitations for PHI disclosure, the Minimum Necessary Rule also specifies six specific situations where the standard does not apply:
- Disclosures to or requests by a healthcare provider for treatment: For example, a primary care physician may send a patient's full medical record to a specialist for consultation without limitation
- Disclosures to the individual who is the subject of the information: Patients can request access to their medical data, with certain exceptions, such as psychotherapy notes
- Disclosures made with the individual’s authorization: If a patient provides written authorization, a covered entity can disclose PHI to a third party without applying the Minimum Necessary standard
- Uses and disclosures needed for HIPAA compliance: Full PHI access may be necessary while preparing for audits or OCR investigations
- Disclosures required by law: When sharing PHI is required by law, such as a court order or subpoena, the Minimum Necessary Rule doesn’t apply according to the exceptions listed in 45 CFR 164.512(e)(1)(ii)
- Disclosures to the HHS for enforcement purposes: Covered entities must provide access to PHI when requested by HHS for enforcement of HIPAA rules
Best practices for complying with the Minimum Necessary Rule
Because of its comprehensive coverage and lack of prescriptive guidance, meeting the Minimum Necessary Rule’s requirements can be challenging. However, you can ensure efficient compliance by following these steps:
- Determine scope
- Create access controls
- Ensure regular training
- Conduct regular audits
- Maintain continuous monitoring
- Collect documentation
{{cta_withimage39="/cta-blocks"}} | The Healthcare compliance checklist
Step 1: Determine scope
The first step towards compliance with the Minimum Necessary Rule is establishing an accurate scope within your organization. Start by cataloguing each asset that contains PHI, including physical formats such as paper documents and electronic systems that store ePHI.
Once you have a comprehensive list of your PHI assets, document what type of PHI each contains. This visibility into your systems enables consistent handling and ensures that access to sensitive data is properly managed across your organization.
You should also establish a written Minimum Necessary policy, which defines your internal standards for disclosing PHI and prescribes how to evaluate access and disclosure requests. This documentation helps ensure operational consistency across departments and supports ongoing HIPAA compliance.
Step 2: Create access controls
Once you’ve identified and documented your organization’s PHI assets, implement access controls to ensure your stakeholders can only access the information necessary for their roles.
Start by defining clear roles and identifying the categories of PHI each role requires access to. Assign those roles to your stakeholders, and clearly specify the conditions under which they are permitted to access sensitive data.
This principle also applies to business associates. Determine the PHI they need to access in order to fulfill their contractual obligations and limit access accordingly. Avoid implementing processes or systems that allow broad access since that increases the risk of potential breaches.
Step 3: Ensure regular training
In a recent Vanta survey, it was found that 49% of HIPAA violations can be attributed to internal employee error. Regular staff training can drastically reduce such risks.
The most effective way to ensure your stakeholders are aware of the Minimum Necessary Rule is to conduct regular training around it, especially for those who interact with PHI directly, such as business relationship owners, engineers, and other technical staff. Tailor your training sessions for specific roles so team members understand how the rule applies to them.
To ensure that your training is effective, put additional focus on making stakeholders aware of the types of information they may access, what the protocols for handling PHI are, and the consequences of unauthorized access.
A common oversight organizations make is not focusing on the outcomes of a breach. Create training scenarios where your teams can see how failing to protect PHI can lead to legal penalties, a loss of patient trust, and reputational damage that can have a long-term impact on your organization.
Step 4: Conduct regular audits
Establish a schedule for internal audits to review PHI access and detect unauthorized activity early. If a breach occurs, you can efficiently meet the Breach Notification Rule’s timelines and reduce the risk of penalties.
While HIPAA’s Security Rule does require covered entities to regularly review system activity, it doesn’t specify how often this should be done. Industry best practices suggest performing audits every three months or following an incident, but depending on your organization’s risk profile, more frequent checks might be necessary.
Focus on high-risk areas such as systems with broad access and PHI that is routinely shared between teams.
Step 5: Maintain continuous monitoring
Continuously tracking all PHI access is essential for ongoing compliance with the Minimum Necessary Rule. As part of this process, your compliance teams should create and maintain a detailed log of all access events so they can review it at any time to identify unauthorized activity.
Real-time insights are important for such monitoring. By setting up alerts, your compliance and security teams can be informed as soon as any unauthorized PHI access happens, enabling them to act quickly and keep potential damage to a minimum. This also reduces reliance on point-in-time information, which can quickly become outdated.
Implementing these measures may require your teams to sift through information across disparate technologies, and that can increase the risk of oversights. The good news is that you can mitigate this risk by using an automated solution that centralizes compliance workflows and logs in a single, easy-to-access dashboard.
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
Step 6: Collect documentation
Maintaining thorough documentation is essential for demonstrating compliance with the Minimum Necessary Rule. Your compliance teams should keep detailed logs of:
- Access events
- Attempts at unauthorized PHI access
- The specific PHI involved
- Enforced sanctions
Aside from being an essential part of HIPAA compliance, documentation becomes particularly significant in the context of audits. In the summer of 2024, the HHS announced plans to conduct unannounced audits of all in-scope entities. To avoid corrective action, it’s best to maintain demonstrable proof of compliance efforts at all times.
Like ongoing monitoring, evidence collection is a time and resource-intensive process that can pull your compliance teams away from higher-priority tasks. Growing teams today can streamline this process by implementing an automated solution that consolidates documentation, making it easier to track, manage, and present when needed.
Vanta: Meet HIPAA rules and standards with confidence
Vanta is a leading trust management platform that supports HIPAA compliance with clear guidance on requirements and built-in resources for documentation, controls, and policies. Depending on your tech stack, Vanta can automate numerous HIPAA compliance workflows, saving significant time and freeing up valuable resources.
The platform offers a tailored HIPAA product that delivers useful features such as:
- Ready-to-use document templates
- Policy templates and a built-in editor
- A unified dashboard to streamline tracking
- Automated evidence collection through 375+ integrations
- Built-in guidance and training solutions
Already compliant with other industry-relevant frameworks such as HITRUST, ISO 27001, and SOC 2? Vanta can map your existing controls to HIPAA requirements, so you won’t have to repeat the same work.
Reach out for a free demo to see how Vanta can support your HIPAA workflows.
{{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.
HIPAA requirements
What is The HIPAA Minimum Necessary Rule?

Looking to streamline the work for HIPAA compliance?

HIPAA is a federal regulation that became law in 1996. Its main purpose is to ensure that individually identifying health information can’t be disclosed or shared without patients’ knowledge or consent.
To keep up with technological changes and the compliance environment, HIPAA received updates in the form of Rules—frameworks that outline specific aspects of securing protected health information (PHI).
One of these updates is the Minimum Necessary Rule, which limits the amount of patient information that can be used, accessed, or disclosed. While the Rule outlines key requirements, it does not prescribe clear criteria on how to meet them, making compliance challenging.
This article will break down everything you need to know about the Minimum Necessary Rule, including:
- Who needs to comply
- Exceptions to the rule
- Best compliance practices
What is the HIPAA Minimum Necessary Rule?
The HIPAA Minimum Necessary Rule is a part of the Privacy Rule, which aims to reduce the risk to PHI by limiting access to it. According to the Rule, covered entities and business associates should take reasonable steps to ensure that only the minimal amount of PHI needed for a given purpose is used or disclosed.
PHI includes information created, maintained, or transmitted by a covered entity related to an individual's treatment, healthcare services, or payment for those services. The Minimum Necessary Rule applies to both physical and electronic PHI, and must be implemented to comply with the Privacy as well as the Security Rule.
One of the common challenges of implementing the Minimum Necessary Rule is its lack of specificity. While the rule states only the minimum necessary information should be used or disclosed, it doesn’t clarify what constitutes that “minimum.” Instead, it requires organizations to determine the minimum based on context, which can result in uneven application across teams or departments.
Who needs to comply?
Compliance with the Minimum Necessary Rule is essential for HIPAA compliance—all covered entities that handle PHI have to meet its requirements. This includes:
- Health plans
- Healthcare clearinghouses
- Healthcare providers
Since the 2013 updates in the form of the Omnibus Rule, this requirement now also extends to business associates—organizations that have entered into a business associate agreement (BAA) with a covered entity and handle, store, or transmit PHI on their behalf. Common examples include:
- Collection agencies
- Billing services
- Cloud service providers
The primary enforcer of the rule (and HIPAA in general) is the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). If a breach occurs as a result of non-compliance, the OCR may issue corrective measures and financial penalties, while the Department of Justice (DoJ) may issue criminal charges in more severe cases.
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
Exceptions to the Minimum Necessary Rule
Aside from prescribing limitations for PHI disclosure, the Minimum Necessary Rule also specifies six specific situations where the standard does not apply:
- Disclosures to or requests by a healthcare provider for treatment: For example, a primary care physician may send a patient's full medical record to a specialist for consultation without limitation
- Disclosures to the individual who is the subject of the information: Patients can request access to their medical data, with certain exceptions, such as psychotherapy notes
- Disclosures made with the individual’s authorization: If a patient provides written authorization, a covered entity can disclose PHI to a third party without applying the Minimum Necessary standard
- Uses and disclosures needed for HIPAA compliance: Full PHI access may be necessary while preparing for audits or OCR investigations
- Disclosures required by law: When sharing PHI is required by law, such as a court order or subpoena, the Minimum Necessary Rule doesn’t apply according to the exceptions listed in 45 CFR 164.512(e)(1)(ii)
- Disclosures to the HHS for enforcement purposes: Covered entities must provide access to PHI when requested by HHS for enforcement of HIPAA rules
Best practices for complying with the Minimum Necessary Rule
Because of its comprehensive coverage and lack of prescriptive guidance, meeting the Minimum Necessary Rule’s requirements can be challenging. However, you can ensure efficient compliance by following these steps:
- Determine scope
- Create access controls
- Ensure regular training
- Conduct regular audits
- Maintain continuous monitoring
- Collect documentation
{{cta_withimage39="/cta-blocks"}} | The Healthcare compliance checklist
Step 1: Determine scope
The first step towards compliance with the Minimum Necessary Rule is establishing an accurate scope within your organization. Start by cataloguing each asset that contains PHI, including physical formats such as paper documents and electronic systems that store ePHI.
Once you have a comprehensive list of your PHI assets, document what type of PHI each contains. This visibility into your systems enables consistent handling and ensures that access to sensitive data is properly managed across your organization.
You should also establish a written Minimum Necessary policy, which defines your internal standards for disclosing PHI and prescribes how to evaluate access and disclosure requests. This documentation helps ensure operational consistency across departments and supports ongoing HIPAA compliance.
Step 2: Create access controls
Once you’ve identified and documented your organization’s PHI assets, implement access controls to ensure your stakeholders can only access the information necessary for their roles.
Start by defining clear roles and identifying the categories of PHI each role requires access to. Assign those roles to your stakeholders, and clearly specify the conditions under which they are permitted to access sensitive data.
This principle also applies to business associates. Determine the PHI they need to access in order to fulfill their contractual obligations and limit access accordingly. Avoid implementing processes or systems that allow broad access since that increases the risk of potential breaches.
Step 3: Ensure regular training
In a recent Vanta survey, it was found that 49% of HIPAA violations can be attributed to internal employee error. Regular staff training can drastically reduce such risks.
The most effective way to ensure your stakeholders are aware of the Minimum Necessary Rule is to conduct regular training around it, especially for those who interact with PHI directly, such as business relationship owners, engineers, and other technical staff. Tailor your training sessions for specific roles so team members understand how the rule applies to them.
To ensure that your training is effective, put additional focus on making stakeholders aware of the types of information they may access, what the protocols for handling PHI are, and the consequences of unauthorized access.
A common oversight organizations make is not focusing on the outcomes of a breach. Create training scenarios where your teams can see how failing to protect PHI can lead to legal penalties, a loss of patient trust, and reputational damage that can have a long-term impact on your organization.
Step 4: Conduct regular audits
Establish a schedule for internal audits to review PHI access and detect unauthorized activity early. If a breach occurs, you can efficiently meet the Breach Notification Rule’s timelines and reduce the risk of penalties.
While HIPAA’s Security Rule does require covered entities to regularly review system activity, it doesn’t specify how often this should be done. Industry best practices suggest performing audits every three months or following an incident, but depending on your organization’s risk profile, more frequent checks might be necessary.
Focus on high-risk areas such as systems with broad access and PHI that is routinely shared between teams.
Step 5: Maintain continuous monitoring
Continuously tracking all PHI access is essential for ongoing compliance with the Minimum Necessary Rule. As part of this process, your compliance teams should create and maintain a detailed log of all access events so they can review it at any time to identify unauthorized activity.
Real-time insights are important for such monitoring. By setting up alerts, your compliance and security teams can be informed as soon as any unauthorized PHI access happens, enabling them to act quickly and keep potential damage to a minimum. This also reduces reliance on point-in-time information, which can quickly become outdated.
Implementing these measures may require your teams to sift through information across disparate technologies, and that can increase the risk of oversights. The good news is that you can mitigate this risk by using an automated solution that centralizes compliance workflows and logs in a single, easy-to-access dashboard.
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
Step 6: Collect documentation
Maintaining thorough documentation is essential for demonstrating compliance with the Minimum Necessary Rule. Your compliance teams should keep detailed logs of:
- Access events
- Attempts at unauthorized PHI access
- The specific PHI involved
- Enforced sanctions
Aside from being an essential part of HIPAA compliance, documentation becomes particularly significant in the context of audits. In the summer of 2024, the HHS announced plans to conduct unannounced audits of all in-scope entities. To avoid corrective action, it’s best to maintain demonstrable proof of compliance efforts at all times.
Like ongoing monitoring, evidence collection is a time and resource-intensive process that can pull your compliance teams away from higher-priority tasks. Growing teams today can streamline this process by implementing an automated solution that consolidates documentation, making it easier to track, manage, and present when needed.
Vanta: Meet HIPAA rules and standards with confidence
Vanta is a leading trust management platform that supports HIPAA compliance with clear guidance on requirements and built-in resources for documentation, controls, and policies. Depending on your tech stack, Vanta can automate numerous HIPAA compliance workflows, saving significant time and freeing up valuable resources.
The platform offers a tailored HIPAA product that delivers useful features such as:
- Ready-to-use document templates
- Policy templates and a built-in editor
- A unified dashboard to streamline tracking
- Automated evidence collection through 375+ integrations
- Built-in guidance and training solutions
Already compliant with other industry-relevant frameworks such as HITRUST, ISO 27001, and SOC 2? Vanta can map your existing controls to HIPAA requirements, so you won’t have to repeat the same work.
Reach out for a free demo to see how Vanta can support your HIPAA workflows.
{{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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