%201%20(1).svg){kind=icon}
The Health Insurance Portability and Accountability Act (HIPAA) is a U.S. law enacted in 1996 to establish standards for safeguarding protected health information (PHI). It ensures that individually identifiable medical data is not shared or accessed without the patients’ consent or knowledge.
To help organizations comply with these requirements, HIPAA enforces a set of regulatory standards known as “Rules.” One of the core standards is the Privacy Rule, which governs the use and disclosure of patients’ health information. The Security Rule and the Breach Notification Rule are equally vital for safeguarding data and ensuring accountability when breaches occur.
In this guide, we’ll break down the scope and requirements of the HIPAA Privacy Rule, focusing on:
- Patients’ rights under the Privacy Rule
- Requirements for covered entities
- Common Privacy Rule compliance challenges
What is the HIPAA Privacy Rule?
The HIPAA Privacy Rule is one of the core protections introduced under HIPAA. Finalized in 2000, the rule was later updated in 2002 to address public concerns raised during the initial rollout (for example, that the rule was overly complex or unintentionally limiting patient rights and care quality).
At its core, the Privacy Rule sets national standards for how PHI can be collected, accessed, used, and disclosed by healthcare organizations and their partners.
Its purpose is twofold—to give individuals greater control over their medical data and to establish clear obligations for entities that handle this data.
PHI includes any health-related information that can be used to identify an individual, such as:
- Names, birthdates, or contact details
- Medical records
- Test results
- Health insurance claims
- Billing information
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
Who needs to comply with the Privacy Rule?
The HIPAA Privacy Rule applies to healthcare providers, health plans, and healthcare clearinghouses, collectively known as covered entities, that are directly responsible for safeguarding PHI. Notable examples include:
- Hospitals
- Doctors
- Pharmacies
- Health insurance companies
- Health maintenance organizations (HMOs)
- Repricing companies
- Community health information systems
It’s important to note that some healthcare providers can be out of scope, such as those that do not transfer any billing or insurance-related information electronically.
The rule also applies to all business associates (BA) that handle PHI on behalf of covered entities. Their obligations under the Privacy Rule must be outlined in the business associate agreement (BAA) signed with the covered entity. This agreement formalizes their relationship and defines specific requirements for safeguarding PHI they should meet.
Common examples of business associates under HIPAA include billing companies, legal firms, and data analytics companies.
“
Certain business associates, such as cloud-service providers, are sometimes overlooked but still fall under the scope of the Privacy Rule. If an organization creates, receives, maintains, or transmits ePHI, they are in scope—even if they only store encrypted data and do not hold the encryption keys. ”
Other commonly overlooked entities include:
- Electronic fax vendors
- Translation services
- IT-managed service providers with administrative access
- Secure messaging platforms
- Document shredding companies that handle PHI before disposal
The Privacy Rule is enforced by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). Depending on the nature and severity of the violation, penalties may include corrective actions, monetary fines, and even criminal charges.
Why does the Privacy Rule matter?
The HIPAA Privacy Rule establishes what is known as the “federal floor” for the protection of private health information. It sets a baseline level of protection that organizations must follow, unless they have implemented more stringent controls.
The HIPAA Privacy Rule prescribes strict rules regarding when PHI can be used or disclosed. In-scope entities are only permitted to disclose PHI in specific situations, such as for treatment, billing purposes, public health reporting, or legal requirements. Other disclosures may require the patient’s written authorization or must meet legal or public health requirements.
The HIPAA Privacy Rule also enforces the Minimum Necessary Requirement, which asks covered entities and business associates to make reasonable efforts to access, use, disclose, or request only the minimum amount of PHI needed to accomplish a specific task.
The Privacy Rule also helps covered entities ensure they provide and adhere to the Notice of Privacy Practices (NPP), which aims to inform individuals about how their PHI is collected, used, and disclosed. It defines the patient’s rights under the Privacy Rule and explains how they can exercise them, such as requesting access to their records or asking for corrections.
To comply with the Privacy Rule, in-scope organizations must implement appropriate administrative practices that safeguard health data and uphold the individual rights the rule protects.
What rights are safeguarded by the Privacy Rule?
The HIPAA Privacy Rule grants individuals four core rights that help them maintain control over their health information:
- The right to access PHI: Individuals have the right to view and obtain a copy of their PHI maintained by covered entities. Exceptions may apply in certain cases, such as when access could cause harm or involves sensitive records like psychotherapy notes. Covered entities may charge reasonable fees for copying and mailing the requested information.
- The right to request corrections: If a person believes their PHI is inaccurate or incomplete, they can request a correction. While covered entities are not required to approve every request, they must review it and respond in writing. If a correction is denied, the individual has the right to submit a written statement of disagreement, which will be included in the record to ensure that their concerns are represented and shared with others who may reference the original information.
- The right to request an accounting of disclosures: Individuals can request a record of disclosures of their health information made by a covered entity or its business associates within the past six years. However, this does not include routine disclosures, such as those made for treatment, payment, or when the individual has provided prior consent.
- The right to request confidential communications or restrictions: Individuals may request restrictions on how their PHI is used or disclosed for treatment, payment, or care coordination. Individuals may also request to receive communications through alternative means or locations—for example, via a different address or phone number. Health plans are required to accommodate reasonable requests when there is a risk to the individual’s safety.
HIPAA Privacy Rule requirements
To comply with the HIPAA Privacy Rule, organizations must adopt specific requirements and safeguards, including:
- Privacy policies and procedures: Entities must develop and enforce written policies that explain how PHI is used, disclosed, and safeguarded.
- Privacy personnel: Organizations need to appoint a privacy official to oversee compliance procedures and designate a contact person to handle privacy-related questions and complaints.
- Stakeholder training: All workforce members must receive appropriate training on privacy policies necessary for them to carry out their functions. Violations must result in disciplinary actions.
- Mitigation strategies: In case of a breach, covered entities must take practical steps to reduce or remedy any harm caused by improper use or disclosure of PHI by their workforce or business associates.
- Data protection: Organizations are required to implement reasonable safeguards to prevent unauthorized access to PHI, whether in paper or electronic form. These safeguards can vary based on the size and nature of business. Some practices include shredding documents with sensitive information before disposal, locking up medical records or protecting them with passwords, and controlling access to keys or passwords.
- Documentation maintenance: Covered entities must maintain privacy-related documentation, including policies, notices, and complaint records, for up to six years.
Many of these requirements also align with recognized industry frameworks such as HITRUST, SOC 2, and ISO 27001. As a result, organizations that are pursuing or already complying with these standards may have a strong foundation for achieving compliance with the HIPAA Privacy Rule.
{{cta_withimage39="/cta-blocks"}} | The Healthcare compliance checklist
Potential Privacy Rule compliance challenges
While the HIPAA Privacy Rule defines what organizations must do to protect sensitive patient health information, it doesn’t clearly explain how to meet those requirements. The lack of clarity can complicate compliance, and even if you have detailed instructions, implementation demands significant time and resources.
Additionally, organizations must maintain ongoing compliance through continuous monitoring and thorough documentation, as OCR may conduct unannounced audits or investigations, especially in response to complaints, breach reports, or risk indicators. This can place a heavy cognitive load on compliance and privacy teams, especially in a busy or resource-constrained workplace.
To simplify management of these processes, you can use automation tools like Vanta to streamline security workflows, reduce manual tasks, and minimize the risk of human error.
Vanta: Your HIPAA compliance partner built for scale
Vanta is a compliance and trust management platform that streamlines HIPAA compliance with step-by-step guidance and valuable resources throughout every stage of the process.
Vanta helps you automate busywork across compliance functions, resulting in faster processes and lower administrative burden. Its HIPAA product comes with time-saving features, such as:
- Policy templates and a built-in editor
- Instant gap assessment to gain an overview of your current security status
- Business associate agreements templates
- A single dashboard to streamline tracking
- Streamlined evidence collection through 375+ integrations
- Ready-made HIPAA training for new employees
If your organization is already compliant with frameworks like HITRUST, ISO 27001, or SOC 2, Vanta can connect your current controls to HIPAA requirements and help you skip duplicate work.
Explore how Vanta can fast-track HIPAA compliance for your team by scheduling a custom demo.
{{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 Privacy Rule?
Looking to streamline the work for HIPAA compliance?
The Health Insurance Portability and Accountability Act (HIPAA) is a U.S. law enacted in 1996 to establish standards for safeguarding protected health information (PHI). It ensures that individually identifiable medical data is not shared or accessed without the patients’ consent or knowledge.
To help organizations comply with these requirements, HIPAA enforces a set of regulatory standards known as “Rules.” One of the core standards is the Privacy Rule, which governs the use and disclosure of patients’ health information. The Security Rule and the Breach Notification Rule are equally vital for safeguarding data and ensuring accountability when breaches occur.
In this guide, we’ll break down the scope and requirements of the HIPAA Privacy Rule, focusing on:
- Patients’ rights under the Privacy Rule
- Requirements for covered entities
- Common Privacy Rule compliance challenges
What is the HIPAA Privacy Rule?
The HIPAA Privacy Rule is one of the core protections introduced under HIPAA. Finalized in 2000, the rule was later updated in 2002 to address public concerns raised during the initial rollout (for example, that the rule was overly complex or unintentionally limiting patient rights and care quality).
At its core, the Privacy Rule sets national standards for how PHI can be collected, accessed, used, and disclosed by healthcare organizations and their partners.
Its purpose is twofold—to give individuals greater control over their medical data and to establish clear obligations for entities that handle this data.
PHI includes any health-related information that can be used to identify an individual, such as:
- Names, birthdates, or contact details
- Medical records
- Test results
- Health insurance claims
- Billing information
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
Who needs to comply with the Privacy Rule?
The HIPAA Privacy Rule applies to healthcare providers, health plans, and healthcare clearinghouses, collectively known as covered entities, that are directly responsible for safeguarding PHI. Notable examples include:
- Hospitals
- Doctors
- Pharmacies
- Health insurance companies
- Health maintenance organizations (HMOs)
- Repricing companies
- Community health information systems
It’s important to note that some healthcare providers can be out of scope, such as those that do not transfer any billing or insurance-related information electronically.
The rule also applies to all business associates (BA) that handle PHI on behalf of covered entities. Their obligations under the Privacy Rule must be outlined in the business associate agreement (BAA) signed with the covered entity. This agreement formalizes their relationship and defines specific requirements for safeguarding PHI they should meet.
Common examples of business associates under HIPAA include billing companies, legal firms, and data analytics companies.
“
Certain business associates, such as cloud-service providers, are sometimes overlooked but still fall under the scope of the Privacy Rule. If an organization creates, receives, maintains, or transmits ePHI, they are in scope—even if they only store encrypted data and do not hold the encryption keys. ”
Other commonly overlooked entities include:
- Electronic fax vendors
- Translation services
- IT-managed service providers with administrative access
- Secure messaging platforms
- Document shredding companies that handle PHI before disposal
The Privacy Rule is enforced by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). Depending on the nature and severity of the violation, penalties may include corrective actions, monetary fines, and even criminal charges.
Why does the Privacy Rule matter?
The HIPAA Privacy Rule establishes what is known as the “federal floor” for the protection of private health information. It sets a baseline level of protection that organizations must follow, unless they have implemented more stringent controls.
The HIPAA Privacy Rule prescribes strict rules regarding when PHI can be used or disclosed. In-scope entities are only permitted to disclose PHI in specific situations, such as for treatment, billing purposes, public health reporting, or legal requirements. Other disclosures may require the patient’s written authorization or must meet legal or public health requirements.
The HIPAA Privacy Rule also enforces the Minimum Necessary Requirement, which asks covered entities and business associates to make reasonable efforts to access, use, disclose, or request only the minimum amount of PHI needed to accomplish a specific task.
The Privacy Rule also helps covered entities ensure they provide and adhere to the Notice of Privacy Practices (NPP), which aims to inform individuals about how their PHI is collected, used, and disclosed. It defines the patient’s rights under the Privacy Rule and explains how they can exercise them, such as requesting access to their records or asking for corrections.
To comply with the Privacy Rule, in-scope organizations must implement appropriate administrative practices that safeguard health data and uphold the individual rights the rule protects.
What rights are safeguarded by the Privacy Rule?
The HIPAA Privacy Rule grants individuals four core rights that help them maintain control over their health information:
- The right to access PHI: Individuals have the right to view and obtain a copy of their PHI maintained by covered entities. Exceptions may apply in certain cases, such as when access could cause harm or involves sensitive records like psychotherapy notes. Covered entities may charge reasonable fees for copying and mailing the requested information.
- The right to request corrections: If a person believes their PHI is inaccurate or incomplete, they can request a correction. While covered entities are not required to approve every request, they must review it and respond in writing. If a correction is denied, the individual has the right to submit a written statement of disagreement, which will be included in the record to ensure that their concerns are represented and shared with others who may reference the original information.
- The right to request an accounting of disclosures: Individuals can request a record of disclosures of their health information made by a covered entity or its business associates within the past six years. However, this does not include routine disclosures, such as those made for treatment, payment, or when the individual has provided prior consent.
- The right to request confidential communications or restrictions: Individuals may request restrictions on how their PHI is used or disclosed for treatment, payment, or care coordination. Individuals may also request to receive communications through alternative means or locations—for example, via a different address or phone number. Health plans are required to accommodate reasonable requests when there is a risk to the individual’s safety.
HIPAA Privacy Rule requirements
To comply with the HIPAA Privacy Rule, organizations must adopt specific requirements and safeguards, including:
- Privacy policies and procedures: Entities must develop and enforce written policies that explain how PHI is used, disclosed, and safeguarded.
- Privacy personnel: Organizations need to appoint a privacy official to oversee compliance procedures and designate a contact person to handle privacy-related questions and complaints.
- Stakeholder training: All workforce members must receive appropriate training on privacy policies necessary for them to carry out their functions. Violations must result in disciplinary actions.
- Mitigation strategies: In case of a breach, covered entities must take practical steps to reduce or remedy any harm caused by improper use or disclosure of PHI by their workforce or business associates.
- Data protection: Organizations are required to implement reasonable safeguards to prevent unauthorized access to PHI, whether in paper or electronic form. These safeguards can vary based on the size and nature of business. Some practices include shredding documents with sensitive information before disposal, locking up medical records or protecting them with passwords, and controlling access to keys or passwords.
- Documentation maintenance: Covered entities must maintain privacy-related documentation, including policies, notices, and complaint records, for up to six years.
Many of these requirements also align with recognized industry frameworks such as HITRUST, SOC 2, and ISO 27001. As a result, organizations that are pursuing or already complying with these standards may have a strong foundation for achieving compliance with the HIPAA Privacy Rule.
{{cta_withimage39="/cta-blocks"}} | The Healthcare compliance checklist
Potential Privacy Rule compliance challenges
While the HIPAA Privacy Rule defines what organizations must do to protect sensitive patient health information, it doesn’t clearly explain how to meet those requirements. The lack of clarity can complicate compliance, and even if you have detailed instructions, implementation demands significant time and resources.
Additionally, organizations must maintain ongoing compliance through continuous monitoring and thorough documentation, as OCR may conduct unannounced audits or investigations, especially in response to complaints, breach reports, or risk indicators. This can place a heavy cognitive load on compliance and privacy teams, especially in a busy or resource-constrained workplace.
To simplify management of these processes, you can use automation tools like Vanta to streamline security workflows, reduce manual tasks, and minimize the risk of human error.
Vanta: Your HIPAA compliance partner built for scale
Vanta is a compliance and trust management platform that streamlines HIPAA compliance with step-by-step guidance and valuable resources throughout every stage of the process.
Vanta helps you automate busywork across compliance functions, resulting in faster processes and lower administrative burden. Its HIPAA product comes with time-saving features, such as:
- Policy templates and a built-in editor
- Instant gap assessment to gain an overview of your current security status
- Business associate agreements templates
- A single dashboard to streamline tracking
- Streamlined evidence collection through 375+ integrations
- Ready-made HIPAA training for new employees
If your organization is already compliant with frameworks like HITRUST, ISO 27001, or SOC 2, Vanta can connect your current controls to HIPAA requirements and help you skip duplicate work.
Explore how Vanta can fast-track HIPAA compliance for your team by scheduling a custom demo.
{{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.
Explore more HIPAA articles
Introduction to HIPAA
HIPAA requirements
Preparing for HIPAA compliance
Streamlining HIPAA compliance
Get started with HIPAA:
Start your HIPAA journey with these related resources.
An 8-step HIPAA compliance checklist to meet privacy and security requirements
Use this handy HIPAA compliance checklist to ensure adherence to the key requirements.
HIPAA violations in 2025: Staff mistakes and vendor blind spots
Discover what a HIPAA violation is, common causes behind violations
Live Demo: Automating Compliance for SOC 2, ISO 27001, HIPAA, and More
Discover how Vanta’s automation and AI tools can help your team simplify compliance, strengthen security, and scale trust across frameworks like SOC 2, ISO 27001, HIPAA, and more.
.png)
.png)
.png)