The HIPAA Privacy Rule is a federal regulation that sets standards for the protection of individuals’ protected health information (PHI) that is held by “covered entities” such as health plans, health care clearinghouses, and certain health care providers. The Privacy Rule requires these entities to provide individuals with certain rights with respect to their PHI, and to implement administrative, physical, and technical safeguards to protect the confidentiality, integrity, and availability of PHI.
The HIPAA Privacy Rule ensures that individuals’ protected health information (PHI) is safeguarded and that patients’ privacy is protected. The Rule gives individuals certain rights regarding their PHI and outlines the procedures for how covered entities must use, disclose and safeguard PHI. These rights include the right to access their PHI, the right to request corrections to their records, and the right to request restrictions on how their PHI is used. The Rule also imposes requirements on covered entities to maintain the privacy and security of PHI, including the implementation of administrative, physical, and technical safeguards, such as encryption and access controls, to protect PHI.
- Uses and Disclosures of Protected Health Information: This component of the Privacy Rule outlines how and when a healthcare provider or organization may use or disclose protected health information.
- Right of Access: This component of the Privacy Rule gives individuals the right to access their own protected health information.
- Right to Amend: This component of the Privacy Rule gives individuals the right to request corrections to their own protected health information.
- Accounting of Disclosures: This component of the Privacy Rule requires healthcare providers and organizations to keep track of when and to whom they disclose protected health information.
- Security: This component of the Privacy Rule requires healthcare providers and organizations to take measures to protect the confidentiality, integrity, and availability of electronic protected health information.
- Breach Notification: This component of the Privacy Rule requires healthcare providers and organizations to notify individuals if their personal health information is compromised.
- Privacy Notice: This component of the Privacy Rule requires healthcare providers and organizations to provide individuals with a notice of their privacy practices.
The HIPAA Privacy Rule protects all individually identifiable health information that is held or transmitted by a covered entity or its business associates. This includes health records, demographic information, financial information, medical history, test results, and other health-related information.
- Establish safeguards to protect the privacy of protected health information.
- Establish limits on the uses and disclosures of protected health information.
- Provide individuals with the right to access and amend their protected health information.
- Establish administrative, physical, and technical safeguards to protect the privacy of protected health information.
- Provide individuals with the right to receive an accounting of disclosures of their protected health information.
- Mandate that covered entities and business associates comply with the regulations.
- Provide individuals with a right to file a complaint with the Department of Health and Human Services.
The Office for Civil Rights (OCR) is responsible for enforcing the HIPAA Privacy Rule. The OCR investigates complaints of violations of the Privacy Rule, educates the public on their rights under the Rule, and works with covered entities to ensure compliance. The OCR also works to resolve complaints with covered entities through voluntary compliance agreements and corrective action plans. The OCR has the authority to impose civil money penalties for violations of the Privacy Rule.
- Administrative Safeguards: These safeguards involve setting up and maintaining policies and procedures for protecting electronic PHI (ePHI). They include risk analysis, security management process, security awareness training, contingency planning, and more.
- Physical Safeguards: These safeguards involve protecting ePHI from physical access, theft, and damage. They include facility access controls, workstation use, and device and media controls.
- Technical Safeguards: These safeguards involve the use of technology to protect ePHI. They include access control, audit controls, integrity controls, authentication, and encryption.
- Organizational Requirements: These requirements involve working with business associates and other organizations to ensure that they have adequate security measures in place to protect ePHI.
- Policies and Procedures: These are the written policies and procedures developed to ensure that the HIPAA Security Rule requirements are met.
The purpose of the HIPAA Security Rule is to establish national standards to protect individuals' electronic personal health information that is created, received, used, or maintained by a covered entity. The Security Rule requires appropriate administrative, physical and technical safeguards to ensure the confidentiality, integrity, and security of protected health information.
A breach notification requirement under the HIPAA Privacy Rule is that a covered entity must provide notification following a breach of unsecured protected health information. The notification must be provided without unreasonable delay and within 60 days of the discovery of the breach. The notification must include a description of the breach, the type of information that was affected, the steps that individuals can take to protect themselves, and the steps that the covered entity is taking to investigate and mitigate the breach.
The HIPAA Privacy Rule gives individuals the right to access their medical records, including the right to inspect and obtain a copy of those records. Individuals can request to view or obtain copies of their medical records by contacting the health care provider or health plan directly. The provider or plan must provide the records within 30 days of receiving the request. If the requested records are not provided within 30 days, the individual can file a complaint with the Office for Civil Rights (OCR).
The HIPAA Privacy Rule limits the use and disclosure of protected health information (PHI). PHI is defined as any information held by a covered entity (such as a health plan, health care provider, or health care clearinghouse) that can be used to identify an individual and that is related to the individual’s past, present, or future physical or mental health or condition, the provision of health care to the individual, or the past, present, or future payment for the provision of health care to the individual.
The HIPAA Privacy Rule provides individuals with certain rights to their PHI, such as the right to access, inspect, and receive copies of their PHI; the right to request corrections to their PHI; and the right to request restrictions on certain uses and disclosures of their PHI. Covered entities must also meet certain requirements when using and disclosing PHI, such as obtaining individuals’ written authorization for certain uses and disclosures of PHI; implementing appropriate security measures to protect PHI; and providing individuals with notice of their privacy rights.
The minimum necessary requirement under the HIPAA Privacy Rule states that covered entities must make reasonable efforts to use, disclose, and request only the minimum amount of protected health information (PHI) necessary to accomplish the intended purpose of the use, disclosure, or request.
- The patient must provide a written request for disclosure of their PHI. This request must be signed and dated by the patient, and must include the name of the person or entity to whom the PHI should be disclosed.
- The covered entity must then establish the patient's identity, verify the request, and determine if the disclosure is permissible under the HIPAA Privacy Rule.
- If the disclosure is permissible, the covered entity must document the authorization, including the date and time of the request, the identity of the person requesting the disclosure, and the name of the person or entity to whom the PHI is to be disclosed.
- The covered entity must also inform the patient of the potential risks associated with the disclosure, and provide the patient with a copy of the authorization.
- The covered entity must then provide the requested PHI to the person or entity specified in the authorization.
- The HIPAA Privacy Rule requires covered entities (health care providers and health plans) to obtain an individual’s written authorization before using or disclosing protected health information (PHI) for marketing purposes.
- The Rule further requires that the authorization must include specific, meaningful information about the purpose of the use or disclosure, the types of PHI to be used or disclosed, and the parties to whom the PHI may be disclosed.
- The Rule also prohibits the sale of PHI without patient authorization.
- The Rule requires covered entities to provide individuals with an opportunity to opt out of receiving marketing communications.
- The Rule also requires covered entities to provide individuals with a “clear and conspicuous” notice about how the covered entity uses and discloses PHI for marketing purposes.
- The Rule requires covered entities to provide individuals with an opportunity to opt out of receiving marketing communications that contain financial incentives.