Jordan Ellis
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 establishes federal standards to protect sensitive health information from disclosure without a patient's consent. The HIPAA Security Rule establishes national standards to protect individuals' electronic personal health information (ePHI) that is created, received, used, or maintained by a covered entity. Covered entities include healthcare providers, healthcare clearinghouses, and health plans. To comply with the HIPAA Security Rule, covered entities must implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and security of ePHI. Hospitals, as healthcare providers, are subject to the HIPAA Security Rule and must ensure compliance with its requirements to protect patient information.
| Characteristics | Values |
|---|---|
| Purpose | To establish national standards to protect individuals' electronic personal health information |
| Covered entities | Healthcare providers, healthcare clearinghouses, health plans, business associates |
| Compliance requirements | Administrative, physical and technical safeguards |
| Administrative safeguards | Policies and procedures to manage the selection, development, implementation, and maintenance of security measures |
| Physical safeguards | Not specified, but may include technology and procedures for its use to control access to ePHI |
| Technical safeguards | Technology and procedures for its use to protect ePHI |
| Evaluation | Periodic technical and non-technical assessment of policies and procedures |
| Documentation | All policies and procedures must be documented and retained for at least six years |
| Training | Staff must be educated on statutory rules and security compliance measures |
| Exceptions | Does not apply to PHI transmitted orally or in writing |
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What You'll Learn
Administrative, physical, and technical safeguards
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule establishes a national set of security standards to protect health information that is maintained or transmitted in electronic form. The Security Rule requires appropriate administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and security of electronic protected health information (ePHI).
Administrative Safeguards
HIPAA defines administrative safeguards as "administrative actions, and policies and procedures, to manage the selection, development, implementation, and maintenance of security measures to protect electronic protected health information and to manage the conduct of the covered entity's workforce in relation to the protection of that information." These safeguards focus on the policies and procedures that govern how a covered entity protects its ePHI. This includes training and procedures for employees of the entity, regardless of whether they have direct access to ePHI.
Physical Safeguards
Physical safeguards involve access to the physical structures of a covered entity and its electronic equipment. ePHI and the computer systems that store it must be protected from unauthorized access, in accordance with defined policies and procedures. This includes protecting against reasonably anticipated threats or hazards to the security or integrity of the information and unauthorized uses or disclosures.
Technical Safeguards
Technical safeguards encompass the technology and the policies and procedures for its use that protect ePHI and control access to it. These regulations are often the most difficult to comprehend and implement. The Security Rule recognizes that security is an evolving target and is not linked to specific technologies or products. Therefore, the rules are designed to be scalable, flexible, and generalizable to accommodate different types of providers, from small rural providers to large entities with significant resources.
To assist with compliance, the U.S. Department of Health & Human Services (HHS) Office of Civil Rights has developed a downloadable "Security Risk Assessment Tool." This tool helps entities assess their security risks and determine the appropriate safeguards to put in place to protect ePHI.
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Compliance with Administrative Simplification provisions
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 established national standards to protect the privacy and security of health information. The Administrative Simplification provisions of HIPAA aim to ensure consistent electronic communication across the US healthcare system. These provisions are enforced by the National Standards Group (NSG) within the Office of Healthcare Experience and Interoperability (OHEI).
The Administrative Simplification provisions require the Secretary of Health and Human Services (HHS) to adopt standards to ensure that covered entities maintain appropriate administrative, physical, and technical safeguards for the security of individually identifiable health information. These standards aim to protect the integrity, confidentiality, and availability of electronic protected health information (ePHI). Covered entities include health care providers such as hospitals, physicians, dentists, and any other individuals or organizations that furnish, bill, or are paid for healthcare.
To comply with the Administrative Simplification provisions, covered entities must implement a series of administrative, physical, and technical safeguards. This includes developing and implementing policies and procedures that restrict access to protected health information based on the specific roles of their workforce. Regulated entities must also perform periodic assessments of their policies and procedures to ensure compliance with the Security Rule.
The NIST HIPAA Security Toolkit Application is a self-assessment survey that can help organizations understand and implement the requirements of the HIPAA Security Rule. The Office of the National Coordinator for Health Information Technology (ONC) and the HHS Office for Civil Rights (OCR) have also jointly launched a HIPAA Security Risk Assessment Tool. Additionally, the NSG provides resources and email updates to help covered entities comply with Administrative Simplification standards.
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Security risk assessment
The Office for Civil Rights (OCR) within the U.S. Department of Health & Human Services (HHS) plays a pivotal role in providing guidance and resources for security risk assessments. The OCR has developed a "Security Risk Assessment Tool," which assists hospitals and other covered entities in evaluating their security posture. This tool helps organizations understand the requirements of the HIPAA Security Rule and assess their implementation effectiveness.
The NIST HIPAA Security Toolkit Application is another valuable resource provided by the National Institute of Standards and Technology (NIST) in collaboration with the OCR. This application serves as a self-assessment survey, enabling hospitals to comprehend the HIPAA Security Rule requirements, implement them, and evaluate their operational impact. Additionally, the NIST has published comprehensive guides, such as the "Guide to Technical Aspects of Performing Information Security Assessments" and "Information Security Handbook," to provide in-depth guidance on conducting security risk assessments.
Hospitals can also refer to the Health Information Trust Alliance's (HITRUST) Common Security Framework (CSF) for risk management insights. The CSF offers methods for implementing a robust risk analysis program and links various frameworks and standards to the information security life cycle. Furthermore, the Office of the National Coordinator for Health Information Technology (ONC) has developed resources specifically for small healthcare practices, such as the "Reassessing Your Security Practices in a Health IT Environment" guide.
Conducting security risk assessments is not just a one-time event but a continuous process. Hospitals must periodically reassess their security environment, including adopting new technologies or responding to emerging risks. This iterative approach ensures that hospitals can proactively identify and mitigate potential threats to the security and integrity of patients' ePHI, maintaining compliance with the HIPAA Security Rule.
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Business associate contracts
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule establishes a national set of security standards to protect health information that is maintained or transmitted in electronic form. The Security Rule requires that covered entities implement a series of administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of electronic protected health information (ePHI).
Before permitting a business associate to create, receive, maintain, or transmit ePHI, a regulated entity must have in place a contract or other written arrangement (collectively referred to as a "business associate agreement") that complies with certain requirements. A "business associate" is a person or entity that performs functions or activities that involve the use or disclosure of protected health information on behalf of, or provides services to, a covered entity.
A written contract between a covered entity and a business associate must include the following:
- Establish the permitted and required uses and disclosures of protected health information by the business associate.
- Provide that the business associate will not use or further disclose the information other than as permitted or required by the contract or as required by law.
- Require the business associate to implement appropriate safeguards to prevent unauthorized use or disclosure of the information, including complying with the requirements of the HIPAA Security Rule with regard to ePHI.
- Require the business associate to report to the covered entity any use or disclosure of the information not provided for by its contract, including incidents that constitute breaches of unsecured protected health information.
- Require the business associate to disclose protected health information as specified in its contract to satisfy the covered entity's obligation with respect to individuals' right to an accounting of disclosures of their protected health information.
It is important to note that these are just sample provisions, and the language may be adapted to more accurately reflect the business arrangements between the covered entity and the business associate. These provisions alone may not be sufficient to result in a binding contract under State law, and do not replace consultation with a lawyer or negotiations between the parties.
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Privacy and security rules
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 establishes federal standards to protect sensitive health information from disclosure without patient consent. The US Department of Health and Human Services (HHS) issued the HIPAA Privacy Rule to implement these requirements. The HIPAA Security Rule protects a subset of information covered by the Privacy Rule. This subset includes all individually identifiable health information that a covered entity creates, receives, maintains, or transmits in electronic form. This information is referred to as electronic protected health information, or e-PHI.
The Security Rule establishes a national set of security standards to protect health information that is maintained or transmitted in electronic form. It requires covered entities to implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of e-PHI. These safeguards are designed to protect against reasonably anticipated threats or hazards to the security or integrity of the information and unauthorized uses or disclosures.
Covered entities under the Privacy Rule include healthcare providers, healthcare clearinghouses, and health plans. Healthcare providers are subject to the rule if they electronically transmit health information in connection with certain transactions, such as claims, benefit eligibility inquiries, and referral authorization requests. Healthcare clearinghouses are entities that process non-standard information and receive identifiable health information when providing processing services to a health plan or healthcare provider. Health plans with fewer than 50 participants, administered solely by the employer, are generally not considered covered entities.
To comply with the HIPAA Security Rule, covered entities must ensure the confidentiality, integrity, and availability of all e-PHI. They must also detect and safeguard against anticipated threats to the security of the information and protect against impermissible uses or disclosures not allowed by the rule. Entities must assess their security risks and implement appropriate safeguards, including administrative, physical, and technical measures. Administrative safeguards refer to the policies and procedures that govern how the covered entity protects e-PHI and manages its workforce in relation to this data. Physical safeguards refer to the physical measures taken to protect e-PHI, such as restricting access to certain areas. Technical safeguards encompass the technology and associated policies and procedures used to protect e-PHI and control access to it.
HIPAA compliance requires the creation and implementation of various policies and procedures, which must be documented and retained for at least six years. These documents should be periodically reviewed and updated as needed. The HHS has developed tools to assist entities in assessing their compliance with the Security Rule, such as the NIST HIPAA Security Toolkit Application and the Security Risk Assessment Tool.
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Frequently asked questions
The Health Insurance Portability and Accountability Act (HIPAA) Security Rule establishes national standards to protect individuals' electronic personal health information. It requires hospitals and other covered entities to implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and security of electronic protected health information (ePHI).
The Security Rule protects a subset of information covered by the HIPAA Privacy Rule. This includes all individually identifiable health information that a covered entity creates, receives, maintains, or transmits in electronic form.
Hospitals must assess their security risks and implement appropriate safeguards to protect ePHI. This includes technical safeguards, such as electronic security systems, as well as administrative safeguards, which are the policies and procedures that govern how employees handle and protect ePHI. Hospitals must also periodically evaluate their security measures and document their compliance.
Compliance with the HIPAA Security Rule is important to protect patient privacy and ensure the security of their electronic personal health information. Non-compliance can result in significant financial and legal consequences, and it can also damage patient trust.
