HIPAA standards are designed to protect sensitive patient information, and as a result, they require covered entities to implement various security measures.
Covered entities must implement administrative, technical, and physical safeguards to ensure the confidentiality, integrity, and availability of electronic protected health information (ePHI).
Administrative safeguards include designating a privacy official and implementing policies and procedures for protecting ePHI.
HIPAA also requires covered entities to train their workforce on handling protected health information.
HIPAA Requirements
Covered entities and business associates must ensure the confidentiality, integrity, and availability of all electronic protected health information (ePHI) they create, receive, maintain, or transmit. They must also protect against any reasonably anticipated threats or hazards to the security or integrity of such information.
To meet these requirements, covered entities and business associates must implement security measures that are reasonable and appropriate. This includes considering factors such as the size, complexity, and capabilities of the organization, as well as the costs of security measures. They must also comply with standards and implementation specifications, including required and addressable implementation specifications.
Here is a brief summary of the key requirements:
Covered Entities
Covered entities are a crucial part of HIPAA compliance. They include health plans, healthcare providers, and healthcare clearinghouses that maintain, transmit, or create PHI in their daily activities.
Healthcare providers employed by a hospital are not considered covered entities themselves, but rather the hospital is the covered entity and is responsible for HIPAA compliance.
HIPAA compliance is enforced by the OCR and regulated by the Department of Health and Human Services (HHS). Two types of organizations are required to be HIPAA compliant: covered entities and business associates.
Here are the two types of organizations required to be HIPAA compliant:
- Covered entity—a health plan, healthcare provider, or healthcare clearinghouse who, in its everyday activities, maintains, transmits or creates PHI.
- Business associates—a business or person that carries out a certain activity or function for, or offers a service to a covered entity, when that activity, function or service requires the business associate to have access to PHI stored by the covered entity.
Compliance
Compliance is a crucial aspect of HIPAA requirements. Every business associate and covered entity must adhere to all HIPAA rules, including the HIPAA Privacy and Security Rules.
To ensure compliance, organizations must establish and follow physical, technical, and administrative measures that comply with the HIPAA Privacy Rule. This includes ensuring that employees are trained annually on policies and procedures, and that all employees understand their roles in protecting patient health information.
Business associates must also comply with the HIPAA Security Rule, which includes standards for protecting electronic Protected Health Information (ePHI) when it's in transit or at rest. This rule is relevant to any system or individual that has access to confidential patient information.
To become HIPAA compliant, organizations must use a HIPAA compliance checklist to ensure their service or product meets all administrative, physical, and technical safeguards of the HIPAA Security Rule. This includes conducting annual self-audits to evaluate technical, administrative, and physical gaps in compliance with HIPAA privacy and security standards.
Organizations must also document all steps taken to become HIPAA compliant, including policies and procedures, employee training, and business associate management. This documentation is essential during a HIPAA investigation with the HHS.
Here's a brief checklist for complying with basic HIPAA requirements:
Organizations must also review and modify their security measures as needed to continue providing reasonable and appropriate protection of electronic protected health information.
Authorization is Required
Authorization is a critical component of HIPAA compliance, and it's required for any disclosure of protected health information (PHI).
To obtain authorization, patients must sign a written document that clearly explains what information will be shared, with whom, and for what purpose.
This document must be signed and dated by the patient, and a copy must be provided to them.
In some cases, a patient's representative may be authorized to make decisions on their behalf, such as a power of attorney or a guardian.
Authorization must be obtained before disclosing PHI to family members or friends, except in emergency situations.
Accounting
Accounting for HIPAA compliance involves a thorough understanding of the law's financial implications. Business associates must ensure they have adequate financial resources to implement and maintain HIPAA-compliant policies and procedures.
The HIPAA Security Rule requires covered entities to implement administrative, technical, and physical safeguards to protect electronic protected health information (ePHI). This includes conducting regular risk analyses to identify vulnerabilities and implementing corrective actions.
Business associates must also ensure they have adequate liability insurance to cover potential HIPAA-related lawsuits. According to the HIPAA Omnibus Rule, business associates can be held liable for HIPAA violations if they fail to comply with the law.
Business associates must also ensure they have adequate financial resources to implement and maintain HIPAA-compliant policies and procedures. This includes conducting regular risk analyses to identify vulnerabilities and implementing corrective actions.
The HIPAA Breach Notification Rule requires covered entities to notify affected individuals, the Department of Health and Human Services (HHS), and the media in the event of a breach. This can result in significant financial costs, including notification and credit monitoring expenses.
HIPAA Compliance Checklist
To ensure your organization meets the HIPAA standards, it's essential to have a clear plan in place. A HIPAA compliance checklist can help you stay on track.
Carry out annual audits to evaluate technical, administrative, and physical gaps in compliance with HIPAA privacy and security standards. This is a crucial step in maintaining compliance.
Remediation plans are also necessary to address compliance violations. Document all remediation plans, including which gaps were fixed and the calendar dates.
Create policies and procedures that align with HIPAA regulatory standards. Regularly update these procedures and policies to reflect any changes to your organization.
Documentation is key to demonstrating compliance. Keep detailed records of all steps taken to become HIPAA compliant.
Organizations must also manage their business associates effectively. This includes documenting all organizations with whom you share PHI and executing business associate agreements.
In the event of a breach, create a process to document the incident and notify patients accordingly. This is a critical step in complying with the HIPAA breach notification rule.
Here is a summary of the key actions to take:
HIPAA Standards
HIPAA Standards require entities to implement technical policies and procedures for electronic information systems that maintain electronic protected health information to allow access only to those persons or software programs that have been granted access rights.
Entities must assign a unique name and/or number for identifying and tracking user identity, establish procedures for obtaining necessary electronic protected health information during an emergency, implement electronic procedures that terminate an electronic session after a predetermined time of inactivity, and implement a mechanism to encrypt and decrypt electronic protected health information.
The following technical safeguards are required by HIPAA Standards:
- Access control
- Audit control
- Integrity
- Transmission security
These technical safeguards must be implemented to protect electronic protected health information from unauthorized access, alteration, or destruction.
Administrative Safeguards
Administrative Safeguards are a crucial part of HIPAA compliance, and they're not just about paperwork. According to §164.308 Administrative Safeguards, entities must implement policies and procedures to ensure the confidentiality, integrity, and availability of electronic protected health information (ePHI). This includes identifying and analyzing potential security risks, as well as providing workforce training and sanctions for policy violations.
Entities must also appoint a privacy officer and security officer responsible for ePHI, and define how to govern the workforce. This includes procedures for managing vulnerabilities, responding to security incidents in real-time, and performing user access management.
Some key administrative requirements include:
- Conducting a risk analysis to identify potential security risks and vulnerabilities
- Developing and implementing policies and procedures for workforce training and management
- Defining sanctions for policy violations and ensuring accountability
- Appointing a privacy officer and security officer responsible for ePHI
These administrative safeguards are essential for ensuring the confidentiality, integrity, and availability of ePHI, and for preventing unauthorized access, use, or disclosure of protected health information.
Law Enforcement Delay
If a law enforcement official states that a HIPAA notification would impede a criminal investigation or cause damage to national security, a covered entity must delay the notification.
The official's statement can be in writing and specify the time for which a delay is required, in which case the covered entity must delay the notification for that time period.
If the statement is made orally, the covered entity must document the statement, including the identity of the official making the statement, and delay the notification temporarily and no longer than 30 days from the date of the oral statement.
A written statement can be submitted during this time to extend the delay period.
Amendment
HIPAA Standards dictate that covered entities must comply with specific amendments to the law. The Health Insurance Portability and Accountability Act of 1996 was amended in 2009 to include the HITECH Act.
The HITECH Act introduced new regulations for breach notifications, increasing the liability for covered entities in case of data breaches. This means that covered entities must notify affected individuals and the Department of Health and Human Services within 60 days of a breach.
The amended law also increased the penalties for non-compliance, with fines ranging from $100 to $50,000 per violation. This emphasizes the importance of adhering to HIPAA standards to avoid costly penalties.
Covered entities must also implement written policies and procedures for breach notifications, which must be made available to the public upon request.
HIPAA Breach Notification
Covered entities are required to report all breaches to the HHS, regardless of size, but there are special protocols for disclosure depending on the type of breach.
A breach of unsecured protected health information is defined as an unauthorized use or disclosure of PHI that compromises the security or privacy of the information. Breaches are categorized into two types: minor breaches and meaningful breaches.
If a breach involves more than 500 residents of a state or jurisdiction, a covered entity must notify prominent media outlets serving the state or jurisdiction.
Breach Notification Rule
The Breach Notification Rule is a crucial part of HIPAA compliance. It requires covered entities to report all breaches, regardless of size, to the HHS.
The rule distinguishes between minor breaches and meaningful breaches. Minor breaches are not defined in the article sections provided, but it implies that there are special protocols for disclosure, depending on the type of breach.
Covered entities remain liable for unsecured Protected Health Information (PHI) and must notify patients if their PHI has been put at risk. This is a safeguard to ensure that patients are protected.
Organizations must notify the HHS of all breaches, and there are special protocols for disclosure, depending on the type of breach. This includes notifying the media in certain situations.
For breaches involving over 500 residents of a State or jurisdiction, covered entities must notify prominent media outlets. This notification must meet the requirements of § 164.404(c).
Covered entities must also notify the Secretary of a breach of unsecured protected health information. The notification must be provided contemporaneously with the notice required by § 164.404(a) for breaches involving 500 or more individuals.
Business associates must notify covered entities of a breach of unsecured protected health information. This notification must be provided without unreasonable delay and in no case later than 60 calendar days after discovery of a breach.
Business associates must also provide the covered entity with any other available information that the covered entity is required to include in notification to the individual under § 164.404(c).
Nothing
Nothing is a concept that can sometimes be overlooked in the context of HIPAA breach notification. The HHS Office for Civil Rights (OCR) defines a breach as an unauthorized use or disclosure of PHI, so even if no information is taken, the incident still constitutes a breach.
The absence of a breach is not always a guarantee that no incident occurred. This was the case with the University of California, Los Angeles (UCLA), which reported a breach involving the unauthorized access of PHI by an employee, even though no information was actually taken.
A breach can occur even if the PHI is not accessed or viewed. This is because a breach can be defined as any unauthorized use or disclosure of PHI, regardless of whether the information is actually used or viewed.
Frequently Asked Questions
What are the HIPAA 3 rules?
The HIPAA 3 rules are the Privacy Rule, Security Rule, and Breach Notification Rule, which work together to safeguard patient health information. Understanding these rules is crucial for protecting sensitive medical data.
Sources
- https://www.nist.gov/programs-projects/security-health-information-technology/hipaa-security-rule
- https://learn.microsoft.com/en-us/compliance/regulatory/offering-hipaa-hitech
- https://www.imperva.com/learn/data-security/hipaa-privacy-rule/
- https://www.netce.com/studypoints.php
- https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164
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