Safeguards
Technical Safeguards: Here are some technical measures that can be applied to safeguard e-PHI:
- Access Controls: A covered entity should have technical rules in place to ensure only authorized people can get to electronic protected health information (e-PHI).
- Audit Controls: A covered entity needs to set up hardware, software, or other methods to keep track of who accesses or interacts with systems containing e-PHI.
- Integrity Controls: A covered entity must create guidelines to make sure e-PHI isn't wrongly changed or deleted. There should be electronic checks to verify that e-PHI remains intact.
- Transmission Security: A covered entity must have technical measures to stop unauthorized access to e-PHI sent over electronic networks.
Organizational Requirements
If a covered entity is aware of a business associate's actions or practices that significantly breach or violate their responsibilities, the covered entity needs to take reasonable steps to fix the issue or stop the violation. These violations can include not having the right safeguards in place to properly protect electronic protected health information (e-PHI).
Responding to a Breach
HIPAA's breach notification rule is designed to ensure that individuals are promptly informed of breaches affecting their private health information so they can take steps to protect themselves from potential harm. Failure to comply with these guidelines can result in significant fines and penalties, as well as damage to the organization's reputation.
Requirements Associated with HIPAA Breaches
Here's a breakdown of the key components:
1. Breach Discovery and Assessment: Upon discovery of a potential breach, covered entities must promptly conduct a risk assessment to determine whether the incident constitutes a breach under HIPAA. This assessment considers factors such as the nature and extent of the PHI involved, the unauthorized person who used the PHI or to whom the disclosure was made, whether the PHI was actually acquired or viewed, and the extent to which the risk to the PHI has been mitigated.
2. Notification Requirements: If an incident is determined to be a breach, HIPAA requires that affected individuals, the Secretary of Health and Human Services (HHS), and, in some cases, the media be notified without unreasonable delay and in no case later than 60 days following the discovery of the breach. The specifics of the notification requirements are as follows:
- Individual Notification: Affected individuals must be notified in written form by first-class mail, or by email if the individual has agreed to electronic communications.
- Media Notification: For breaches affecting more than 500 residents of a state or jurisdiction, covered entities must notify prominent media outlets serving the state or jurisdiction.
3. Notification to the Secretary of HHS: For breaches affecting fewer than 500 individuals, covered entities must maintain an internal log and annually submit the information to HHS. For breaches involving 500 or more individuals, notification must be provided to HHS simultaneously with the individual notifications.
4. Breach Documentation and Log: Covered entities must document all breaches, regardless of size, including their discovery, the investigation, mitigation actions taken, and the notifications provided. This documentation must be retained for at least six years.
5. Mitigation and Prevention: In addition to responding to breaches, covered entities are required to take steps to mitigate harm to affected individuals and to revise their privacy and security practices to prevent future breaches.
6. Business Associate Obligations: Business associates of covered entities, who also handle PHI, are directly liable for compliance with certain provisions of the HIPAA Rules, including breach notification requirements. They must notify the covered entity of a breach without unreasonable delay and no later than 60 days from the discovery of the breach.
Knowledge Check Choose the best answer for the question.
3-8. Which of the following technical safeguards ensures e-PHI is not improperly altered or destroyed?
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