The Health Insurance Portability and Accountability Act (HIPAA) sets the standard for protecting sensitive patient data in the United States. Organizations that handle protected health information (PHI) must ensure that all the required physical, network, and process security measures are in place and followed. However, if breaches and violations do occur, organizations have a responsibility to contain the incident and may face penalties if the organization is found partially responsible for the incident.
According to Paubox, “a violation is a failure to comply with HIPAA rules and regulations.” Conversely, a HIPAA breach “happens when someone gets unauthorized access to or discloses personal health information.”
Go deeper: Understanding HIPAA violations and breaches
The Enforcement Final Rule (2006) grants the Office for Civil Rights (OCR) the power to issue penalties against non-compliant entities. In the event of a violation being discovered during an inquiry, the OCR can impose different repercussions that may even comprise criminal allegations. Therefore, these sanctions function as deterrence while simultaneously ensuring covered bodies are liable for their actions.
According to the HSS Enforcement Results as of April 30, 2024, “to date, OCR settled or imposed a civil money penalty in 145 cases resulting in a total dollar amount of $142,663,772.00. OCR has investigated complaints against many different types of entities including: national pharmacy chains, major medical centers, group health plans, hospital chains, and small provider offices.”
See also: HIPAA Compliant Email: The Definitive Guide
A corrective action plan (CAP) aims to determine the causes behind security breaches that occur within an organization. By implementing this plan, healthcare establishments can modify their cyber defense measures and prevent similar incidents from recurring. CAPs may require financial investment along with time and effort on the part of the healthcare entity involved.
The emphasis of a CAP can vary based on the type of infraction and may center around how a healthcare facility operates, including updating policies and procedures, enhancing employee training programs, and strengthening technological safeguards. In addition to dealing with the particular breach, the objective of a CAP is to create a stronger and more durable system for safeguarding confidential patient data. This comprehensive approach ensures that healthcare organizations remain compliant with HIPAA regulations and better equipped to handle future threats.
A CAP may include:
See also:
HIPAA violations can result in significant monetary penalties, which are categorized into four tiers based on the level of negligence and the organization's awareness and correction of the issue.
The Enforcement Final Rule has granted OCR the authority to prosecute specific violators, who usually performed deliberate/ conscious criminal offenses. These crimes may include PHI stealing for monetary benefits, revealing PHI maliciously, or non-compliance in executing a CAP within the designated timeframe.
Penalty tier |
Culpability level |
Potential jail time |
Tier 1 |
Reasonable cause or no knowledge of the violation |
Up to one year |
Tier 2 |
Obtaining PHI under false pretenses |
Up to five years |
Tier 3 |
Obtaining PHI for personal gain or malicious intent |
Up to ten years |
A breach is an incident where PHI is accessed, used, or disclosed without authorization. Here's what to do if a breach occurs:
Read more: How to respond to a data breach
A violation occurs when an organization fails to comply with HIPAA rules. Here's how to handle a violation:
Organizations must notify affected individuals within 60 days of discovering the breach. If the breach affects 500 or more individuals, the OCR and the media must also be notified within 60 days. Smaller breaches should be reported to the OCR annually.
Go deeper: What are the HIPAA breach notification requirements
The HIPAA Enforcement Final Rule, issued in 2006, establishes the procedures and penalties for enforcing compliance with the Health Insurance Portability and Accountability Act (HIPAA). This rule outlines how the Department of Health and Human Services (HHS) handles investigations, imposes penalties, and ensures adherence to HIPAA's privacy and security provisions.
See also: What is the HIPAA Enforcement Rule?
The OCR is entrusted with several crucial responsibilities concerning HIPAA enforcement, such as conducting investigations of possible breaches. Investigations include complaints submitted by individuals, reports from covered entities, or incidents reported by business associates.