What are the Consequences of Non-Compliance?

Protecting Patient Data Through Training and Security

What are the Consequences of Non HIPAA Compliance?

Patient data holds tremendous value, making training and security awareness essential in preventing data breaches. Most employees don’t set out to cause a breach—violations usually occur because they lack knowledge about what they should or shouldn’t do with devices that access protected health information (PHI).

Organizations achieve HIPAA compliance by enforcing clear policies, implementing strong procedures, and providing consistent education. These efforts, combined with multiple layers of security, protect patient data from unauthorized access. The specific security layers your organization needs depend on how data flows in and out of your network. Conducting a thorough risk analysis identifies the exact safeguards required.

Consequences of Non-Compliance

Regulators actively enforce HIPAA rules, and violations carry serious consequences. Non-compliance can lead to resolution agreements, civil money penalties (CMPs), class action lawsuits, and even jail time. These penalties apply even if you did not know you were violating HIPAA. Healthcare providers and business associates alike face significant financial and legal risks when they fail to comply.

A Resolution Agreement is a formal settlement between the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) and a covered entity or business associate accused of violating HIPAA.

  • In this agreement, the organization accepts responsibility, agrees to take corrective action, and often pays a settlement amount (sometimes called a “Resolution Amount”).
  • These agreements usually last several years, during which OCR closely monitors the organization’s compliance with the corrective action plan (CAP).
  • Resolution Agreements allow OCR to fix systemic issues without going through lengthy litigation while still holding the organization accountable.

If OCR cannot resolve violations informally or through a Resolution Agreement, it may impose Civil Money Penalties (CMPs).

  • CMPs are financial fines assessed against covered entities or business associates that fail to comply with HIPAA requirements.
  • Penalties range from $141 to $71,162 per violation, with an annual maximum of $ 2,134,831 for identical violations (amounts can be higher in some cases under HITECH).
  • CMPs take into account factors such as the level of negligence, the severity of the violation, the organization’s history of compliance, and whether the organization took corrective action.

Key Difference:

  • A Resolution Agreement is a negotiated settlement with corrective actions and oversight.
  • Civil Money Penalties are unilateral fines imposed when OCR determines that a violation occurred and the entity failed to correct it or resolve the issue through settlement.

HIPAA Violation

Individual did not know (and by exercising reasonable diligence would not have known)
that he/she violated HIPAA

HIPAA violation due to reasonable cause and
not due to willful neglect

HIPAA violation due to willful neglect but violation is corrected within the required time period

HIPAA violation is due to willful neglect and is not corrected

Minimum Penalty

$141 per violation, with an annual
maximum of $35,581
for repeat violations (Note: maximum that can be imposed by State Attorneys General regardless of the type of violation)

$1,424 per violation, with an
annual maximum of $142,355 for repeat violations

$14,232 per violation, with an annual maximum of $250,000 for repeat violations

$71,162 per violation, with
an annual maximum of
$2,134,831

Maximum Penalty

$71,162 per violation, with an
annual maximum of $2,134,831

$71,162 per violation, with an
annual maximum of $2,134,831

$71,162 per violation, with an
annual maximum of $2,134,831

$71,162 per violation, with an
annual maximum of $2,134,831

Criminal Penalties

Consequences of Non-HIPAA Compliance

The U.S. Department of Justice (DOJ) clarified who faces criminal liability under HIPAA. Covered Entities and certain individuals who knowingly obtain or disclose individually identifiable health information in violation of the Administrative Simplification Regulations face fines of up to $50,000 and imprisonment for up to one year.

If someone commits the offense under false pretenses, penalties rise to $100,000 in fines and up to five years in prison. When individuals act with the intent to sell, transfer, or use the information for commercial advantage, personal gain, or malicious harm, penalties increase to $250,000 in fines and up to ten years in prison.

Covered Entities and Specified Individuals

The DOJ confirmed that HIPAA criminal penalties apply directly to Covered Entities, including:

  • Health plans
  • Health care clearinghouses
  • Health care providers who transmit claims electronically
  • Medicare prescription drug card sponsors

In addition, directors, officers, and employees of Covered Entities may face direct criminal liability under HIPAA based on principles of corporate criminal liability. Even if individuals are not directly liable, prosecutors can still charge them with conspiracy or aiding and abetting a violation.

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