HIPAA breaches and reporting

HIPAA breaches and reporting

HIPAA breaches and reporting

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HIPAA Breaches - Code Red, Data Spilled

  • Breach Definition: An impermissible use or disclosure of Protected Health Information (PHI). It is presumed a breach unless the covered entity can demonstrate a low probability that PHI has been compromised based on a 4-factor risk assessment.

  • Notification Timeline: All notifications must occur without unreasonable delay, and in no case later than 60 calendar days after discovery.

  • Reporting Requirements:

    • To Individuals: Direct written notification (or email if permitted).
    • To HHS:
      • Affecting ≥500 people: Notify the Secretary of HHS within 60 days.
      • Affecting <500 people: Maintain a log and submit it to HHS annually.
    • To Media: If a breach impacts >500 residents of one state, prominent media outlets in that state must be alerted.

⭐ The 60-day notification clock starts from the moment the breach is discovered, including when it should have been discovered by the organization through reasonable diligence.

Breach Reporting - Sound the Alarm!

  • Breach Definition: Unauthorized acquisition, access, use, or disclosure of unsecured Protected Health Information (PHI).
  • Notification Obligation: All affected individuals must be notified without unreasonable delay, not to exceed 60 days.
  • HHS/OCR Reporting: The timeline hinges on the number of individuals affected.
  • 📌 Mnemonic: "MEDIA 500"
    • If a breach impacts 500 or more people, you must notify the MEDIA (and HHS) promptly.

⭐ The burden of proof is on the covered entity to demonstrate that notification was not required. They must produce a risk assessment showing a low probability that PHI was compromised.

Penalties - The Price of Silence

  • Civil Monetary Penalties: Tiered system based on the level of culpability, not patient harm.
    • Tier 1 (Unknowing): $100 - $50,000 per violation.
    • Tier 2 (Reasonable Cause): $1,000 - $50,000 per violation.
    • Tier 3 (Willful Neglect, Corrected): $10,000 - $50,000 per violation if corrected within 30 days.
    • Tier 4 (Willful Neglect, Uncorrected): Minimum $50,000 per violation.
  • Criminal Penalties: For knowingly obtaining or disclosing PHI.
    • Can result in fines up to $250,000 and imprisonment up to 10 years.

⭐ The annual penalty cap for multiple violations of the same provision is $1.5 million for each penalty tier.

High‑Yield Points - ⚡ Biggest Takeaways

  • A HIPAA breach is an impermissible use or disclosure of Protected Health Information (PHI) that compromises its security or privacy.
  • Breaches impacting >500 individuals mandate prompt notification to the HHS Secretary and prominent media outlets.
  • All affected individuals must be notified without unreasonable delay, and no later than 60 days after discovery.
  • For breaches affecting <500 individuals, entities must log them and notify HHS annually.
  • The Safe Harbor exception applies if PHI is encrypted per HHS standards.

Practice Questions: HIPAA breaches and reporting

Test your understanding with these related questions

The surgical equipment used during a craniectomy is sterilized using pressurized steam at 121°C for 15 minutes. Reuse of these instruments can cause transmission of which of the following pathogens?

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Flashcards: HIPAA breaches and reporting

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Which type of medical error analysis involves a retrospective approach, applied after failure to prevent recurrence?_____

TAP TO REVEAL ANSWER

Which type of medical error analysis involves a retrospective approach, applied after failure to prevent recurrence?_____

Root cause analysis

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