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HIPAA Breach Risk Assessment

HIPAA Breach Risk Assessment

A four-factor risk assessment template for evaluating unauthorized use or disclosure of PHI and determining whether breach notification is required.

Incident Overview

  • Incident date and time recorded
    Document when the unauthorized use or disclosure occurred or was discovered.
  • Incident type identified
    Classify the event as unauthorized use, unauthorized disclosure, loss, theft, misdirected communication, improper access, or other.
  • PHI involved confirmed
    Confirm whether the incident involved protected health information.
  • Incident summary documented
    Provide a concise factual summary of what happened, including systems, documents, or communications involved.
  • Discovery source identified
    Identify how the incident was discovered.
  • Incident report reference number
    Enter the internal case, ticket, or incident reference number.

Factor 1: Nature and Extent of PHI

  • PHI identifiers included
    Select the types of identifiers present in the disclosed or accessed information.
  • Minimum necessary standard applied
    Determine whether the PHI involved was limited to the minimum necessary information for the intended purpose.
  • Sensitivity of PHI assessed
    Rate the sensitivity and potential harm associated with the PHI involved.
  • Volume of PHI involved
    Enter the approximate number of records, files, or data subjects affected.
  • Likelihood of re-identification evaluated
    Assess whether the information could reasonably be used to identify the individual if not fully de-identified.
  • PHI was encrypted or otherwise secured
    Indicate whether the PHI was secured using an approved encryption or equivalent protection method at the time of the incident.

Factor 2: Unauthorized Person

  • Recipient identity determined
    Identify the unauthorized person or entity that received or accessed the PHI.
  • Recipient had authorization to receive PHI
    Confirm whether the recipient was authorized under policy, contract, or role to receive the PHI.
  • Recipient relationship to covered entity assessed
    Describe the recipient's role, contractual relationship, or other relevant connection to the covered entity or business associate.
  • Recipient confidentiality obligations confirmed
    Determine whether the recipient is bound by confidentiality obligations, privacy agreements, or legal restrictions.
  • Potential for further disclosure assessed
    Rate the likelihood that the recipient could further use or disclose the PHI inappropriately.

Factor 3: Actual Acquisition or Viewing

  • Evidence of access reviewed
    Review logs, email tracking, access records, or other evidence to determine whether the PHI was accessed.
  • Actual viewing confirmed
    Confirm whether the PHI was actually viewed or acquired by the unauthorized person.
  • Evidence source documented
    Select the evidence used to support the determination.
  • Time to containment documented
    Enter the approximate number of hours from discovery to containment or access restriction.
  • Access successfully terminated or restricted
    Confirm whether access was terminated, revoked, or otherwise restricted after discovery.

Factor 4: Mitigation and Notification Determination

  • Mitigation steps completed
    Select all mitigation actions taken to reduce the risk of compromise.
  • Residual risk after mitigation assessed
    Rate the remaining risk after mitigation actions were completed.
  • Breach notification required determination
    Document the final determination based on the four-factor assessment.
  • Notification deadline calculated
    If notification is required, record the deadline for required notifications.
  • Corrective action plan initiated
    Confirm whether a corrective action plan, policy update, or retraining plan has been initiated.

Review, Approval, and References

  • Privacy officer or compliance reviewer approval
    Signature of the privacy officer, compliance officer, or designated reviewer approving the assessment.
  • Legal counsel consulted
    Indicate whether legal counsel was consulted for the final determination.
  • Reference document
    Record the applicable HIPAA breach risk assessment policy, incident response SOP, or legal memo reference.
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