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Instructions for Submitting Notice of a Breach to the Secretary

A covered entity must notify the Secretary if it discovers a breach of unsecured protected health information. See 45 C.F.R. § 164.408. All notifications must be submitted to the Secretary using the Web portal below.

A covered entity’s breach notification obligations differ based on whether the breach affects 500 or more individuals or fewer than 500 individuals. If the number of individuals affected by a breach is uncertain at the time of submission, the covered entity should provide an estimate, and, if it discovers additional information, submit updates in the manner specified below. If only one option is available in a particular submission category, the covered entity should pick the best option, and may provide additional details in the free text portion of the submission.

If a covered entity discovers additional information that supplements, modifies, or clarifies a previously submitted notice to the Secretary, it may submit an additional form by checking the appropriate box to indicate that it is an addendum to the initial report, using the transaction number provided after its submission of the initial breach report.

Please review the instructions below for submitting breach notifications.

Breaches Affecting 500 or More Individuals

If a breach of unsecured protected health information affects 500 or more individuals, a covered entity must notify the Secretary of the breach without unreasonable delay and in no case later than 60 calendar days from the discovery of the breach. The covered entity must submit the notice electronically by clicking on the link below and completing all of the required fields of the breach notification form.

Submit a Notice for a Breach Affecting 500 or More Individuals

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Breaches Affecting Fewer than 500 Individuals

If a breach of unsecured protected health information affects fewer than 500 individuals, a covered entity must notify the Secretary of the breach within 60 days of the end of the calendar year in which the breach was discovered. (A covered entity is not required to wait until the end of the calendar year to report breaches affecting fewer than 500 individuals; a covered entity may report such breaches at the time they are discovered.) The covered entity may report all of its breaches affecting fewer than 500 individuals on one date, but the covered entity must complete a separate notice for each breach incident. The covered entity must submit the notice electronically by clicking on the link below and completing all of the fields of the breach notification form.

Submit a Notice for a Breach Affecting Fewer than 500 Individuals

 

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If you have any questions, you may call HHS OCR toll-free at: 1-800-368-1019, TDD: 1-800-537-7697 or send an email to OCRPrivacy@hhs.gov.