Not every unauthorized access is a reportable breach — but every unauthorized access requires a breach risk assessment to make that determination. You do not get to skip the assessment because you believe the risk is low.
The four-factor test under 45 CFR 164.402 evaluates: the nature and extent of the PHI involved (including identifiers and likelihood of re-identification), the unauthorized person who accessed the PHI, whether the PHI was actually acquired or viewed, and the extent to which the risk to the PHI has been mitigated.
If the assessment concludes there is more than a low probability that the PHI was compromised, it is a reportable breach. You must notify affected patients within 60 days. For 500 or more affected individuals, you must also notify HHS and local media.
The burden of proof is on the covered entity. If you cannot demonstrate that the probability of compromise was low, the presumption is that a breach occurred. Document the assessment regardless of the outcome.