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Expert Determination Standard

Meaning

The Expert Determination Standard refers to a specific, recognized methodology for de-identifying protected health information (PHI) where a qualified, experienced professional reviews the data and certifies that the risk of re-identification is extremely low, following specific statistical and scientific principles. This standard provides an alternative pathway to the Safe Harbor method under HIPAA for rendering data anonymous and suitable for secondary research or analysis. The determination requires the expert to assess the complexity of the quasi-identifiers, the data’s intended recipient, and the presence of any unique or rare clinical characteristics that could inadvertently lead to patient identification. It serves as a rigorous, judgment-based safeguard for patient privacy in nuanced clinical data sets.