OCR Releases HIPAA Guidance on De-Identification of PHI
Earlier this week the U.S. Department of Health and Human Services Office of Civil Rights (OCR) released guidance for covered entities regarding methods and approaches to achieve de-identification of protected health information (PHI) in accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The guidance assists covered entities with understanding what de-identification is, the general process by which de-identified information is created, and the options available for performing de-identification.
OCR’s guidance outlines two methods that can be used to satisfy the Privacy Rule’s de-identification standard: (1) expert determination and (2) safe harbor. The expert determination method requires: (a) application of statistical or scientific principles and (b) the determination that there is a very small risk that the information could be used by an anticipated recipient – alone or in combination with other reasonably available information – to identify an individual who is a subject of the information. The safe harbor method requires: (a) removal of 18 types of identifiers and (b) no actual knowledge that residual information can identify an individual who is a subject of the information. The de-identification methods are illustrated by OCR as:
[Available via OCR's guidance (linked above).]
The guidance also provides answers to industry questions regarding the expert determination and safe harbor methods of de-identification. With regard to the expert determination method, the guidance addresses, among other topics: (1) qualifications of an expert; (2) an acceptable level of and method for determining identification risk; (3) approaches by which an expert assesses the risk that health information can be identified and mitigates the risk of identification of an individual in health information; and (4) when a data-use agreement should be used.
The guidance addresses the following topics, among others, related to the safe harbor method: (1) use of the first three digits of a ZIP code in de-identified information; (2) the prohibition against disclosing parts or derivatives of any of the identifiers; (3) examples of prohibited dates; (4) what constitutes “any other unique identifying number, characteristic, or code” for purposes of the Privacy Rule; and (5) what constitutes actual knowledge regarding potential use of information.
OCR’s guidance provides useful information on de-identification for privacy officers and others who deal with the exchange of PHI. The guidance was developed based on comments from stakeholders attending OCR’s public de-identification workshop in 2010. A webcast of OCR’s de-identification workshop is available here.