The HIPAA Privacy Rule protects most "individually identifiable health information" held or transmitted by a covered entity or its business associate, in any form or medium, whether electronic, on paper, or oral. The Privacy Rule calls this information protected health information (PHI). Protected health information is information, including demographic information, which relates to:
* the individual's past, present, or future physical or mental health or condition,
* the provision of health care to the individual, or
* the past, present, or future payment for the provision of health care to the individual, and that identifies the individual or for which there is a reasonable basis to believe can be used to identify the individual.
Protected health information includes many common identifiers (e.g., name, address, birth date, Social Security Number) when they can be associated with the health information listed above.
For example, a medical record, laboratory report, or hospital bill would be PHI because each document would contain a patient's name and/or other identifying information associated with the health data content.
By contrast, a health plan report that only noted the average age of health plan members was 45 years would not be PHI because that information, although developed by aggregating information from individual plan member records, does not identify any individual plan members and there is no reasonable basis to believe that it could be used to identify an individual.
The relationship with health information is fundamental. Identifying information alone, such as personal names, residential addresses, or phone numbers, would not necessarily be designated as PHI. For instance, if such information was reported as part of a publicly accessible data source, such as a phone book, then this information would not be PHI because it is not related to health data (see above). If such information was listed with a health condition, health care provision, or payment data, such as an indication that the individual was treated at a certain clinic, then this information would be PHI.
OCR just published guidance about methods and approaches to achieve de-identification in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The guidance explains and answers questions regarding the two methods that can be used to satisfy the Privacy Rule's de-identification standard:
- Expert Determination, and
- Safe Harbor.
This guidance is intended to assist covered entities to understand what is de-identification, the general process by which de-identified information is created, and the options available for performing de-identification.
In developing this guidance, the Office for Civil Rights (OCR) solicited input from stakeholders with practical, technical, and policy experience in de-identification. OCR convened stakeholders at a workshop consisting of multiple panel sessions held March 8-9, 2010, in Washington, DC. Each panel addressed a specific topic related to the Privacy Rule's de-identification methodologies and policies. The workshop was open to the public and each panel was followed by a question and answer period.
To access this OCR guidance click here.