What is Protected Health Information (PHI)?
Regulatory basis: PHI is defined at 45 CFR 160.103. De-identification standards are specified at 45 CFR 164.514(a)-(c). The Privacy Rule governing use and disclosure of PHI is codified at 45 CFR Part 164, Subpart E.
Definition
Protected Health Information (PHI) is individually identifiable health information that is created, received, maintained, or transmitted by a covered entity or business associate. Under 45 CFR 160.103, individually identifiable health information is a subset of health information, including demographic information, that:
- Is created or received by a health care provider, health plan, employer, or health care clearinghouse
- Relates to the past, present, or future physical or mental health condition of an individual, the provision of health care to an individual, or the past, present, or future payment for health care
- Identifies the individual, or for which there is a reasonable basis to believe it can be used to identify the individual
The 18 HIPAA Identifiers
The Safe Harbor method of de-identification (45 CFR 164.514(b)(2)) specifies 18 categories of identifiers that must be removed for information to be considered de-identified:
| # | Identifier | Scope |
|---|---|---|
| 1 | Names | Full name or any part (first, last, maiden, alias) |
| 2 | Geographic data | All geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code (first 3 digits may be retained if the geographic unit contains more than 20,000 people) |
| 3 | Dates | All elements of dates (except year) directly related to an individual, including birth date, admission date, discharge date, date of death; ages over 89 and all elements of dates for such ages |
| 4 | Telephone numbers | All telephone numbers |
| 5 | Fax numbers | All fax numbers |
| 6 | Email addresses | All email addresses |
| 7 | Social Security numbers | All SSNs |
| 8 | Medical record numbers | Numbers assigned by the covered entity |
| 9 | Health plan beneficiary numbers | Numbers assigned by health plans |
| 10 | Account numbers | Any account number |
| 11 | Certificate/license numbers | Any certificate or license number |
| 12 | Vehicle identifiers and serial numbers | Including license plate numbers |
| 13 | Device identifiers and serial numbers | Including medical device UDIs |
| 14 | Web URLs | Any web universal resource locator |
| 15 | IP addresses | Any internet protocol address number |
| 16 | Biometric identifiers | Fingerprints, voiceprints, retinal scans |
| 17 | Full-face photographs | Any comparable images |
| 18 | Any other unique identifying number, characteristic, or code | Except as permitted for re-identification under 164.514(c) |
PHI vs. ePHI
PHI
Protected Health Information in any form -- paper records, oral communications, electronic data. Governed by the Privacy Rule (45 CFR Part 164, Subpart E).
ePHI
Electronic Protected Health Information -- PHI that is created, received, maintained, or transmitted in electronic form. Governed by both the Privacy Rule and the Security Rule (45 CFR Part 164, Subpart C).
De-identification Methods
Expert Determination
45 CFR 164.514(b)(1)
A person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods for rendering information not individually identifiable applies such principles and methods and determines that the risk is very small that the information could be used, alone or in combination with other reasonably available information, to identify an individual. The methods and results of the analysis must be documented.
Safe Harbor
45 CFR 164.514(b)(2)
Remove all 18 categories of identifiers listed above, and the covered entity has no actual knowledge that the remaining information could be used alone or in combination with other information to identify an individual.
What is NOT PHI
The following are commonly mistaken for PHI but do not meet the regulatory definition:
- De-identified data -- information that has been de-identified per 45 CFR 164.514(a)-(c) is no longer PHI and is not subject to HIPAA.
- Employment records -- health information held by a covered entity in its role as employer (not as health care provider) is not PHI under HIPAA, though it may be protected by other laws.
- Education records -- covered by FERPA, not HIPAA, for educational institutions.
- Data held by non-covered entities -- fitness trackers, health apps, and consumer health devices not operated by or on behalf of a covered entity are generally not subject to HIPAA (though may be subject to FTC or state laws).
Practical Guidance
When in doubt about whether information constitutes PHI, apply the conservative interpretation: if the data relates to health and could reasonably identify an individual, treat it as PHI. The penalties for unauthorized disclosure of PHI range from $100 to $50,000 per violation under 45 CFR 160.404, with an annual maximum of $1.5 million per violation category. Criminal penalties under 42 USC 1320d-6 can include fines up to $250,000 and imprisonment up to 10 years.