What is the HIPAA safe harbor method?

According to an article Understanding Safe Harbor and Expert Determination in Healthcare Data Security by SynapseHealthTech, published on LinkedIn: “The Safe Harbor method is a prescriptive approach to de-identification that focuses on the removal of specific identifiers from patient data. According to HIPAA regulations, the Safe Harbor method requires the removal of 18 distinct types of identifiers before the data can be considered de-identified. The logic behind this method is that by stripping away these key identifiers, the risk of re-identifying an individual is significantly reduced.”

Related: How to de-identify protected health information for privacy

The 18 identifiers

45 CFR § 164.514(b)(2)(i) provides for the following identifiers to be removed When applying the Safe Harbor method:

1. Names
2. Geographic subdivisions smaller than a state (with some exceptions for initial three digits of ZIP codes)
3. All dates (except year) directly related to an individual
4. Phone numbers
5. Fax numbers
6. Email addresses
7. Social Security numbers
8. Medical record numbers
9. Health plan beneficiary numbers
10. Account numbers
11. Certificate/license numbers
12. Vehicle identifiers and serial numbers, including license plates
13. Device identifiers and serial numbers
14. Web URLs
15. IP addresses
16. Biometric identifiers (including fingerprints and voice prints)
17. Full-face photographs and comparable images
18. Any other unique identifying numbers, characteristics, or codes

Benefits of using safe harbor

SynapseHealthTech notes, “One of the key advantages of the Safe Harbor method is its clarity. By providing a well-defined list of identifiers that must be removed, the Safe Harbor approach is relatively easy to implement and validate. It offers a clear, standardized way for healthcare organizations to comply with HIPAA’s de-identification requirements.”

Additionally, “The Safe Harbor method can be applied to large datasets with relative efficiency, making it a practical solution for healthcare providers and researchers looking to de-identify large volumes of data quickly.”

Implementation challenges

“While Safe Harbor is a straightforward method, it is not without its limitations. One of the most significant criticisms is that it operates under a "one-size-fits-all" model, which may not be suitable for all contexts. The removal of geographic identifiers smaller than a state, for instance, can reduce the data’s utility for certain types of research, such as epidemiological studies that require regional specificity,” states SynapseHealthTech

Furthermore, “The Safe Harbor method can be vulnerable to re-identification attacks, especially if de-identified data is combined with external datasets. For instance, advances in data mining techniques and the availability of supplementary data sources (e.g., public voting records or social media) have increased the risk of re-identification, even in datasets that meet Safe Harbor standards.”

This analysis is supported by TechTarget in their article De-Identification of PHI According to the HIPAA Privacy Rule, which states, “The biggest downside to the safe harbor method is its potential to remove so much valuable data that the information is no longer useful for research purposes.”

Best practices for safe harbor implementation

• Develop policies and procedures that outline the exact steps for identifying and removing all 18 HIPAA identifiers
• Train all staff members involved in data handling on proper de-identification procedures
• Implement a quality control system that includes multiple layers of verification
• Maintain detailed documentation of all de-identification activities, including the specific methods used, timestamps of when the process was performed, who performed it, who verified it, and what quality control measures were applied
• Establish a regular review cycle for de-identification procedures to ensure they remain current with evolving technology and emerging privacy risks

Read also: How to choose the right method for deidentification

FAQs

Can organizations still use de-identified data for research purposes after applying Safe Harbor? 

Yes, organizations can freely use and share the data for research, quality assessment, and other purposes without HIPAA restrictions.

What happens if you miss removing one of the 18 identifiers? 

Even a single overlooked identifier means the data is not properly de-identified and remains subject to all HIPAA regulations and potential penalties for unauthorized disclosure.

Do international organizations need to follow Safe Harbor for HIPAA compliance? 

Any organization handling protected health information of U.S. patients must comply with HIPAA requirements, including proper de-identification through Safe Harbor or Expert Determination, regardless of their location.