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What is image de-identification? Why it is important in clinical trials? And how is it done?

Nowadays image de-identification is considered the “base expectation” for data handling in clinical trials, but striking the right balance between patient privacy and preserving valuable data that is needed for research purposes is a daunting task.

What regulates the collection of personal health information (PHI)?

The use of PHI in research is regulated by the “Privacy Rule”. The Privacy Rule is a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996. The Privacy Rule protects specific personal health information that can be used to identify living or deceased individuals. The Privacy Rule allows for the preservation of patient confidentiality without affecting the values and the information that could be needed for different research purposes.

What is PHI?

PHI is defined as "individually identifiable health information” i.e., information that can be used to directly or indirectly identify an individual in relation to the individual’s past, present or future health condition and the provision of health care to the individual. Common types of PHI include: patient name, address, birth date, social security number, medical and laboratory reports, physician name, hospital name, and date of examination.

Automatic de-identification in SliceVault

Image de-identification in SliceVault is a fully automated process consisting of the following steps:

1. Redaction of PHI in DICOM tags

2. Optical character recognition of burned in annotations

3. Formal determination by qualified expert

All steps of the de-identification process are executed locally, by means of a de-identification script provided by SliceVault that runs locally in the submitting investigator's internet browser. Local de-identification means no images containing PHI leaves the investigator site's closed network. Only after successful completion of the de-identification process, the de-identified images get transferred via secure communication to the SliceVault’ servers.

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