Challenge # 12 Anonymization and pseudonymization? What is the difference?
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Hello everyone, this is Vanessa Montanari from the clinical research blog for Pharmaspecific. Today we’re going to look at a new topic. We’re going to be talking about pseudonymization and anonymization.
Today, in clinical research, people use the term anonymization a lot. It’s a problem that in many countries the term is used when in fact we do pseudoanonymization. I’ve really wanted to do this video for a while because it’s important for you to know that there’s a difference between those two terms. You can’t use them without having the real definition. When we talk about anonymization, when you’re working in clinical trials, sometimes you may need to retrieve a report or send a report, for example a medical report, to the pharmacovigilance service to document a serious adverse event. This is done less and less, but at one time it was done and in this case you may have to anonymize the document. Anonymization means removing the surname, first name, medical record number, hospitalization code, any information that could be traced back to the patient. On the other hand, what will be noted on the document is the alphanumeric code. So, for example, a number and the patient’s initials. This is what is generally done in many CROs or pharmaceutical companies. So today it’s called anonymization. Most people call it anonymization. You have to know that it’s not called anonymization. It’s actually pseudonymization.
Anonymization in reality is not being able to find the patient at all. When on the document you write down the alphanumeric code, a number and an initial, it is possible to find the patient thanks to the identification list that is at the investigator’s premises in the hospital. So if you can find out who the patient is, that means you’re not anonymous. Anonymization is the fact that you can’t trace a person at all. You take away all the information that would allow you to find that person, and you can never find that person because you can never trace that person. That’s what anonymization is all about. Pseudonymization, on the other hand, is being able to have this correspondence table, this identification list at the investigator’s home and being able to know who that person really is if you want to know at some point in time. That’s the point. So this is a subject that was addressed several years ago by the G29. In fact, at the time, it was a European organization that brings together the European personal data management authorities and which was discussing certain subjects and which had precisely highlighted this difference. At the time, I said to myself, I really need to tell the public about this on the clinical research blog because you need to be aware of this difference, so there you go, it’s done today.
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