How do research organisations ensure that personal information about individuals remains confidential?

Anonymisation and pseudonymisation are two important data protection concepts that ensure the protection of personal data to varying degrees. Anonymisation aims for a complete removal of personal identifiers, whilst pseudonymisation enables a controlled obscuring of identity.

Here we explain some important terms and concepts for GCP-compliant and legally conformant studies.

What is anonymisation?

Anonymisation is the alteration of personal data in such a way that certain information about personal or other details can no longer be attributed to a specific person, or only with a disproportionate amount of time, expense and labour. (In Germany, this is in accordance with Section 3, Paragraph 6 of the Federal Data Protection Act, BDSG).

What is  pseudonymisation?

Pseudonymisation means replacing personal information such as names or other characteristics that can directly identify a person with an identifier or code. The aim is to prevent or at least make significantly more difficult the identification of the person concerned. (In Germany, this is in accordance with Section 3, Paragraph 6a of the Federal Data Protection Act, BDSG).

Pseudonymisation is carried out by a so-called pseudonymising body of the IDAT, i.e. it generates a pseudonym, whereby in multi-stage procedures, several pseudonymised bodies can be passed through in succession. In many cases, the pseudonymising body simultaneously maintains the patient list, insofar as one is needed.

What are iDATs?

IDAT is an abbreviation for Identifying Data of patients such as name, address, date of birth and, in particular, combinations thereof.

What is MDAT?

MDAT is an abbreviation for Medical Data of patients. These include all medical information arising from treatment such as diagnoses, medical histories, therapies, prescribed medications, operations, etc., as well as any additional data collected for research. These data must be specially protected.

As a patient, it is important for you to know that companies like MEDIACC take special care to protect your personal data in clinical studies. We use special techniques such as anonymisation and pseudonymisation in clinical studies to conceal your identity and preserve your privacy. This allows important medical findings to be gained without unauthorised persons learning exactly who participated in the study.

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