ALADDIN - User manual Rev. 19 EN of 10/07/2019
The processor is/are the person/s designed by the practise, clinic or hospital to operate the device and use
the results.
Device characteristics to support Data Protection
Data Protection
The device provides by default encryption of data stored, to avoid unauthorized access to Personal Data.
The device provides by default technical measures to provide integrity, availability and resilience of subject
data by means of encryption, data integrity checksum and redundancy.
The data can be accessed in relation to subject identification only within the application itself which is
protected by login that can be configured by the controller to grant confidentiality.
The subject data it is used within the device on-board application only for storage and identification purpose.
The controller can apply an explicit pseudonymisation rule to handle subject identification by using only ID
subject identification and not using subject name, DoB, gender in the device.
Right of Access by the data subject
The controller and processor have access to data related to the subject which can be stored on the device
and can make the data available to the subject in the normal operating mode. The data can be also accessed
in the form of printable or electronic file (PDF or XML file).
Right to Rectification or Erasure
The controller and processor can, upon request from the data subject, rectify the subject identification data.
The controller and processor can, upon request from the data subject, erase permanently the subject
identification data and subject physical/physiological data. After erasure no trace of the subject data is
present on the device.
Refer to section 11.4.2.2 for details on how to rectify or erase patient data.
Right to restriction of processing
The device application doesn’t automatically process or transmit the subject data.
Right to data portability
The controller and processor can provide to the data subject the data in the form of exported or printed
reports or XML data file.
Right to object
No automated processing of data subject is performed in this device. The processing is performed on decision
of the processor.
Automated individual decision-making, including profiling
No automated decision-making or profiling is performed in this device.
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