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GDPR Data processing modelHealth vigilance and risk management systems

By: Ludwig Karneth
PrivateHealthPublic
The purpose of this processing is to study data relating to all undesirable health events and to contact the person who reported the event.

Purposes (2)

A purpose is the objective pursued by the setting up of your file. It indicates what the processing of personal data will be used for, its purpose. This purpose must be clear and understandable

1
Management of contacts with the person who notified the adverse health event
Contacts with the data controller and the Member of an approved association, healthcare professional, member of a health authority, patient, etc., or the healthcare professional who can be contacted to obtain, in compliance with medical confidentiality, details about the adverse health event reported (professional following the person who was the victim of the adverse health event, etc.).
Public interest
Ensuring compliance with high standards of quality and safety of healthcare and medicines, devices or products in accordance with the provisions of Article 9 of the RGPD and Article 66 of the amended Act of January 6, 1978.
2
Study of data relating to all adverse health events
Collection, recording, analysis, follow-up, documentation, transmission and storage of information
Public interest
Ensuring compliance with high standards of quality and safety of healthcare and medicines, devices or products in accordance with the provisions of Article 9 of the RGPD and Article 66 of the amended Act of January 6, 1978.

Data categories (4)

Personal data is any information relating to an identified or identifiable natural person. A natural person can be identified either directly (eg surname and first name) or indirectly (eg phone number, social security number, email or postal address, but also voice or image)

Contact details of the person reporting the adverse health event

Data details


healthcare professional's specialtyrequired
Telephone numberrequired
Emailrequired
Postal Addressrequired
Name and surnamerequired

Data conservation rules

Active base:

limited to what the controller needs to know in order to meet its health vigilance obligations, and for a duration strictly limited to what is necessary to meet those obligations.n

data relating to the identification of the product concerned by the alert

Data details


Serial numberrequired
Device or product usedrequired
Type of drugrequired

Data conservation rules

Active base:

current data usage time

Intermediate archiving:

legal or regulatory duration applicable to each health vigilance

Destruction

Identification data of the person exposed to the event

Data details


Identification numberrequired
Size and weightrequired
Sexerequired
Year or date of birthrequired
Agerequired

Data conservation rules

Active base:

current data usage duration

Intermediate archiving:

legal or regulatory duration applicable to each health vigilance

Destruction

Health data of the person exposed to the event

Data details


Data relating to working liferequired
Lifestylerequired
Therapeutic conduct of prescriber or healthcare professionalsrequiredsensitive data
Prescribing mode and drug userequiredsensitive data
Search for antecedents and risk factorsrequiredsensitive data
Related diseases or eventsrequiredsensitive data
Medical Historyrequiredsensitive data
Nature of adverse effectsrequiredsensitive data
Medical Examination Resultsrequiredsensitive data
Treatments in progressrequiredsensitive data

Data conservation rules

Active base:

current data usage time.

Intermediate archiving:

legal or regulatory duration applicable to each health vigilance

Destruction

Data subject (1)

A data subject is any person whose data is collected, retained or processed by the data processing. e.g. In a recruitement process, any candidate for a position proposed in recruitement management process

  • Patients

Author:
Ludwig Karneth
Ludwig Karneth

Created at:07/08/2023

Updated on:00/01/1970

License: © Creative commons :
Attribution / Pas d'utilisation commerciale
CC-BY-NC AttributionPas d'utilisation commerciale

Nb using:2


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