Consent

ADDI Medical
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Consent

The Consent building block in the HOPE Platform is the basis for access to the entire information flow for all parties involved, including the patient and guarantees compliance with the statutory requirements of the Swedish Patient Data Act (2008:355), the Swedish Ethical Review Act (2003:460) and the regulations of the General Data Protection Regulation (GDPR). The patient has full control over their own specified consents and who can be given access to the information registered by the patient.

Consent can also be linked to the Communication building block through which the patient can be reminded to give feedback on a request for an individual consent.

General Data Protection Regulation (GDPR)

Registration and management of stated consent for a patient is based on the requirements of the GDPR for data collection, data access and communication.

Consent refers to:

givingconsent
getting an overview of your specified consent(s)
withdrawing specified consent(s)

Swedish Patient Data Act (PDA)

The patient gives consent to healthcare staff being given access to information in the Consent building block.

The building block records and stores information relating to consent given by patient regarding access to the consolidated healthcare documentation, within which period of time and for which healthcare resource(s) and healthcare unit(s).

Swedish Ethical Review Act

The ethical guidelines include that the principal investigator must have an informed consent from the person who is enrolled in the research study or for minors, from a person who is acting in the best interests of the research participant.

Informed consent refers to all medical research that uses samples and personal data that make it possible to identify an individual patient.

Consent

General Data Protection Regulation (GDPR)

Swedish Patient Data Act (PDA)

Swedish Ethical Review Act

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