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General Information

Informed Consent 

The existence of an active ‘informed patient consent’ is one of the fundamental prerequisites for the healthcare providers to access patient’s medical data. Therefore, the eHealth platform makes available to the concerned patients and the health care actors involved in the exchange,

storage or referencing personal data a service to manage the ‘informed patient consent’ as defined by the deliberation 12/047 of the CSSSS/SCSZG1.

Technically, we identify the following attributes for an ‘informed patient consent’:

  • The SSIN of the patient.
  • The date of the consent registration (at the end-user side).
  • The “type” of the consent If the consent is only valuable for data posterior to the signing date, it is called ‘prospective’ and ‘retrospective’ in the other case . According to the rules defined now, the only possible value for this attribute is ‘retrospective’. The attribute is present for backwards compatibility.
  • The identity of the HCParty acting in the patient’s name (if applicable).

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The “informed consent” can be managed and verified throughout several ways and associated components. The above scheme provides an overview of all those components.
The “eHealth Consent WS” described here is only available for the software of the authorized healthcare professionals and institutions
  • .


KMEHR

This service is a ‘KMEHR-based’ WS. We thus strongly recommend consulting the documentation related to the KMEHR normative elements. The KMEHR site aims to offer a central point for the documentation of the KMEHR normative elements.

https://www.ehealth.fgov.be/standards/kmehr/en

The three following generic elements are, in particular, essentials to build the request and the reply of eHealth Consent WS.

Basic Flow

FlowSpecifications


ID
AR
UC-
UC148
135-BF
NameGet Patient Consent - Pharmacy holder
DescriptionGet Patient consent allows end-users to check the existence and the latest status of the informed patient consent for the concerned patient. Get consent is done by a pharmacy holder
Actor(s)Pharmacy holder
Requirements
  • End-user is a pharmacy holder
  • Informed patient consent is managed in a recognized pharmacy throughout its usual software
  • Valid
eID
  • eHeatlh Certificate of the pharmacy
  • Consent WS is integrated in the software of the end-user
  • INSS concerned patient
  • An active consent
    • Identification pharmacy:  NIHII (if available), organization category
    • Identification pharmacy holder: SSIN number, NIHII number (if available), professional category
    • Criteria relative to the consent 

          °Information concerned patient: INSS, Support card number (optional)

          °Type op consent (optional)

    TriggerThe user wants to
    get a Patient Consent 
    retrieve the status of the informed consent
    Precondition(s)
    • The user has an account for the application
    • The user is logged out
    Flow
    1. The user attempts to access the eHealth Consent WS
    2. The user needs to request a SAML Token by
    using his eID 
    1. using a eHealth Certificate
    2. A request for a SAML Token is sent to the Secure Token Service (STS)
    3. The STS responds with a SAML Token
    4. The user has access to the eHealth WS Consent
    5. The user does a request for Get Patient Consent 
    6. The Get Patient Consent Request is sent to the WS Consent 
    °
    1. The information relative to the consent is returned
    2. The request is logged 
    3. The WS Consent responds with a Get Patient Consent Response

          ° The request is logged 

    Post Condition(s)
    • The request is logged
    • The information relative to the consent is returned

          °SSIN of concerned patient

          °Consent type

          °Date of declaration

          °Author of declaration

    Test Data
    End point(s)
    • WS Consent
    • eHealth Database
    Additional Information
    • SSIN support card number is not mandatory, if provided then it is discarded i.e. not submitted to the compliance validation in order to increase the performance of the consultation



    Alternative Flow

          °
    FlowSpecifications


    IDUC-135-AF
    NameGet Patient Consent - Pharmacist who isn't the pharmacy holder
    DescriptionGet Patient consent allows end-users to check the existence and the latest status of the informed patient consent for the concerned patient. Get consent is done by a pharmacist who isn't the pharmacy holder
    Actor(s)Pharmacist who isn't the pharmacy holder
    Requirements
    • End-user is a pharmacist who isn't the pharmacy holder
    • Informed patient consent is managed in a recognized pharmacy throughout its usual software
    • Valid eHeatlh Certificate of the pharmacy
    • Consent WS is integrated in the software of the end-user
    • Identification pharmacy:  NIHII (if available), organization category
    • Identification pharmacy holder: SSIN number, NIHII number (if available), professional category
    • Identification pharmacist: SSIN number, NIHII number (if available), professional category
    • Criteria relative to the consent 

          °Information concerned patient: INSS, Support card number (optional)

          °Type op consent (optional)

    TriggerThe user wants to retrieve the status of the informed consent
    Precondition(s)
    • The user has an account for the application
    • The user is logged out
    Flow
    1. The user attempts to access the eHealth Consent WS
    2. The user needs to request a SAML Token by using a eHealth Certificate
    3. A request for a SAML Token is sent to the Secure Token Service (STS)
    4. The STS responds with a SAML Token
    5. The user has access to the eHealth WS Consent
    6. The user does a request for Get Patient Consent 
    7. The Get Patient Consent Request is sent to the WS Consent 
    1. The information relative to the consent is returned
    2. The request is logged 
    3. The WS Consent responds with a Get Patient Consent Response
    Post Condition(s)
    • The request is logged
    • The information relative to the consent is returned

          °SSIN of concerned patient

          °Consent type

          °Date of declaration

          °Author of declaration

    Test Data
    End point(s)
    • WS Consent
    • eHealth Database
    Additional Information
    The
    • SSIN
    & NIHII of the doctor end-user are optional for consultation method. If provided, they must be compliant with SSIN, NIHII validation (format and check-digit)SSIN
    • support card number is not mandatory, if provided then it is discarded i.e. not submitted to the compliance validation in order to increase the performance of the consultation
    Alternative Flow