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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-
UC135
123-BF
NameRevoke Patient Consent - HC Professional
AR78
AR78 (Physician, Dentist, Nurse, midwife)
DescriptionRevoke Patient consent allows end-users to revoke an active consent of the concerned patient. Request Revoke consent is done by a HC professional of AR78.
Actor(s)HC professional of
AR78
AR78 (Physician, Dentist, Nurse, midwife)
Requirements
  • End-user is a HC professional of AR78 (Physician - Dentist - Nurse - Pharmacist - Midwife)
  • The
consent is managed in a recognized hospital throughout its usual software
  • end-user acts as author of the request through his software and manages himself the informed patient consent
  • Valid personal eHeatlh Certificate 
Valid eID
  • Consent WS is integrated in the software of the end-user
  • INSS concerned patient
    • Identification HC professional AR78: SSIN number, NIHII (if available), professional category
    • Information about the consent to revoke

         °Identification data of concerned patient: SSIN, support card number, first and family name (optional)

         °Type

    Type

    of consent: retrospective

    Date

         °Date of revocation

  • An active consent
  • Support card number: e-ID or ISI+
  • TriggerThe user wants to revoke a Patient 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 
    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 Revoke Patient Consent 
    7. The Revoke Patient Consent Request is sent to the WS Consent 
    °
    1. The revoked consent is stored in eHealth Database
    2. The request is logged 
    3. The WS Consent responds with a Revoke Patient Consent Response

          ° The request is logged 

          ° The revoked consent is stored in eHealth Database
    Post Condition(s)
    • The request is logged 
    • The revoked consent is stored in eHealth Database with following information

             °SSIN of concerned patient 

             °Initial signing date of the consent

             °Consent type

             °Author of the request

             °Revocation date

    Test Data
    End point(s)
    • WS Consent
    • eHealth Database
    RemarksIf concerned patient is a new-born (0 < patient < 3 months) the support card number is not mandatory
    Additional InformationDate of revocation of an active consent must be equal or anterior to the request date. If so, it must be also anterior to the current date. 
    Remark end-usersShould be available soon for Physician, Nurse, Dentist, Midwife, Audician, Physiotherapist, Occupational therapist, Practical nurse, Dietician, Audiologist, Podologist, Truss maker, Logopedist, Orthoptist, Lab technologist, Imaging technologist, clinical orthopedic pedagogue, clinical orthopedic pedagogue, clinical psychologist, dental hygienist 



    Alternative Flow

    FlowSpecifications


    ID
    AR
    UC-
    UC135
    123-AF01
    NameRevoke Patient Consent - Physician who is holder of the Global Medical File of the patient
    DescriptionRevoke Patient consent allows end-users to revoke an active consent of the concerned patient. Request Revoke consent is done by a Physician who is holder of the Global Medical File of the patient.
    Actor(s)Physician who is holder of the Global Medical File of the patient
    Requirements
    • End-user is a HC professional of AR78
    • The
    consent is managed in a recognized hospital throughout its usual software
    • end-user acts as author of the request through his software and manages himself the informed patient consent
    • Valid eID
    • Consent WS is integrated in the software of the end-user
  • INSS concerned patient
    • Identification HC professional AR78: SSIN number, NIHII (if available), professional category
    • Information about the consent to revoke

         °Identification data of concerned patient: SSIN, first and family name (optional)

         °Type

    Type

    of consent: retrospective

    Date

         °Date of revocation

  • An active consent
  • TriggerThe user wants to revoke a Patient 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 
    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 Revoke Patient Consent 
    7. The Revoke Patient Consent Request is sent to the WS Consent 
    °
    1. The revoked consent is stored in eHealth Database
    2. The request is logged 
    3. The WS Consent responds with a Revoke Patient Consent Response
          ° The request is logged 

          ° The revoked consent is stored in eHealth Database

    Post Condition(s)
    • The request is logged 
    • The revoked consent is stored in eHealth Database with following information

             °SSIN of concerned patient 

             °Initial signing date of the consent

             °Consent type

             °Author of the request

             °Revocation date

    Test Data
    End point(s)
    • WS Consent
    • eHealth Database
    Additional InformationDate of revocation of an active consent must be equal or anterior to the request date. If so, it must be also anterior to the current date



    Exception Flow 1

    FlowSpecifications


    IDUC-123-EF01
    NameRevoke Patient Consent - HC Professional AR78 - Deceased patient
    DescriptionRevoke Patient consent allows end-users to revoke an active consent of the concerned patient. Request Revoke consent is done by a HC professional of AR78. Deceased patient
    Actor(s)HC professional of AR78 (Physician - Dentist - Nurse - Pharmacist - Midwife)
    Requirements
    • End-user is a HC professional of AR78 (Physician - Dentist - Nurse - Pharmacist - Midwife)
    • The end-user acts as author of the request through his software and manages himself the informed patient consent
    • Valid personal eHeatlh Certificate 
    • Consent WS is integrated in the software of the end-user
    • Identification HC professional AR78: SSIN number, NIHII (if available), professional category
    • Information about the consent to revoke

         °Identification data of concerned patient: SSIN, support card number, first and family name (optional)

         °Type of consent: retrospective

         °Date of revocation

    • Concerned patient is deceased
    Trigger The user wants to revoke a Patient 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 Revoke Patient Consent 
    7. The Revoke Patient Consent Request is sent to the WS Consent 
    8. The WS Consent responds with a Revoke Patient Consent Response: error message
    Post Condition(s)Error message
    Test Data
    End point(s)
    • WS Consent
    • eHealth Database
    Remark end-usersShould be available soon for Physician, Nurse, Dentist, Midwife, Audician, Physiotherapist, Occupational therapist, Practical nurse, Dietician, Audiologist, Podologist, Truss maker, Logopedist, Orthoptist, Lab technologist, Imaging technologist, clinical orthopedic pedagogue, clinical orthopedic pedagogue, clinical psychologist, dental hygienist 



    Exception Flow 2

    FlowSpecifications


    IDUC-123-EF02
    NameRevoke Patient Consent - HC Professional AR78 - The consent of the concerned patient is already revoked
    DescriptionRevoke Patient consent allows end-users to revoke an active consent of the concerned patient. Request Revoke consent is done by a HC professional of AR78. The consent of the concerned patient is already revoked
    Actor(s)HC professional of AR78 (Physician - Dentist - Nurse - Pharmacist - Midwife)
    Requirements
    • End-user is a HC professional of AR78 (Physician - Dentist - Nurse - Pharmacist - Midwife)
    • The end-user acts as author of the request through his software and manages himself the informed patient consent
    • Valid personal eHeatlh Certificate 
    • Consent WS is integrated in the software of the end-user
    • Identification HC professional AR78: SSIN number, NIHII (if available), professional category
    • Information about the consent to revoke

         °Identification data of concerned patient: SSIN, support card number, first and family name (optional)

         °Type of consent: retrospective

         °Date of revocation

    • The consent of the concerned patient is already revoked
    TriggerThe user wants to revoke a Patient 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 Revoke Patient Consent 
    7. The Revoke Patient Consent Request is sent to the WS Consent 
    8. The WS Consent responds with a Revoke Patient Consent Response: error message
    Post Condition(s)Error message
    Test Data
    End point(s)
    • WS Consent
    • eHealth Database
    Remark end-usersShould be available soon for Physician, Nurse, Dentist, Midwife, Audician, Physiotherapist, Occupational therapist, Practical nurse, Dietician, Audiologist, Podologist, Truss maker, Logopedist, Orthoptist, Lab technologist, Imaging technologist, clinical orthopedic pedagogue, clinical orthopedic pedagogue, clinical psychologist, dental hygienist 



    Exception Flow 3

    FlowSpecifications


    IDUC-123-EF03
    NameRevoke Patient Consent - HC Professional AR78 - The consent of the concerned patient does not exist
    DescriptionRevoke Patient consent allows end-users to revoke an active consent of the concerned patient. Request Revoke consent is done by a HC professional of AR78. The consent of the concerned patient does not exist
    Actor(s)HC professional of AR78 (Physician - Dentist - Nurse - Pharmacist - Midwife)
    Requirements
    • End-user is a HC professional of AR78 (Physician - Dentist - Nurse - Pharmacist - Midwife)
    • The end-user acts as author of the request through his software and manages himself the informed patient consent
    • Valid personal eHeatlh Certificate 
    • Consent WS is integrated in the software of the end-user
    • Identification HC professional AR78: SSIN number, NIHII (if available), professional category
    • Information about the consent to revoke

         °Identification data of concerned patient: SSIN, support card number, first and family name (optional)

         °Type of consent: retrospective

         °Date of revocation

    • The consent of the concerned patient does not exist
    TriggerThe user wants to revoke a Patient 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 Revoke Patient Consent 
    7. The Revoke Patient Consent Request is sent to the WS Consent 
    8. The WS Consent responds with a Revoke Patient Consent Response: error message
    Post Condition(s)Error message
    Test Data
    End point(s)
    • WS Consent
    • eHealth Database
    Remark end-usersShould be available soon for Physician, Nurse, Dentist, Midwife, Audician, Physiotherapist, Occupational therapist, Practical nurse, Dietician, Audiologist, Podologist, Truss maker, Logopedist, Orthoptist, Lab technologist, Imaging technologist, clinical orthopedic pedagogue, clinical orthopedic pedagogue, clinical psychologist, dental hygienist