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  • Created by Unknown User (gaelle.laurent.ext@imec.be), last modified on Aug 27, 2019

Used Documentation

Cookbook / MaterialsVersionLocation
Consent WS1.9https://www.ehealth.fgov.be/ehealthplatform/nl/service-ehealthconsent

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).


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

IDUC-121-BF
NamePut Patient Consent - HC Organization - Pharmacy holder
DescriptionA pharmacist, who is the holder of the pharmacy, declares an "Informed Patient Consent" on behalf of the patient by using the WS Consent. The personal eHealth Certificate of the pharmacy is used to access to the WS Consent. 
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 eHeatlh Certificate of the pharmacy
  • Consent WS is integrated in the software of the end-user
  • Identification pharmacy: NIHII, organization category
  • Identification pharmacy holder: SSIN number, NIHII (if available), professional category
  • Information consent: 

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

      °Type of consent: retrospective

      °Signing date of consent

Trigger The user wants to declare a Patient Consent on behalf of the patient
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 Put Patient Consent 
  7. The Put Patient Consent Request is sent to the WS Consent 
  8. The informed Patient Consent is stored in eHealth Database
  9. The request is logged
  10. The WS Consent responds with a Put patient consent response
Post Condition(s) 
  • Request is logged
  • The informed patient consent is stored in the eHealth Database
Test Data
End point(s)
  • WS Consent
  • eHealth Database
Remarks
  • If support card number is provided then it must be compliant e.g. correct format, check-digit and combination
  • Support card number is not mandatory if the concerned patient is a new born (0 < patient < 3 months)
Additional InformationAdditional information about the software of the pharmacy or pharmacist name etc. may be added for the audit purpose

Alternative Flow

FlowSpecifications

IDUC-121-AF01
NamePut Patient Consent - HC Organization - Pharmacist is not the pharmacy holder
DescriptionA pharmacist who isn't the holder of the pharmacy declares an "Informed Patient Consent" on behalf of the patient by using the WS Consent. The personal eHealth Certificate of the pharmacy is used to access to the WS Consent. 
Actor(s)
  • A pharmacist who isn't the holder of the pharmacy 
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, organization category
  • Identification pharmacy holder: SSIN number, NIHII (if available), professional category
  • Identification pharmacist: SSIN numbern NIHII (if available), professional category
  • Information consent: 

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

      °Type of consent: retrospective

      °Signing date of consent

TriggerThe user wants to declare a Patient Consent on behalf of the patient
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 Put Patient Consent 
  7. The Put Patient Consent Request is sent to the WS Consent 
  8. The informed Patient Consent is stored in eHealth Database
  9. The request is logged
  10. The WS Consent responds with a Put patient consent response
Difference in flowIdentification of the end-user → SSIN number, NIHII number if available, professional category of the pharmacist
Post Conditions
  • Request is logged
  • The informed patient consent is stored in the eHealth Database
Test Data
End point(s)
  • WS Consent
  • eHealth Database
Remarks
  • If support card number is provided then it must be compliant e.g. correct format, check-digit and combination
  • Support card number is not mandatory if the concerned patient is a new born (0 < patient < 3 months)
Additional InformationAdditional information about the software of the pharmacy or pharmacist name etc. may be added for the audit purpose

Exception Flow 1

FlowSpecifications

IDUC-121-EF01
NamePut Patient Consent - HC Organization - Pharmacy holder - deceased patient
DescriptionA pharmacist, who is the holder of the pharmacy, updates an "Informed Patient Consent" on behalf of the patient by using the WS Consent. The personal eHealth Certificate of the pharmacy is used to access to the WS Consent. Deceased patient
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 eHeatlh Certificate of the pharmacy
  • Consent WS is integrated in the software of the end-user
  • Identification pharmacy: NIHII, organization category
  • Identification pharmacy holder: SSIN number, NIHII (if available), professional category
  • Information consent: 

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

      °Type of consent: retrospective

      °Signing date of consent

  • Concerned patient is deceased
TriggerThe user wants to update 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 the eHealth Certificate of the pharmacy
  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 Put Patient Consent 
  7. The Put Patient Consent Request is sent to the WS Consent 
  8. The WS Consent responds with a Put Patient Consent Response: error message
Post Condition(s)Error message
Test Data
End point(s)
  • WS Consent
  • eHealth Database

Exception Flow 2

FlowSpecifications

IDUC-121-EF02
NamePut Patient Consent - HC Organization - Pharmacy holder - Active consent already exists for the concerned patient
DescriptionA pharmacist, who is the holder of the pharmacy, updates an "Informed Patient Consent" on behalf of the patient by using the WS Consent. The personal eHealth Certificate of the pharmacy is used to access to the WS Consent. Active consent already exists for the concerned patient
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 eHeatlh Certificate of the pharmacy
  • Consent WS is integrated in the software of the end-user
  • Identification pharmacy: NIHII, organization category
  • Identification pharmacy holder: SSIN number, NIHII (if available), professional category
  • Information consent: 

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

      °Type of consent: retrospective

      °Signing date of consent

  • Active consent already exists for the concerned patient
TriggerThe user wants to update 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 the eHealth Certificate of the pharmacy
  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 Put Patient Consent 
  7. The Put Patient Consent Request is sent to the WS Consent 
  8. The WS Consent responds with a Put Patient Consent Response: error message
Post Condition(s)Error message
Test Data
End point(s)
  • WS Consent
  • eHealth Database
  • No labels

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