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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).

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 MetaHub Consent WS.


Basic Flow

FlowSpecifications


IDAR-UC12-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 personal eHeatlh Certificate of the pharmacy
  • Consent WS is integrated in the software of the end-user
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 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

      ° The request is logged 

      ° The Informed Patient Consent is stored in eHealth Database

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


IDAR-UC12-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 pharmacy 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 personal eHeatlh Certificate of the pharmacy
  • Consent WS is integrated in the software of the end-user
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 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

      ° The request is logged 

      ° The Informed Patient Consent is stored in eHealth Database

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



To Do 

Exceptional flows