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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 Consent WS.
Basic Flow
Flow | Specifications |
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| ID | AR-UC11-BF | Name | Put Patient Consent - HC Organization - Group of nurses | Description | A group of nurses declares an Informed Patient Consent on behalf of the patient. Using the eHealth Certificate of the group of nurses to access the Consent WS. | Actor(s) | - A nurse who is part of the group of nurses
| Requirements | - End-user is a nurse who is part of the group of nurses
- Valid eHealth Certificate of the Group of nurses
- Consent WS is integrated in the software of the end-user
- The Informed Patient Consent is managed within a group of nurses thru its usual software
- Identification group of nurses: NIHII number, professional category
- Identification nurse: SSIN number, NIHII (if available), professional category
- Information consent:
°Identification concerned patient: SSIN, Support card number, 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 | - The user attempts to access the eHealth Consent WS
- The user needs to request a SAML Token by using the eHealth Certificate of the Group of nurses
- A request for a SAML Token is sent to the Secure Token Service (STS)
- The STS responds with a SAML Token
- The user has access to the eHealth WS Consent
- The user does a request for Put Patient Consent
- The Put Patient Consent Request is sent to the WS Consent
- ° 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
- 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 Info | Additional information about the software and/or nurse e.g. first name and family name may be added for the audit purpose |
|
Exception Flow
Flow | Specifications |
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| ID | AR-UC11-EF | Name | Put Patient Consent - HC Organization - Group of nurses - Deceased patient | Description | A group of nurses updates an Informed Patient Consent on behalf of the patient. Using the eHealth Certificate of the group of nurses to access the Consent WS. Deceased patient | Actor(s) | - A nurse who is part of the group of nurses
| Requirements | - End-user is a nurse who is part of the group of nurses
- Valid eHealth Certificate of the Group of nurses
- Consent WS is integrated in the software of the end-user
- The Informed Patient Consent is managed within a group of nurses thru its usual software
- Identification group of nurses: NIHII number, professional category
- Identification nurse: SSIN number, NIHII (if available), professional category
- Information consent:
°Identification concerned patient: SSIN, Support card number, first and family name (optional) °Type of consent: retrospective °Signing date of consent - Concerned patient is deceased
| 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 | - The user attempts to access the eHealth Consent WS
- The user needs to request a SAML Token by using the eHealth Certificate of the Group of nurses
- A request for a SAML Token is sent to the Secure Token Service (STS)
- The STS responds with a SAML Token
- The user has access to the eHealth WS Consent
- The user does a request for Put Patient Consent
- The Put Patient Consent Request is sent to the WS Consent
- 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
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