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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.
Flow | Specifications |
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| ID | AR-UC08-BF | Name | Put Patient Consent -Health care professional of AR 78 in a hospital | Description | A health care professional of AR 78 in a hospital declares an Informed Patient Consent on behalf of the patient by using the WS Consent. The eHealth Certificate of the hospital is used to access the WS Consent. Only the hospital is checked in the rules of access. | Actor(s) | - A health care professional of AR 78 in a hospital
| Requirements | - End-user is a professional of AR 78 working in a hospital
- Valid eHealth certificate of the hospital
- Consent WS is integrated in the software of the hospital
- The informed patient consent is managed in a recognized hospital throughout its usual software
- Identification hospital: NIHII, the organization category
- Identification of care giver: SSIN number, NIHII number (if available), professional category
- Information on the consent
°Identification concerned patient: SSIN, 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 | Preconditions | - The user has an account for the application
- The user is logged out
| Flow | - The user attempts access the eHealth Consent WS
- The user needs to request a SAML Token by using the eHealth Certificate of the hospital
- 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 | Postcondition(s) | - Request is logged
- The informed patient consent is stored in the eHealth Database
| Test Data | | Endpoint(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 Information | Additional information about the hospital, doctor, software name, address, doctor name, may be added for the audit purpose |
|
Alternative Flow
Flow | Specifications |
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| ID | AR-UC08-AF01 | Name | Put Patient Consent -Administrative working in a hospital | Description | An administrative working in a hospital under the responsibility of a doctor declares an Informed Patient Consent on behalf of the patient by using the WS Consent. The eHealth Certificate of the hospital is used to access the WS Consent. | Actor(s) | - An administrative working in a hospital under the responsibility of a doctor
| Requirements | - Administrative working a hospital under the responsibility of a doctor
- Valid eHealth certificate of the hospital
- Consent WS is integrated in the software of the hospital
- The informed patient consent is managed in a recognized hospital throughout its usual software
- Identification hospital: NIHII, the organization category
- Identification of physician: SSIN number, NIHII number (if available), professional category
- Identification of admin: SSIN number, professional category
- Information on the consent
°Identification concerned patient: SSIN, 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 hospital
- 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 | Difference in flow | Put Patient Consent Request - Request: Identification of the admin: SSIN number, the professional category is mandatory | Post conditions | - Request is logged
- The informed patient consent is stored in the eHealth Database
| Test Data | | Endpoint(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 Information | Additional information about the hospital, doctor, administrative e.g. software name, address, doctor name, administrative name may be added for the audit purpose |
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