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Created by Unknown User (gaelle.laurent.ext@imec.be), last modified on Aug 27, 2019
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
Flow | Specifications |
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| ID | UC-119-BF | Name | Put Patient Consent - HC Organization- Authorized organization in behalf of HIO - Doctor | Description | The doctor, working in a Health Insurance Organization (HIO) and the request is transmitted via a recognized authorized organization, declares an Informed Patient Consent on behalf of the patient. Using the eHealth Certificate of the Authorized Organization to access the Consent WS. | Actor(s) | - The actor is working in a Health Insurance Organization (HIO) and the request is transmitted via a recognized authorized organization.
| Requirements | - The end-user is working in a Health Insurance Organization (HIO) and the request is transmitted via a recognized authorized organization.
- The informed patient consent is managed by a recognized authorized organization thru its usual software in behalf a HIO
- Valid eHealth Certificate of the authorized organization
- Consent WS is integrated in the software of the end-user
- Identification of the HIO: CBE number, HIO category
- Identification of the doctor: SSIN number, NIHII (if available), professional category
- Information consent
°Identification of concerned patient: SSIN, First and family name (optional) °Type of consent: retrospective °Signing date of consent | Trigger | The user wants to declare a Patient Consent in the behalf of a HIO | 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 his eID
- 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 informed Patient Consent is stored in eHealth Database
- The request is logged
- The WS Consent responds with a Put patient consent response
| Post Conditions | - Request is logged
- Informed Patient Consent is stored in the eHealth Database
| Test Data | | Endpoint(s) | - WS Consent
- eHealth Database
| Remarks | - The identification of the Authorized organization is not mandatory in the Author of the request as the Trusted Third Party rule is applied
- 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 HIO, doctor, administrative, patient e.g. software name, address, doctor, administrative, patient first and family name may be added for the audit purpose |
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Alternative Flow
Flow | Specifications |
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| ID | UC-119-AF01 | Name | Put Patient Consent - HC Organization - Authorized organization in behalf of HIO - Administrative | Description | An administrative, working in a Health Insurance Organization (HIO) under the responsibility of a doctor and the request is transmitted via a recognized authorized organization, declares an Informed Patient Consent. Using the eHealth Certificate of the Authorized Organization to access the Consent WS. | Actor(s) | - An administrative working in a Health Insurance Organization (HIO) under the responsibility of a doctor and the request is transmitted via a recognized authorized organization.
| Requirements | - An administrative working in a Health Insurance Organization (HIO) under the responsibility of a doctor and the request is transmitted via a recognized authorized organization
- The informed patient consent is managed by a recognized authorized organization thru its usual software in behalf a HIO
- Valid eHealth Certificate of the Authorized Organization
- Consent WS is integrated in the software of the end-user
- Identification of the HIO: CBE number, HIO category
- Identification of the doctor: SSIN number, NIHII (if available), professional category
- Identification of the admin: SSIN number, professional category
- Information consent
°Identification of concerned patient: SSIN, First and family name (optional) °Type of consent: retrospective °Signing date of consent | Trigger | The user wants to declare a Patient Consent in the behalf of a HIO | Preconditions | - 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 his eID
- 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 informed Patient Consent is stored in eHealth Database
- The request is logged
- The WS Consent responds with a Put patient consent response
| Difference in flow | Identification of the end-user --> Identification of the admin: SSIN Number, professional category needs to be added to the request | Post Conditions | - Request is logged
- Informed Patient Consent is stored in the eHealth Database
| Test Data | | Endpoint(s) | - WS Consent
- eHealth Database
| Remarks | - The identification of the Authorized organization is not mandatory in the Author of the request as the Trusted Third Party rule is applied
- 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 HIO, doctor, administrative, patient e.g. software name, address, doctor, administrative, patient first and family name may be added for the audit purpose |
|
Exception Flow 1
Flow | Specifications |
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| ID | UC-119-EF01 | Name | Put Patient Consent - HC Organization- Authorized organization in behalf of HIO - Doctor - Deceased patient | Description | The doctor, working in a Health Insurance Organization (HIO) and the request is transmitted via a recognized authorized organization, updates an Informed Patient Consent. Using the eHealth Certificate of the Authorized Organization to access the Consent WS. Deceased patient | Actor(s) | - The actor is working in a Health Insurance Organization (HIO) and the request is transmitted via a recognized authorized organization.
| Requirements | - end-user is a doctor, working in a Health Insurance Organization (HIO) and the request is transmitted via a recognized authorized organization.
- The informed patient consent is managed by a recognized authorized organization thru its usual software in behalf a HIO
- Valid eHealth Certificate of the authorized organization
- Consent WS is integrated in the software of the end-user
- Identification of the HIO: CBE number, HIO category
- Identification of the doctor: SSIN number, NIHII (if available), professional category
- Information consent
°Identification of concerned patient: SSIN, First and family name (optional) °Type of consent: retrospective °Signing date of consent - Concerned patient is deceased
| Trigger | The user wants to update a Patient Consent in the behalf of a HIO | 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 Authorized Organization
- 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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Exception Flow 2
Flow | Specifications |
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| ID | UC-119-EF02 | Name | Put Patient Consent - HC Organization- Authorized organization in behalf of HIO - Doctor - Active consent already exists for the concerned patient | Description | The doctor, working in a Health Insurance Organization (HIO) and the request is transmitted via a recognized authorized organization, updates an Informed Patient Consent. Using the eHealth Certificate of the Authorized Organization to access the Consent WS. Active consent already exists for the concerned patient | Actor(s) | - The actor is working in a Health Insurance Organization (HIO) and the request is transmitted via a recognized authorized organization.
| Requirements | - End-user is a doctor working in a Health Insurance Organization (HIO) and the request is transmitted via a recognized authorized organization.
- The informed patient consent is managed by a recognized authorized organization thru its usual software in behalf a HIO
- Valid eHealth Certificate of the authorized organization
- Consent WS is integrated in the software of the end-user
- Identification of the HIO: CBE number, HIO category
- Identification of the doctor: SSIN number, NIHII (if available), professional category
- Information consent
°Identification of concerned patient: SSIN, First and family name (optional) °Type of consent: retrospective °Signing date of consent - Active consent already exists for the concerned patient
| Trigger | The user wants to put a Patient Consent in the behalf of a HIO | 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 Authorized Organization
- 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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