Consent

The DUP Pipeline calculates consent based on the description here

In the standard use case the following addition to the cohort part of the CRTDL will extract consents for central analysis while considering retrospective consent:

CRTDL insert: Consent for central analysis

json

[
    [
        {
            "termCodes": [
                {
                    "code": "2.16.840.1.113883.3.1937.777.24.5.3.8",
                    "display": "MDAT wissenschaftlich nutzen EU DSGVO NIVEAU",
                    "system": "urn:oid:2.16.840.1.113883.3.1937.777.24.5.3",
                    "version": "1.0.7"
                }
            ],
            "context": {
                "code": "Einwilligung",
                "display": "Einwilligung",
                "system": "fdpg.mii.cds",
                "version": "1.0.0"
            }
        }
    ],
    [
        {
            "termCodes": [
                {
                    "code": "2.16.840.1.113883.3.1937.777.24.5.3.6",
                    "display": "MDAT erheben",
                    "system": "urn:oid:2.16.840.1.113883.3.1937.777.24.5.3",
                    "version": "1.0.7"
                }
            ],
            "context": {
                "code": "Einwilligung",
                "display": "Einwilligung",
                "system": "fdpg.mii.cds",
                "version": "1.0.0"
            }
        }
    ],
    [
        {
            "termCodes": [
                {
                    "code": "2.16.840.1.113883.3.1937.777.24.5.3.6",
                    "display": "MDAT erheben",
                    "system": "urn:oid:2.16.840.1.113883.3.1937.777.24.5.3",
                    "version": "1.0.7"
                }
            ],
            "context": {
                "code": "Einwilligung",
                "display": "Einwilligung",
                "system": "fdpg.mii.cds",
                "version": "1.0.0"
            }
        },
        {
            "termCodes": [
                {
                    "code": "2.16.840.1.113883.3.1937.777.24.5.3.46",
                    "display": "MDAT retrospektiv wissenschaftlich nutzen EU DSGVO NIVEAU",
                    "system": "urn:oid:2.16.840.1.113883.3.1937.777.24.5.3",
                    "version": "1.0.7"
                }
            ],
            "context": {
                "code": "Einwilligung",
                "display": "Einwilligung",
                "system": "fdpg.mii.cds",
                "version": "1.0.0"
            }
        },
        {
            "termCodes": [
                {
                    "code": "2.16.840.1.113883.3.1937.777.24.5.3.45",
                    "display": "MDAT retrospektiv speichern verarbeiten",
                    "system": "urn:oid:2.16.840.1.113883.3.1937.777.24.5.3",
                    "version": "1.0.7"
                }
            ],
            "context": {
                "code": "Einwilligung",
                "display": "Einwilligung",
                "system": "fdpg.mii.cds",
                "version": "1.0.0"
            }
        }
    ]
]

Full example CRTDL here

Based on this input, TORCH will extract resources and check each resource against the consent period. It is important to verify this calculation against site-specific data using samples from the extraction.

Take a random extracted resource from a patient bundle or the CSV.

Example row from a Condition CSV:

id,patient,...,Condition_recordedDate,...
mii-exa-test-data-patient-9-diagnose-1,Patient/mii-exa-test-data-patient-9,...,2024-02-20,...

Step 1 — Extract the consent-relevant date

The date field to use depends on the resource type. The mapping is defined here. For Condition, use recordedDate → in this example: 2024-02-20

Step 2 — Fetch the patient's consent

GET http://fhir-base-url/fhir/Consent?patient=mii-exa-test-data-patient-9&_format=json

Step 3 — Check provision .6 (MDAT erheben)

Find the provision with code 2.16.840.1.113883.3.1937.777.24.5.3.6 and check whether the resource date falls within its period.

Example patient — provision .6 period

json

{
    "type": "permit",
    "period": {
        "start": "2024-02-15",
        "end": "2054-02-28"
    },
    "code": [
        {
            "coding": [
                {
                    "system": "urn:oid:2.16.840.1.113883.3.1937.777.24.5.3",
                    "code": "2.16.840.1.113883.3.1937.777.24.5.3.6",
                    "display": "MDAT erheben"
                }
            ]
        }
    ]
}

Result: 2024-02-20 falls within the consent period 2024-02-15 – 2054-02-28 ✅

If the date is outside the provision .6 period

Work through the following steps in order:

1. Check for retrospective consent (.45 / .46)

If either provision is present, extend the effective start date back to 1900-01-01, giving an effective period of 1900-01-01 – 2054-02-28. Re-check the resource date against this extended period.

2. Check for an overlapping Encounter

If retrospective consent does not cover the date, check whether the patient had an encounter that overlaps the consent period — an overlapping encounter moves the effective start date forward to the encounter's start.

GET http://fhir-base-url/fhir/Encounter?patient=mii-exa-test-data-patient-9&_format=json&date=lt2054-02-28&date=gt2024-02-15

If a matching encounter is found, use its start date as the effective consent start and re-check.

3. Multiple consents per patient

If your site stores multiple Consent resources per patient, the above checks are not sufficient. You will need to reconstruct the effective period by combining all PERMIT and DENY provisions for the same provision code.

⚠️ If you find that consent has not been correctly enforced, please contact the FDPG team.

Consent ​

Verifying Consent ​

If the date is outside the provision .6 period ​

Verifying Consent

If the date is outside the provision .6 period