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Data management in the AKTIN infrastructure

The problem: data protection in emergencies and critically ill patients
Patients in life-threatening situations are often not in a position to consent to the use of their data.

Nevertheless, we need the data for:

  • Public health surveillance
  • Health services research for better treatment
  • Clinical-epidemiological research questions
  • Quality assurance in Emergency Departments

The solution: A way without explicit consent but with information and opt-out.
AKTIN uses a technical-organisational framework that enables research without the need for explicit patient consent, while complying with data protection regulations. The comprehensive data protection concept of the AKTIN platform has been positively evaluated by the TMF AG Datenschutz and has already been recognised by data protection officers in the 102 participating study centres.

How AKTIN manages data

  • Patient data is documented according to your processes and converted into an interoperable, machine-readable format (HL7 CDA/FHIR)
  • The data is automatically sent to the local AKTIN data warehouse (DWH) in your clinic
  • The export takes place after the completion of care in the Emergency Departments
  • On import, they are pseudonymised (name/date of birth removed, patient ID is pseudonymised using a one-way hash procedure)
  • Only your clinic has access to the AKTIN DWH

 

1. researcher submits a request for data analysis
2. the AKTIN Data Use and Access Committee (DUAC) reviews the request for ethical & scientific quality
3. request approved? Yes: Request is sent to all clinics via AKTIN Broker
4. Each clinic decides independently on the provision of data for each request.

1. released data from the clinics is sent to the AKTIN Broker.
2. the AKTIN Trusted Data Analysing Centre (TDAC) carries out the quality assurance and analysis.
3. only the analysis results are sent to the applicant(s).

What does NOT happen:

  • No export of patient IDs, address or birth data.
  • No access to complete patient files.
  • No "tracing" back to individual patients possible.
  • No storage in a central database.

What happens instead:

  • Only the data required for the question is requested.
  • Data processing takes place in the TDAC - a protected research data room.
  • Analyses provide aggregated results (e.g. totals, averages).

Documents

The following documents are to be considered as attachments to the data protection concept:

Translated Documents

*The documents are English translations of the respective Rules of Procedure, Publication Policy and Data Management Concept for the AKTIN Emergency Department Data (ED) Registry, provided for the convenience of non-German speaking users. Please note that this translation is intended for informational purposes only and may not capture every detail or nuance of the original German text. It is not legally binding. For all legal and formal purposes, the original German version of the document should be referred to as the authoritative source.