The Data on the Operating Table
Having data is not the same as having proof: registries, InEK and EHDS will ask who owns each record and whether it can be trusted. Learn how surgical departments can answer that with confidence, starting at the operating table.
December 2, 2026
10:00 CET
Online
Speaker
Alena Burdzialouskaya
Director of Healthcare Technologies at Andersen
12+ years in healthcare IT, leading digital transformation with interoperable, compliant cloud solutions (HL7, FHIR, HIPAA). Builds teams and partnerships that turn healthcare trends into practical technology impact
Agenda
18:00–18:03
Your Department, Measured in Data
- What the Länder handed over to InEK on October 31, 2026
- Which quality criteria and minimum volumes apply from January 2027
- Why the proof for all of it starts in the operating room
18:03–18:18
Where the Three Hours Go
- Three hours a day on documentation: where that time actually goes
- One case, three entries: the HIS, the Implantateregister and quality reporting
- What a missed registry entry costs the department
18:18–18:30
Built by Clinicians, Regulated Anyway
- When an in-house app becomes a medical device under MDR
- Why sharing it with another clinic counts as placing it on the market
- What changes once AI is added, and why 2028 is a window, not a pause
18:30–18:43
Captured Once at the Table: How One Clinic Did It
- Valve sizing and mismatch prediction from annulus measurements
- Case records captured after implantation and sent on without re-entry
- Who carries classification, technical documentation and IEC 62304
18:43–18:53
When Records Become Evidence
- Ownership and data quality: who answers for each record
- Access and protection after the unimed breach
- Getting data to registries safely before EHDS applies in March 2027
18:53–19:00
Q&A Session