Date: 24.10.2025 (2025-10-24)
Sören Hornof (24.10.2025) • Scientist at Bfarm
Questions: • Notes: • His task: Anträge bearbeiten auf Klassifizierung und rechtlicher Status -> unklar ob MD oder medication etc. -> he makes decision and he does classification (which rule anwendbar) • Always complex projects -> Schiedsstelle • He is also in a European group -> asks other countries -> working group -> MDCG guidance -> examples of decisions • Look at former Gerichtsentscheidungen -> maximum objective • Automation? • They do not use workflow tools • They buy enterprise solutions • One company that does document management -> feature requests (not that large) • Enaio - Optimus systems • Potential: • They have a lot of Verwaltungsangestellte -> Email comes in then they put it into a digital Akte - thats everything -> document management and • Paperwork in general? • • Legacy systems? • He does not think the SW has an API -> all on premise • They use different SW • E.g. they have to work with Arnzneimittel und Medizinprodukt -> different document management system -> communicate per email -> assistants have to pull it into Akte • They have to put Vorgangsnummer manually into the mail • -> very incompetent people - it is unclear that they could automate • SW procurement: • Document management system -> there since years • It is like SAP • Ausschreibungsprozess, budget has to be approved etc. • OpenReg: • They tried to predefine processes -> for them it worked • If it is too general there is too much competition -> has to be tailored to requirements - they knew what are the Stolpersteine and what do Auditoren want to see