Editing PHKG Business Opportunities (section)

=== Challenges ===

* '''Clinical safety is the binding constraint:''' Not integration cost. Not technology readiness. A prospective clinical study showing the summarisation doesn't increase diagnostic misses is a prerequisite for GP trust and regulatory clearance.
* '''MDR / AI Act compliance:''' Any tool that highlights "relevant" history for the current complaint makes a clinical relevance judgment → clinical decision support under EU MDR → likely 12-18 months and significant capital for CE marking. Klinik has been navigating this for a decade; Stamen starts from scratch.
* '''Epic competition:''' In Helseplattformen regions, Epic's own GPT-4 summarisation comes bundled. Stamen needs to be demonstrably better, not just different.
* '''Integration:''' Connecting to CGM Allmenn, Infodoc Plenario, Pridok is technically complex. Each has different APIs, data models, authentication. 6-12 months per EHR.
* '''Automation bias:''' If GPs start relying on summaries without verifying, the tool becomes a liability. Product design must include verification nudges.