Open Letter to Standing Committee of European Doctors
6 May 2026
Letter to Dr. Ole Johan Bakke
Bart de Witte
CEO & Co-Founder,
Isaree GmbH
Friedrichstraße 155
10117 Berlin,
Germany
Dr. Ole Johan Bakke
President
Standing Committee of European Doctors (CPME)
Rue Guimard 15
1040 Brussels
Belgium
Belgium Subject: Respectful concerns on CPME’s position on medical AI in the AI Act, unintended subsidy to US Big Tech and harm to European physicians
Dear Dr. Bakke,
I am writing to you in my capacity as CEO and Co-Founder of Isaree, an open, clinician-centric platform that enables European doctors to build, validate, and safely deploy their own AI agents at the point of care. I am also the founder of the non-profit HIPPO AI Foundation, dedicated to democratising medical AI and returning real control to frontline physicians.
Last week I reached out to 35 European physician associations, including those aligned with CPME, because I am deeply concerned that your organisations are currently being misrepresented on this issue. Fear-mongering from US providers such as OpenAI, Anthropic and Microsoft, amplified by certain NGO lobbying, appears to be shaping the narrative around “safety first.”
I respect CPME’s March 2026 call to keep medical devices fully within the high-risk obligations of the AI Act (Chapter III, Section 2) and to reject the streamlining in the Digital Omnibus. Your commitment to patient safety and medical ethics is genuine and commendable.
However, the current CPME stance risks delivering exactly the opposite outcome for the physicians you represent. Recent economic analysis shows that maintaining the full dual regulatory burden (MDR/IVDR + standalone AI Act Chapter III) creates a structural subsidy for US Big Tech while imposing crushing costs on European medical AI builders:
- A French hospital that simply rents GPT-4 via Microsoft Azure for clinical decision support is classified as a deployer. First-year compliance: €50K–€100K. No notified body. No full conformity assessment.
- A European startup building the same clinical capability from the ground up is a provider. It faces MDR plus the full AI Act Chapter III: 12–18 months delay, €180K–€450K in costs before first revenue.
Same clinical output. Three times the cost, and often more, for the EU-native builder. DIGITALEUROPE estimates the EU-wide annual compliance bill at €3.3 billion. For a typical 50-person medical AI company this means €320K–€600K upfront plus €150K every year thereafter.
The deployer–provider distinction was designed for general-purpose AI. When applied to medical models it hands OpenAI, Anthropic and Microsoft precisely the competitive advantage the AI Act was meant to prevent. European Series A deals are already pricing this in: native medical AI transactions are clearing more slowly, and many of the teams that do succeed are simply wrapping US APIs instead of building locally.
The trilogue on the Digital Omnibus collapsed on 28 April after twelve hours of talks. If no agreement is reached by June, the original August 2026 deadline still applies. The consequence is clear: higher barriers for home-grown, hospital-based innovation; accelerated consolidation; and cheaper acquisition targets for US strategics. EU startups facing these costs become depressed-valuation M&A opportunities, producing exactly the capital outflow and loss of physician agency that CPME seeks to avoid.
Platforms such as Isaree were built for the agentic future you yourself have highlighted in CPME statements — multi-agent orchestration on open-weight models, designed by clinicians, validated in hospitals, and owned by doctors rather than corporations. The Omnibus’s single integrated conformity assessment would make that workflow realistic while preserving safety. The current CPME position risks locking European physicians into passive consumption of foreign black-box tools instead of empowering them to innovate.
In short, Dr. Bakke, the stance CPME is advocating may inadvertently subsidise the very technology giants whose “move fast and break things” philosophy you rightly criticise, while limiting the practical scientific freedom and professional autonomy of the European doctors you represent. Supporting a well-designed Digital Omnibus streamlining would better serve your core mission: trusted, safe, and physician-controlled medical AI.
I would be grateful for the opportunity to discuss this directly with you or your team. I am happy to demonstrate Isaree’s clinician-led approach and share concrete examples of how the Omnibus would enable, rather than hinder, responsible innovation at the bedside.
Thank you for your leadership and for the vital work of CPME. I remain confident that open dialogue can align regulation with the real needs of practising physicians in the age of agentic medical AI.
Yours sincerely,
Bart de Witte
CEO & Co-Founder, Isaree GmbH