Pharma Beyond the Pill: AI, Patient Data & the Hacker’s Jackpot
Pharma wants real-world data; adversaries want it more. Case Studies Risk Hotspots Mitigations Your real-world data strategy is only as strong as your real-world security.
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Startups at Risk: The AI Security Blind Spot in HealthTech Funding
VCs love TAM slides. Users love not being breached. Why Startups Under-Secure Investors Waking Up Diligence Questions Minimal Security Stack Secure runway beats growth at any cost, especially in health.
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Towards Trust: Can Europe Lead on Secure AI in Healthcare?
Europe wrote the rules. Now it has to monetise them. The EU Stack Why It Can Be a Moat Risks & Tensions If Europe aligns security, standards, and procurement, trust becomes a market advantage — not a compliance tax.
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FAQ: AI Security in Healthcare
Is AI safe to use in healthcare? AI can improve diagnostics, treatment recommendations, and patient monitoring but without safeguards it can be manipulated. Adversarial attacks on medical imaging AI have been shown to cause misclassifications (European Journal of Radiology). The EU recognises this: under the AI Act, most health AI is “high-risk” and must meet…
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AI Security in Healthcare: Europe’s Strategic Fault Line (and How to Win It)
AI in healthcare is often sold as a story of improved diagnostics, personalised therapies, and predictive medicine. But beneath that dream lies a fragile backbone: security. One breach, one exploited model, and reputations, finances, even lives are at stake. In Europe, this tension is amplified. The Artificial Intelligence Act entered into force on 1 August…
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Europe MedTech & Digital Health — Weekly Brief (Week of Aug 9–15, 2025, #2)
A crisp week: AI diagnostics raised, sports concussion wearables funded, a Dutch conversational-AI startup got scooped up, and the UK nudged its devices policy closer to home care. People on the move Jade Leung has been appointed as the UK’s Prime Minister’s AI Adviser while continuing as CTO at the AI Safety Institute; expect ripple…
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Why SaMD Launches Fail in Europe
Common Pitfalls Fixes: Learn more at Scaling MedTech: From Product to Market This post is part of SaMD Europe Launch Guide. This content has been enhanced by GenAI tools.
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Investment Trends in European Digital Health
Where Capital Flows Investors favor: Valuation Benchmarks: Learn more at Scaling MedTech: From Product to Market This post is part of SaMD Europe Launch Guide. This content has been enhanced by GenAI tools.
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Post-Market Surveillance for SaMD
Staying Compliant Post-Launch Post-market surveillance (PMS) is required for all devices. Requirements: For Class IIa+, submit PSUR every 1–2 years. This post is part of SaMD Europe Launch Guide. This content has been enhanced by GenAI tools.
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SaMD Market Access & Reimbursement in Europe
CE Mark ≠ Reimbursement Each EU country has its own reimbursement process. Highlights: – Germany (DiGA): Fast track, 12-month provisional access – France: Multiple programs (ETAPES, PECAN) – UK: NICE approval + local commissioning (ICBs) Evidence needs differ, it can be Randomized Controlled Trials (RCTs) or real-world evidence depending on system. Learn more on Scaling…
