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 requirements for risk management, logging, transparency, and human oversight (European Commission).
What makes healthcare AI especially vulnerable?
- High-value data: medical records and biomarkers can be monetised.
- Legacy IT systems: hospitals often run outdated software.
- Safety-critical use cases: an AI mistake can harm patients.
A striking example: the WannaCry ransomware attack (2017) disrupted the UK NHS, cancelling appointments and locking critical systems (UK National Audit Office).
What regulations apply to AI in healthcare in Europe?
- AI Act (2024) high-risk AI systems must comply with strict risk, logging, and oversight rules (European Commission).
- MDR/IVDR safety and performance rules for devices, including AI-powered ones.
- NIS2 Directive (2023) cybersecurity rules for hospitals and health infrastructure (European Commission).
- European Health Data Space (EHDS) secure EU-wide health data access and exchange from 2025 (European Commission).
What real-world health data breaches should I know about?
- MyFitnessPal (2018): 150m accounts exposed (TIME).
- Flo Health (2021): settled with US FTC for sharing sensitive reproductive data without consent (FTC).
- Flo Health (2025): faced new lawsuits; a California jury also found Meta liable for illegally collecting Flo users’ menstrual data (Reuters).
These cases underline that health data is both sensitive and heavily scrutinised.
What can startups do to avoid AI security pitfalls?
- Secure training data integrity
- Audit trails from day one
- Adversarial testing
- Incident response plans
- Data Protection Impact Assessments (DPIAs) under GDPR
Investors increasingly check these; a weak security posture is becoming a deal-breaker.
Can Europe lead on AI security in healthcare?
Yes, if it turns regulation into a competitive advantage.
Europe’s bet is that “trustworthy AI” will attract hospitals, regulators, and patients. If secure-by-design becomes the norm, EU firms may gain a global edge, provided compliance doesn’t strangle startups.
In healthcare, AI is only as valuable as it is trustworthy. Europe is trying to legislate that trust into existence.
