Tag: Digital therapeutics

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Digital Health MedTech

AI Security in Healthcare: Europe’s Strategic Fault Line (and How to Win It)

AI Security in Healthcare

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 2024, putting health AI under new obligations (European Commission). At the same time, NIS2 extends cyber resilience rules to hospitals, while the European Health Data Space (EHDS) (in force from March 2025) will demand interoperable, secure data exchange.

This series of posts dissects that tension from five angles:

  1. Why AI in Healthcare Has a Security Problem: Overview of attack vectors, real-world risk, regulatory context.
  2. From MRI to MedTech: Securing AI-Powered Devices: How embedded and edge AI in devices create vulnerabilities.
  3. Pharma Beyond the Pill: AI, Patient Data & the Hacker’s Jackpot: Why pharma’s “beyond the pill” strategies are hacker magnets.
  4. Startups at Risk: The AI Security Blind Spot in HealthTech Funding: Why early-stage ventures often underinvest in security.
  5. Towards Trust: Can Europe Lead on Secure AI in Healthcare?: Can the EU turn trust and compliance into a competitive advantage?
  6. FAQ: AI Security in Healthcare

The future of health AI won’t be won on models — it’ll be won on trust.

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Digital Health MedTech

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 - a new UK Prime Minister AI Adviser. Source: Linkedin

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 effects on health AI policy and procurement.

Tom Moore - President and CEO of Minze Health

Thomas Moore named President & CEO of Minze Health to scale digital urology diagnostics/therapeutics across EU and the US.

Money flows

Sports Impact Technologies (Ireland): €650K Pre-Seed for behind-the-ear concussion-detection wearable; beta with athletes kicks off in September, full launch targeted for 2026.

Better Medicine (Estonia): €1M Pre-Seed to expand CE-certified AI for kidney cancer detection, fund EU rollout and FDA-aligned pilots.

VentriJect (Denmark) — €1.7M (round type undisclosed) to scale its cardiorespiratory fitness monitoring device (SEISMOfit) and push commercialization.

HOPCo × Caro Health (the Netherlands) — Amsterdam’s conversational-AI health startup Caro Health acquired by US-based HOPCo; Caro’s team to expand HOPCo’s European digital division and integrate across products.

On the press

Automated insulin delivery — Utrecht’s ViCentra says its next-gen closed-loop Kaleido system is slated for a Europe launch next year, signaling more AID competition on the continent.

Say hello to Kaleido!

UK devices policy — MHRA opens a stakeholder survey on the Health Institution Exemption (HIE), floating extensions to community/home use and tighter PMS/governance—practical for hospital “in-house” SaMD/device teams.

Macro: Italy watch — New data show Italy’s tech funding momentum; healthtech has already raised ~$126M in 2025, underlining ongoing digital health demand.

One thing to remember

AI-heavy workflow tools are getting their first cheques (imaging, concussion safety) while cross-border consolidation (Caro→HOPCo) accelerates go-to-market—set against a UK policy tweak that could legitimize more hospital-built software/devices beyond the hospital walls. If you’re raising: show path to deployment (pilots, CE status) and a plan for integration into care pathways.


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Digital Health MedTech

Why SaMD Launches Fail in Europe

Common Pitfalls

  1. Vague intended use leading to misclassification
  2. No QMS or weak cybersecurity
  3. Poor clinical evidence strategy
  4. Failure to engage clinicians or users

Fixes:

  • Start regulatory early
  • Build real clinical value
  • Design with adoption in mind

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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Digital Health MedTech

Investment Trends in European Digital Health

Where Capital Flows

Investors favor:

  • AI-powered platforms
  • Value-based care tools
  • Female health (menopause, hormones)

Valuation Benchmarks:

  • 4–6x revenue for most healthtech
  • 6–8x for AI/diagnostics
  • 10–14x EV/EBITDA for EBITDA-positive firms

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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Digital Health MedTech

Post-Market Surveillance for SaMD

Staying Compliant Post-Launch

Post-market surveillance (PMS) is required for all devices.

Requirements:

  • Plan for data collection
  • Trend analysis and signal detection
  • Regular updates to clinical files
  • Vigilance reporting (e.g. EUDAMED)

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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Digital Health MedTech

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 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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Digital Health MedTech

Clinical Evidence for SaMD in the EU

MDR Requirements

SaMD must show:

  • Clinical association (medical logic)
  • Analytical validity (correct processing)
  • Clinical validation (real-world benefit)

Documentation:

  1. Clinical Evaluation Plan (CEP) = how you’ll gather evidence
  2. Clinical Evaluation Report (CER) = full evaluation
  3. Post-Market Clinical Follow-up (PMCF) = follow-up after launch

Use real-world evidence, literature, or clinical studies.

This post is part of SaMD Europe Launch Guide.

This content has been enhanced by GenAI tools.

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Digital Health MedTech

The CE Marking Process for SaMD

Get CE Mark

Most SaMD is Class IIa or higher—requiring Notified Body involvement.

Key Steps:

  1. Prepare tech documentation (Annex II, III)
  2. Implement QMS (ISO 13485)
  3. Create clinical evaluation plan (CEP) and report (CER)
  4. Work with a Notified Body

Class-specific routes:

  • Class I: self-certify
  • Class IIa-III: Notified Body review + ongoing surveillance

This post is part of SaMD Europe Launch Guide.

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Digital Health MedTech

SaMD Cybersecurity and GDPR

Security = Safety

Under EU MDR, cybersecurity is a General Safety and Performance Requirement. Failure to secure software is a patient safety risk.

Technical Steps:

  • Secure architecture and testing (MDCG 2019-16)
  • Access control, encryption, logging
  • Vulnerability management and patches

GDPR Considerations:

  • Health data = special category
  • Explicit consent and purpose limitation
  • DPIA (Data Protection Impact Assessment) required if high-risk AI involved

This post is part of SaMD Europe Launch Guide.

This content has been enhanced by GenAI tools.

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Digital Health MedTech

Building a Compliant QMS for SaMD

To enter the EU market, your SaMD must be developed under a Quality Management System (QMS) that complies with ISO 13485.

What You Need

  • ISO 13485: General quality framework
  • ISO 14971: Risk management integration
  • IEC 62304: Software development lifecycle

Best Practices

  • Build your QMS, don’t buy a generic one
  • Ensure continuous documentation and audits
  • Tie QMS to real clinical risk management

Cybersecurity Integration

Use MDCG 2019-16 as a guideline for secure development. Cybersecurity is considered a safety issue under EU MDR, it is not just IT hygiene.

Learn More:

This post is part of SaMD Europe Launch Guide.

This content has been enhanced by GenAI tools.

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