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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 September 13-19, 2025, #6)

Chronic care raises capital, CE-marks keep flowing, leadership benches shift, and new data reveals just how underfunded CEE’s healthtech sector remains. I am travelling, so this brief will be, well, brief.

People on the move

Venous Stent B.V. — Darren Spencer appointed CEO to drive its iliac venous stent programme into first-in-human trials and through EU regulatory milestones. NLC Health (Sep 2025)

Data4Life (Germany) — Dr. Ben Illigens named CEO to scale its health data platform (Data2Evidence) and tighten focus on compliance and translational research. Yahoo / Data4Life (Sep 1, 2025)

Money flows

Doctor.One (Poland/Europe) — €4M Seed led by YZR Capital with Impact Ventures and existing investors. The asynchronous chronic care platform is expanding into Germany, Spain, and the UK, with pharma partnerships already underway. EU-Startups (Sep 17, 2025); EIT Health (Sep 17, 2025)

On the press

  • Johnson & Johnson Shockwave Javelin Catheter Launch — New peripheral intravascular lithotripsy catheter hits Europe, promising better outcomes for below-knee calcified lesions. Johnson & Johnson (Sep 15, 2025)
  • Roche SmartGuide + mySugr CE Mark — CE approval for Roche’s Accu-Chek SmartGuide CGM integrated with the mySugr app; rollout planned across multiple EU markets. Biospace (Sep 17, 2025)
  • AVITA Medical RECELL GO CE Mark — CE approval expands European access to RECELL GO burn care device. BioPharma Boardroom (Sep 15, 2025)
  • CEE Funding Gap Report — New EU-backed investor guide highlights that CEE health ventures raise on average €1.8M vs €4.1M across Europe, and the region captures only 3.9% of EU’s VC funding. Medvia (Sep 12, 2025)

One thing to remember

Capital is flowing, but not evenly: while Western Europe powers up chronic care and device launches, CEE healthtech founders remain chronically underfunded. For investors, this looks like arbitrage. For founders, it means sharper evidence, earlier partnerships, and bolder cross-border strategies will be key to attract scale-up capital.

This content has been enhanced with GenAI.


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Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of September 6–12, 2025, #5)

Workflow AI meets hard regs: funding into clinical workforce & pathology AI, a CEE mental health roll-up, and CE marks in resuscitation, MSK and neuro-mobility.

People on the move

Haughton Design (UK) appoints Dr. Ash Ghadar as CEO to scale medtech/drug-delivery design services; a reminder that device commercialisation chops are in demand.

Allianz Partners (FR) names Okan Özdemir Chief Officer for Health & Board Member; payer-side signal for digital health distribution.

Money flows

Teton.ai (DK) $20M Series A, predictive eldercare AI; Plural leads with Bertelsmann Investments, Antler Elevate, Nebular and PSV Tech. Funds to push EU/US rollout and dataset expansion.

TERN Group (UK) €20M Series A; AI clinical workforce platform to optimise staffing across Europe & GCC; led by Notion Capital with RTP Global, LocalGlobe, EQ2, Leo Capital et al.

Aiosyn (NL) €2.4M to advance AI pathology tools for cancer diagnostics; supports validation and productisation with Dutch partners.

SafeHeal (FR) €10M Series C extension led by Asabys to accelerate EU commercial launch of Colovac and continue U.S. study.

Hedepy (CZ) acquires Poland’s HearMe (terms undisclosed) to consolidate CEE online psychotherapy; adds 80+ corporate clients and 120+ professionals; founders join leadership

On the press

• Neurescue (DK) wins CE mark under MDR for its intelligent aortic balloon catheter; the first device approved to treat non-shockable cardiac arrest in Europe.

• Varian (Siemens Healthineers) secures CE mark for Embozene microspheres in genicular artery embolisation (GAE) for knee osteoarthritis; first CE-marked embolic for GAE.

• Lifeward (IL/US) gains CE mark for ReWalk 7 personal exoskeleton; EU commercial launch enabled, with Germany a key reimbursed market.

• Report: Europe’s 10 biggest healthtech deals in H1 2025: €4B raised; UK led by volume. Useful late-stage context.

One thing to remember

Regulatory traction is back: three CE marks in one week (resuscitation, MSK pain, neuro-mobility) while capital flowed to workflow AI (staffing, lab data) and pathology. EU buyers will reward products that unblock staffing, data, and function bottlenecks.

This content has been enhanced with GenAI.

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MedTech

Quantum & Supercomputers: How Hybrid Computing Could Shave Decades off MedTech R&D

Quantum and Supercomputers hybrid in MedTech R&D

Think AI alone is transforming healthcare? Think again. The real game-changer could be quantum computing, particularly when paired with supercomputers. This isn’t future fiction anymore. It’s happening now.

What’s New—and Why It Matters

Combining quantum computing and supercomputers enables molecular simulations, like insulin dynamics involving tens of thousands of orbital. Classical systems simply could not handle it.

Experts are calling this the “AI on steroids” era, and the real test is whether quantum hardware can catch up to the hype.

Expected impact: quantum systems promise to make drug development far more accurate and efficient than ever before.

Strategic Insight—Why It Matters for European Commercialisation

  • Regulation won’t slow us down: Quantum tools could help Europe leapfrog red tape by enabling faster, in-silico trials and predictive toxicology.
  • Startups must recalibrate: As this tech moves from testing labs to real-world deployment, funding and venture strategies must shift, think hybrid infrastructure, not cloud-only or chip-only bets.
  • Policy windows opening: EU research programmes (e.g., Horizon Europe, Digital Europe) could be primed to support hybrid computing capabilities as they realise their impact on healthcare ROI.

What Are the Challenges? (Because of course there are.)

  • Hardware still nascent: Supercomputer capacity is real—but quantum hardware still lags and faces error-correction hurdles. “AI on steroids” isn’t quite combat-ready yet.
  • Integration complexity: Hybrid systems bring technical, regulation, and cost challenges, especially for SMEs.
  • Talent crunch: Few European researchers bridge computational chemistry, quantum algorithms, and AI. Building that capability will be critical.

Quantum‑supercomputer hybrids aren’t tomorrow’s sci‑fi. They’re today’s infrastructure for slashing decades off MedTech R&D. Don’t sleep on this. Europe’s commercial edge will go to those who code quantum-native, not just cloud‑native.

This content has been enhanced with GenAI.

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Digital Health MedTech

Quantum Healthcare in Europe: Funding, Regulation and the Path to Market

Quantum Healthcare in Europe - Funding, Reugulations and Path to Market

Europe’s Quantum Moment

Europe is not just a consumer of quantum technologies, it’s investing heavily to become a global leader. The Quantum Technologies Flagship commits €1 billion over 10 years to research and commercial pilots.

Add Horizon Europe and EuroHPC’s hybrid supercomputers, and you get a uniquely European playbook: strong public co-funding, national champions, and cross-border infrastructure.

Key hubs include:

  • France: Pasqal, a neutral-atom hardware leader, and Qubit Pharma, focused on quantum drug discovery.
  • Germany: Fraunhofer institutes leading applied research and partnerships with IBM.
  • Finland: Algorithmiq, developing quantum algorithms for pharma and life sciences.

Regulation as Strategy

What makes Europe unique is not qubit counts but regulation as market infrastructure. For quantum healthcare, three frameworks matter most:

  • GDPR: mandates privacy and security by design, critical for sensitive genomic and clinical data.
  • Medical Device Regulation (MDR) & In Vitro Diagnostic Regulation (IVDR): quantum-enabled diagnostics must clear the same CE-marking hurdles as any AI-driven device.
  • AI Act: classifies healthcare AI (quantum or not) as “high-risk,” requiring transparency, bias monitoring, and human oversight.

For founders, this is not just a compliance burden but a potential export advantage: build under Europe’s strict rules, and your product is more likely to pass scrutiny in the US, UK, and Asia.

The Funding Landscape

European investors are cautiously optimistic. Quantum is a long game, but public–private models are de-risking the early stage. The European Investment Bank (EIB) has begun backing quantum startups, and national governments (e.g. France’s €1.8bn quantum plan) provide direct subsidies.

Still, private VC funding in Europe lags the US. The opportunity lies in co-investment: pairing deep-tech VCs with public grants to build resilient ventures that can survive the long runway to commercial ROI.

Strategic Takeaway

For Europe’s medtech and pharma founders:

  • Embrace regulation early: treat MDR, GDPR, and the AI Act as design inputs, not afterthoughts.
  • Leverage co-funding: combine EU and national grants with private capital to extend runway.
  • Anchor in hubs: partner with HPC centres, Fraunhofer, or national quantum labs to gain credibility.

Quantum healthcare in Europe won’t be won by the first to 1,000 qubits. It will be won by the first to regulation-ready, market-accessible solutions that can scale across 27 member states and then export globally.

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Digital Health MedTech

Harvest Now, Decrypt Later: Why Healthcare Must Go Post-Quantum Today

Harvest now, Decrypt later - post-quantum healthcare - medtech security

The Threat

Healthcare runs on trust — but its digital backbone is fragile. A sufficiently powerful quantum computer will run Shor’s algorithm, breaking RSA and elliptic curve cryptography. That means everything from EHRs to connected pacemakers is at risk.

And the danger isn’t hypothetical. Adversaries are already engaging in “Harvest Now, Decrypt Later” (HNDL) — collecting encrypted medical data today to crack open once quantum machines catch up. Health records are especially valuable because they must remain confidential for decades, often a century.

The Urgency

The US NIST finalised the first post-quantum cryptography (PQC) standards in 2024, including CRYSTALS-Kyber for key establishment and CRYSTALS-Dilithium for signatures. The EU has yet to mandate PQC explicitly, but under GDPR’s requirement for “appropriate technical measures”, regulators will likely interpret compliance as requiring migration.

Medtech and pharma firms cannot afford to wait. Migration is not a patch but a multi-year transformation: inventorying cryptographic assets, building crypto-agile architectures, and upgrading every system from EHRs to clinical trial platforms.

The European Edge

Europe is not passive. The EuroQCI initiative aims to build a pan-European quantum communication infrastructure based on quantum key distribution (QKD) — an ultra-secure backbone for critical sectors, healthcare included.

But PQC migration remains the urgent first step. Quantum-secure comms infrastructure is years away; vulnerable encryption is a present reality.

Strategic Takeaway

For European healthcare organisations:

  • Start the migration now: waiting until Y2Q is too late.
  • Prioritise PQC vendors and services: the “picks and shovels” of the quantum security gold rush.
  • Engage boards early: GDPR fines (4% of global turnover) make PQC a board-level risk.

Quantum computing’s promise in drug discovery may take a decade. Its threat to healthcare cybersecurity is here today. The winners will be those who treat post-quantum cryptography not as R&D, but as critical infrastructure.

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Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of August 30–September 5, 2025, #5)

Hospitals want evidence, investors want traction: this week mixed the two: GI diagnostics, insulin delivery, genomics M&A. And sprinkled in fresh CE marks for surgical robots.

People on the move

Data4Life (DE), a digital health nonprofit backed by SAP founder, Hasso Plattner, appoints Dr. Ben Illigens as CEO to steer its health data and research initiatives. Data4Life is building open source platform Data2Evidence, which is based on the international OMOP data model.

“We are at a turning point where digital technologies are fundamentally transforming research and care. My goal is to strengthen Data4Life as a bridge between clinical research, technology, and practice,”
Dr. Ben Illigens.

Lottie (UK): George Hadjigeorgiou, cofounder of ZOE, a personalized nutrition health company, joins the board of Lottie as NED, signaling deeper crossover between consumer health and eldercare ops. Lottie is a UK’s marketplace for care homes and care services.

Money flows

Kaleido Insulin Pump visualisation - Source: https://hellokaleido.com/

ViCentra (NL) — $85M Series D; insulin patch pump maker (Kaleido) fuels next-gen device development and scale-up.  Round was led by new investor Innovation Industries, a leading European deeptech venture capital firm, with matching participation from existing investors Partners in Equity and Invest-NL, alongside continued support from EQT Life Sciences and Health Innovations.

Cyted Health (UK) — €37.5M Series B; GI molecular diagnostics to improve early detection and prevention of oesophageal cancer. Round aims to expand US commercialization while consolidating NHS footprint. Investment led by EQT Life Sciences, Advent Life Sciences and British Business Bank with continued support from existing investors Morningside and BGF.

ArcaScience (FR): $7M round led by The Moon Venture; AI “benefit–risk” intelligence platform for life-sciences R&D to clean, link and query messy evidence.

Aiomics (DE) — €2M pre-Seed; clinical-grade AI agents to reduce clinical documentation burden and improve care pathways.

M2Care (FR): €26M venture-studio raise from Bpifrance’s FTA2 fund to create/develop eight healthtech projects. Other investors in M2Care are Mérieux Développement (who actully created this incubator), Institut NAOS des Sciences de la Vie, Crédit Agricole Centre-Est. 

SeqOne (FR) aquired Congenica (UK), on undisclosed terms.
This merger creates a larger AI-powered genomics software group with strong UK presence.

On the press

One thing to remember

Evidence-first commercialisation is back: capital flowed to diagnostics and chronic-care delivery while robotics snagged CE marks. A cross-border genomics deal underlined that European buyers will pay for software that shortens time-to-impact. If you’re fundraising, pair outcomes data with a path to multi-market reimbursement; if you’re buying, look for software that accelerates clinical workflows, not just visibility.

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MedTech Pharma Marketing

Omnichannel Marketing Metrics That Actually Deliver in Pharma & MedTech

Omnichannel Marketing KPI template for pharma and medtech

Omnichannel is non‑negotiable in pharma and medtech marketing. In recent study 97% of industry leaders say it’s vital. Yet execution remains consistently fragmented, and fewer than half even measure ROI regularly. That’s the mission-critical gap any marketer needs to bridge. I am here to help.

Benchmarks That Put ROI in Frame

1. Revenue Uplift
When omnichannel is done right, top performers record over 15% revenue gains.
Many report 5–15% lifts, particularly where personalised, multi-channel approaches are scaled.

2. Marketing Efficiency Gains
Pharma innovators using hybrid commercial models see 10–40% improvements in marketing efficiency—faster time to market and lower cost per outcome.

3. Investment Signals
Companies allocate 10–15% of their promotional and advertising budget to omnichannel solutions—evidence of meaningful investment.

4. Strategic Capability Gaps

As BCG study shows medtech and biopharma marketing leaders identifycritical gaps:

  • 30% lack a clear omnichannel strategy, especially SMEs.
  • 90% cite data silos as a major barrier; only 10% have fully integrated data systems.
  • Only 7% are broadly leveraging AI/GenAI in omnichannel.
  • Less than 17% review performance metrics more than monthly.

Pharma and MedTech Omnichannel Marketing KPI Template

Use this template as your go-to scorecard in dashboards or meetings. Tweak thresholds to match your maturity stage.

MetricDescription / Use CaseBenchmark Range
Revenue Uplift (%)Compare current period vs. baseline revenue5–15%, top performers >15%
Marketing Efficiency Gain (%)Cost savings, time-to-market improvements10–40%
Revenue Growth Attribution (%)Portion of growth tied directly to omnichannel efforts≥5%
Budget Allocation (%)% of total ad/promo spend, dedicated to omnichannel10–15%
Data Integration MaturityInternal scale (1–5) or Yes/No for integrated platformsFull integration
AI/GenAI Adoption Rate% workflows using AI-driven personalisation≥7%
ROI Tracking CadenceFrequency of KPI reviews (daily, weekly, monthly)Target: Monthly or finer
Next Best Experience Adherence Rate% of next best-experience suggestions followedAim for >60%
HCP Satisfaction (NPS)Net Promoter Score of omnichannel engagementTop quartile

How to Use This Template as a Tool for Change

  1. Start with the high-impact metrics revenue uplift, efficiency gain, budget share. Then layer in Omnichannel Marketing maturity and AI adoption.
  2. Set realistic benchmarks: for emerging teams aim at the 5–10% uplift band; for execution-capable teams push for 15%+.
  3. Track performance monthly those who review less frequently (only 17% do so monthly or more often) risk losing momentum.
  4. Address barriers consciously if AI or data integration scores are low, plan targeted investments or pilot programs.
  5. Use Next Best Experience adherence as a cultural pulse. Low compliance signals change management, not tech, is the bottleneck.

Final Take

Omnichannel in pharma and medtech is a strategic advantage—unless you fail to measure it. Now you have hard benchmarks and a KPI template proven in the field. Use them to bridge the gap between ambition and impact.

Metrics aren’t optional: they transform omnichannel from buzzword to business model.

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Digital Health MedTech

Pharma’s Quantum Bet: Can Qubits Fix Drug R&D’s 90% Failure Rate

Quantum computing in pharma drug discovery R&D

The Promise

Pharma spends billions on R&D only to see 90% of drug candidates fail in trials. At the heart of the problem: chemistry is a quantum system, but we’ve been simulating it with classical approximations. Quantum computing, in principle, can simulate molecules and protein folding with physics-native precision, potentially cutting years and billions from discovery pipelines.

The Reality

We are not about to quantum-simulate an entire antibody. Today’s quantum machines remain noisy, small, and fragile. The most credible progress has come from hybrid models, where quantum handles a computational bottleneck and classical HPC does the rest. For example:

  • Cleveland Clinic & IBM: Predicted Zika virus protein fragments more accurately than AlphaFold using a hybrid quantum-classical framework (Cleveland Clinic).
  • Japan Tobacco & D-Wave: Used quantum annealing to train generative AI, producing more “drug-like” molecules than classical methods (MedPath).
  • Biogen & Accenture: Quantum-enabled molecular comparison delivered richer structural insights than classical screening (Accenture).

Each success is narrow, but collectively they show a pragmatic pattern: don’t replace classical, augment it.

The European Edge

Europe is well-positioned. Startups like Pasqal (France) are already running protein hydration analyses on neutral-atom quantum computers (Qubit Pharmaceuticals). The Quantum Technologies Flagship (€1bn over 10 years) funds such projects (EU Commission). Combined with Horizon Europe grants and EuroHPC’s hybrid supercomputers, pharma here has access to sovereign infrastructure and public co-funding that US peers often lack.

Strategic Takeaway

For European pharma and biotech:

  • Think long-term: validated drug design use cases are 5–15 years out (Roche).
  • Back hybrids: near-term ROI lies in workflows where quantum complements AI, not replaces it.
  • Partner early: collaborations with quantum startups and HPC centres are essential to de-risk.

Quantum won’t cure R&D inefficiency overnight. But when 9 in 10 candidates still fail, even a narrow, validated quantum edge could mean the difference between another failed trial and Europe’s next blockbuster drug.

This content has been enhanced with GenAI tools.

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Digital Health MedTech

Europe MedTech & Digital Health — Weekly Brief (Week of August 23–29, 2025, #4)

OrganOx metra transport. Source: OrganOx website

This week’s highlights: a landmark UK medtech exit, a €403 million EU funding boost for AI-powered devices, and strategic momentum building across Europe for medtech commercialization. Otherwise it seems we are on annual leave.

People on the move

No newly reported high-level hires, board moves, or fund leadership changes in the European medtech/digital health sector this week.

Money flows

One thing to remember

Founders: now is the time to align innovation pipelines with EU priorities—combine clinical validation and AI integration with a clear path to strategic M&A to attract both Brussels funding and corporate buyers.