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Shadow AI in health systems refers to clinicians and staff using AI tools (like public chatbots or unapproved apps) without their organisation’s formal approval or oversight and it is now widespread in hospitals and health systems.What “shadow AI” means in healthcareShadow AI is the unsanctioned use of AI tools, models or features without visibility from IT, security or governance teams. In healthcare, that often means staff pasting patient details into public generative AI tools, using unvetted documentation assistants, or standing up their own models in cloud environments outside official processes. Evidence it’s a growing issue at health systems A Wolters Kluwer survey of more than 500 hospital and health system workers found 40% had encountered unauthorised AI tools at work, and about 17–20% admitted using them themselves. Around one in ten respondents said they had used an unauthorised AI tool for direct patient care use cases, underscoring that this is not just back‑office experimentation. Healthcare workers report turning to shadow AI primarily to speed workflows, cope with documentation burden, and access functionality they feel approved tools lack or do not yet offer. Why it’s particularly risky in health systems Data privacy and cybersecurity: Uploading PHI or other sensitive data into public or unvetted AI tools can bypass organisational controls, create “silent” cross‑border data leaks, and increase breach costs. Patient safety and clinical quality: Unvalidated models can give inaccurate or biased outputs; if clinicians rely on them for documentation or decision support, errors may not be visible to governance teams until harm occurs. Regulatory and legal exposure: Unapproved AI use can trigger violations of HIPAA and other privacy regimes and also complicate accountability when an AI output influences care without traceable oversight. What’s driving shadow AI in hospitals Burnout and workload: Clinicians and admin staff use generative AI to draft emails, summarise notes, or translate content because it feels like the only way to keep up with documentation and communication demands.​ Innovation gap: Staff perceive that official AI programmes are moving too slowly or that approved tools are less capable than consumer‑grade offerings, so they “experiment” on their own. Low AI literacy and unclear policy: Many organisations have not yet provided clear, practical guidance on what is permitted, where data may go, and how to request new tools, which fuels informal workarounds. How leading health systems are responding Visibility and monitoring: Security leaders are starting with discovery tools to detect unauthorised AI usage and data flows, especially those involving patient information. Governance structures: Some systems have created cross‑functional AI governance councils (clinical, IT, legal, compliance, operations) to evaluate tools, set guardrails, and approve use cases. “Enable, don’t ban” strategies: Rather than blanket blocking, a number of organisations allow controlled experimentation, provide sanctioned AI options (e.g., ambient scribe, clinical decision support), and educate staff to keep usage inside safe channels.To discuss how Nelson Advisors can help your HealthTech, MedTech, Health AI or Digital Health company, please email <a data-mce-href="mailto:lloyd@nelsonadvisors.co.uk" href="mailto:lloyd@nelsonadvisors.co.uk" title="lloyd@nelsonadvisors.co.uk" target="_blank" rel="noopener" data-mce-selected="inline-boundary">lloyd@nelsonadvisors.co.uk</a>

Shadow AI is becoming a growing issue for hospitals and  health systems

Health AI has moved from hype to execution, with a new cohort of AI-native businesses scaling faster, with better unit economics, and attracting both IPO and private-market capital; Bessemer’s thesis is that this “Health Tech 2.0” wave is real, not another ZIRP-style bubble.​1. Health Tech 2.0 vs 1.0 Health Tech 1.0 IPOs (telehealth, virtual care, broad “digital health”) rode COVID/ZIRP tailwinds with weak unit economics and subsequently destroyed public-market trust, closing the IPO window through 2023.​ Health Tech 2.0 IPOs (Waystar, Tempus, Hinge, Omada, Caris, HeartFlow) came public 2024–25 with profitable or near-profitable models, strong net retention and clear ROI, and now represent ~30% of the $121B BVP Health Tech Index market cap.​ 2. Public market comeback, but with a trust gap New Health Tech 2.0 stocks rose ~18% in 2025, roughly in line with NASDAQ and S&amp;P 500, while the broader health tech index was up 4% and cloud software (EMCLOUD) fell 7%.​ Despite 2x the revenue growth and FCF margins of high‑growth software peers, health tech still trades at a 10–20% valuation discount due to perceived complexity, regulatory risk, and memories of 2020–21, a gap Bessemer expects to narrow over 12–24 months.​ 3. Private-market proof: M&amp;A, funding, valuations Global health tech M&amp;A hit ~400 deals in 2025 (vs 350 in 2024), with acquirers using AI to drive both revenue growth and margin expansion (e.g., SmarterTechnologies–Access Healthcare–SmarterDx roll‑up, Waystar–Iodine, R1–Phare Health).​ Venture deal volume (~527 health tech VC deals, ~$14B deployed) and a 42% jump in average round size to $29.3M show deal-making back at pandemic levels; 55% of all health tech funding now goes to AI, and late-stage valuations (especially Series D+) are rising fastest, led by mega‑rounds such as Abridge, Ambience, Function Health, and OpenEvidence.​ 4. Health AI X Factor and “supernovas” A small set of Health AI “supernovas” (e.g., SmarterDx, Abridge, OpenEvidence) are growing 6–10x annually, hitting $100–200M ARR in under five years and compressing the time to $100M ARR from a decade to as little as 18–36 months.​ The Health AI X Factor is the justification for premium NTM multiples, arguing some $30M ARR businesses can be fairly valued at $1B+ because growth curves are structurally steeper than traditional SaaS.​ 5. Four pillars of X Factor companies Velocity: Continuous 6x+ growth supported by visible pipeline, strong customer references, and no “lumpy” resets; future growth must already be embedded in implementations and expansions.​ Durability &amp; defensibility: High NRR, recurring revenue, deep workflow integration, proprietary data moats, clinical validation, and pricing power; companies competing mainly on price or with sub‑100% NRR are flagged as fragile.​ AI productivity &amp; margins: Truly AI‑native firms show ARR/FTE of $500k–$1M+ (vs $100–200k in services, $200–400k in pre‑AI SaaS) and can reach 70–80% gross margins by automating human work rather than merely wrapping services with “AI”.​ Platform expansion: The strongest players land with a high‑ROI wedge and expand to “systems of action” across workflows (e.g., Zingage moving from AI care navigation into rev‑ops, claims, recruiting), rather than trying to build a full platform from day one.​ 6. Prediction: Payers race to catch up Provider‑side AI in RCM has improved documentation, appeals and revenue capture, putting pressure on payers via higher medical loss ratios, more complex claims, and rising administrative load.​ Bessemer expects 2026 to be an inflection point where payers accelerate AI adoption across payment integrity, prior authorization/utilization review, and member engagement, with founders advised to pick high‑ROI, high‑complexity wedges.​ 7. Prediction: Clinical AI in triage and risk, not autonomy (yet) Clinical AI is shifting from concept to scale in triage and risk assessment use cases that keep clinicians in the loop: pre‑visit risk stratification, inpatient deterioration prediction, triage optimization, and smarter specialty referral.​ Regulatory, liability, and reimbursement constraints still limit fully autonomous diagnosis, so founders are urged to start from front‑office/admin entry points that naturally extend into decision support, risk scoring, and coordination.​ 8. Prediction: CMS pilots AI-first reimbursement The key bottleneck for clinical AI is payment, not tech; most providers are still paid for time and procedures, not AI‑enabled prevention or monitoring.​ CMS is expected in 2026 to test new CPT codes and models for AI‑assisted diagnosis, preventive care and AI‑enhanced remote monitoring, with the logic that successful CMS pilots will pull commercial payers into similar reimbursement within 12–24 months.​ 9. Prediction: Consumer cash-pay drives fastest clinical AI uptake Consumers are already paying out of pocket for AI‑enhanced care, exemplified by RadNet’s study where 36% of 747k+ women chose $40 AI mammography, yielding 43% higher cancer detection and ~93% accuracy when radiologists used AI assistance.​ Direct‑to‑consumer models (AI‑first primary/urgent care, AI second opinions, AI health coaches) offer a faster route to revenue and validation than waiting for reimbursement, and are framed as laying the groundwork for “AI doctors” over the next decade.​ 10. Prediction: Infrastructure, VBC, and digital CROs as next wave A new health AI data infrastructure layer is emerging to serve model labs and AI apps, but founders must differentiate from Snowflake/AWS/Databricks, design recurring “AI‑services‑as‑software” revenue, and eventually capture some application‑layer value.​ AI is expected to revive value‑based care by radically lowering the marginal cost of engagement and monitoring, and to enable “digital CROs” that replace large swathes of wet‑lab and animal testing with in silico models, robotic labs, and AI‑optimized trial design, attacking drug R&amp;D’s cost–speed–competition “trilemma”.Source: <a href="https://www.bvp.com/atlas/state-of-health-ai-2026">https://www.bvp.com/atlas/state-of-health-ai-2026﻿</a>

Bessemer Venture Partners 'State of Health AI 2026' Report: 10 Key Takeaways

European HealthTech this week is being shaped by fresh EU-level funding calls for digital health and AI, tightening but slightly simplified device and AI regulation, and continued emphasis on compliance‑driven M&amp;A and scaling of AI decision‑support. Capital is available but flowing selectively into data‑rich platforms, cross‑border care models, and AI‑enabled diagnostics that can navigate the emerging AI Act / MDR / HTA stack.Policy and regulatory movesThe EU’s 2026 Health Technology Assessment work programme is ramping up, with around 50 joint clinical assessments planned for medicines and high‑risk devices, raising the bar for evidence and pan‑EU launch planning. Draft MDR/IVDR simplification removes the five‑year certificate validity cap and shifts toward continuous, risk‑based surveillance, aiming to ease bottlenecks while tightening expectations on cybersecurity, documentation and post‑market data. New EU‑wide cybersecurity obligations via the Cyber Resilience Act and device‑specific rules will push connected devices, SaMD and apps to treat security and incident reporting as core compliance workstreams, not optional add‑ons.​ EU and national funding windows The Innovative Health Initiative’s “Call 12” opened this week, offering large‑ticket funding for AI‑driven decision support, mobile health, remote monitoring and interoperability projects, with submissions due in April 2026.​ The 2026 Future of Health Grant cycle is opening for early‑stage digital health startups in Switzerland, targeting telemedicine, preventive care, patient analytics and digital therapeutics as priority themes. Horizon Europe’s 2026–2027 work programme earmarks a meaningful slice of a €14bn envelope for health and digital technologies, reinforcing EU‑level co‑funding for data, AI and platform‑centric HealthTech. Market, adoption and M&amp;A signals Expert commentary this week frames European MedTech and HealthTech as entering a “compliance‑driven M&amp;A” phase, where acquisitive strategics buy smaller players as much for regulatory approvals and MDR‑ready infrastructure as for the underlying tech. Nelson Advisors highlights this as a core 2026 pattern.​ Adoption of AI‑powered clinical administration (ambient voice, AI scribes, workflow tools) is expected to become widespread in European clinical settings, with usage governed tightly by the EU AI Act and national health‑system guidelines.​ Broader European thought‑pieces position 2026 as the year digital health moves from pilots to scaled deployment, but with investor selectivity increasing around real‑world data, interoperability and reimbursement readiness. Country‑level highlights (UK and DACH focus) In the UK, planned “Innovator Passports” should allow HealthTech validated in one NHS organisation to scale across others without repeating assessments, directly benefiting proven digital tools and AI platforms.​ The UK is also backing an AI research‑screening platform and expansion of surgical robotics aligned with NICE guidance, signalling sustained appetite for AI‑enabled diagnostics, workflow tools and high‑acuity MedTech.​ Swiss‑backed programmes such as the Future of Health Grant continue to position Switzerland as a hub for early‑stage digital health, offering non‑dilutive capital that can be leveraged alongside VC for telemedicine and analytics plays. Signals for dealmakers and operators Regulatory simplification plus tougher HTA and cybersecurity rules make evidence generation, interoperability and cyber‑hardening central value drivers in valuations and due diligence. Portfolio reviews at strategics are likely to favour targets that combine MDR/IVDR‑ready status with AI or data moats, enabling acquirers to “buy compliance” and accelerate EU‑wide scale under the new regime. For founders, the live IHI and Horizon calls provide a window to de‑risk capital plans for data‑heavy or infrastructure‑like platforms, especially if structured around cross‑border consortia and HTA‑aligned clinical programmesTo discuss how Nelson Advisors can help your HealthTech, MedTech, Health AI or Digital Health company, please email <a data-mce-href="mailto:lloyd@nelsonadvisors.co.uk" href="mailto:lloyd@nelsonadvisors.co.uk" title="lloyd@nelsonadvisors.co.uk" target="_blank" rel="noopener">lloyd@nelsonadvisors.co.uk</a>&gt;&gt;&gt;European MedTech this week is defined by tightening but clearer MDR/IVDR and EUDAMED timelines, a visible “compliance‑driven M&amp;A” narrative, and at least one notable cross‑border platform acquisition alongside continued interest in cardiology and AMR‑linked devices. Regulatory simplification is easing some bottlenecks while making cyber, data and AI readiness central to value, due diligence and portfolio strategy.Regulation and guidance The Commission’s late‑2025 MDR/IVDR “simplification” package is setting the 2026 agenda, targeting notified‑body bottlenecks and shifting toward more risk‑based, continuous surveillance while keeping high evidence expectations. EUDAMED has four functional modules live, with a six‑month transition to full mandatory use by 28 May 2026, making registration and vigilance data a non‑negotiable gateway for EU market access. New draft rules and guidance sharpen expectations around software, AI‑enabled devices and cybersecurity, aligning MDR/IVDR with the AI Act and broader “Digital Omnibus” data framework from 2026 onwards. Funding rounds and capital flows French MedTech FineHeart has raised around €83m (mix of private and European public capital) to advance its implantable device for advanced heart failure, underlining persistent appetite for complex cardiovascular hardware plus data.​ Eindhoven‑based ShanX Medtech has secured roughly €24m to scale ultra‑rapid AMR diagnostics, reinforcing antimicrobial resistance as a strategic EU theme and the Netherlands as a diagnostics hub.​ Weekly deal wraps continue to place these cardiology and AMR diagnostics financings among the top European MedTech startup transactions in early January, setting a strong tone for Q1 2026 fundraising.​ M&amp;A and strategic moves Sector commentary highlights a growing pattern of “compliance‑driven M&amp;A”, as larger strategics acquire smaller players partly to secure MDR/IVDR‑ready product lines and regulatory approvals as financial assets. G Square has acquired a majority stake in Finnish MedTech company Serres from Paree Group, with the partners aiming to develop Serres into a leading international platform via new product investment and global expansion.​ US investors are reported to be increasingly active in European robotics and AI‑enabled MedTech, seeking exposure before valuations converge with US peers, which supports cross‑border growth and exit options.​ Market and adoption themes Analysts frame 2026 European MedTech growth around AI‑supported workflows in cardiovascular, neurovascular, advanced diagnostics and surgical robotics, designed to plug into emerging European health data infrastructures. EUDAMED‑driven transparency on actors, certificates and vigilance is expected to raise payer scrutiny and to hard‑wire regulatory quality into commercial and M&amp;A evaluations. Trade bodies continue to push for pragmatic implementation of MDR/IVDR timelines and notified‑body rules to avoid device shortages, while broadly supporting reforms that are innovation‑friendly but well governed. Implications for dealmakers and operators Evidence generation, real‑world performance data, and cyber/AI governance are becoming central value drivers in MedTech transactions, not hygiene factors. For acquirers, MDR/IVDR‑ready portfolios and EUDAMED‑clean data create opportunities to “buy compliance” and accelerate pan‑EU scale; for founders, this favours device‑plus‑data platforms with clear regulatory narratives. Funding and M&amp;A activity indicate particular strength in high‑acuity cardiology hardware and AMR diagnostics, suggesting these niches will remain heavily competed for capital and strategic interest.To discuss how Nelson Advisors can help your HealthTech, MedTech, Health AI or Digital Health company, please email <a data-mce-href="mailto:lloyd@nelsonadvisors.co.uk" href="mailto:lloyd@nelsonadvisors.co.uk" title="lloyd@nelsonadvisors.co.uk" target="_blank" rel="noopener">lloyd@nelsonadvisors.co.uk</a>

This Week in European HealthTech and MedTech: 23rd January 2026

Medtech in 2026 to be shaped by innovation and complianceA stronger focus on femtech and innovative AI-powered wearables are just some of what we can expect from medtech moving forward.AI-powered administrationLloyd Price, a Partner at Nelson Advisors predicts a “widespread” adoption of ambient voice technologies and AI scribes in European clinical settings with the aim of reducing administrative burden on healthcare staff.Compliance-driven M&amp;AsThe European health-tech market is poised for “a robust, albeit structurally transformed” resurgence in capital deployment and mergers and acquisitions, says Nelson Advisors, adding that EU regulations will cause harm to firms that lack capital to check all compliance boxes.Source: <a href="https://www.siliconrepublic.com/innovation/medtech-2026-ai-innovation-compliance-tech-trends-silicon-republic">https://www.siliconrepublic.com/innovation/medtech-2026-ai-innovation-compliance-tech-trends-silicon-republic</a>

Nelson Advisors featured in Silicon Republic's "Medtech in 2026 to be shaped by innovation and compliance' article

The enterprise value (EV) to equity value bridge represents the critical calculation that determines what shareholders actually receive in a transaction, the difference between a buyer's headline offer and the cash distributed to founders and investors. In the European HealthTech and MedTech sectors entering 2026, this bridge calculation has become increasingly complex, driven by structural market shifts including the end of the zero interest rate policy (ZIRP) era, heightened regulatory compliance burdens under MDR/IVDR, refinancing pressures from 2019-2021 vintage debt, and the maturation of the sector from "growth at all costs" to "industrial efficiency." &nbsp; This report examines the ten most significant factors affecting the EV to equity value bridge, ranked by their typical financial impact and prevalence in 2026 European HealthTech and MedTech transactions. Each factor is analysed through the lens of current market conditions, including the €2.5 Trillion private equity dry powder deployment cycle, distressed M&amp;A driven by regulatory Darwinism, and the flight to quality favouring profitable, compliant platforms over high-burn ventures. &nbsp; Understanding these bridge factors is essential for founders, investors and acquirers navigating an environment where enterprise values for AI-enabled, MDR-compliant assets command 6x-8x revenue multiples and 12x-15x EBITDA multiples, while non-compliant or sub-scale assets face distressed exits at 3x-4x revenue. &nbsp; 10 Key Factors affecting the Enterprise Value to Equity Value bridge in European HealthTech and MedTech 2026 &nbsp; 1. Net Debt Adjustment 2. Preferred Stock Liquidation Preferences 3. Working Capital Adjustments 4. Transaction Costs and Advisory Fees 5. Earn outs and Deferred Consideration 6. Escrow and Holdback Provisions 7. Minority Interest and Non-Controlling Interest Adjustments 8. Pension Liabilities and Unfunded Obligations 9. Options, Warrants and Dilution 10. Normalised EBITDA Adjustments and Other Balance Sheet Items &nbsp; The ten factors examined, net debt, liquidation preferences, working capital adjustments, transaction costs, earn outs, escrows, minority interests, pension liabilities, dilution, and EBITDA normalisation, collectively determine the translation of headline enterprise values into actual cash distributed to founders and investors. In an environment where AI-enabled, MDR-compliant assets command 12x-15x EBITDA multiples while non-compliant or sub-scale assets face distressed exits at 3x-4x revenue, understanding these bridge mechanics is essential for maximising shareholder value. &nbsp; Source: <a href="https://www.healthcare.digital/single-post/10-key-factors-affecting-the-enterprise-value-to-equity-value-bridge-in-european-healthtech-and-medt">https://www.healthcare.digital/single-post/10-key-factors-affecting-the-enterprise-value-to-equity-value-bridge-in-european-healthtech-and-medt</a>

10 Key Factors affecting the Enterprise Value to Equity Value bridge in European MedTech and HealthTech 2026

The winners in the 2026 HealthTech and MedTech ecosystem are those with the strongest "Compliance Moats," the most "Interoperable Data," and the clearest "Industrial Logic", profitability, unit economics, and infrastructure status. The industry is graduating from the "laboratory" phase to the "factory" phase, and consolidation is the primary mechanism of this maturation.Sustainable competitive advantage is no longer about first-to-market technology or venture capital firepower; it is about constructing institutional-grade moats at the intersection of regulatory approval, proprietary data assets, workflow integration, reimbursement pathways, clinical evidence, and operational scale.&nbsp; &nbsp; For investors and M&amp;A professionals, understanding which moats compound versus which erode under competitive pressure is the difference between acquiring strategic assets and overpaying for features that commoditise within 18 months.The companies that will command premium valuations in this environment are those that demonstrate not just innovation, but defensible innovation, moats that deepen with every regulatory approval, every patient enrolled, every data point captured, and every year of clinical evidence accumulated. These are the businesses that executives, investors, and decision-makers would pay premium consulting fees to access, and they represent the future of healthcare technology M&amp;A. &nbsp; I. &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; Regulatory and Compliance Moats: The New Infrastructure Advantage II. &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;Proprietary Data Moats: The Fuel for AI Flywheels III. &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; Clinical Workflow Integration and Switching Costs IV. &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;Reimbursement and Payor Pathway Moats V. &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;Brand, Trust and Clinical Evidence Moats VI. &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;Scale, Network Effects and Platform Economics VII. &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; Intellectual Property and Patent Portfolios VIII. &nbsp; &nbsp; &nbsp; &nbsp; Clinical Trial Infrastructure and Real-World Evidence Capabilities IX. &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;X. Vertical Integration and End-to-End Solutions X. &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;Customer Lifetime Value and Retention Economics &nbsp; Source: <a href="https://www.healthcare.digital/single-post/the-10-best-moats-in-healthtech-and-medtech">https://www.healthcare.digital/single-post/the-10-best-moats-in-healthtech-and-medtech</a>To discuss how Nelson Advisors can help your HealthTech, MedTech, Health AI or Digital Health company, please email <a data-mce-href="mailto:lloyd@nelsonadvisors.co.uk" href="mailto:lloyd@nelsonadvisors.co.uk" title="lloyd@nelsonadvisors.co.uk" target="_blank" rel="noopener" data-mce-selected="inline-boundary">lloyd@nelsonadvisors.co.uk</a> &nbsp;

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Shadow AI is becoming a growing issue for hospitals and ...

Bessemer Venture Partners 'State of Health AI 2026' Repor...

This Week in European HealthTech and MedTech: 23rd Januar...

Nelson Advisors featured in Silicon Republic's "Medtech i...

10 Key Factors affecting the Enterprise Value to Equity V...

The 10 Best MOATs in MedTech and HealthTech