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Digital Health & Medtech Insurance: Blended Tech E&O, Cyber & Medical Malpractice
Whether you are operating a telemedicine network, deploying Software as a Medical Device (SaMD) or manufacturing smart diagnostic hardware, your liability profile is uniquely different and will require careful consideration to provide the right protection.
Blended Tech E&O, Medical Malpractice, and Cyber Programme
Protection may be required for software failure, medical malpractice, product liability (hardware), cyber security and liabilities (sensitive personal data). The challenge is that these exposures can overlap and it can be difficult to accurately determine the proximate cause.
A claim for example may involve a combination of a software malfunction, hardware failure and a clinical decision. If your insurer only provides cover for software failure, they may decline to provide a legal defence and pay damages if they determine the proximate cause to be a clinical decision.
Bodily Injury Exclusion
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Policies may or may not provide cover for bodily injury arising from healthcare services, technology activities, and cyber events. Exclusions can be present for claims arising from bodily injury, sickness, disease, mental anguish, or death.
A software bug may delay a diagnosis. A triage tool may misclassify symptoms. A remote monitoring platform may fail to alert a clinician. An AI imaging tool may produce an incorrect output. A medication reminder app may fail to notify a patient at the right time.
Digital health businesses should ensure that their insurance programme includes an appropriate carve-back or blended cover for bodily injury allegations arising from technology services, clinical workflows, software performance, or algorithmic outputs.
Medical Practitioner Vicarious Liability
Digital health businesses can face vicarious liability claims where doctors, clinicians, pharmacists, nurses, therapists, or other medical practitioners deliver services through their platform.
Even where practitioners hold their own Medical Malpractice Insurance, patients can still pursue the digital health provider given they are the legal entity which they obtained the healthcare services through.
Governance or supervision failure can be alleged, in addition to the individual practitioner’s own medical malpractice not being available can lead to the digital health business being held strictly liable for the actions of the practitioner.
Access to London Market HealthTech Insurers
Core Modules of the Indemnity Framework
A comprehensive HealthTech Insurance programme should bring together the cover sections most relevant to health technology, patient data, medical devices, and the provision of healthcare.
The right structure will specifically depend on the business model, product type, regulatory status, clinical use case, contracts, geographies, and whether the company is developing, manufacturing, prescribing, or operating the technology.
Technology E&O & Medical Malpractice
Technology E&O responds to claims alleging that software, systems, implementation, configuration, or technology services failed to perform as intended and caused financial loss.
Medical Malpractice responds to allegations involving clinical negligence, patient harm, misdiagnosis, delayed treatment, or failure to meet professional healthcare standards.
A blended policy helps reduce ambiguity by recognising that the financial loss or injury may be triggered by software / technology failure or clinical decision making, or a combination of both.
Medical Product Liability: Hardware & IoT
Medical Product Liability cover protects against claims alleging that a device, component, wearable, sensor, implant, diagnostic tool, or connected medical product caused injury, or financial loss because of a defect.
This is particularly important for MedTech businesses developing medical IoT devices, wearables, smart delivery systems, monitoring tools, surgical devices, diagnostic kits, or connected hardware.
Where the product combines physical hardware and software, Product Liability and Tech E&O should be provided by the same insurer to ensure the cover responds as expected.
A claim involving a connected insulin delivery system, for example, may involve hardware design, embedded software, connectivity failure, data security, and clinical outcome allegations.
Cyber Security & Health Data Privacy: GDPR
A cyber incident involving personal health data privacy can trigger severe financial, regulatory, and reputational consequences.
Health data is among the most sensitive categories of personal data. Digital health and MedTech businesses may hold patient records, medical histories, diagnostic results, prescriptions, imaging files, genetic information, biometric identifiers, mental health records, wearable device data, or clinical trial data.
Cyber Insurance can help fund: 24/7 incident response, forensic investigation, legal advice, ransomware demands, ICO regulatory defence, breach notification, affected individual communications, credit or identity monitoring, public relations support, and claims for damages.
Review our detailed asset map of Cyber Insurance Coverage Modules.
Specialist Sectors We Protect
The programme structure should reflect how the business delivers healthcare, where clinical responsibility sits, what sensitive data is processed, and whether there is provision of a service, hardware, software, platform, or a combination.
Telemedicine & Virtual Clinics
Telemedicine and virtual clinic providers face a blend of clinical, technology, privacy, and operational risk. This may include digital consultation, e-pharmacies, online prescribing services, remote triage tools, mental health platforms, or referral pathways.
Claims may arise from delayed or misdiagnosis, inappropriate prescribing, failure to escalate, platform downtime, patient identity errors, clinical record issues, or data privacy breaches
Healthcare SaaS & AI Diagnostics
Healthcare SaaS and AI diagnostic companies often provide the infrastructure that clinicians, hospitals, laboratories, or patients rely on.
This may include analysing medical imaging, clinical decision support, health records, patient administration, laboratory systems, predictive analytics, diagnostic workflow, and operational software.
The key exposure is that a software output may influence clinical decision making. A platform failure, error, biased dataset, integration, or poor data mapping can have consequences that contribute to injury, illness, or death.
Medical IoT & Wearables
Medical IoT and wearable device companies face combined hardware, software, data, and connectivity risk. Examples include: remote patient monitoring, smart insulin delivery, , connected inhalers, cardiac monitoring devices, orthopaedic tracking, rehabilitation wearables, fertility tracking, sleep and respiratory monitors.
Claims may involve sensor failure, inaccurate readings, connectivity loss, firmware defects, battery failure, poor device design, data corruption, delayed alerts, or unauthorised access to patient information.
The insurance programme should combine Product Liability, Technology E&O, Cyber, Privacy Liability, Recall or Product Safety support where appropriate, and Clinical Trials Liability where devices are being tested before full deployment.
Protecting The Board, Founders, & Investor's Interests
Digital health and MedTech businesses often operate under intense board and investor scrutiny because their products can affect patient safety, regulatory compliance, data security, and clinical outcomes.
Directors, founders, and investor appointed board members may face personal allegations if the business fails to manage product safety, cyber resilience, fundraising disclosures, regulatory obligations, or cash runway appropriately.
Directors & Officers Insurance should therefore sit alongside the core indemnity framework, protecting decision makers against claims involving breach of duty, mismanagement, regulatory investigations, shareholder disputes, insolvency related allegations, or failure to supervise material risks.
Protect your executive team by exploring our Directors & Officers Insurance Brokerage framework.
Expert Open Market Advocacy for Health Technology Businesses
Claim Advocacy
A system outage, APP fraud event, data breach, or compliance failure can damage client trust, trigger reporting obligations, and put investor confidence at risk. Unfortunately, FinTech claims can be complex and involve multiple policy triggers, such as technology failure, regulatory investigation, client financial loss, fraud, cyber event, and contractual disputes all at once.
Without expert claim advocacy, there is a real risk that insurers view the issue too narrowly, dispute which policy should respond, or delay decisions whilst your business is under pressure.
Meet the Brokers
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