Regulatory Insurance Requirements for HealthTech Providers (UK)

Who this guide is for

If you run a UK HealthTech business—software, SaaS, connected devices, diagnostics, digital therapeutics, telemedicine platforms, or medical device manufacturing—insurance is not just a “nice to have”. It’s often required by contracts, regulators, investors, and your risk profile.

This article explains the main regulatory and quasi-regulatory insurance expectations HealthTech providers face in the UK, what policies typically respond, and how to evidence cover to clients, partners, and authorities.

“Regulatory requirement” vs “commercial requirement” (important)

In the UK, many insurance obligations don’t appear as a single law saying “you must buy X policy”. Instead, requirements come from:

• Statute (e.g., Employers’ Liability is legally required if you employ staff)

• Regulators and standards (e.g., MHRA, HSE, ICO expectations around governance and risk controls)

• Contracts (NHS frameworks, hospital trusts, distributors, research partners, landlords)

• Investor and lender due diligence

In practice, HealthTech firms need an insurance programme that matches their regulated activities and demonstrates good risk management.

The core “must-have” policies for most HealthTech providers

Employers’ Liability (EL) – legally required

If you employ anyone in the UK (including many contractors treated as employees), Employers’ Liability insurance is a legal requirement in most cases.

• Typical limit: £5m (often bought as £10m)

• Evidence: EL certificate must be accessible to employees

• Why it matters in HealthTech: lab work, manufacturing, field installations, clinical environments, lone working, and travel can increase exposure.

Public Liability (PL) – often contractually required

Public Liability isn’t usually a legal requirement, but it’s frequently required by:

• Landlords and property managers

• NHS and private healthcare sites

• Trade bodies and event organisers

• Clients where your staff visit premises

PL covers injury or property damage to third parties arising from your operations (e.g., a contractor trips a patient in a clinic, or you damage a hospital server room during an installation).

Professional Indemnity (PI) – critical for HealthTech

Professional Indemnity is the policy most often scrutinised in HealthTech contracts because it responds to:

• Negligent advice, design, or specification

• Software errors and omissions

• Failure to deliver services as promised

• Breach of professional duty

For HealthTech, PI is especially important where your product influences clinical decisions, triage, diagnostics, or patient outcomes.

Common contractual PI limits: £1m, £2m, £5m, £10m (sometimes higher for NHS or enterprise). Your required limit depends on revenue, risk, and contract terms.

HealthTech-specific insurance areas regulators and clients care about

Cyber insurance and data protection exposure

HealthTech firms often process special category data (health data). While the UK GDPR and Data Protection Act 2018 don’t mandate cyber insurance, regulators and enterprise clients expect robust cyber governance.

Cyber insurance can help with:

• Incident response and forensics

• Notification costs and PR

• Business interruption from cyber events

• Liability claims and regulatory investigations (where insurable)

Key point: Cyber insurance is not a substitute for compliance. Underwriters will expect controls such as MFA, backups, patching, access management, encryption, and vendor risk management.

Medical device and product liability (including software as a medical device)

If you manufacture, supply, or distribute devices—or your software qualifies as a medical device—your risk profile changes.

Product liability typically responds to:

• Bodily injury or property damage caused by a defective product

• Legal defence costs

For HealthTech, “product” can include:

• Connected devices and wearables

• Diagnostic equipment

• In vitro diagnostics (IVDs)

• Software embedded in a device

• In some cases, software as a medical device (SaMD)

Regulatory angle: MHRA expectations around quality management, post-market surveillance, and vigilance reporting can influence what insurers will cover and on what terms.

Clinical trials and research activities

If you run or sponsor clinical investigations, you may need specialist cover such as:

• Clinical trials liability

• Medical malpractice/clinical negligence (depending on activities)

• Research liability for studies involving human participants

Requirements can come from:

• Ethics committees

• Research partners and universities

• NHS trust contracts

• Sponsors and CROs

Clinical trials insurance is often arranged on a study-by-study basis, with limits and wording aligned to the protocol and jurisdiction.

Medical malpractice / clinical negligence exposure

Not every HealthTech company needs medical malpractice cover—but you should consider it if you:

• Employ clinicians providing advice or treatment

• Provide telemedicine services directly to patients

• Offer clinical decision support that could be interpreted as clinical advice

Some PI policies can be extended, but true clinical negligence exposures often require specialist wording.

Technology E&O vs PI (and why wording matters)

HealthTech sits between “tech E&O” and “traditional PI”. The difference is often in:

• Definitions of professional services

• Exclusions for bodily injury, clinical activities, and product performance

• Coverage for contractual liability and warranties

A common pitfall is assuming a generic tech PI policy will respond to patient injury allegations. The policy wording and your business model decide this.

Common regulatory bodies and how they influence insurance expectations

Insurance isn’t usually “approved” by regulators, but regulators influence what good governance looks like.

MHRA (Medicines and Healthcare products Regulatory Agency)

If you develop or supply medical devices (including certain software), MHRA oversight and UKCA marking obligations can apply.

Insurance implications:

• Product liability and recall considerations

• Post-market surveillance and vigilance processes

• Quality management systems (often aligned to ISO 13485)

HSE (Health and Safety Executive)

If you have labs, manufacturing, field engineers, or installation teams, HSE expectations around risk assessments and safe systems of work matter.

Insurance implications:

• Employers’ Liability pricing and conditions

• Contractors’ risk management

• Evidence of training, PPE, and incident reporting

ICO (Information Commissioner’s Office)

If you process health data, ICO expectations around lawful processing, security, and breach management are central.

Insurance implications:

• Cyber underwriting questions will mirror ICO guidance

• Vendor management and data processing agreements affect risk

FCA (Financial Conduct Authority) – only if you’re doing regulated insurance/finance

Most HealthTech firms aren’t FCA-regulated. But if you provide regulated financial services (or partner in ways that create regulated activity), FCA compliance can drive PI expectations.

If you are FCA-authorised, PI can be a formal requirement depending on permissions and activities.

Contractual requirements you’ll see in HealthTech (and how to meet them)

Even when not mandated by law, contracts can effectively make insurance “required”. Common clauses include:

• Minimum limits for PL/PI/cyber

• Indemnities and hold harmless provisions

• Waiver of subrogation (less common, but possible)

• Primary/non-contributory wording

• Evidence of cover: certificates, schedules, endorsements

• Notification obligations (e.g., notify client of material changes)

Tip: Don’t accept insurance clauses blindly. Some are uninsurable (e.g., unlimited indemnities) or inconsistent with market wordings.

Typical insurance limits (rule-of-thumb)

Limits should be based on worst-case loss scenarios, not just turnover.

• Early-stage SaaS HealthTech: PI/Tech E&O often £1m–£2m

• NHS/enterprise contracts: commonly £5m–£10m PI and higher cyber

• Device manufacturers: product liability often £5m–£10m (sometimes more)

Your broker should align limits to:

• Patient impact and severity

• Data volumes and sensitivity

• Contract requirements

• International exposure (US is a major driver)

Key exclusions and “gotchas” to watch

HealthTech insurance programmes fail when exclusions clash with the real risk.

Common issues:

• Bodily injury exclusions on PI/tech E&O

• Clinical trials exclusions

• Product performance/warranty exclusions

• Cyber exclusions on PI (and vice versa)

• Retroactive date problems (claims-made policies)

• Territorial limits (especially US/Canada)

Claims-made reminder: PI and many cyber policies are claims-made. Continuous cover matters, and switching insurers should be handled carefully.

Evidence and documentation: what you may need to provide

Insurers, clients, and procurement teams may ask for:

• Insurance certificate(s)

• Policy schedule and endorsements

• Summary of cover for cyber (including incident response)

• Confirmation of retroactive date and run-off options

• Risk management documents (ISO certifications, policies, pen test summaries)

Having a “compliance pack” ready can speed up procurement.

Building an insurance programme that stands up to scrutiny

A good HealthTech insurance programme typically includes:

• EL + PL as a base

• PI/Tech E&O aligned to your services and patient impact

• Cyber with appropriate limits and incident response

• Product liability (and recall where relevant)

• Clinical trials/medical malpractice where applicable

• Directors’ & Officers’ (D&O) for investor confidence

The goal is not to buy every policy available—it’s to match cover to your regulated activities and contractual commitments.

FAQs

Is Employers’ Liability insurance mandatory for HealthTech startups?

If you employ staff in the UK, it’s usually mandatory. There are limited exemptions, but most trading businesses need EL.

Do we need cyber insurance to be UK GDPR compliant?

No—UK GDPR doesn’t mandate cyber insurance. But strong security controls are expected, and cyber insurance can support incident response.

If our software influences clinical decisions, is PI enough?

Not always. You may need wording that addresses bodily injury allegations, or specialist cover depending on how the product is used.

We manufacture devices—do we need product recall insurance?

Not always, but it’s worth considering if a recall would be financially severe or contractually required.

Do NHS contracts require specific insurance limits?

Often yes. Limits vary by framework and contract. Always review the insurance schedule and confirm what is realistically available in the market.

Next steps

If you want, share:

• What you do (SaaS, device manufacturing, telemedicine, diagnostics, etc.)

• Whether you handle patient data

• Any contract insurance clauses you’ve been given

…and I’ll help you map the likely insurance requirements and the safest way to present them in proposals and procurement packs.