In-depth guides on life sciences insurance.

Clinical Labs

What Is an Additional Insured Endorsement and When Does Your Lab Need One?

Lab contracts with hospitals require additional insured status. Agreeing to it and holding a policy that actually provides it are two different things.

Clinical Labs

Does My AI Billing Tool Create False Claims Act Exposure for My Lab?

An AI billing tool that sends a wrong claim to Medicare puts the False Claims Act exposure on your lab, not the vendor. Indemnification does not fix that.

Medical Devices

Is Your AI-Powered Medical Device Covered Under Your Current Product Liability Policy?

An AI device keeps changing after it ships. Most product liability policies were written for a device that does not, which leaves post-market updates exposed.

Medical Devices

Does Your Business Owners Policy Cover a Medical Device Startup?

Most BOPs exclude medical device companies from eligibility because of product liability. A device startup that buys one finds the exclusion at claim.

Clinical Labs

What Is a Certificate of Insurance and What Should Your Lab Check Before Signing?

A certificate of insurance proves coverage at issuance. It does not guarantee future coverage, amend the policy, or create new rights for the holder.

Clinical Labs

What Is the Difference Between Claims-Made and Occurrence Coverage for a Clinical Lab?

Claims-made and occurrence policies answer lab claims on different timelines. The difference stays hidden until a claim arrives, often after a carrier switch.

Clinical Labs

What Insurance Does a Clinical Lab Need to Process International Specimens?

Foreign specimens add jurisdictional, governing law, and currency questions a standard US lab professional liability policy was not built to answer.

Medical Devices

How Does a Clinical Trial Affect Your Medical Device Insurance Program?

A device trial is an investigational activity your standard product liability policy was not built to cover. The exposure needs its own clinical trial coverage.

Medical Devices

Does Your Commercial Auto Policy Cover a Medical Device Delivery?

Commercial auto covers the vehicle and transit. It does not answer a product liability claim from a delivered device that later causes harm.

Medical Devices

What Insurance Does a Contract Research Organization Need?

A CRO running a device study has product, professional, and sponsor-side exposure at once. Programs placed as professional services miss the device risk.

Clinical Labs

What Is Cyber Liability Insurance and Does My Clinical Lab Actually Need It?

A lab breach is not just an IT incident. It triggers HIPAA notification, OCR risk, and patient claims. Cyber covers the response; general liability does not.

Clinical Labs

Does Your Cyber Policy Cover a Ransomware Attack on Your Lab?

Cyber covers ransomware response: negotiation, restoration, business interruption. The HIPAA notification, penalties, and patient claims need a broader program.

What Is Difference in Conditions Insurance and Does Your Life Sciences Company Need It?

DIC insurance closes the gaps between a US program and foreign exposures by harmonizing coverage across jurisdictions instead of stacking local policies.

Clinical Labs · Medical Devices

What Insurance Does a Digital Cytology Platform Need?

A digital cytology platform is a lab service and, where AI reads slides, a medical device. Insurance placed as only one of those leaves the other exposed.

Digital Health

What Coverage Does a Digital Health Company Need Before Its First Enterprise Contract?

Enterprise health system and payor contracts set insurance minimums as a condition of signing. The coverage you bought at formation rarely meets them.

Digital Health

Does Your Digital Health Platform Need Insurance for International Users?

A digital health platform accessible outside the US picks up GDPR and foreign privacy obligations the moment a non-US user signs up. US cyber rarely follows.

Clinical Labs · Medical Devices · Digital Health

What Insurance Does a Digital Pathology Company Need?

A digital pathology company is a software vendor, a device maker, and a clinical service at once. Insurance placed in only one of those categories leaves gaps.

Medical Devices

What Insurance Do You Need Before Signing a Distribution Agreement for Your Medical Device?

A device distribution agreement requires specific insurance, additional insured status, and limits that often exceed a startup's existing program.

Clinical Labs

What Does the Enhancing CLIA Act Mean for Your Lab Insurance Program?

CLIA modernization brings paperless reporting and tougher oversight. A survey deficiency or certificate action sits outside most lab professional liability.

Medical Devices

Does the EU MDR Affect the Insurance Requirements for US Medical Device Companies?

A US device company selling into Europe takes on EU jurisdiction exposure most US insurance programs do not cover. EU MDR compliance does not close that gap.

Medical Devices

How Does FDA Section 524B Cybersecurity Affect Your Medical Device Insurance?

Section 524B made cybersecurity a premarket requirement for connected devices. It also widened a liability surface most device insurance was not built for.

Clinical Labs

What Does the FDA LDT Final Rule Mean for Your Lab Insurance Program?

The FDA finalized LDT oversight, a court vacated it, and the FDA rescinded it. That volatility is a liability-planning problem for a lab's coverage.

Medical Devices

What Is the FDA Predetermined Change Control Plan and Why Does It Affect Your Device Insurance?

A PCCP pre-specifies AI device changes. It is also a documented standard a plaintiff can use if the algorithm underperforms, and few device programs reflect it.

Clinical Labs

Does Your General Liability Policy Cover a Data Breach at Your Clinical Lab?

General liability answers bodily injury, not a data breach. A lab breach triggers notification, regulatory response, and patient claims it never covers.

Medical Devices

Does General Liability Insurance Cover a Medical Device Recall?

General liability does not pay to pull a device off the market. Recall expense is a separate line, and assuming GL covers it is a costly device-company mistake.

Digital Health

Does General Liability Cover a Patient Injury at Your Digital Health Company?

GL covers bodily injury on your premises or from operations. Harm from a clinical decision via your platform is a professional liability and tech E&O claim.

Clinical Labs

Does Your Lab's General Liability Policy Cover Specimen Loss or Damage?

Specimen loss or damage is a professional liability exposure, not a general liability one. Lab directors confuse the two and find out at the claim.

Clinical Labs · Medical Devices · Digital Health

What Insurance Do Government Contracts Require from Life Sciences Companies?

Federal contracts like NIH, BARDA, and DoD awards carry FAR clauses commercial programs do not address. Winning one means reviewing coverage first.

Digital Health

What Insurance Do Health System Contracts Require from Digital Health Vendors?

Health system contracts demand per-occurrence professional liability limits and additional insured status that early-stage vendor programs rarely meet.

Clinical Labs

How Does HIPAA Security Rule Enforcement Affect Your Lab Insurance Program?

OCR penalizes labs for missing risk-management documentation, not just breaches. Cyber covers breach response, but a documentation penalty can fall outside it.

Medical Devices

Does Your Homeowners Policy Cover Your Medical Device Startup?

A homeowners policy excludes business activity. The first product liability claim or equipment loss at a home-based device startup will not be covered.

Digital Health

How Much Professional Liability Insurance Does a Digital Health Company Actually Need?

Limit is set by customer contracts, revenue at risk in top engagements, and defense costs in the jurisdictions you operate. Not by what a founder can stomach.

How Do You File an Insurance Claim as a Life Sciences Company?

Late notice is one of the most common reasons life sciences claims are denied. The first 24 hours after a potential claim are as important as having the policy.

Clinical Labs

What Is an Indemnification Clause and How Does It Affect Your Lab Insurance Program?

Lab contracts shift liability through indemnification clauses. Signing one and having a policy that covers it are different things, and many forms sub-limit it.

Medical Devices

What Changes About Your Insurance Program When You Get FDA Clearance?

FDA clearance turns an investigational device into a commercial product. Clinical trial liability gives way to product liability, and distribution terms shift.

Digital Health

What Is an Insurer Risk Assessment and Why Does Your Digital Health Company Need One?

Cyber and professional liability underwriters now ask digital health companies for a documented risk assessment. It is what unlocks better pricing and terms.

Medical Devices

What Insurance Does a Life Sciences Company Need for a Clinical Trial Outside the US?

International clinical trials require coverage that answers host country law, ICH-GCP obligations, and the indemnification terms in the foreign site agreement.

Clinical Labs

Does My Lab Need Separate Liability Insurance for Billing and Coding Errors?

Lab professional liability covers testing errors. Billing and coding mistakes that draw a payor audit or False Claims Act exposure are a different line.

Clinical Labs

Does My Lab Need Employment Practices Liability Insurance?

A wrongful termination or harassment claim against a lab is not covered by professional or general liability. EPLI is the separate line most lab programs skip.

Clinical Labs

What Happens to Your Lab Insurance When You Add a New Test Menu?

Adding tests your insurer never underwrote can leave the new work outside your lab's professional liability coverage. The fix is notice, not assumption.

What Happens to Your Insurance Program When Your Life Sciences Company Gets Acquired?

An acquisition triggers change-of-control clauses, tail coverage decisions, and prior-acts questions that can void coverage if not addressed before close.

What Insurance Does a Life Sciences Company Need During Due Diligence?

Acquirers review the insurance program in diligence. Gaps become price adjustments, escrow holdbacks, or reps and warranties exclusions at close.

Clinical Labs · Medical Devices · Digital Health

What Insurance Does a Life Sciences Company Need at the Seed Stage?

A seed-stage life sciences company needs a minimum viable program. Most overbuy on lines they don't need yet and underbuy on the ones tied to real activity.

Clinical Labs · Medical Devices · Digital Health

What Insurance Do Investors Require at Series A for a Life Sciences Company?

Series A term sheets carry insurance requirements founders have not seen before. D&O, increased limits, and diligence on the program are the common surprises.

Clinical Labs · Medical Devices · Digital Health

How Should a Life Sciences Startup Think About Insurance at Each Funding Stage?

Insurance is not a one-time purchase. Each funding round changes what a life sciences startup needs, and the gaps tend to show up in due diligence.

Medical Devices

What Is the Difference Between Malpractice Insurance and Professional Liability for a Medical Device Company?

Malpractice covers licensed clinicians. A device company's professional liability covers errors in design, software, and labeling. The wrong one leaves a gap.

Medical Devices

Does My Medical Device Company Need Directors and Officers Insurance?

D&O is not just for public companies. A device company with a board, outside investors, or a funding round has leadership exposure no other policy covers.

Medical Devices

What Happens to Your Medical Device Insurance if Your Product Gets Recalled?

Product liability answers the injury claims that follow a recall. The direct cost of executing the recall is a separate line most device companies skip.

Digital Health

What Is Network Security Liability and Does Your Digital Health Company Need It?

Network security liability covers third-party harm from your network failing. Standard cyber policies sub-limit it where a connected platform needs full grant.

Medical Devices

What Is an Occurrence Policy and How Does It Differ From Claims Made for a Medical Device Company?

Occurrence covers when the event happened. Claims made covers when the claim is filed. For a device company the difference shapes long-tail exposure.

Digital Health

What Does OCR Risk Management Enforcement Mean for a Digital Health Startup?

OCR is penalizing organizations that find a risk and fail to act. Cyber covers breach response, but the penalty for missing risk management can fall outside it.

Digital Health

What Insurance Do Payor Contracts Require from Digital Health Companies?

Payor contracts require cyber limits, clinically framed professional liability, and sometimes data-analytics E&O, beyond what tech-company insurance covers.

Clinical Labs

What Is Premises Liability Insurance for a Clinical Lab?

Premises liability covers injury or property damage at the lab. It is part of general liability and does not reach the professional errors that happen inside.

Medical Devices

Does Your Medical Device Product Liability Policy Cover Software Updates?

Traditional product liability was built for fixed products. A device whose software updates after launch raises a question most policies never had to answer.

Medical Devices

What Is Product Recall Expense Insurance for a Medical Device Company?

Product recall expense pays the direct cost of executing a recall. It is a different line from products liability and most device programs carry only one.

Clinical Labs · Medical Devices · Digital Health

Does Professional Liability Insurance Cover a Regulatory Fine?

Professional liability answers third-party error claims. Fines from the FDA, OCR, or CMS are government penalties, and most E&O policies exclude them.

Clinical Labs

Does Your Property Insurance Cover a Lab Equipment Breakdown?

Property insurance covers physical damage from a covered peril. A centrifuge or analyzer that fails mechanically is equipment breakdown, a separate line.

Digital Health · Medical Devices

What Insurance Does a Remote Patient Monitoring Company Need?

An RPM platform is a connected device, a clinical decision support tool, and a data holder at once. The insurance program has to answer all three exposures.

Medical Devices

What Does Tail Coverage Mean for a Medical Device Company?

On a claims-made policy, a claim filed after it expires has no coverage without tail. Acquisitions and carrier switches are when device firms hit this gap.

Digital Health

What Is Technology Errors and Omissions Insurance for a Digital Health Company?

Tech E&O answers a failure in your software or service. Professional liability answers a failed clinical judgment. A digital health company needs both.

Clinical Labs

Does Umbrella Insurance Cover a Clinical Lab Professional Liability Claim?

An umbrella usually sits over general liability, not professional liability. A lab counting on it to extend E&O limits is carrying an uncovered gap.

Medical Devices

Does Your US Medical Device Insurance Cover International Distribution?

US product liability is written on a US-and-Canada territory. Shipping a device into Europe, the UK, or Asia-Pacific creates uninsured exposure on every unit.

Clinical Labs

What Is a Waiver of Subrogation and When Does Your Lab Need One?

A waiver of subrogation stops your insurer from recovering from a contracting party. Signing one without telling the carrier can void coverage on the claim.

Clinical Labs

Does Workers Compensation Cover a Needlestick Injury at Your Lab?

Workers comp covers the injured employee. It does not cover the lab if the source patient later claims negligence in handling their specimen or data.

Medical Devices

What Is Errors and Omissions Insurance for a Medical Device Company?

Errors and omissions covers a medical device company when a service or its software fails, the exposure products liability misses. Here is when you need it.

Digital Health

Does the FTC Health Breach Notification Rule Affect My Digital Health App?

If your health app sits outside HIPAA, you may still owe breach notice. The FTC rule creates a parallel duty many digital health founders are not insured for.

Clinical Labs

What Insurance Does a Lab That Handles Human Specimens Need?

A lab that handles human specimens is insurable. Here are the insurance lines specimen handling drives and where the workflow creates extra exposure.

Medical Devices

Do I Need Product Liability Insurance Before FDA Clearance?

Clearance is not the trigger for product liability coverage. The real triggers are first human use and first shipment, and both can arrive before clearance.

Medical Devices

What Does the QMSR Mean for Your Medical Device Insurance Program?

The QMSR reset the device compliance baseline on February 2, 2026. It also reshaped the liability surface your insurance program is supposed to answer.

Digital Health

Does My SaaS Health Platform Need Cyber Liability Coverage?

If your SaaS health platform handles health data, cyber liability is the line that answers a breach. Here is what it covers and why HIPAA raises the stakes.

Digital Health

What Triggers a Professional Liability Claim for a Digital Health App?

A professional liability claim hits a digital health app when a user relies on its output or a missed alert and alleges that reliance caused harm or loss.

Medical Devices

Is My Class II Medical Device Covered Under a Standard BOP?

A standard business owners policy was not built for the products liability a cleared Class II device creates. Here is what it covers and what it leaves out.

Clinical Labs

Do Send-Out Tests Need Separate Lab Liability Insurance?

Send-out tests create a liability gap most lab E&O policies don't close automatically. Here's the liability insurance you actually need and why it matters.

Clinical Labs · Digital Health

2026 HIPAA Security Rule Updates for Life Sciences

What changed, why the shift from addressable to required specifications matters, what OCR expects under the Risk Analysis Initiative, and the insurance impact.

Medical Devices · Digital Health

Clinical Trial Site Insurance: A Sponsor's Guide

How site insurance differs from sponsor coverage, what hospitals and AMCs require, indemnification framework behind the certificate, and where sponsors miss.

Medical Devices

FDA Enforcement Trends: What 2026 Warning Letters Reveal

Reading FDA Warning Letter patterns from 2024 to 2026, what QMSR and Section 524B mean for inspections, and how the enforcement posture affects underwriting.

Digital Health · Medical Devices · Clinical Labs

First Insurance for Pre-Seed and Seed Life Sciences

What pre-seed and seed founders need before the first placement: which lines matter now, what investors expect, what to defer, and common mistakes to avoid.

Digital Health · Medical Devices · Clinical Labs

Life Sciences M&A Insurance: A Guide for Buyers and Sellers

How insurance shows up in life sciences M&A diligence, asset versus stock implications, R&W coverage mechanics, and what each side prepares before close.

Clinical Labs · Digital Health

OCR Enforcement Actions: What They Mean for HIPAA Insurance

What recent OCR settlements reveal about agency priorities, the patterns in resolution agreements, Risk Analysis Initiative findings, and the insurance impact.

Medical Devices

Products Liability Insurance for Medical Devices

What products liability covers, how indication and device class drive underwriting, the three defect theories, and the overlap with recall and clinical trial.

Clinical Labs

Professional Liability for Clinical Labs

What lab professional liability covers, how testing-accuracy claims differ from E&O, the CLIA and CAP frameworks underwriters review, and how policies respond.

Medical Devices

Recall Insurance Coverage Gaps for Medical Device Companies

Recall gaps that surface at claim: BI sub-limits, third-party recall absence, market withdrawal wording, software-driven response, and the EU MDR dimension.

Digital Health · Medical Devices · Clinical Labs

Renewal Strategy: Prepare 90 Days Before Expiry

What to do in the 90-day window before policy expiration, the renewal cycle brokers run, the data underwriters need, and when a broker change is justified.

Digital Health · Medical Devices

Tech E&O vs Products Liability for SaMD

Why SaMD sits across two coverage lines, where Tech E&O and Products Liability overlap, where gaps form, and how to structure the program to close them.

Medical Devices · Digital Health

Clinical Trial Insurance Requirements for Sponsors and CROs

How sponsor and site coverage interact, the IRB and IDE framework, the Significant Risk versus NSR distinction, and key choices in CRO placements.

Clinical Labs

Cyber and HIPAA Insurance for Clinical Laboratories

How clinical lab PHI exposure differs from healthcare cyber, where EHR and payer interfaces drive claims, and what OCR's Risk Analysis Initiative changes.

Digital Health · Clinical Labs

Cyber Insurance for HIPAA-Regulated Companies

Covered entity versus business associate cyber structure, what the 2026 Security Rule update changes for underwriting, and the components a HIPAA program needs.

Digital Health · Medical Devices · Clinical Labs

D&O Insurance for Life Sciences, Stage by Stage

How D&O exposure shifts from pre-seed through pre-exit, why regulated-sector D&O differs from SaaS, and the underwriting conversation at each stage.

Digital Health · Medical Devices · Clinical Labs

EPLI for Life Sciences: When to Buy, What to Cover

When EPLI becomes a substantive line for life sciences, the employment exposures unique to clinical staff and labs, and how diligence treats EPLI gaps.

Medical Devices

Class II Device Insurance Before Commercialization

The four coverage areas every Class II manufacturer needs at commercialization, exposures most companies underestimate, and how the program evolves with scale.

Clinical Labs

CLIA Lab Insurance Needs by Revenue Stage

Four risk categories every clinical lab carries, how the program shifts across $1-5M, $5-25M, and $25M+ revenue, and the exposures operators most often miss.

Digital Health

Digital Health Insurance for a Series A Raise

The four coverage lines investors examine for digital health Series A, typical limit ranges, common founder mistakes, and how to time placement with the close.

Digital Health · Medical Devices

What Insurance Does an FDA-Regulated SaMD Company Need?

How SaMD sits at the intersection of medical device regulation, software development, and PHI exposure, and why generic SaaS coverage fails it.

Medical Devices

Medical Device Insurance: Clinical Trials and 510(k)

The four coverage areas pre-clearance medical device companies need during clinical trials and 510(k) review, and how to plan the post-clearance restructure.

Digital Health · Medical Devices · Clinical Labs

What Investors Look for in Life Sciences Insurance Diligence

The insurance review inside venture or strategic diligence, what counsel checks, the red flags that trigger concern, and how insurance affects valuation.

Medical Devices

Class II Medical Device Recall Coverage: A Pre-Launch Guide

Why recall is under-insured for Class II manufacturers, what the components cover, and where the gap with products liability causes the largest losses.

Digital Health · Medical Devices · Clinical Labs

Series B Insurance Program Restructure

Why the Series A program rarely scales to Series B, how D&O, EPLI, cyber, and international coverage restructure, and the underwriting at Series B.

Digital Health · Medical Devices · Clinical Labs

Specialty vs Generalist Brokers for Life Sciences

The failure modes generalists show on FDA, HIPAA, and CLIA placements, what specialty knowledge looks like in practice, and questions to ask broker candidates.

Digital Health

Telehealth Platform Insurance: A Virtual Care Coverage Stack

State-by-state licensing, prescription liability under DEA flexibilities, medical professional liability, and platform liability for third-party providers.

Clinical Labs

What Insurance Does a CLIA-Certified Clinical Lab Need?

The core insurance every CLIA-certified clinical lab should evaluate: professional liability, cyber and HIPAA, property and equipment, and workers compensation.