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Before launch, show the broker what your app or device collects, what you promise it can do, and whether you sell a test or offer clinical care. FTC and FDA guidance can help you describe consumer health data and test products by their role and intended use.
Consider cyber liability, technology errors and omissions (E&O), general liability, and product recall. Start with the coverages tied to your day-to-day operations, then use the situations and buying questions below to compare your options.
Your app collects, infers, stores, or shares health information, or a vendor handles that data for you.
Cyber policies are customized, and most commercial property and general liability policies do not cover cyber risks. Compare the proposed cyber terms for consumer health data, vendor-held information, incident response, interruption, customer claims, and defense costs.[4][5][1]
How do the proposed terms treat consumer health data, vendor-held information, incident response, business interruption, customer claims, and defense costs?
Customers rely on your app, recommendations, integrations, or service uptime to make health-related decisions.
Ask the broker to map software errors, inaccurate outputs, and service interruptions to the exact technology E&O terms. Neither the product label nor a cyber policy description settles how a particular claim is treated.[2][1][4]
Which services, outputs, integrations, and customer contracts appear in the application, and what exclusions or sublimits apply to alleged product or service errors?
You ship a wearable, home-use device, sample kit, or other physical product, or host in-person events.
General liability can address certain third-party injury and property-damage risks, including some product-related claims. Check how the proposed wording treats your specific product and activity; a general guide is not a policy form.[6][2]
Are the products, event activities, sales territories, and completed work described, and what injury, product, or advertising exclusions apply?
A product issue could lead you or a customer to stop sales, notify consumers, or withdraw a kit or device.
Ask a specialist whether a separate product-recall form is available for your product and what event and expense definitions it uses.[2]
What triggers a covered recall, which notification, shipping, replacement, and consultant costs are included, and which are excluded?
Give the broker your actual product claims, intended users, data flows, vendors, and launch channels. If the product includes a test, FDA distinguishes direct-to-consumer tests by purpose and risk; describe the particular test rather than calling the whole company a wellness app.[2]
List any physical kits or devices separately from the software. Ask how each item, customer-facing claim, and sales territory appears in the quote, and request the terms behind any promised product or recall protection.[6][2]
List who collects, stores, receives, and shares health information, including analytics and hosting vendors. FTC guidance says its Health Breach Notification Rule applies to most health apps and similar technologies, while HIPAA-covered businesses follow a different rule; applicability depends on the organization and information involved.[1]
When clinicians, tests, or medical recommendations enter the product, update the operating description and ask the broker whether the application or current terms need to change.[2][4]
No. HHS and FTC describe different rules with different scopes. HHS ties HIPAA status to covered-entity and business-associate roles; FTC says its Health Breach Notification Rule applies to most health apps and excludes HIPAA-covered businesses.[3][1]
Read the Full AnswerA test adds a physical product, specimen workflow, result claim, and possibly a laboratory or clinician relationship. FDA says DTC tests follow different pathways based on purpose and risk, so update the product description and ask the broker to review the test separately from the app.[2]
Read the Full AnswerCheck FTC guidance on health apps, consumer health information, and the boundary with HIPAA-covered organizations.
Describe a consumer test by its intended use and product type before discussing the quote.
Compare first-party incident expenses, third-party claims, vendor-held data, and defense wording as questions for your policy.
Spot, a product of Tools for Enlightenment, publishes this guide and works in the commercial insurance market. This is general buyer education; policy terms and state-specific obligations determine coverage and requirements.
Updated 2026-09-28. Editorial Policy
Spot, which publishes this research, gets quotes from 50+ providers, picks the options that fit your coverage and budget, and manages renewals after you buy. The first consultation is free. Book a free consultation
