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1Repair Windows errors before they cause bigger problems2Scan for outdated or missing drivers - takes under a minute3Clear out junk files and repair common Windows errorsBefore launching a U.S. AI health app, define what each feature is intended to do, identify which legal roles and rules apply, map every flow of health data, and test whether your privacy, security, breach-response, and AI-risk practices match the product users will actually encounter. “AI” does not automatically make an app an FDA-regulated device, and handling health information does not automatically make a consumer app subject to HIPAA. The checks below reflect federal guidance reviewed through October 4, 2026; applicability depends on your app, organization, users, and business relationships.
1. Define what the app does—and what happens if it is wrong
Start with the app’s intended use, not its technology label. Write down each feature and the claims made about it, then assess the consequences if it produces an incorrect result or fails.
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- Does it provide general wellness information or let users view health records?
- Does it triage symptoms, support diagnosis, recommend treatment, monitor a condition, or inform a clinician’s workflow?
- What is the likely harm if its output is inaccurate, unavailable, or misunderstood?
- What will users and clinicians be told the feature can and cannot do?
FDA’s September 2022 guidance focuses on software functions that meet the device definition, including functions that could pose a patient-safety risk if they fail as intended. It does not mean every health app needs FDA approval, nor that software is never a device. Assess the intended use and each function against the FDA policy for device software functions and mobile medical applications. A product-specific determination may require regulatory expertise.
2. Work out which rules apply to your role and data
There is no single U.S. federal rule that automatically covers every health app. Your obligations depend on what the app does, what information it handles, who operates it, and whether it acts for a healthcare organization or another entity. Use the FTC Mobile Health App Interactive Tool with your real product and service model, alongside HHS’s Resources for Mobile Health Apps Developers.
| Rule or regime | Question to resolve before launch |
|---|---|
| HIPAA | Is your organization a covered entity, or are you handling protected health information as a business associate? A consumer app is not automatically covered just because it handles health information or receives it from a healthcare organization. |
| FTC Act privacy and security requirements | Do your express or implied privacy claims match actual collection, use, sharing, and security practices? FTC guidance says companies must honor their privacy promises and use security appropriate to the information they hold. |
| FTC Health Breach Notification Rule | Could your service be a personal health record vendor, a PHR-related entity, or a relevant third-party service provider subject to the rule? Being outside HIPAA does not by itself settle this question. |
| FDA device-software policy | Does a feature meet the device definition and have an intended use or safety impact that brings it within FDA oversight? |
| Other federal requirements | Does the audience or service bring other rules into play? HHS identifies, among potentially relevant federal laws and regulations, COPPA and ONC-related regulations as well as HIPAA, FTC requirements, and the FD&C Act. |
HHS says HIPAA does not apply to health information maintained by someone who is neither a covered entity nor a business associate; other federal protections may still apply. Avoid describing a consumer app or vendor as “HIPAA compliant” as a blanket claim. Determine the actual role and scope first, and get legal advice where the answer affects launch decisions.
3. Map health data and make every disclosure match reality
Build a data-flow inventory that follows information through the entire product, including information inferred by AI as well as information users enter or connect. Record:
- What is collected, inferred, generated, or imported, and from which users, devices, records, or services.
- Where information is stored and processed, including model prompts and outputs.
- Which employees, model providers, analytics or advertising SDKs, cloud services, and other vendors can access it, and for what purpose.
- What is shared onward, how long it is retained, how deletion works, and what users can access or export.
- Whether prompts, outputs, or other information may be used for model training or service improvement.
Compare that map with the privacy notice, consent screens, app-store disclosures, and marketing claims. The FTC says: “If your company makes privacy promises – either expressly or by implication – the FTC Act requires you to live up to those claims.” A policy alone does not make the product behave as described: verify the actual integrations, data settings, and defaults against what users are told. See the FTC’s Health Privacy guidance.
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4. Check model, cloud, and other vendors against the real data flow
For each service provider that handles app information, document the purpose and scope of access, permitted onward sharing, retention and deletion terms, security commitments, breach-notice timing, and whether information can be used for training or service improvement. Confirm that the technical configuration matches the contract; do not infer protections from a vendor’s brand or marketing language.
If the app handles information on behalf of a HIPAA covered entity, determine whether a provider is acting as a business associate and whether the required agreement and deployment arrangements fit that role. HHS’s health-app resources include guidance on cloud computing for covered entities and business associates. The relevant question is whether the specific service, information, use, and relationship are covered—not whether the vendor generally advertises healthcare capabilities.
5. Put security controls across the app’s lifecycle
The FTC’s mobile-health best practices ask: “Do you incorporate data security at every stage of your app’s lifecycle: design, development, launch, and post-market?” Turn that lifecycle principle into a review of controls appropriate to the information and risks in your product. The following are practical areas to assess, not a regulator-issued checklist or a guarantee of compliance.
- Access: authentication, authorization, least-privilege access, and periodic review of employee and service-account permissions.
- Data protection: secure storage and transmission, secrets management, and careful handling of sensitive content in logs and diagnostics.
- Dependencies and integrations: review SDKs, libraries, and third-party connections for the access they receive and the exposure they introduce.
- Testing and maintenance: test security before release, monitor for vulnerabilities, and have a process to patch the app and its dependencies.
- Resilience and response: assess backups, recovery, monitoring, and the people and procedures needed to handle a security incident.
Use the FTC’s Mobile Health App Developers: FTC Best Practices and Health Privacy guidance to inform the review. Security needs to continue after launch as the app, its integrations, and its risks change.
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6. Decide how a breach would be handled before one occurs
Map each data relationship to the breach requirements that may apply, then assign decision ownership and prepare to contain an incident, preserve evidence, assess its scope, and communicate with affected parties and regulators when required. Do not assume one notification rule covers every app or every data flow.
The FTC Health Breach Notification Rule covers certain personal health record vendors, PHR-related entities, and certain third-party service providers. The FTC says its 2024 amendments took effect July 29, 2024; covered businesses may need to notify consumers, the FTC, and, in some cases, the media. HIPAA-regulated entities have separate HHS notification obligations. Review the FTC’s Health Breach Notification Rule: The Basics for Business and determine which obligations fit your actual role and incident. A breach plan should also specify who can make notification decisions and how vendor escalation deadlines fit your response process.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.7. Govern and evaluate the AI feature as it changes
Document the intended use and foreseeable harms for each AI feature. Set an evaluation and monitoring process that addresses the quality and limits of input data, performance across relevant user groups, unsafe or fabricated outputs, human oversight, model updates, and incident response. Decide how people can identify, escalate, and correct a problematic output in the context where the app is used.
NIST’s AI Risk Management Framework organizes this work into Govern, Map, Measure, and Manage and is intended to apply across AI system design, development, deployment, use, and evaluation. NIST describes the framework as voluntary and version 1.0 as being revised; it is not a legal mandate, certification, or proof that a model is safe. For generative AI, the NIST Generative AI Profile, published July 26, 2024, is a cross-sector companion with suggested actions for managing generative-AI risks. Use these resources to structure risk work, not to substitute for product-specific clinical, regulatory, privacy, or security decisions.
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If children may use the app, assess COPPA and any other requirements relevant to the product and audience; HHS lists COPPA among federal requirements that can be relevant to health apps. If you plan to launch in multiple U.S. states or outside the United States, obtain separate jurisdiction-specific analysis. The federal resources here do not determine which state consumer-health privacy, international medical-device, AI, or data-transfer rules apply to a particular launch.
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9. Make the launch decision using product-specific evidence
Before release, bring the conclusions from the preceding reviews into one decision record. For each feature and data flow, keep the intended-use description, role and rule assessment, data inventory, user-facing disclosures, vendor terms, security review, breach-response ownership, and AI evaluation plan together. Where implementation or vendor options remain open, compare them on:
- What information leaves the app, where it is processed, and who can access it.
- Whether the provider will enter into the agreement required for the actual relationship.
- Retention, deletion, model-training, and onward-use settings.
- Access controls, encryption, auditability, and incident-notification commitments.
- The safety impact of the feature’s intended use and the burden of monitoring and updating it.
These are practical comparison criteria drawn from federal guidance on roles, data, security, and AI risk—not a regulator-issued rating system. If a key relationship, claim, safety impact, or notification obligation is still unclear, resolve it before launch rather than relying on a generic compliance label.
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