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Before launching an AI health app, decide what each feature is intended to do, map the data it collects and shares, and identify which legal roles and rules apply. HIPAA does not automatically cover every app that handles health information, and the word “AI” does not determine whether FDA device requirements apply. Privacy, security, breach response, and AI-risk controls still need to match the app’s actual functions and data flows.
This checklist focuses on U.S. federal considerations. Whether a particular app is covered by a law or regulated as a device depends on its features, claims, users, data, and business relationships.
1. Define what the app does and what users are told it does
Document each feature and intended use
List each function separately: for example, wellness information, access to health records, symptom triage, diagnosis support, treatment recommendations, monitoring, or clinician workflow. Record the user-facing claims and the intended user for each feature. A broad label such as “AI health assistant” is not a substitute for defining the function.
For each function, consider what could happen if it gives an incorrect, incomplete, or unavailable result. The FDA’s September 2022 guidance explains its approach to device software functions and mobile medical apps, focusing on software functions that meet the device definition and could pose a patient-safety risk if they fail as intended. An AI feature is not automatically an FDA-regulated device, but software is not categorically outside device oversight either. See FDA’s policy for device software functions and mobile medical applications.
Keep the intended use consistent across the product
Compare the function’s design and actual use with its app-store description, onboarding, marketing, and in-app language. A disclaimer cannot resolve a mismatch between what the product does and what users are led to expect. If a feature supports diagnosis, treatment, or clinical decisions, assess its safety implications and regulatory status before release rather than assuming the wellness label settles the question.
2. Work out which legal roles and federal rules may apply
Check HIPAA based on the organization and relationship
HIPAA applies to covered entities and business associates for protected health information within the scope of the rules. A consumer app is not automatically covered merely because it handles health information or receives data from a healthcare organization. Conversely, an app or service provider working for a covered entity may have a business-associate role. HHS explains the relevant HIPAA relationships and provides resources for app developers. Review HHS resources for mobile health app developers.
Do not use “HIPAA compliant” as a blanket claim about a consumer app or vendor. 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.
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Check other possible federal rules
Use the FTC and HHS Mobile Health App Interactive Tool with the app’s real functions, information, and service model. HHS identifies laws and regulations that can be relevant to health apps, including the FTC Act, the FTC Health Breach Notification Rule, the FD&C Act, COPPA, and ONC-related regulations. Which ones apply depends on the facts; the tool is a way to work through those facts, not a product-specific legal determination.
3. Map data flows and make privacy disclosures accurate
Inventory what the app and its partners handle
Follow information from collection through deletion. Include data users enter, data imported from records or devices, inferences the AI creates, prompts and outputs, storage, analytics, advertising SDKs, support tools, and onward sharing. Identify who can access each category, where it is processed, how long it is kept, and how users can access or delete it.
Compare practice with every privacy promise
Check the privacy notice, consent screens, app-store disclosures, and marketing against the actual configuration, integrations, and defaults. FTC guidance says companies must honor express or implied privacy promises and maintain security appropriate to the information they hold. A privacy policy does not make the app behave as described; verify what the app and its connected services actually do. Read the FTC’s health privacy guidance.
4. Review cloud, model, and other service providers
For every provider that receives or can access app information, document the purpose of access and the terms governing it. Ask whether the provider may use data for model training or service improvement, share it onward, retain it after the service ends, or access it for support. Check deletion options, security commitments, breach-notification timing, and the contract’s permitted uses.
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5. Build security into the app’s full lifecycle
The FTC’s mobile health app best practices ask developers to incorporate security at design, development, launch, and post-market stages. Translate that lifecycle principle into a review of the controls that fit the app’s data and risks; no single checklist guarantees compliance.
- Access: review authentication, authorization, least-privilege access, and administrative access to sensitive data.
- Data handling: assess secure storage and transmission, secrets management, backups, and data deletion.
- Dependencies: inventory SDKs, libraries, analytics tools, and other integrations that can expose information or create vulnerabilities.
- Operations: review logging, security testing, patching, monitoring, and incident handling before and after launch.
The FTC’s best-practice guidance frames the core lifecycle question directly: “Do you incorporate data security at every stage of your app’s lifecycle: design, development, launch, and post-market?” See the FTC’s mobile health app developer best practices.
6. Decide how breach duties and response will work
Identify the rule that could apply to each relationship
Do not assume HIPAA is the only possible breach-notification regime. The FTC Health Breach Notification Rule covers vendors of personal health records, PHR-related entities, and certain third-party service providers. The FTC says its 2024 amendments took effect on July 29, 2024; covered businesses may need to notify affected consumers and the FTC, and in some cases the media. HIPAA-regulated entities have separate HHS notification obligations. Which duties apply depends on the app’s role and data relationships. Read the FTC’s Health Breach Notification Rule guidance for businesses.
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Prepare the response path before an incident
Assign who can escalate an incident and who decides whether it is a reportable breach. Establish steps for containment, evidence preservation, investigation, and communications with users, regulators, and affected partners. Make sure provider contracts support timely notice and that the team knows which rule and deadlines to assess for each data flow.
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7. Establish an AI risk and evaluation process
Document foreseeable harms and how the app will detect and respond to them. The review should cover intended use, human oversight, data quality, performance across relevant user groups, hallucinations or unsafe recommendations, model changes, monitoring, and incident response. The depth of evaluation should reflect the feature’s intended use and the harm a failure could cause; the available federal sources do not set one universal clinical-validation threshold for every app.
NIST’s AI Risk Management Framework organizes risk work under Govern, Map, Measure, and Manage, and applies across AI design, development, deployment, use, and evaluation. NIST marks the framework as voluntary and currently being revised. Its Generative AI Profile, published July 26, 2024, is a cross-sector companion with suggested actions for managing generative-AI risks. Neither document is a legal mandate, certification, or proof that an app or model is safe. Read about the NIST AI Risk Management Framework and the NIST Generative AI Profile.
8. Check audience and launch geography
If children may use the app, assess COPPA and any other requirements relevant to its audience; HHS lists COPPA among federal laws that can be relevant to health apps. If the launch includes states beyond the initial market or countries outside the United States, obtain separate jurisdiction-specific analysis. The federal sources linked here do not determine which state consumer-health privacy laws or non-U.S. rules apply to a particular launch.
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Compare implementation options against the same questions
When deciding between vendors, architectures, or model services, compare them on the factors that affect privacy, compliance, safety, and the work required after release:
- What data leaves the app, where it is processed, and who can access it?
- Will the provider sign the agreement required for the actual legal relationship?
- What are the retention, deletion, model-training, and onward-use settings?
- What access controls, encryption, auditability, and incident-notification terms are available?
- How could a failure affect a user’s health or a clinician’s decision?
- What ongoing work is required for monitoring, security updates, and model changes?
These questions are practical comparison criteria drawn from federal guidance on app roles, data handling, security, and AI risk; they are not a regulator-issued product rating scheme.
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