HIPAA does not automatically cover every company that handles information about your health. It applies to defined health care organizations and their business associates. Other federal rules and state laws may apply to consumer apps and other businesses outside HIPAA, but which protections you have depends on who holds the data, what the data is, what the company does with it, and which laws apply.
Does HIPAA protect health information held by every company?
No. HIPAA’s Privacy Rule applies to covered entities—health plans, health care clearinghouses, and health care providers that conduct certain standard transactions electronically—and to certain business associates that perform functions for covered entities or handle protected health information (PHI) in connection with services for them. The U.S. Department of Health and Human Services (HHS) describes those categories in its Collecting, Using, or Sharing Consumer Health Information? overview.
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PHI is not simply any fact that could be described as health-related. HIPAA’s rules apply within the statute’s defined relationships and to information handled in that context. A clinic’s records and a consumer’s entries in an independent wellness app may both concern health, but the app does not become subject to HIPAA solely because it collects health information. A company may, however, have a HIPAA role when it handles PHI on behalf of a covered entity; the relationship and service matter.
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One free scan finds every outdated or missing driver and matches the right update for your exact hardware.Free scan · exact hardware matchThat is why the answer to “Does HIPAA protect my health app data?” is not a universal yes or no. A product’s label—fitness tracker, symptom checker, telehealth service, or wellness app—does not by itself establish its legal status. Ask who operates it, whether it works for a covered entity, and which other laws govern its particular data practices.
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What can protect health data outside HIPAA?
The FTC Act
The Federal Trade Commission Act can apply to companies handling health information even when they are not HIPAA-covered. HHS’s joint consumer-health overview explains that the FTC Act’s obligations apply to HIPAA-covered entities and business associates as well as companies that collect, use, or share health information without a HIPAA obligation. In practical terms, a company may face scrutiny if its health-data practices are unfair or if it misleads people about collection, use, retention, or sharing.
This is not the same as a single comprehensive federal privacy code for every health app. The FTC Act does not mean every app is subject to identical requirements, and its application depends on the company’s conduct and circumstances.
The FTC Health Breach Notification Rule
A separate federal rule requires breach notices from specified vendors of personal health records, related entities, and third-party service providers. HHS’s overview describes covered breaches as including unauthorized acquisition of information from a security incident and unauthorized disclosure by the company. The rule’s scope is defined: having a health app does not, on its own, prove that the app falls under it.
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Other laws and obligations
State consumer-protection, health-privacy, security, and breach-notification laws may also be relevant. A company can face more than one legal regime, and a rule that governs a breach does not necessarily settle questions about consent, routine sharing, access, or deletion.
How do HIPAA and state laws interact?
HHS calls HIPAA a federal “floor” of privacy protections for individually identifiable health information held by covered entities or their business associates. State requirements that are contrary to HIPAA are generally preempted, but that is not the end of the analysis: exceptions include certain state laws that provide greater privacy protections or rights, as well as specified public-health, disease-reporting, and health-plan-reporting laws. HHS explains this in its Does the HIPAA Privacy Rule preempt state laws? FAQ.
So neither “HIPAA preempts all state privacy law” nor “state law always wins” is a sound shortcut. Which rule controls can depend on the subject and purpose of the state requirement, whether it is more protective, and whether an exception applies.
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Washington: a consumer-health-data law beyond HIPAA
Washington enacted its My Health My Data Act in 2023. The Washington State Attorney General describes it as protecting personal health data outside HIPAA’s ambit. The statute defines “consumer health data” broadly as personal information linked or reasonably linkable to a consumer that identifies the consumer’s past, present, or future physical or mental health status. Listed examples include conditions, treatment, diagnoses, interventions, procedures, medication use, and bodily functions or measurements.
The statute’s consumer and regulated-entity definitions connect its reach to matters including Washington residents, collection in Washington, and entities doing business in or targeting Washington while determining the purposes and means of processing. Its codified provisions require regulated entities and small businesses to maintain a consumer health data privacy policy and generally restrict collecting, using, or sharing additional data categories without disclosure and affirmative consent. The statute has defined terms and exceptions, so these points do not determine whether a particular company or activity is covered.
Connecticut: a different statutory boundary
Connecticut’s 2026 codification of its consumer data privacy chapter lists HIPAA PHI among the chapter’s exclusions. That is an example of a state law defining its own scope; it does not establish a nationwide rule or show that all health-related information is excluded from Connecticut law.
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These two examples illustrate why state protections cannot be reduced to one national formula. The applicable state, statutory definitions, covered entities, data categories, and exceptions all matter.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Can health information be shared without telling you?
Sometimes the law permits or requires a disclosure without the individual’s authorization, but the answer depends on the entity, information, purpose, and governing law. HIPAA is not an absolute secrecy rule. For example, HHS says covered entities may disclose PHI without authorization for specified public-health activities, such as reporting to legally authorized public-health authorities to prevent or control disease, injury, or disability. HIPAA also permits disclosures required by law, including certain state reporting obligations.
Outside HIPAA, a company’s privacy notice, promises, applicable FTC obligations, and state law may shape whether and how it can collect or share data. The fact that a company is not covered by HIPAA does not mean it has unrestricted permission to share information. Nor does the existence of a privacy policy by itself show that every practice complies with applicable law.
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What does a health-data breach rule cover?
A breach-notification rule addresses a particular event; it is not a complete account of privacy rights or routine data use. Under HHS’s HIPAA Breach Notification Rule, an impermissible use or disclosure of unsecured PHI is presumed to be a breach unless an exception applies or a risk assessment shows a low probability that the PHI was compromised.
That risk assessment considers the nature and extent of the information and identifiers, who received it, whether it was actually acquired or viewed, and what mitigation followed. For breaches affecting 500 or more individuals, notice to HHS is due without unreasonable delay and no later than 60 days. For breaches affecting fewer than 500, reporting to HHS may be annual and is due within 60 days after the end of the calendar year in which the breach was discovered. Those are HIPAA reporting rules for covered entities and business associates, not a universal deadline for every app or business.
Specified personal-health-record businesses and related entities may instead have notification duties under the FTC Health Breach Notification Rule. Whether that rule applies depends on the business’s role and the rule’s scope, not simply on whether an incident involved health data.
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How to assess a particular app, service, or dataset
For a specific product or disclosure, work through these questions rather than relying on the word “health” or the company’s marketing label:
- Identify the holder and its role. Is it a health plan, qualifying provider, clearinghouse, business associate, personal health record vendor, related entity, service provider, or another business?
- Identify the data. Is the information PHI handled in a HIPAA-covered relationship, information in a personal health record, or consumer health data as defined by a state law?
- Identify the activity. Is the question about collection, use, disclosure, sale, security, breach notice, access, deletion, or consent? Different rules may address different activities.
- Check jurisdiction. Consider the states connected to the person, collection, business activity, or targeting, and the scope rules in each potentially relevant law.
- Check exclusions and exceptions. Look for provisions covering particular entities, records, research, public-health reporting, or legally required activity.
This is a general U.S. overview, not legal advice about a particular company, dataset, or incident. State laws differ and change; Washington and Connecticut are examples, not a fifty-state survey. For a consequential decision, the relevant statutes, agency guidance, and facts of the data relationship need to be assessed together.
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