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The agreement asserts that Oura's services do not constitute a medical device, do not provide medical advice, and are not intended for diagnostic or treatment purposes; Oura additionally disclaims liability for any information users provide that may constitute electronic patient health records.
This analysis describes what Oura's agreement states, permits, or reserves. It does not constitute a legal determination about enforceability. Regulatory applicability and practical outcomes may vary by jurisdiction, enforcement context, and individual circumstances. Read our methodology
This provision asserts a non-medical-device characterization and disclaims all liability for health record information, which may warrant evaluation under FDA guidance on mobile medical applications and wellness devices, and under applicable state health privacy laws, depending on the features and health-related claims associated with the product.
Interpretive note: The non-medical-device characterization is an assertion by Oura; whether it applies to all current and future product features is subject to FDA guidance, applicable state law, and the specific health-related features offered at any given time.
Under this clause, Oura expressly disclaims responsibility for health or medical outcomes arising from use of the services, and disclaims liability for any user-provided information that may constitute electronic health records. Users are directed to consult physicians before making changes to sleep or activity based on Oura data.
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"THE SERVICES ARE NOT A MEDICAL DEVICE AND YOU EXPRESSLY AGREE THAT THE SERVICES DO NOT INVOLVE THE PROVISION OF MEDICAL ADVICE BY ŌURA. THE SERVICES ARE NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE OR MEDICAL CONDITION. THE SERVICES ARE FOR INFORMATIONAL PURPOSES ONLY AND CANNOT REPLACE THE SERVICES OF PHYSICIANS OR MEDICAL PROFESSIONALS. ŌURA DISCLAIMS ANY OF THE FOREGOING WARRANTIES FOR THE OURA RESEARCH APP AND ANY STUDY CONDUCTED THROUGH THE OURA RESEARCH APP, UNLESS EXPRESSLY SET FORTH IN A RESEARCH AGREEMENT. ŌURA disclaims all liability under this Agreement for any information you provide to ŌURA that may constitute electronic patient health records or similar information supplied by you or an end user, notwithstanding anything to the contrary in this Agreement or as otherwise required by any applicable federal, state, or international laws, rules, or regulations.Excerpt from Oura's Terms of Service
1. REGULATORY LANDSCAPE: The FDA has issued guidance on mobile medical applications and general wellness devices that distinguishes between wellness products and regulated medical devices based on intended use and risk profile; the characterization of Oura's services as non-medical is an assertion that may warrant evaluation under applicable FDA guidance, particularly for features marketed in connection with health monitoring outcomes. The FTC has enforcement authority over health claims in consumer product marketing. HIPAA does not generally apply to consumer wellness apps unless they operate as business associates of covered entities, but state health data privacy laws (including Washington's My Health MY Data Act and similar statutes) may apply to physiological data collected by wearables. 2. GOVERNANCE EXPOSURE: Medium. The disclaimer of liability for electronic patient health record information provided by users is notable given that Oura's products collect physiological data (sleep, heart rate, temperature, activity) that may be used in clinical research contexts through the Oura Research App. The disclaimer's interaction with applicable federal and state health data laws is acknowledged in the provision itself ('notwithstanding anything to the contrary in this Agreement or as otherwise required by any applicable federal, state, or international laws, rules, or regulations'). 3. JURISDICTION FLAGS: Washington State's My Health MY Data Act and similar emerging state health data privacy laws may apply to biometric and physiological data collected by Oura regardless of the non-medical-device characterization. EU users may have rights under GDPR Article 9 special category protections for health data. Research participants using the Oura Research App are subject to the applicable Research Agreement and informed consent framework, which may create separate regulatory obligations. 4. CONTRACT AND VENDOR IMPLICATIONS: Organizations deploying Oura in healthcare or clinical research contexts should evaluate whether a Business Associate Agreement is required under HIPAA and whether the agreement's health data disclaimer is consistent with applicable data protection obligations. Research Sponsors using the Oura Research App should review data governance obligations under the applicable Research Agreement. 5. COMPLIANCE CONSIDERATIONS: Compliance teams should monitor FDA guidance updates regarding wellness wearables and connected health features to assess whether Oura's non-medical-device characterization remains accurate for each specific product feature. Data mapping should identify all physiological data categories collected by Oura hardware and assess applicable state health data privacy law requirements.
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This provision asserts a non-medical-device characterization and disclaims all liability for health record information, which may warrant evaluation under FDA guidance on mobile medical applications and wellness devices, and under applicable state health privacy laws, depending on the features and health-related claims associated with the product.
Under this clause, Oura expressly disclaims responsibility for health or medical outcomes arising from use of the services, and disclaims liability for any user-provided information that may constitute electronic health records. Users are directed to consult physicians before making changes to sleep or activity based on Oura data.
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