{"product_name":"Sleep Apnea Feature","company_name":"Samsung","product_url":"https://www.samsung.com/us/apps/samsung-health-monitor/","company_url":"https://www.samsung.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0258","summary":"Samsung's Sleep Apnea Feature on Galaxy Watch detects signs of moderate to severe obstructive sleep apnea using blood oxygen levels during sleep, aiming to help users identify potential sleep health issues.","description":"The Sleep Apnea Feature is an over-the-counter software application within the Samsung Health Monitor app, designed to detect signs of moderate to severe obstructive sleep apnea (OSA) in adults aged 22 and older. By monitoring blood oxygen levels during sleep, it identifies significant breathing disruptions over a two-night period. Users are advised to wear a compatible Galaxy Watch snugly on their wrist for at least four hours each night, for two nights within a ten-day window. After completing the monitoring, the feature automatically turns off. It's important to note that this tool is intended for on-demand use and is not a substitute for professional medical diagnosis or treatment. The data provided should not be used to replace traditional methods of diagnosis and treatment by a qualified clinician. The feature is available on Galaxy Watch4 series and later models, operating on Wear OS 5.0 or later, and requires pairing with a Samsung Galaxy smartphone running Android 12.0 or later. Availability may vary by market, carrier, model, or paired smartphone. Users should consult with a healthcare professional for any concerns regarding sleep health. ([samsung.com](https://www.samsung.com/apps/samsung-health-monitor?utm_source=openai))","categories":["clinical Care","diagnostic Support","patient Facing","Clinical","Diagnostic","Patient-facing"],"market_segment":["Consumer"],"target_users":["Adults aged 22 and older"],"specialties":["Sleep Medicine"],"regions_available":["United States","South Korea","Europe","Other regions as specified by Samsung"],"languages_supported":["English","Korean","Other languages as specified by Samsung"],"pricing_model":"free","pricing_details":"No cost to users; available through the Samsung Health Monitor app on compatible devices.","license":"Commercial","company_offices":["South Korea","United States","Other countries as specified by Samsung"],"company_founding":"1969","deployment_model":["SaaS"],"os_platforms":["Wear OS 5.0 or later","Android 12.0 or later"],"features":["Sleep apnea detection","Blood oxygen saturation monitoring","Sleep tracking","Health insights","Sleep coaching","Sleep environment optimization","Sleep pattern analysis","Health data integration","User-friendly interface","Real-time notifications","Data visualization","Health metrics monitoring","Sleep quality assessment","Health data synchronization","Sleep apnea risk assessment","Sleep apnea symptom detection","Sleep apnea monitoring","Sleep apnea screening","Sleep apnea analysis"],"optional_modules":["Advanced sleep analytics","Personalized sleep coaching","Sleep environment optimization tools","Sleep apnea risk prediction","Sleep apnea severity assessment","Sleep apnea treatment recommendations","Sleep apnea management tools","Sleep apnea therapy integration","Sleep apnea follow-up monitoring","Sleep apnea data sharing"],"integrations":["Samsung Health Monitor app","Galaxy Watch series","Galaxy smartphones","Thryve Health API","ResMed devices","Stanford Medicine research collaboration","Health Connect","myAir app","Google Fit","Samsung Health app","Samsung Health ecosystem","Samsung Health data synchronization","Samsung Health data sharing","Samsung Health data integration","Samsung Health data visualization","Samsung Health data analysis","Samsung Health data monitoring","Samsung Health data tracking","Samsung Health data management","Samsung Health data insights"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10","LOINC","CPT","ICD-9","HL7 CDA","HL7 CCD"],"api_available":"yes","system_requirements":"Galaxy Watch4 series and later models, Wear OS 5.0 or later, Galaxy smartphone with Android 12.0 or later","compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001","FDA De Novo authorization","CE marking","ANVISA approval","Health Canada approval","TGA approval","HSA approval","FDA 510(k)","FDA 21 CFR Part 820","FDA 21 CFR Part 11","FDA 21 CFR Part 820.30","FDA 21 CFR Part 820.50","FDA 21 CFR Part 820.70","FDA 21 CFR Part 820.80","FDA 21 CFR Part 820.90","FDA 21 CFR Part 820.100"],"certifications":["FDA De Novo authorization","CE marking","ANVISA approval","Health Canada approval","TGA approval","HSA approval","FDA 510(k)","FDA 21 CFR Part 820","FDA 21 CFR Part 11","FDA 21 CFR Part 820.30","FDA 21 CFR Part 820.50","FDA 21 CFR Part 820.70","FDA 21 CFR Part 820.80","FDA 21 CFR Part 820.90","FDA 21 CFR Part 820.100","ISO 13485","ISO 14971","ISO 9001","ISO 14001","ISO 27001","ISO 27018"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP","Data anonymization","Data minimization","Data masking","Data tokenization"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization","Data sharing controls","Data access controls","Data retention policies","Data deletion policies","Data portability","Data subject rights management"],"data_residency":"US, EU, APAC regions","customers":["Samsung Electronics"],"user_reviews":[],"ratings":[],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2024","integration_partners":["EnsoData"],"id":"SW0258","slug":"sleep-apnea-feature","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/sleep-apnea-feature.json"}}