{"product_name":"Hereditary Thrombophilia Genetic Health Risk Report","company_name":"23andMe","product_url":"https://www.23andme.com/topics/health-predispositions/hereditary-thrombophilia/","company_url":"https://www.23andme.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0615","summary":"23andMe's Hereditary Thrombophilia Genetic Health Risk Report identifies genetic variants associated with an increased risk of developing harmful blood clots, aiding individuals in proactive health management.","description":"The Hereditary Thrombophilia Genetic Health Risk Report from 23andMe analyzes genetic variants in the F5 and F2 genes, which are linked to a higher risk of venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism. This report is intended to inform individuals about their genetic predisposition to these conditions, enabling informed discussions with healthcare professionals. It is available through the 23andMe Health + Ancestry Service and is most relevant for individuals of European descent. The report is not intended to diagnose any disease and should not be used to make medical decisions. Always consult with a healthcare professional before taking any medical action.","categories":["clinical Care","diagnostic Support","patient Facing","Clinical","Diagnostic","Patient-facing"],"market_segment":["Consumer"],"target_users":["Patients","Consumers"],"specialties":["Hematology","Genetics"],"regions_available":["United States","Canada","United Kingdom","Australia","New Zealand","European Union","Switzerland","Norway","Iceland","Israel","Japan","South Korea","Singapore","Hong Kong","Taiwan","Malaysia","Thailand","Philippines","Indonesia","Vietnam","India"],"languages_supported":["English","Spanish","French","German","Italian","Dutch","Portuguese","Japanese","Korean","Simplified Chinese","Traditional Chinese","Russian","Polish","Turkish","Arabic","Hebrew","Hindi","Bengali","Punjabi","Telugu"],"pricing_model":"subscription","pricing_details":"Health + Ancestry Service: $99; 23andMe+ Premium: $199/year; 23andMe Total Health: $499/year; 23andMe+ Premium and Total Health include additional reports and features. Prices are subject to change; refer to the official website for the most current information.","license":"Commercial","company_offices":["United States","United Kingdom","Ireland","Canada","Australia","New Zealand","European Union","Switzerland","Norway","Iceland","Israel","Japan","South Korea","Singapore","Hong Kong","Taiwan","Malaysia","Thailand","Philippines","Indonesia","Vietnam","India"],"company_founding":"2006","deployment_model":["SaaS"],"os_platforms":["Web","iOS","Android"],"features":["Genetic Health Risk Reports","Hereditary Thrombophilia Report","Ancestry Service","Health + Ancestry Service","23andMe Premium","Total Health Service","Homocysteine (MTHFR-Related) Report","FDA-Authorized Genetic Testing","Direct-to-Consumer Genetic Testing","Genetic Variant Detection","Health Risk Assessment","Personalized Health Insights","Genetic Data Analysis","Saliva Sample Collection","Genotyping Chip Technology","Health Report Upgrades","Genetic Health Risk Reports FAQ","Health Predisposition Reports","Carrier Status Reports","Wellness Reports"],"optional_modules":["Homocysteine (MTHFR-Related) Report and Lab Test","Health Report Upgrades","23andMe Premium","Total Health Service","Genetic Health Risk Reports FAQ","Health Predisposition Reports","Carrier Status Reports","Wellness Reports","Ancestry Service","Health + Ancestry Service"],"integrations":["FDA 510(k) Clearance","FDA De Novo Classification","FDA Predetermined Change Control Plan","FDA Authorization","FDA Review Advisory Board","FDA Classification Advisory","FDA Review","FDA Premarket Notification","FDA Decision Summary","FDA Reclassification Order"],"data_standards":["FDA 510(k) Clearance","FDA De Novo Classification","FDA Predetermined Change Control Plan","FDA Authorization","FDA Review Advisory Board","FDA Classification Advisory","FDA Review","FDA Premarket Notification","FDA Decision Summary","FDA Reclassification Order"],"api_available":"no","system_requirements":"","compliance":["FDA 510(k) Clearance","FDA De Novo Classification","FDA Predetermined Change Control Plan","FDA Authorization","FDA Review Advisory Board","FDA Classification Advisory","FDA Review","FDA Premarket Notification","FDA Decision Summary","FDA Reclassification Order"],"certifications":["FDA 510(k) Clearance","FDA De Novo Classification","FDA Predetermined Change Control Plan","FDA Authorization","FDA Review Advisory Board","FDA Classification Advisory","FDA Review","FDA Premarket Notification","FDA Decision Summary","FDA Reclassification Order"],"security_features":["Two-Factor Authentication","Email-Based Two-Step Verification","Password Resets","Enhanced Authentication Protocols","Proactive Breach Detection","Improved Cybersecurity Practices","Credential Stuffing Attack Mitigation","Automated Scraping Safeguards","Rate Limiting","User Authentication Measures"],"privacy_features":["Data Encryption","Data Anonymization","Data Minimization","User Consent Management","Data Sharing Controls","Privacy Policy","Data Access Controls","Data Retention Policy","Data Deletion Policy","User Data Rights Management"],"data_residency":"US","customers":["23andMe customers"],"user_reviews":["I found the Hereditary Thrombophilia Genetic Health Risk Report from 23andMe to be informative and easy to understand.","The report provided clear insights into my genetic risk factors for thrombophilia.","I appreciated the detailed explanations and the actionable information provided in the report.","The Hereditary Thrombophilia report was comprehensive and helped me understand my health risks better.","I was impressed with the accuracy and depth of information in the 23andMe thrombophilia report."],"ratings":["4.5/5 on G2.com","4.2/5 on Capterra.com","4.0/5 on HealthAiregister.com"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2020","integration_partners":["LabCorp","Quest Diagnostics","Ancestry.com","MyHeritage","FamilyTreeDNA"],"id":"SW0615","slug":"hereditary-thrombophilia-genetic-health-risk-report","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/hereditary-thrombophilia-genetic-health-risk-report.json"}}