Security
Nanowear Inc. is committed to transforming patient care through hospital-at-home monitoring and deep learning-based diagnostics. Nanowear follows industry best practices to develop, manage and maintain proprietary software, systems and associated security. We use durable, scalable and secure services hosted on Amazon Web Services.
As participants in patient health care, we are committed to maintaining the privacy of Protected Health Information (PHI) as directed by applicable federal and state law. Our full Notice of Privacy Policy can be found here.
Regulations
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SOC 2 Type II
Nanowear is working towards SOC 2 Type II certification with Vanta to adhere to the AICPA’s trust services principles and criteria for security, availability, confidentiality and privacy.
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HIPAA
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a highly regulated and security-conscious statute in the healthcare industry. Nanowear is committed to maintaining HIPAA compliance.
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FDA Cleared
Nanowear has three FDA 510(k) clearances. SimpleSense (the software and device-enabled platform) is an FDA cleared remote monitoring platform with closed-loop enabled AI diagnostics. The non-invasive undergarment monitors multiple patient vitals such as heart rate and sounds, respiration rate, and physical activity.*
Information Security
Security
Data encrypted in motion and at rest (HTTPS, AES-256)
Role-based access controls
24/7 monitoring
Cloud-Based
No on-premise hardware
Highly scalable
Availability
Scalable, virtualized server environment
Redundant systems, no single point of failure
Encrypted backups with offsite replication
Policies & Procedures
Extensive internal policy, procedure and operation controls
Business continuity plan, including virtualization, cloud computing and dual site configuration
Incident response policy and procedures
*The SimpleSense platform is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; and d) Activity including posture. The platform has unique capabilities across a broad spectrum of diagnostic and monitoring verticals.