ISO Certification seal

Security & Compliance

EnsoData supports sleep centers securely and effectively by prioritizing data, availability, and integrity. Our products are built on top of ClearDATA, our infrastructure security provider who is HIPAA compliant, HITRUST certified, and SOC 2 Type II audited. EnsoData also undergoes SOC 2 Type II audits.

MDSAP Certification

EnsoData™ products are manufactured using a Quality Management System that is certified by Intertek under the Medical Device Single Audit Program (MDSAP) as being in conformity with ISO 13485, United States, and Health Canada regulations.

Clearances

EnsoSleep™ is cleared for use in the USA, Canada, Australia, and Colombia.

EnsoHST™ is cleared for use in the USA, Canada, and Australia.

Celeste+™ is cleared for use in the USA, Canada, and Australia.

AASM Full Autoscoring Certification™

EnsoSleep v8.3 earned Full Autoscoring Certification from the American Academy of Sleep Medicine (AASM). EnsoSleep is the first software to receive full certification across all four evaluated scoring parameters: sleep staging, respiratory events, arousals, and leg movements.

AASM Full Autoscoring Certification™ is a trademark of the American Academy of Sleep Medicine and is used with permission.

How EnsoData Focuses on Security

Authentication Controls

  • Two-factor authentication
  • Expiring token authentication

Authorization Controls

  • Layered authorization model
  • Data access restrictions

Cryptographic Controls

  • At-rest encryption
  • In-transit encryption
  • Cryptographic hashing of checksum data
  • Cryptographic hashed password authentication

Access Controls

  • Content-security-policy (CSP)

Integrity Controls

  • Cross-site request forgery (CSRF) tokens
  • HTTP strict transport security (HSTS)

Please contact security@ensodata.com with any security issues or concerns.