Security & Compliance
Trust, security and regulatory status
Patient data is handled in a secured, SOC-certified environment. Aegis is working toward its own SOC 2 and ISO 27001 certification and toward medical device licensing.
Secured, SOC-certified hosting
Aegis systems run in a hosting environment that holds SOC certification. Access is controlled, activity is logged, and data is encrypted.
Patient privacy first
Aegis is built to support the requirements of PIPEDA in Canada, PHIPA in Ontario and HIPAA in the United States.
Audit trails
Each processing stage records what was done to a study, so a result can be traced back to the original recording.
Designed for disruption
The edge and mesh architecture is designed so that processing can continue when a connection to the central cloud is slow or lost.
Roadmap
Certification and regulatory status
Encrypted data routing, audit logging and token-based authentication.
ActiveThe environment where Aegis systems and data run.
In placePreparing procedures for a Medical Device Establishment Licence.
In progressCompiling software-as-a-medical-device documentation and starting pre-submission discussions.
ScheduledAegis's own SOC 2 certification.
PlannedAegis's own information security management certification.
PlannedIntended use
The Aegis Sleep Tool is not currently offered for independent commercial diagnostic use. It is limited to validation, pilot evaluation and investigational research while Health Canada MDEL and FDA requirements are completed.
Questions
Security and compliance questions
Where is Aegis data hosted?+
In a secured, SOC-certified hosting environment, with encryption and audit logging.
Is Aegis SOC 2 or ISO 27001 certified?+
Aegis runs in a SOC-certified environment and is working toward its own SOC 2 and ISO 27001 certification. Both are shown as planned in the roadmap on this page.
What privacy laws does Aegis design for?+
Canada's PIPEDA, Ontario's PHIPA and the US HIPAA.
Is the Sleep Tool a licensed medical device?+
Not yet. Aegis is preparing for a Health Canada Medical Device Establishment Licence (MDEL) and an FDA 510(k) pre-submission. Until then the Sleep Tool is limited to validation, pilot evaluation and investigational research.
Security and compliance enquiries
Hospital IT, privacy and procurement teams can request documentation and ask questions.