What are KardiaSync's PIPEDA compliance principles?

KardiaSync follows PIPEDA principles including: Accountability for personal information under our control, Consent-based data collection and processing, Limited collection to necessary purposes only, Transparent use and disclosure practices, Accurate and up-to-date information maintenance, Appropriate security safeguards, Openness about policies and practices, Individual access to personal information, and Ability to challenge compliance.

Is KardiaSync a medical device?

KardiaSync does not diagnose, treat, or prevent disease. It provides information for healthcare professional review, requires human oversight for clinical decisions, and complements but does not replace clinical judgment.

What are the benefits of Canadian data hosting?

Canadian data hosting provides: Compliance with Canadian data sovereignty requirements, Reduced risk of foreign data access requests, Lower latency for Canadian users, and Alignment with provincial health data requirements.

What is KardiaSync's approach to responsible AI?

KardiaSync's responsible AI approach includes: Transparency in AI capabilities and limitations, Human oversight required for high-risk decisions, Regular bias assessment and mitigation, Explainable AI outputs for clinical users, and Continuous monitoring and improvement.

Compliance & Regulatory

Last Updated: September 2025

Our Commitment to Compliance

KardiaSync is committed to maintaining the highest standards of regulatory compliance, data protection, and ethical practice. Our platform is designed with compliance at its core, ensuring we meet all applicable Canadian and international requirements.

Privacy & Data Protection

PIPEDA Compliance
We comply with the Personal Information Protection and Electronic Documents Act (PIPEDA), Canada's federal privacy law governing how private sector organizations collect, use, and disclose personal information.

Key Privacy Principles

The key privacy principles are:

Accountability for personal information under our control
Consent-based data collection and processing
Limited collection to necessary purposes only
Transparent use and disclosure practices
Accurate and up-to-date information maintenance
Appropriate security safeguards
Openness about policies and practices
Individual access to personal information
Ability to challenge compliance

Healthcare Regulations

Regulatory Classification
KardiaSync is designed as a clinical decision support tool that does NOT meet the definition of a medical device under current Health Canada regulations. Our platform:

Does not diagnose, treat, or prevent disease
Provides information for healthcare professional review
Requires human oversight for clinical decisions
Complements but does not replace clinical judgment

We continuously monitor regulatory developments and will pursue appropriate certifications if our platform's capabilities or regulatory requirements change.

Security Standards

Data Encryption

AES-256 encryption for data at rest and TLS 1.3 for data in transit

Access Controls

Role-based access with multi-factor authentication

Infrastructure Security

SOC 2 Type II certified cloud infrastructure

Audit Trails

Comprehensive logging and monitoring of all access

Data Residency & Sovereignty

All Canadian user data is stored in Canadian data centers, ensuring:

Compliance with Canadian data sovereignty requirements
Reduced risk of foreign data access requests
Lower latency for Canadian users
Alignment with provincial health data requirements

Ethical AI Practices

Our AI-assisted analysis follows responsible AI principles:

Transparency in AI capabilities and limitations
Human oversight required for high-risk decisions
Regular bias assessment and mitigation
Explainable AI outputs for clinical users
Continuous monitoring and improvement

Vendor Management

We conduct thorough due diligence on all third-party vendors:

Security and privacy assessments
Contractual data protection obligations
Regular audits and reviews
Business associate agreements where required

Incident Response

We maintain a comprehensive incident response plan that includes:

24/7 security monitoring and alerting
Defined escalation procedures
Breach notification protocols compliant with PIPEDA
Regular incident response drills and updates

Training & Awareness

All KardiaSync team members receive regular training on privacy, security, and compliance obligations. We maintain a culture of compliance throughout our organization.

Continuous Improvement

We regularly review and update our compliance practices through:

Annual privacy and security assessments
Monitoring of regulatory developments
Engagement with legal and compliance experts
Feedback from healthcare partners
Industry best practice adotion

Questions & Concerns

For compliance-related questions or concerns, please contact:
Compliance Officer: compliance@kardiasync.com
‍Privacy Officer: privacy@kardiasync.com
‍Security Team: security@kardiasync.com
‍Address: 1725, 16th Ave, Richmond Hill, ON