DeepCardio

TECHNOLOGY

SmartECG is designed to operate securely in an environment that meets the security and regulatory requirements specific to medical data.

Medical Data Security Principles

SmartECG is designed and operated in full compliance with healthcare security standards and applicable laws and regulations, with the protection of patient personal information and medical data as its top priority.

Data Access Control

Data access is managed so that only authorized users can access it.

Data Processing Security

Security standards are applied throughout the entire data processing workflow.

Privacy Protection

An operational framework is in place that addresses legal requirements related to personal data protection.

Security & Regulatory Compliance Framework

SmartECG includes a proprietary middleware developed in-house alongside the AI engine for ECG data analysis.
This middleware enables a flexible system configuration that supports data communication, security policy implementation, and compliance with healthcare environment certification and regulatory requirements.

System Access and Operational Privilege Management

Data Processing and Operational Environment Security

Compliance with Medical Device and Healthcare Regulatory Requirements

Continuous Adaptation to Certification and Regulatory Changes

Compliant with Digital Medical Device Manufacturing and Quality Management Standards (GMP)

EN ISO 13485 Certified

Operational Framework for Healthcare Trust

  • Healthcare Environment-Centered Design

    Designed with a security architecture that accounts for use in real healthcare environments.

  • Continuous Management

    Security and operational status are continuously monitored and managed.

  • Trust-Based Operations

    Provides an environment that healthcare institutions can use with confidence.