ECG Software Threat Modeling: Security & FDA Compliance with Triophore
Triophore ensured LifeSignals Inc.'s ECG streaming software met stringent FDA cybersecurity requirements through comprehensive Threat Modeling.
The Challenge
Business Problem
LifeSignals Inc. faced the challenge of securing sensitive patient health information (PHI) processed by their ECG streaming software to meet the U.S. FDA's stringent cybersecurity requirements for medical devices, necessary for 510(k) submission.
The Goal
The primary objective was to identify, assess, and mitigate potential security vulnerabilities within the ECG streaming software to ensure its security, regulatory compliance, and successful FDA 510(k) submission.
Technology Stack
Service
The Solution
Discovery & Architecture
Triophore conducted a comprehensive Threat Model, performing an in-depth analysis of LifeSignals' ECG streaming software architecture, design, and implementation. This involved a detailed review of system components, data flows, and interaction points across the wearable device, mobile applications, backend servers, and data storage. All potential attack vectors, including external, internal, and supply chain vulnerabilities, were investigated. The architecture was examined to identify weak points and data exposure risks.
Development Phase
Triophore employed the STRIDE threat modeling framework to systematically identify and classify potential threats. The team analyzed potential security risks, including spoofing, tampering, repudiation, information disclosure, denial of service, and elevation of privilege. The process was meticulously tailored to align with the specific cybersecurity requirements and expectations of the FDA for medical device submissions.
Key Feature Implementation
The solution included a detailed threat model report, analysis of various attack vectors, STRIDE-based threat categorization, and documentation tailored for FDA 510(k) submission.
The Results
Performance
The threat modeling process enhanced the security of the ECG streaming software, reducing the risk of potential vulnerabilities and ensuring reliable operation.
Scalability
By addressing security considerations early in the development cycle, the software's ability to scale while maintaining security was improved.
User Impact
Ensuring secure handling of patient health information through the ECG streaming software built trust and safeguarded patient privacy.
Business Efficiency
Achieving FDA compliance through comprehensive threat modeling streamlined the regulatory submission process, preventing delays and reducing the risk of rejection.