Security assessment and protection framework for connected medical devices including implants, monitors, and diagnostic equipment.
Objectives
The primary objective of the Medical Device Security project is to develop a robust security assessment and protection framework for connected medical devices. This initiative aims to address the growing cybersecurity vulnerabilities in healthcare technology, ensuring patient safety, data privacy, and the reliable operation of essential medical equipment.
Key Objective 1: Vulnerability Assessment & Risk Profiling
Conduct comprehensive vulnerability assessments of various connected medical devices, identifying potential attack vectors and creating risk profiles for different device categories (e.g., implants, wearables, diagnostic tools).
Key Objective 2: Secure Design & Development Guidelines
Develop a set of secure design and development guidelines for medical device manufacturers, promoting security-by-design principles throughout the product lifecycle.
Key Objective 3: Post-Market Surveillance & Incident Response
Establish a framework for continuous post-market security surveillance of medical devices, including threat monitoring, vulnerability management, and rapid incident response protocols.
Methodology
Our methodology integrates cybersecurity engineering principles with healthcare regulatory compliance. We will adopt a holistic approach, considering both technical and organizational aspects of medical device security, and emphasize collaboration with industry stakeholders.
Phase 1: Threat Modeling & Attack Surface Analysis
Perform detailed threat modeling for typical medical device use cases and conduct attack surface analysis to understand potential entry points for cyber threats.
Phase 2: Security Controls Implementation
Implement and test various security controls, such as secure firmware updates, strong authentication mechanisms, data encryption, and network segmentation, tailored for medical device environments.
Phase 3: Compliance & Certification Support
Provide guidance and tools to assist medical device manufacturers in achieving compliance with relevant cybersecurity regulations and industry standards, including support for pre-market and post-market security documentation.
Expected Results & Impact
The Medical Device Security project is expected to significantly enhance the security posture of connected medical devices, leading to improved patient safety and increased trust in healthcare technology. This will have a critical impact on public health by reducing the risk of cyber attacks that could compromise device functionality or expose sensitive patient data. The project aims to contribute to the development of national and international standards for medical device cybersecurity.