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Medical Devices Penetration Testing

MEDICAL DEVICE PENETRATION TESTING

A Medical Device Penetration Test assesses the security of healthcare equipment and medical devices against potential vulnerabilities, ensuring compliance with FDA cybersecurity requirements.

What you'll get:

  • Executive Summary: Outlining risk management implications
  • Technical Report: Detailling vulnerabilities in your medical device
  • Recommendations: Walkthrough on how to fix identified vulnerabilities
  • Expert Guidance: Actions plan to improve your medical device security
  • Attestation: To meet FDA pre-market cybersecurity requirements

SERVICES OVERVIEW

What is Medical Device Penetration Testing?

Medical Device Penetration Testing is a specialized service designed to identify and remediate vulnerabilities within medical devices and healthcare systems. In the healthcare sector, where patient data and safety are paramount, ensuring the security of medical devices against potential cyber-attacks is critical. Our tests simulate sophisticated attack scenarios and identify vulnerabilities that could be exploited by malicious actors, protecting sensitive patient information, and ensuring the uninterrupted operation of critical healthcare devices.

Our cybersecurity experts follow a systematic approach that comply with regulatory standards such as HIPAA and FDA guidelines by providing a thorough assessment of your medical device security posture. We not only identify vulnerabilities, but also provide actionable insights and recommendations to mitigate risk, ensure devices are robustly protected against potential cyber threats, and facilitate compliance with industry-specific cybersecurity standards.

CHALLENGES IN MEDICAL DEVICE SECURITY

Why Should you Perform a Medical Device Penetration Test ?

  • Patient safety and data security
    Ensuring the integrity and confidentiality of sensitive patient data and safeguarding against disruptions to medical services.
  • Regulatory compliance
    Adhering to stringent regulatory requirements, such as HIPAA, FDA-2018-D-3443 ISO/IEC 62304, ISO/IEC 81001-5-1 and others, to ensure compliance and prevent potential fines.
  • Complex device ecosystem
    Managing and securing a diverse and complex ecosystem of interconnected medical devices and systems.
  • Evolving cyber threat landscape
    Adapting to and mitigating the risks posed by the continuously evolving cyber threat landscape targeting healthcare.

SECURING MEDICAL DEVICES

How Will Medical Device Pentesting Help Secure my Healthcare Equipment?

  • Uncover device-specific vulnerabilities
    Identify and address unique vulnerabilities inherent to medical devices and their unique design, ensuring robust defenses against potential exploitation and unauthorized access.
  • Simulate real-world attacks against your device
    Replicate advanced exploits targeting medical devices to gauge their resilience against current and emerging cyber threats, ensuring readiness against sophisticated adversaries.
  • Benchmark with healthcare and cybersecurity standards
    Evaluate your medical device security posture against recognized healthcare cybersecurity frameworks, such as the FDA’s guidance and top security standards (MITRE, OSSTMM, OWASP, etc.).
  • Implement effective security measures
    Gain detailed insights into the required security measures to safeguarding your medical device against modern cyber threats and vulnerabilities.

ASSESSMENT FOCUS AREAS

What Will be Assessed During a Medical Device Test?

  • Device Communication
    Communication protocols, data transmission security, and interface vulnerabilities, etc.
  • Authentication Mechanisms
    User access controls, password policies, and multi-factor authentication, etc.
  • PHI Data Storage and Processing
    Data encryption, storage security, and data processing integrity, etc.
  • Software and Firmware
    Device software, firmware updates, and patch management, etc.
  • Network Security
    Network configurations, firewall settings, communication protocols, and data transmission, etc.
  • And More
    Legacy system integration, third-party components, backup and recovery systems, etc.

SECURITY BEFORE MARKET LAUNCH

The FDA's Premarket Guidance for
Medical Device Cybersecurity

FDA’s Premarket Guidance provides recommendations for medical device manufacturers to address cybersecurity risks during the design and development of their products.

  • Perform a risk assessment to identify potential cybersecurity issues.
  • Develop a risk management plan to mitigate identified risks.
  • Provide documentation to support the measures implemented.
  • Conduct regular penetration testing to discover and address security vulnerabilities prior to market launch.

The FDA's Postmarket Guidance for
Medical Device Cybersecurity

FDA’s Postmarket Guidance provides recommendations for manufacturers to addess postmarket cybersecurity vulnerabilities for marketed and distributed medical devices

  • Implement a robust cybersecurity risk management program.
  • Monitor and detect cybersecurity vulnerabilities.
  • Assess the risk of identified vulnerabilities & implement appropriate actions.
  • Communicate and collaborate with stakeholders for coordinated vulnerability disclosure.

 

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