Medical Devices Penetration Testing

• System Security
• December 03, 2018

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.

WHY IS THE CYBERSECURITY OF MEDICAL DEVICES / IVDS IMPORTANT? 

There are regulatory, ethical and financial reasons why cybersecurity must be considered and ensured in medical devices, IVDs and their accessories. For example:

• Compliance to regulatory requirements are the prerequisite to access the medical device markets in all major regions such as Africa, EU, China, Australia and UK. Among those are the European Medical Device Regulation (MDR) and In Vitro Diagnostics Medical Device Regulation (IVDR), which defines several cybersecurity requirements in annex I of the regulation under the “general safety and performance requirements”.  The United States Food and Drugs Administration (FDA) on the other hand provides guidance documents, such as the “Postmarket Management of Cybersecurity in Medical Devices”, which explains how to fulfil the respective cybersecurity requirements. 

• Unauthorized access to a medical device might lead to severe consequences. Attacks against a medical device can put at risk the safety of the patient, with fatal consequences in certain cases. If cybersecurity risks are not effectively minimized or managed, it could potentially result in patient harm such as injury or death, for instance by intentional malfunction of a medical device or its unavailability and delayed treatment.
• Connected medical devices bring new opportunities to medical devices, however, they also rise data privacy challenges in light of the global data protection regulations. These devices store and transmit very sensitive medical information that requires protection, as dictated by the European (GDPR), US (e.g. CFR 164.312) or UK (DPA18) laws and provisions.
• Breaches could lead to expensive vigilance activities and field safety actions; negative publicity can damage trust and cost millions in regulatory penalties

REGULATORY BODIES GUIDELINES

Globally, there is an increasing awareness of cybersecurity for medical devices from the regulatory bodies. For example, the FDA, the European Commission and Health Canada have published guidelines on how to meet cybersecurity regulations. These guidelines rise awareness on the necessity to carry out vulnerability scans, penetration tests or other security tests throughout the whole life cycle of a medical devices. Securing a medical device starts in the design stages and includes

• a secure development lifecycle process,
• security risk management process,
• tests to verify and validate the “security implantations” and “security risk mitigation measures” and
• a security post market process.

The primary means for the verification and validation tasks are penetration testing, vulnerability scanning and fuzz testing, security feature testing and source code review. Additional tests can be performed to identify components with known issues.

Stay updated on the latest developments with our Frequently Asked Questions. 

OUR SERVICES TO TEST AND ASSESS THE CYBERSECURITY OF MEDICAL DEVICES

Our testing labs, supported by a global team of over 750 healthcare and medical device testing experts, offer a comprehensive range of services to test and assess the cybersecurity of your medical devices. TÜV SÜD security tests are performed under accreditation according to IEC/TR 60601-4-5 ensuring the highest possible competence and expertise in medical device penetration testing. These services include:

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.