What is Medical Device Penetration Testing?
Medical device penetration testing is one of the primary assessments used to identify and fix vulnerabilities within smart healthcare equipment. With the recent digitalization of healthcare providers, the risks of leaking sensitive data and disrupting patient care has increased significantly. Our services will ensure you are compliant with the NIST framework and the FDA best practices, revealing real-world opportunities for hackers to attack your medical devices.
Why Conduct a Penetration Test of Your Medical Devices?
Validate your existing security controls
A penetration test will evaluate the effectiveness of your current security measures, helping you understand whether they are adequate to protect your medical devices from potential threats and improving your ability to prevent attacks.
Test the resilience of your devices against targeted attacks
By simulating targeted attacks in a safe and controlled manner, our penetration testing services will ensure that your medical devices can withstand real-world threats and help develop additional measures to prevent potential disruptions to your patient care, giving you confidence in the security of your devices.
Understand the potential impact of an attack on your medical devices
Our team of experts will analyze the potential outcome of a successful breach on your medical devices for each vulnerability and security risk that could be exploited by hackers in a real-world scenario, enabling you to prioritize remediation efforts and allocate resources efficiently.
Identify & fix all existing vulnerabilities
Our team will identify all existing vulnerabilities and security risks within your medical devices and their underlying infrastructure, allowing you to systematically address these issues, strengthen your overall security posture and reduce your overall risk exposure.
Enhance the security of your medical devices and patient data
By uncovering and addressing vulnerabilities, our penetration testing services will help you enhance the security of your medical data and smart healthcare devices, protecting them from potential disruptions that may disrupt patient care or leak sensitive data.
Comply with FDA and other regulatory requirements
Our services will help your organization achieve compliance with FDA requirements and other industry standards by identifying and helping you fix any vulnerabilities currently present in your smart devices. Once our remediation recommendations have been implemented, we will provide an official attestation confirming that you’ve addressed all risks, helping you meet any requirements with ease and confidence.
SERVICES TRUSTED BY TOP MEDICAL PROVIDERS
When Should You Perform a Penetration Test of Your Medical Device?
- Annually as part of a proactive security strategy
- After major changes or updates to the device or infrastructure
- Before deploying a new feature or integration
- As part of regulatory or compliance requirements
- Following a security breach or incident
- In response to a new security threat targeting healthcare
Common Cybersecurity Risks & Vulnerabilities Identified
Our methodology covers an extensive attack surface, identifying vulnerabilities that are unique to your medical device, as well as the most commonly found security risks in modern smart devices:
Insecure communication protocols
A security risk where attackers exploit weak or unencrypted communication channels between medical devices and other systems, potentially intercepting sensitive data or manipulating device operations.
Unsecured wireless communications
A security risk where wireless communication between medical devices and other systems is not properly secured, enabling attackers to intercept data, inject malicious payloads, or disrupt device functionality.
Insufficient network segmentation
A vulnerability that occurs when medical devices are not properly isolated from other parts of the network, allowing attackers to move laterally through the network and potentially compromise additional devices or systems.
Exposed cloud infrastructure
A security risk where medical devices or their associated data are stored in improperly configured cloud environments, leaving them vulnerable to unauthorized access, data breaches, or other malicious activities.
Lack of encryption for sensitive data
A vulnerability that occurs when sensitive data, such as patient information, is stored or transmitted without proper encryption, making it easier for attackers to intercept, access, and misuse the data.
Vulnerable configurations and settings
A vulnerability that exists when medical devices are deployed with insecure default settings or configurations, potentially exposing them to unauthorized access or other security risks.
COMPLY WITH FDA’S CYBERSECURITY REQUIREMENTS
The FDA’s Role in Keeping Medical Devices Cyber Secure
The U.S. Food and Drug Administration regulates medical devices and works aggressively to reduce cybersecurity risks in what is a rapidly changing environment. The following medical device cybersecurity awareness video is provided by FDA’s medical device cybersecurity team:
BEST PRACTICES
Build Secure & FDA-Compliant Medical Devices
Limit access to trusted users through passwords, usernames, smartcards, biometrics, automatic timers, and physical locks.
Ensure that only trusted content is within the device and/or system by measures such as restricting updates to the same or using encryption.
Detect and respond to hacking attempts with security compromise alerts.
Leverage a structured and systematic approach to identify, characterize, and assess cybersecurity vulnerabilities.
DID YOU KNOW?
Need to Conduct a Penetration Test of Your Medical Device?
The FDA's Regulations For Medical Device Cybersecurity
FDA's Premarket Guidance:
- Perform a risk assessment to identify potential cybersecurity vulnerabilities.
- Develop a risk management plan to mitigate identified risks.
- Provide documentation to support the cybersecurity measures implemented.
FDA's Postmarket Guidance:
- Implement a robust cybersecurity risk management program.
- Monitor and detect cybersecurity vulnerabilities.
- Assess the risk of identified vulnerabilities and implement appropriate actions.
- Communicate and collaborate with stakeholders for coordinated vulnerability disclosure.
Frequently Asked Questions
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