Medical device cyber security FAQs（英語）

The FDA, EU, NMPA and other key regulators have clearly indicated that cybersecurity must be considered throughout the whole life cycle of the medical device. The primary means of verification and validation of the cybersecurity measures is testing, which includes vulnerability scans, fuzz testing and penetration testing. Below are some frequently asked questions regarding the cybersecurity of medical devices:

1. DOES A VULNERABILITY SCAN, FUZZ TESTING AND PENETRATION TEST THAT DO NOT REVEAL ANY FINDINGS INDICATE THAT MY MEDICAL DEVICE IS SECURE?

No, the lack of findings does not indicate that the device is secure. The device might be secure with respect of vulnerabilities that have been part of the security test at a specific point in time. Keep in mind that the security situation for software may change rapidly due to newly emerging security vulnerabilities, or due to new attack vectors.

 

2. IS THERE A LAW THAT REQUIRES A VULNERABILITY SCAN TO BE CONDUCTED?

No, there are no laws that requires it to be conducted. However, dedicated security guidance such as the FDA guidance on content of premarket submission for cybersecurity in medical devices and European MDCG 2019-16 guidance and standards such as IEC 81001-5-1 indicate that such a scan must be considered. This means that you should have good arguments in the event you decide to skip it. The same applies for penetration tests.

 

3. DO I HAVE TO REPEAT A VULNERABILITY SCAN OR PENETRATION TEST AFTER EACH SOFTWARE CHANGE?

You must consider security related tests regarding to the change as well as regression tests which show that your change did not have a negative effect on the cybersecurity of your device. In many cases, a vulnerability scan or penetration test should be repeated; at least partly.

 

4. CAN I CONDUCT THE VULNERABILITY SCAN AND PENETRATION TEST ON MY OWN?

Yes, you can conduct these tests on your own but you need to have the appropriate competences within your organisation. Nonetheless, it helps to have a second pair of eyes on your devices.

 

5. WHY SHOULD I USE A 3RD PARTY FOR A CYBERSECURITY ASSESSMENT?

The most important argument for a 3rd party assessment is the impartiality of the 3rd party provider. Depending on the provider you choose; you may also benefit from a provider that has a broader knowledge. In case of cybersecurity testing the medical device specific knowledge and expertise of the 3^rd party-provider should be ensured, preferably by accreditation according to a medical device standard such as IEC 60601-4-5. Products having tests conducted by accredited laboratories would provide a higher level of assurance for the industry in addition to ensuring the harmonisation of test categories based on risks.

 

6. WHAT MEDICAL DEVICE CYBERSECURITY SERVICES DOES TÜV SÜD PROVIDE

Cybersecurity Trainings

Trainings are provided to bring awareness and understanding of cybersecurity in medical devices. The objective of the training is to understand requirements defined in regulatory frameworks such as:

Furthermore, trainings can be provided to understand the implementation of Cybersecurity in medical devices according to international standards such as:

• European requirements such as MDCG 2019-16
• US FDA requirements such as
  • FDA QSR
  • Pre-Market Management of Cybersecurity
  • Post-Market Management of Cybersecurity
  • Cybersecurity for networked medical devices
• Chinese NMPA
• On Demand trainings for local frameworks such as Japanese, Singaporean, Brazil and Korean
• IEC TR 60601-4-5 Medical device Cybersecurity
• ISO 14971:2019 Medical device Risk Management
• ISO 62443-3-2 Security for industrial automation
  
  

Concept evaluations

The concept evaluations aim to identify cybersecurity GAPs by assessing against international/harmonized standards, cybersecurity state-of-the art and regulatory requirements including:

• IEC TR 60601-4-5 Medical device Cybersecurity
• IEC 81001-5-1 Security - Activities in the product life cycle
• ISO 62443-3-2 Security for industrial automation
• MDCG 2019-16 Medical device cybersecurity
• Pre-Market Management of Cybersecurity
• Post-Market Management of Cybersecurity
• Cybersecurity for networked medical devices
  
  

Vulnerability Scans / Assessment and Static / dynamic code analysis

The objective of vulnerability scans is to identify and detect known weaknesses in computers, networks or applications (programs). The aim is to perform remediation activities once critical vulnerabilities are identified by the manufacturer. The benefit of this approach is to close Vulnerability Gaps and maintain strong security in medical devices. 

The services include:

• Vulnerability scans (e.g., Network scanning, Web-Application Scanning, Firmware/software scanning) with documentation and grading of the identified vulnerabilities in a vulnerability assessment report.
• Static and dynamic code analysis including a dedicated test report with grading of the vulnerabilities

Penetration Tests and fuzz testing

The objective of a penetration test is to simulate a cyber attack to evaluate the security status of the medical device/software. The aim is to identify unknown weaknesses found during manual tests. Test report results can be used as an objective evidence for the effectiveness of cybersecurity in a medical device (similar to a 60601-1 report being used as an objective evidence for the safety of a medical device).The services include:

• Penetration tests at TÜV Süd are performed according to the best practice from all major frameworks (such as OSSTM, PTES, NIST 800-115, ISSAF and OWSAP)
• Penetration testing and fuzz testing are performed under DAkkS accreditation for medical device cybersecurity according to IEC/TR 60601-4-5 considering the basic safety and essential performance of a medical device.
• Identification of extra testing requirements not covered by the standards listed above
• Development of product-specific testing methods
• Assessment of provider-specific security solutions

Request for medical device cybersecurity testing services today