Navigating FDA Cybersecurity Guidelines

Medical device cybersecurity has become a significant concern in recent years. As medical devices have become increasingly connected to the internet, they have become vulnerable to cyberattacks. These attacks can compromise patient safety, lead to data breaches, and damage the reputation of medical device companies.

To address these concerns, the FDA has issued guidance for medical device cybersecurity, including recommendations for premarket submissions and postmarket monitoring. End-to-end security testing is a critical component of these recommendations, as it can identify and remediate vulnerabilities before a medical device is released to market.

Premarket Submissions

Premarket submissions are the first step in obtaining FDA approval for a medical device. The process can be lengthy, with the average time from submission to approval taking 177 days in 2020. Penetration testing can help streamline this process by identifying and remediating vulnerabilities early in the development cycle.

According to a 2021 report by the Ponemon Institute, medical device companies that conduct penetration testing during the development cycle experience a 33% reduction in material vulnerabilities. This reduction in vulnerabilities can help speed up the FDA approval process by reducing the number of issues that need to be addressed before approval can be granted.

Security requirement testing, threat mitigation, vulnerability testing, and penetration testing can also help medical device companies meet the FDA’s requirements for cybersecurity risk management. The FDA recommends that medical device companies identify and mitigate risks related to cybersecurity throughout the product lifecycle. By conducting penetration testing during the development cycle, medical device companies can demonstrate their commitment to cybersecurity risk management and increase the likelihood of obtaining FDA approval.

Postmarket Monitoring

Postmarket monitoring is the process of monitoring medical devices after they have been approved by the FDA. This process is critical for ensuring the ongoing safety and efficacy of medical devices. Because most modern medical device ecosystems now reside in the cloud, attack surface management, continuous red teaming, and managed offensive security are all essential components of postmarket monitoring.

Attack surface management involves identifying and monitoring the various entry points that attackers could use to gain access to a medical device. By understanding the attack surface, medical device companies can implement controls to reduce the risk of a successful attack. According to a 2021 report by Gartner, companies that use attack surface management can reduce their risk of a data breach by up to 70%.

Continuous red teaming involves simulating realistic attack scenarios to identify and remediate vulnerabilities. This process can be ongoing, with new attack scenarios added over time as new vulnerabilities are discovered. By continuously testing their products, medical device companies can stay ahead of evolving threats and ensure the ongoing safety of their products.

Managed offensive security involves outsourcing the task of testing a medical device to a third-party provider. This approach can be beneficial for medical device companies that lack the internal expertise or resources to conduct effective penetration testing. According to a 2020 report by Forrester, companies that use managed offensive security experience a 42% reduction in the cost of managing vulnerabilities.