Research, not marketing

With medical devices being increasingly network-connected, we leveraged our collective expertise in medical device security and clinical risk management, to provide a holistic analysis of vulnerabilities in the medical device space through the assessment of clinical case studies using quantitative analytics, and a discussion of incident prevention recommendations.

There is no silver bullet. Complying with FDA cybersecurity regulations requires a variety of processes and technologies. A hypothetical device vendor’s approach to securing their product is analyzed, and leading tools are identified.

In this paper we highlight the specific cybersecurity requirements that can be satisfied using various features of MedCrypt.

Medical device cybersecurity requirements from global regulators will continue to evolve as the industry and ecosystem matures. The industry must be cautious against over reliance on “security frameworks” and must rapidly iterate to keep up with emerging technology best practices.

International regulators as well as customers are expecting Medical Device Manufacturers to deliver proactively secured devices. A deep dive into the unique considerations when threat modeling for medical devices.

An analysis of ICS-CERT cybersecurity disclosures reveals no correlation between a vulnerability’s CVSS score and the likelihood a patch will be made available by the manufacturer.