Best of 2016: 5 steps manufacturers must take now

Today’s medical devices connect to each other and to hospital networks in more ways than ever before. This connectivity greatly benefits patients and healthcare workers, but it also opens up new avenues of risk.

In some cases, hackers may be able to harm patients directly by hacking into a medical device and tampering with data or programming. While preventing these types of attacks is critical, the more likely risk may be in using medical devices to break into a hospital network or database. Unprotected devices present a weak link hackers can exploit to gain access to sensitive medical or financial data, disrupt hospital operations, or launch data ransom attacks. Developers of connected medical devices need to consider cybersecurity, even if the device cannot harm patients directly.

The Identity Threat Resources Center (IRTC) reports that cyber-attacks on the medical/healthcare sector account for 42.5% of reported data breaches, more than any other single industry. Hospital purchasing agents are increasingly aware of these threats, and many have added cybersecurity requirements into purchasing guidelines. With more mHealth apps and connected devices entering the market, the FDA also has taken notice. The FDA’s Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (http://goo.gl/sWxU2r) provides draft guidance for the industry. As the industry evolves, expect cybersecurity to be part of new FDA regulations for medical apps and connected devices.

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