New Draft Guidelines by the FDA to Improve Medical Device Security

Technology > Security

FDA released an updated draft guidance to ensure all future medical devices are being protected from attackers / Photo by Yuriy Klochan via 123rf


Hackers have many targets. They range from banks to corporations, and sometimes even medical equipment. With the last, however, they could potentially physically harm patients who are affected whatever device they choose to hack. This is the reason why a a number of government bodies, as well as those creating and manufacturing these medical devices, are making it a top priority to create safer and more secure devices that are more resistant to targeted hacking and malware. Recently, the Food and Drug Administration (FDA) released an updated draft as guidance, ensuring that all future medical devices are protected from attack and clinics are aware of how to handle these concerns.

Scott Gottlieb, the current FDA Commissioner, said, “Cybersecurity threats and vulnerabilities in today’s modern medical devices are evolving to become more apparent and more sophisticated, posing new potential risks to patients and clinical operations.” They, as well as other government bodies, are hard at work to create safer environments for everyone involved with these products. They are currently working with the many stakeholders in the medical sector to better prepare for the evolving threats in cybercrime.

Their most recent solution, the draft premarket guidance released a few days ago, will provide updated recommendations for device manufacturers on how to protect their products from cyber criminals. This is an updated version of a previous one that they made back in 2014. The FDA hopes to ensure that all future medical devices undergo rigorous testing and adhere to improved safety and security standards before release.