New US Law Requires Medical Device Cybersecurity Standards

April 27, 2023Tealio3 min read time
New US Law Requires Medical Device Cybersecurity Standards
A new law (H.R.2617) in the United States now requires medical device manufacturers to prove that their products meet certain cybersecurity standards before submitting them for approval to the Food and Drug Administration (FDA). The Medical Device Cybersecurity Act of 2021 requires manufacturers to submit documentation that shows their devices can resist cyber attacks and protect patient data.

The FDA will use this documentation to evaluate the security of the device and determine if it is safe for patients to use. This move is seen as a necessary step in ensuring that medical devices are secure and safe for use in healthcare settings. The medical device industry has been under increasing scrutiny in recent years due to concerns about cybersecurity vulnerabilities.

This new law is a response to the growing number of cyber attacks on healthcare organizations and the devices they use. These attacks can compromise patient data and even cause harm to patients if the devices are manipulated or controlled by unauthorized individuals. The risks associated with cyber attacks on medical devices have been a growing concern in the healthcare industry, and this new law is an attempt to mitigate those risks.

The Medical Device Cybersecurity Act of 2021 will impact medical device manufacturers, who will now have to invest in cybersecurity measures to ensure that their devices meet the standards set forth by the FDA. It will also impact the FDA, which will have to evaluate the cybersecurity of medical devices as part of its approval process.

Overall, the new law is a step in the right direction for ensuring the safety and security of medical devices. It is important that manufacturers take cybersecurity seriously and implement measures to protect their devices and the patients who use them. With this new law in place, patients can have greater confidence in the devices they use, and healthcare organizations can have greater assurance that their devices are secure and safe to use.

If you're a medical device manufacturer, it's important to ensure that your devices meet the new cybersecurity standards set forth by the FDA. This will not only help protect patients but also ensure that your devices can gain FDA approval. Our team can help you develop a plan to meet the new requirements set forth by the FDA. To learn about how we can help you ensure the safety and security of your devices, Contact us
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