New FDA Guidelines – What You Need to Know

On December 27, 2016, the Food and Drug Administration issued a final guidance regarding medical device cyber vulnerabilities.

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The guidelines outline how medical device manufacturers should maintain the security of devices connected to the internet.

These devices include pacemakers, insulin pumps, and imaging systems.

The FDA released 30 pages of guidance that recommended that manufactures monitor cybersecurity vulnerabilities, create a program to protect against risks, and determine how risks could potentially affect patients.

The FDA has also stated that manufacturers should address issues as soon as possible – this includes by fixing vulnerabilities in products that are already on the market.

This guidance will not be the last from the FDA. The FDA will continue to address cybersecurity as both risks and technology advance.

The new guidelines are in response to issues faced over the past several years. There has been a spike in research on potentially life threatening security bugs in devices. This research has been carried out by ‘white hat’ hackers attempting to identify flaws before they are used to harm patients.

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If the guidelines are effective, it will be easier to determine what devices have cyber bugs or potential risks.

The guidelines have offered greater clarity for everyone involved, including manufacturers, patients, providers and hospitals.

In our next blog post, we will keep you informed of related issues.  To get this important information delivered directly to your mail box, 

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