The Security Scrutinizer with Howard Anderson

Protecting the Safety of Medical Devices

Protecting the Safety of Medical Devices

The Food and Drug Administration, which regulates medical devices, and The Federal Communications Commission, which regulates networks, have agreed to coordinate their efforts in this arena. In a joint statement of principles issued July 26, they said, "Developing and integrating wireless and broadband communications technology with medical devices and applications requires agencies to assure that such devices operate in a safe, reliable and secure manner."

It goes on to say, "The American public - including industry, providers, patients and other interested stakeholders - should have clear regulatory pathways, processes and standards to bring broadband and wireless-enabled medical services to market."

It's good to see the agencies acknowledge that the new generation of devices raises both patient safety and security issues because of their reliance on wireless and broadband communications. 

It's good to see the agencies acknowledge that the new generation of devices raises both patient safety and security issues because of their reliance on wireless and broadband communications.

In making the announcement, FDA Commissioner Margaret Hamburg said, "The benefits that wireless technologies can provide to healthcare are clear, but to harness the full power of those benefits, we must navigate a delicate balance between innovation and safety and effectiveness."

Let's hope the two agencies work together closely to achieve that "delicate balance" to ensure that new devices are not vulnerable to hacking and do keep patient information secure.



About the Author

Howard Anderson

Howard Anderson

News Editor, ISMG

Anderson is news editor of Information Security Media Group and was founding editor of HealthcareInfoSecurity and DataBreachToday. He has more than 40 years of journalism experience, with a focus on healthcare information technology issues. Before launching HealthcareInfoSecurity, he served as founding editor of Health Data Management magazine, where he worked for 17 years, and he served in leadership roles at several other healthcare magazines and newspapers.




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