“Cybersecurity isn’t just a design issue. It’s not just at product launch. It’s a life cycle issue. It requires a change in mindset.”

So said FDA’s Suzanne Schwartz, MD, MBA, the Director of Emergency Preparedness/Operations and Medical Countermeasures in the Center for Devices and Radiological Health (CDRH), at the 10x Medical Device Conference in San Diego this past May.

At heightened risk are devices with configurable embedded computer systems, plus the challenge of legacy devices, she explained before taking questions from the audience.

See http://medgroup.biz/FDA-cybersecurity-10x for her presentation.

The slides and transcript are also available there.

Suzanne noted, “FDA typically will not need to review or approve medical device software changes made solely to strengthen cybersecurity.”

She made too many valuable points to effectively summarize here. Please bookmark the talk and watch it when you can.

But I want to highlight an issue we need to discuss.

Suzanne said, “Stakeholders aren’t really sure how they’re supposed to prioritize vulnerability.”

Adding, “What is that value proposition for the C-suite in terms of making early on that careful, intentional effort to make sure our patient-serving devices have better cybersecurity?”

Your thoughts?

And watch the video! It’s important.

http://medgroup.biz/FDA-cybersecurity-10x (no log-in required)

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Future Crimes author Marc Goodman will build on Suzanne’s talk at next year’s 10x Conference.

The event will be May 2-4, 2016, again in San Diego. Put it on your calendar now, while it’s on your mind.

See http://medgroup.biz/10x-photos for photos of this year’s event.

And for Marc’s best-selling book (really, a must read if you ask me) see http://medgroup.biz/Future-Crimes

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I’m making a rare trip to Eastern Europe in September to speak at SMIT 2015.

The formal event name is the 27th International Conference of the Society for Medical Innovation and Technology. It’s being held in Brno, Czech Republic on September 10-12, 2015 and has an impressive faculty.

If you can join me in that part of the world, see http://medgroup.biz/SMIT2015 for details.

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Happy Birthday, Mom!

Joe Hage
Medical Devices Group Leader

P.S. Thanks again to my Australian hosts, Innovyz, and to all those who came out to share conversation and food with me. (It’s good to be home though.)

Laerte Gessi
Corsi Primo Soccorso IRC-Com, DAN Europa N.R.C. AMIETIP
Aprezzo il vostro impegno il cui ambito è pregevole

Mikhail Ziougaev
Unusual doctor. The doctor should be dressed in rich clothes, not distract the physician from care for the patient.
As they say: but not for that. Always happy to selflessly help, good man. Because kindness always comes back a hundredfold good deeds.