Hi. I’m Suzanne Schwartz, Director of the Office of Strategic Partnerships
and Technology Innovation, or OST. Here at the FDA, we work to bring innovations
such as connected medical devices to market that are safe and effective.
Connected medical devices connect to the Internet or use other digital technologies.
Many patients experience the enormous benefit of these medical advances each day. Diabetes, heart
disease, Parkinson’s, and chronic pain are just a sample of many conditions that can be improved
through connected devices. The more connected we are—through innovations like continuous glucose
monitoring, pacemakers, and neurostimulation–the more aware we must be of cybersecurity threats
and other types of cybersecurity risks.
Cybersecurity is the protection of connected devices
and other information systems from cyber threats and other unauthorized activities.
Our FDA team is dedicated to ensuring that connected medical devices are protected from
hackers or other cybersecurity threats that could compromise the safety of your device.
I'm Michelle Tarver, Deputy Director of the Office of Strategic Partnerships and
Technology Innovation. We want you to know some ways you can help protect your device.
Know your Cybersecurity Vitals: Protect Your Device--Personal information
- Use good password practices such as a unique password and do not share it with others.
- Keep your device within your physical control.
- Only connect your device to other devices and software
if the device manufacturer or your health care provider indicate it is okay to do so.
- Keep your device updated. Updates may have useful things to protect you like patches or
fixes for new cybersecurity risks. Stay up-to-date so your device has the best protection available.
- Check in with your device manufacturer or health care provider
about other best practices specific to your device.
Devices can also show signs that there’s something wrong.
Pay attention to symptoms that may need to be checked.
Cybersecurity Vitals: Symptoms and Check-ups
- Call your health care provider or device manufacturer, if you see
inconsistencies, or strange behavior from your device.
- While you should ensure you keep your device up-to-date with any manufacturer-supplied patches,
don’t try to apply other fixes to the device yourself—
especially ones you may find on the Internet. You could end up making a bad situation worse.
- Follow up on any alerts from your device.
- Make the most of your regularly scheduled check-ups with your health care provider.
Have a list of questions about your device health ready to bring to your appointment.
- What are the specific risks for my connected medical device?
- What (or what else) can I do to keep my device safe?
Keep your cybersecurity vitals in check to maintain the health of your medical device.
Take the advice of the CDRH Medical Device Cyber Security Team:
Jessica Wilkerson, Matt Hazelett and Aftin Ross.
Remember, connected medical devices provide significant benefit to many patients,
but are not without risk.
Protect your personal information. Monitor for unusual symptoms or behaviors from your device,
and remember to get a device check-up from your health care provider or the device manufacturer.
For more information on cybersecurity vitals and the health of medical devices, please visit us
at the FDA's Medical devices Cybersecurity webpage, or click on the link below.
Thanks for watching!