Pacemakers and other cardiovascular implantable electronic devices could be at risk for hacking.
- Medical devices including pacemakers and implantable cardioverter-defibrillators could be at risk for hacking.
- Hacking can lead to battery depletion and oversensing, which inhibits the implantable device to perform as required.
- FDA has issued guidance to improve the cybersecurity of medical devices in both the pre-marketing and post-marketing stage.
The Food and Drug Administration has issued guidance to improve cybersecurity of medical devices in both the pre-marketing and post-marketing stage. Legislative proposals related to medical device security have also been advanced in the U.S. Congress.
How hacking may affect the performance of medical devices:
The hacking of a cardiac device for example can result in a number of possible clinical consequences.
- In case of patients with pacemakers, oversensing and battery depletion may be the major concerns of hacking. Oversensing may inhibit pacing and could result in life-threatening shocks. Battery depletion could make the device unable to deliver therapies during life-threatening arrhythmias.
- In the case of patients with implantable cardioverter-defibrillators (ICDs), hackers may be able to interrupt wireless communications, inhibiting the value of tele-monitoring by not allowing the system to detect any clinically relevant event.
While the study team looks forward to reduce the risks of potential hacking of medical devices by tightening cybersecurity, they do not promote patients and physicians to stop the use of medical devices when required.
"Given the lack of evidence that hacking of cardiac devices is a relevant clinical problem, coupled with evidence of the benefits of remote monitoring, one should exercise caution in depriving a patient of the clear benefit of remote monitoring," Lakkireddy said.
- Baranchuk A, et al. ACC panel: Hacking of cardiac devices possible but unlikely. Journal of the American College of Cardiology (2018). DOI: 10.1016/j.jacc.2018.01.023
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