The WSJ is among media reporting that the FDA has just issued a stern warning to Abbott for failing to properly investigate and resolve cybersecurity risks and battery malfunctions for its pacemaker and defibrillator devices. Rod Schultz, VP of Product at Rubicon Labs commented below.
Rod Schultz, VP of Product at Rubicon Labs:
“The FDA warning to Abbott is an echo of challenges we’ve seen in other technology verticals that are built with batteries and software. Every mobile device in the field today is available and affordable because of advances in those two areas. The healthcare industry must build on technology advancement to innovate, but patient safety and FDA requirements have got to be addressed as top-most priorities. The FDA works closely with federal agencies, DHS, and medical device manufacturers to increase reliability and security, but it seems that more guidance is needed, and perhaps the incentive structure needs to be changed.
“For this specific case, advice from a few key technology companies (Samsung, Apple, and Google) could have helped tremendously. Each of those companies has processes and advice that the FDA could solicit to prevent battery, cybersecurity, and other mobile device pitfalls – all of which are only going to become more frequent with smart medical devices. We are at the beginning of an incredible transformation in how medical care is given and received, and the FDA can probably do more than send out strongly worded letters. They have the power to proactively connect the world’s technology pioneers with its health care pioneers so that the patient can benefit.”
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