Three-quarters of a million pacemakers have a vulnerability that could let hackers access the implanted equipment, running down the battery or meddling with the pacing.
The US Food and Drug Administration (FDA) issued a warning that anyone with a specific model of radio frequency-enabled pacemaker from manufacturer Abbott needs to visit a medical professional to have the firmware updated.
There are no reports of the flaws being used to hack a pacemaker, the FDA and Abbott stressed. “There are no known reports of patient harm related to the cybersecurity vulnerabilities in the 465,000 (US) implanted devices impacted,” the alert said. Alongside the half million pacemakers in use in the US, the company told the BBC that there were a further 280,000 used in other countries.
Unlike other industries, medical updates are complicated as they need to be approved by the FDA first, to ensure code doesn’t brick the hardware — not unheard of with other smart devices that receive updates.
The FDA has approved the firmware update, but it can’t be installed over-the-air, requiring patients to visit their doctors. “The update process will take approximately three minutes to complete,” the alert notes. “During this time, the device will operate in backup mode (pacing at 67 beats per minute), and essential, life-sustaining features will remain available.”
The alert warns that there’s a tiny risk of losing data or settings, but it’s below 1%. However, it warned that the update should be run for patients dependent on the device at a facility that can offer temporary cardiac pacing in case of any failures.
The firmware isn’t only patching the vulnerabilities, Abbot said, but boosting security via encryption and network connectivity management tools. “To further protect our patients, Abbott has developed new firmware with additional security measures that can be installed on our pacemakers,” said Robert Ford, executive vice president of medical devices at Abbott, in a statement.
It isn’t clear why the update is being rolled out. Abbott said it was “scheduled” while the FDA said it had “reviewed information concerning potential cybersecurity vulnerabilities,” but didn’t say where the information came from.
The warning applies to a specific set of devices made by Abbott, formerly known as St Jude Medical. The FDA alert has the full details here.
Disclaimer: Some pages on this site may include an affiliate link. This does not effect our editorial in any way.
