by John R. Fischer
, Senior Reporter | August 30, 2017
Abbott Laboratories has released new FDA-approved software updates to protect 465,000 implanted pacemakers against hackings, following criticism by U.S. health regulators.
According to Fox Business News
, the updates, designed to enhance protection for heart patients, come following the release of a letter by regulators, pointing out safety flaws in the devices and criticizing Abbott for not thoroughly investigating and addressing the risks.
“This firmware update provides an additional layer of security against unauthorized access to these devices that further reduces the potential for a successful cybersecurity attack,” Abbott said in a letter it sent to doctors, as reported by Fox Business News.
Abbott acquired the devices in January through its $23.6 billion acquisition of St. Jude Medical. It asserts that issues referenced by regulators occurred before the acquisition was completed.
The new features are a type of software that will be embedded into all new pacemakers that use radiofrequency communications. Existing pacemaker patients are advised not to replace their pacemakers but to instead meet with their doctors, who can administer the updates using a wand held over the location of the pacemaker. The update does carry a small risk of causing the device to malfunction, however.
The FDA has confirmed that none of the pacemakers have suffered cybersecurity hacking incidents that pose harm to patients, but stated that flaws in the products could allow hackers to gain access to, and modify, program settings, thereby creating the potential for harm, such as depletion of battery life or alteration of heart pace.
On a separate note, Abbott released a software update for 398,000 implanted cardioverter defibrillators to alert doctors to premature battery depletion, in order to prevent the risk of cardiac arrest in patients with fast heartbeats. This update also follows criticism mentioned in the same letter by health regulators.
The brands for the pacemakers are Accent, Anthem and Assurity.