Abbott Labs makes a costly mistake as FDA targets cybersecurity deficiencies
By Cameron Abbott and Giles Whittaker
The Food and Drug Administration (FDA), after a previous warning in 2014, threatens legal action against Abbott Labs if the company fails to address safety and security issues in implanted cardiac devices sold by St Jude Medical – a recent subsidiary acquired by Abbott Labs. The internet of things takes a much more serious tenure when it’s a medical device compared to your fridge!
The company recently purchased St. Jude Medical, which makes implanted cardiac devices that have been the subject of cybersecurity concerns. A warning letter issued by the FDA gives Abbott Labs 15 days to submit a plan to address errors in the products’ design that could allow hackers to tamper with the settings and drain the batteries of the devices. Many of the cybersecurity concerns first came to light after medical device security research firm MedSec submitted a report outlining a variety of alleged security flaws in St. Jude products to investment firm Muddy Waters Research (MWR). MWR subsequently publically announced the product design failures while short-selling St. Jude Medical’s stock in order to capitalise on the expected market response.
As the public increases its awareness of cybersecurity issues it becomes apparent that a failure to adequately consider these issues – as a day to day function of operating a business or prior to the acquisition of a new business – can result in significant damage to a company’s bottom line. The recent short-selling by MWR indicates the necessity for cybersecurity considerations to form central in a company’s business model, otherwise risk having its inadequacies called out in a public forum. And we are not even thinking about what litigation liability risk these sorts of issues might raise.