Abbott recall signals new era in medical-device cybersecurity

The FDA's recall of 465,000 Abbott Laboratories pacemakers earlier this week alerted medical-device makers that they increasingly need to be prepared to issue security updates and take cybersecurity issues more seriously.

The agency recalled the devices Tuesday, saying the cardiac pacemakers made by Abbott (formerly St. Jude Medical) required firmware updates to correct vulnerabilities that leave the devices open to hackers. Rather than removing the devices, patients and physicians can install the update at a medical facility, but not remotely.

Cybersecurity issues in medical devices are now a point of concern for devicemakers and the FDA, according to Mac McMillan, CEO and co-founder of the privacy and cybersecurity consulting firm Cynergistek.

Given the added attention from regulators, devicemakers will have to be more proactive about developing and releasing updates.

"If devicemakers didn't already have developers sitting around looking at cybersecurity, they now have to incur the costs of making sure their devices stay current," McMillan said. "In the past, they've developed devices and put them on the market and moved onto the next device. This is a new thing for them."

The vulnerabilities were first discovered last year, after cybersecurity firm Medsec Holdings informed the investment firm Muddy Waters Capital about the issue. In January, St. Jude Medical, which was acquired by Abbott in January 2016, released a patch for a different set of cybersecurity problems.

The medical device industry can learn some lessons from consumer tech companies, which actively push updates before problems even become public.

"When Apple releases an iPhone update that includes security updates, everyone applauds Apple," said Mike Kijewski, CEO of Medcrypt. "If you have a device and a vendor never does a cybersecurity software update for it, it doesn't mean they're great at cybersecurity—it means they're not taking cybersecurity seriously."

Companies that don't shift their cybersecurity approach will take a hit, said Stephanie Domas, lead security engineer for Battelle's DeviceSecure services. "Manufacturers that are not taking cybersecurity as seriously as they should will realize that this is something that causes business impact."

As devicemakers transition into a new cybersecurity model, some may be more proactive and announce updates before FDA mandates, Kijewski said. But those changes likely won't occur until Abbott's recall shakes out.

If Abbott feels a huge backlash from patients, providers and investors, other devicemakers may hold off on issuing updates, Kijewski said. If the updates aren't weighed down by FDA requirements, devicemakers could act quicker.

The FDA could encourage proactivity by easing regulations, Kijewski said. "If the FDA can say you're just doing the update for cybersecurity and the changes are minimal and the functionality of the device isn't changing, they can make the update happen faster," he said, which will be cheaper for the vendor. "I expect you'll see in the next 90 days one device vendor releasing something about a device update," he said.

But getting updates installed and determining who is responsible for installing the upgrade is another issue, Domas said. In the case of Abbott's pacemakers, it's on physicians, since in the advisory the company released it recommended physicians "determine if the update is appropriate given the risk of update for the patient."

"That seems insane to me," she said. "A physician does not know cybersecurity. How can we be asking physicians to make that decision?"