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FEDERAL MANDATES ON MEDICAL-DEVICE CYBERSECURITY GET SERIOUS

In October, the US Food and Drug Administration will start rejecting medical
devices that lack a secure design or a post-market cybersecurity plan.
Robert Lemos
Contributing Writer, Dark Reading
September 13, 2023
Source: ESB Professional via Shutterstock
PDF


For six months, medical device makers have had to comply with new cybersecurity
regulations aimed at hardening medical devices against cyber attacks, but the US
Food and Drug Administration has largely refrained from using its "refuse to
accept" power up to now. 



On Oct. 1, the FDA's grace period — during which the agency stated it would try
not to use its ability to reject medical devices that lack appropriate
cybersecurity controls and a post-market patching capability — will end. The
manufacturers of medical cyber devices must now submit plans to monitor and
patch post-market cybersecurity vulnerabilities, have a process in place for the
secure design and development of devices, and provide a software bill of
materials (SBOM) to the FDA. Those who do not satisfy the requirements could
have their devices rejected on the grounds that they pose too great a cyber
risk.

The agency's focus on medical-device cybersecurity stems from Congressional
passage of an omnibus appropriations act in December 2022 that included a
section, "Ensuring Cybersecurity of Medical Devices," requiring medical-device
manufacturers submit cybersecurity information to the FDA regarding any cyber
device. The powers granted to the FDA, which went into effect in March, could go
a long way toward forcing the makers of medical devices to consider and plan for
vulnerabilities and cyberattacks, says Ty Greenhalgh, industry principal for
healthcare at Claroty, an IoT security firm.

"This legislation addresses specifically that you have to do something about
patching and updating on the new devices, and how are you going to get patches
and updates out over the lifecycle in a reasonable time," he says. "The way this
is set up, it's given broad authority for interpretation to the FDA on what it
takes to get medical devices cyber-secure and what are the penalties, if you are
not compliant with their interpretation."



Medical devices have concerned cybersecurity experts for more than a decade,
with a demonstration of the ability to hack an insulin pump stripping away many
illusions of security in 2011. Major ransomware attacks on hospitals have laid
bare the weaknesses and consequences, with the US Department of Health and Human
Services estimating that slowed response times and patient triage led to as many
as 36 more deaths per 10,000 heart attacks.



Yet medical devices manufacturers have been slow to change. In 2022, only about
a quarter of manufacturers (27%) maintained an SBOM, while less than half (47%)
took even the most common countermeasure: Binary code analysis.

The FDA, which allocated $5 million of its budget to medical device
cybersecurity, could change that.



"Cybersecurity exploits are one of the most substantial threats faced by this
nation, and the impact is particularly harmful for our health care system, where
vulnerabilities could compromise entire hospital systems or disrupt
manufacturing of countless devices if they are impacted," the FDA stated in its
annual appropriations estimate. "Ultimately, these threats are of national
security concern because if they go unchecked, they could cripple healthcare
delivery."


ENSURING CYBERSECURITY OF MEDICAL DEVICES

The US Food and Drug Administration has pushed for more cybersecurity in medical
devices for more than a decade, outlining cybersecurity best practices for
network medical devices in 2005 and publishing draft guidance to manufacturers
in 2016. Cyber devices are defined as those with software, an ability to connect
to the Internet, or having a technical component that could be vulnerable to
cybersecurity threats.

Putting these new requirements into law is a first step, but is far from being
an answer in and of itself, says David Brumley, a cybersecurity professor at
Carnegie Mellon and CEO of software security firm ForAllSecure.

"We're building a muscle at this point, and that muscle isn't gonna allow us to
lift this open-source [security] weight yet. But if we don't start building this
muscle we won't be able to in 20 years," he says. "I just wish that they took it
a step further, to say how they're going to hold people responsible, and what
powers they have to hold people responsible."


NOT DETAILED ENOUGH TO HELP

While the government has correctly avoided prescribing technological measures in
law due to rapidly changing technology, the legislation could have created a
board of experts to determine the best practices for securing medical devices,
says Brumley.

"If you don't want the government dictating exactly how you should do things,
because that can be slow and bureaucratic, then you should have an industry
board that says what [the best practices] are for a practitioner," he says.
Brumley points out engineers building bridges have industry- and
government-prescribed standards and codes to follow for due diligence, and could
be found negligent if they don't follow them. "These requirements are so vague
that you could do basically nothing, other than maybe running an SCA (software
component analysis) scan, and you would satisfy the legislation."

In addition, the law does not have a component that addresses the legacy devices
out there, which are among the most vulnerable, some of which are 15 years old,
adds Claroty's Greenhalgh.

"This legislation is designed to start addressing the problem, but even if you
are plugging the hole in the boat ... it's not really clear in the legislation
what are you going to do about the legacy devices," he says.

The FDA has significant resources on cybersecurity in medical devices, including
an incident response playbook, a threat-modeling guide, and a best practices
document for communicating cybersecurity vulnerabilities to patients.

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