Have you ever experienced the frustration of trying to hit a bullseye on a moving target? In the medical device industry, cybersecurity is one of the fastest-moving targets. Medical device companies are now faced with the challenge of becoming archers as skilled as Katniss Everdeen to adjust their aim to the cybersecurity target in motion. As we discussed in “Process and Design Looping: Medtech’s Total Product Lifecycle,” all products should travel a circle of collecting feedback, improving the product, and verifying the modifications, but that product lifecycle is much faster for cybersecurity. Hackers and evildoers are working day and night to find and exploit the vulnerabilities of these devices.

A 2022 report from the FBI cited research that found 53% of digital and connected hospital devices had known vulnerabilities. It is likely that when these devices were first commercialized they were not vulnerable, but they have not been updated to deflect more recent and innovative threats. In 2020, a ransomware attack on a German hospital forced an ambulance to be turned away to another hospital 32 kilometers away and a woman died as a result of the delay of treatment: “The attack compromised the digital infrastructure that the hospital relies on to coordinate doctors, beds, and treatment, forcing the cancellation of hundreds of operations and other procedures. It also limited the hospital’s capacity drastically: whereas it normally treats more than 1,000 patients each day, it could attend to no more than half this during and after the attack.”

Another ransomware attack occurred in the last month on the nationwide Ascension hospital network and the clinical staff had to suddenly shift to a paper-based system. This slowed the internal processes for medications, diagnoses, and treatment. The industry as well as the FDA recognizes the importance of preventing a digital attack on our medical system, which is why the FDA released an updated final guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” on Sept. 27, 2023.

This guidance, among other things, provided directions on what to include for cybersecurity testing for premarket approval submissions. However, this final guidance left the defining boundaries of the target blurry for many. In the few short months since the release of this final guidance, FDA has heard cries from the industry for more clarification from the agency for what is considered the center of the target one must hit to comply with Section 524B of the FD&C Act. FDA recently released a draft of select updates for the cybersecurity guidance that are in the works to provide additional information on cybersecurity and hosted a webinar to provide more insight into the updates.

As technology continues to advance, even something as simple as the definition of a cyber device is evolving. In FDA’s select updates draft guidance, one of the major definitions is clarified: the “ability to connect to the internet” may be intentional or unintentional, both of which deem the device as a “cyber device.” This means devices not intended to be connected to the internet, but have the ability to be, will be considered a cyber device and required to provide all relevant documentation. The full definition of a cyber device is one that “(1) includes software validated, installed, or authorized by the sponsor as a device or in a device; (2) has the ability to connect to the internet; and (3) contains any such technological characteristics validated, installed, or authorized by the sponsor that could be vulnerable to cybersecurity threats.” Additionally, the FDA provided examples of devices that have the ability, even unintentionally, to connect to the internet:

• Wi-Fi or cellular
• Network, server, or Cloud Service Provider connections
• Bluetooth or Bluetooth Low Energy
• Radiofrequency communications
• Inductive communications
• Hardware connectors capable of connecting to internet (e.g., USB, ethernet, serial port)

These proposed definitions might be shocking to some who have digital health devices not intended to connect to the internet but might have the hardware or firmware to connect to the intranet or other digital health devices. Although legacy devices are currently marketed based on previous clearances, updates to hardware, firmware, and software might be needed to meet the new definitions and expectations. This means that internal procedures and processes should be updated to reflect these new expectations.

Another area of concern from the final guidance surrounded Section 524B(b)(1) of the FD&C Act, which “requires manufacturers of cyber devices to submit to FDA ‘a plan to monitor, identify, and address, as appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures’ in their premarket submissions.” The challenge for device manufacturers is that these vulnerabilities are changing continuously; just when one is identified, another is exposed. Industry demanded more clarification from FDA on the expectations of such a plan. This clarification is addressed in the draft guidance with clarification on what to include for coordinated vulnerability disclosure:

• Coordinated disclosure of vulnerabilities and exploits identified by external entities
• Disclosure of vulnerabilities and exploits identified by the manufacturer of cyber devices
• Manufacturer procedures to carry out disclosures of the vulnerabilities and exploits identified above

Cyberattacks are evolving and expose new vulnerabilities every day. Medical device companies are responsible for responding to this changing landscape as they make plans to include updates as new threats, assets, or vulnerabilities are identified on both marketed devices and devices no longer marketed, but still in use. Such a situation may have companies cross-eyed as they aim to hit one target by addressing vulnerabilities in a software update, while also needing to hit a second target by addressing existing vulnerabilities in the old software version before the update is completed. Because of this requirement, all digital health manufacturers must have an effective process in place to identify and mitigate all newly identified threats and vulnerabilities in a “reasonable time.” The question for the FDA and the industry to answer together is what a “reasonable time” is. This is part of the moving target archers are seeking to hit.

Manufacturers of cyber devices must “design, develop, and maintain processes and procedures to provide a reasonable assurance that the device and related systems are cybersecure…” (section 524B(b)(2) of the FD&C Act). FDA states in the draft guidance that “reasonable assurance of cybersecurity can be part of FDA’s determination of a device’s safety and effectiveness,” but what does “reasonable assurance” really mean? This is a second question for the FDA and the industry to answer.

Metaphoric archers may also be challenged to extend their skills when it comes to predicate comparisons for cyber devices. The draft guidance gives an example of a situation where the subject device is identified to have an increased risk, due to a newly identified cybersecurity vulnerability, compared to a predicate resulting in a not substantially equivalent decision. Medical device companies and regulators will be further challenged to evaluate risks associated with cybersecurity when considering predicate devices.

The draft guidance draws more defined boundaries around the topic of changes to cyber devices. It provides examples of changes that may impact cybersecurity requiring additional documentation versus examples of changes that wouldn’t impact cybersecurity. This clarification aims to help determine what situations lead to additional submission requirements.

In order to keep up with the world of cybersecurity, the medical device industry must adapt and overcome new challenges to ensure the safety of their devices. Navigating through these changes is akin to an archer hitting a moving target; it requires constant adjustment. The FDA and industry are working together to define the boundaries of this moving target. The draft guidance document aims to provide more clarification on the FDA’s current positions on cyber devices to assist the industry in hitting the bullseye. It is more critical than ever that manufacturers have sufficient processes in place for design development, testing (including cybersecurity), feedback, and security updates for all digital health devices. 

Hannah Taggart is a forward-thinking biomedical engineer and regulatory associate with Empirical Technologies who is helping to navigate clients through the complex regulatory landscape to provide innovative and compliant medical devices for their patients.

Meredith P. Vanderbilt is an internationally known medical device regulatory affairs consultant unafraid to communicate directly and honestly with regulatory bodies and clients about strategies and submissions to provide compliant and high-quality devices to the market.