The Food and Drug Administration (FDA), with the issuance of its recent 2016 Draft Guidance “Postmarket Management of Cybersecurity in Medical Devices,” continues to step up its involvement with medical devices having a software component. This is consistent with the Office of Inspector General’s 2016 Work Plan, wherein the OIG specifically intends to focus on the vulnerability of networked, as well as software-driven medical devices.

This is just the latest move in the FDA’s focus on medical device software, which began as early as 2002, when the agency published its Guidance on Software Validation. Since that time, the use of software in medical devices has increased and become more complex. This has coincided with the emergence of the mobile medical app industry. This market growth, along with the growing sensitivity on cyber safety, has caused the FDA to turn its attention to cybersecurity and protecting public health from vulnerabilities presented by the increasing use of software in medical devices.

Premarket management of cybersecurity

The FDA has approached the management of cybersecurity risks from both a premarket position, as well as a postmarket management perspective. In October 2014, the FDA published a Guidance entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” which aimed at assisting companies submitting 510(k) premarket notifications, Premarket Approvals (PMA), Product Development Protocols (PDPs) and Humanitarian Device Exemption (HDE) submissions to ensure that all such submissions adequately address cybersecurity considerations. This guidance suggests that entities filing a premarket submission with the FDA include the following components in the filings:

  • Identification of cybersecurity assets, threats and vulnerabilities
  • Assessment of the impact of these threats and vulnerabilities on device functionality and the consumer, customer or patient
  • Assessment of the likelihood of a threat or vulnerability being exploited
  • A determination of the risks levels and suitable mitigation strategies
  • An assessment of residual risk and risk acceptance criteria

This list is not all inclusive, and each point requires a consideration of the nature and function of the device that is subject to the premarket submission. The FDA has implemented a risk-based approach to these analyses. In these submissions, medical device manufacturers are directed to consider cybersecurity risks, assess the vulnerabilities and identify how they will protect against exploitation of those vulnerabilities. The submissions should include preemptively designed measures that proportionally deal with the identified vulnerabilities, the risk those vulnerabilities pose if exploited, and the potential impact on consumers or patients. The FDA recommends that medical device companies spend a significant amount of time in their submissions addressing these vulnerabilities while justifying all controls and mitigating efforts in light of the vulnerabilities and risks they address. In the analysis of these vulnerabilities, the FDA envisions that these analyses will be divided into two stages:

  1. Identify and Protect: Pre-emptive measures to identify possible vulnerabilities and proactively implement controls to reasonably prevent exploitation.
  2. Detect, Respond, Recover: These steps are implemented to respond when a vulnerability is exploited, responding to the exploit to minimize the risk to the device and the patient or user, and recover information from the device so that further exploitation can be prevented.

Under this final Guidance, premarket submissions require manufacturers and developers to possess a significant understanding of how their products will be used in the market, what access is available to those devices for vulnerability exploitation, and how they can properly address these issues during the design of the product itself. Since the inception and finalization of this premarket submission guidance, the FDA has further examined the role of cybersecurity and developed/adopted industry vocabulary and applied it to susceptible medical devices.

A new postmarket guidance scheme, a new vocabulary

As the FDA has considered the issue of cybersecurity, it has refined the risk-based concepts by dealing with risks in ways proportional to their potential impact. The FDA has accomplished this by drafting another guidance, yet to be finalized, which it issued on Jan. 22, 2016 wherein it addresses Postmarket Management of Cybersecurity in Medical Devices. The FDA’s approach, as reflected in this draft Guidance, is evidenced in a new set of terms the FDA has defined in order to help the industry deal with cybersecurity issues with a clear set of parameters. Among the most important concepts are:

  • Compensating Controls: A safeguard or countermeasure external to the device employed by the end user in the place of sufficient controls implemented by the manufacturer. These Compensating Controls provide sufficient protection for the medical device such that it is not necessary for the control to be implemented within the device itself. Compensating Controls may be used for a variety of reasons, but the FDA envisions them being used where it is more efficient for the end user to provide the control rather than the manufacturer.
  • Cybersecurity Routine Updates and Patches: Medical devices, like any other piece of modern technology, utilize firmware and software that may contain bugs or vulnerabilities that the manufacturer must fix via patches or updates. They may also impact the product instructions for use and labeling. Generally, these are not considered a repair and are not required to be reported to the FDA. Not included are those updates, patches or repairs that are associated with a reasonable probability that use of or exposure to the medical device will cause serious adverse health consequences or death.
  • Controlled Risk: A risk is considered controlled when steps taken by the manufacturer, through capabilities of the device itself or through Compensating Controls, are effective such that there is sufficiently low risk that the device’s essential clinical performance could be compromised by a cybersecurity vulnerability. A risk becomes an Uncontrolled Risk where there exists an unacceptable risk that the device could be so compromised as to impair its essential function.
  • Cybersecurity Signal: A Cybersecurity Signal is any indication or information that indicates the potential for or confirmation of a cybersecurity vulnerability or exploit that could affect a medical device. Such signals may include internal monitoring, business partners, postmarket surveillance, customer complaints, researchers and Information Sharing and Analysis Organizations (or ISAOs).
  • Essential Clinical Performance: Performance levels necessary to achieve freedom from unacceptable clinical risk as defined by the manufacturer. If the Essential Clinical Performance is compromised, users may be exposed to harm or may require intervention to prevent that harm.
  • Exploit, Threat, Vulnerability: The FDA has defined several classes of risks to medical devices and software that result from vulnerabilities in the software that may be exploited, intentionally or unintentionally, and represent a threat to the essential clinical performance of the medical device or software. It is this three-step system of risk identification that the FDA’s cybersecurity efforts revolve around.
  • Remediation: Any action taken to reduce the risk to a medical device or software’s essential clinical performance. These may include through patches and updates or compensating controls. Complete remediations are actions that entirely address a risk to sufficiently categorize it as a Controlled Risk. Any other remediation is considered an incomplete risk.

This draft guidance emphasizes the FDA’s concerns about the risk to medical devices and therefore public health when medical device manufacturers and health care providers are not vigilant as to cybersecurity vulnerabilities and breaches. This then is what has led to the FDA’s recommendation within the draft Guidance that medical device manufacturers implement a “comprehensive cybersecurity risk management program.” These programs will have to be designed to include a reporting requirement for the most serious risks that pose safety issues, as well as a patching requirement for the less serious risks. Critical components of each of these management programs will have to include: monitoring; assessing and detecting risks; handling of the vulnerabilities once identified or realized; and mitigation strategies to respond and recover from cybersecurity breaches.

The filing of premarket submissions for medical devices which carry a cybersecurity risk, as well as the drafting of the postmarket management plan noted above, require the involvement of experienced regulatory counsel in coordination with cybersecurity counsel. Thompson Coburns’ Life Science and Cybersecurity practices have a coordinated approach in assisting our medical device clients in complying with not only these regulatory requirements, but assisting them in responding should a cybersecurity breach occur. If you have any questions about cybersecurity matters, or any other content on this blog, contact the authors at Thompson Coburn where we have attorneys experienced in medical device compliance, FDA compliance programs, cybersecurity breaches and related counselling.