In 2014, the Food and Drug Administration (“FDA”) articulated its expectations for how device manufacturers address cybersecurity premarket in Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Recently, the FDA released complementary draft guidance in Postmarket Management of Cybersecurity in Medical Devices. In the new guidance, the FDA explains what constitutes an effective cybersecurity risk management program, how manufacturers should evaluate postmarket cybersecurity vulnerabilities, and when manufacturers must report to the FDA cybersecurity risks and improvements. Comments on the draft guidance are due by April 21, 2016.
Here are the key takeaways from the guidance:
- Cybersecurity programs should be documented, systematic, and comprehensive.
- Consider medical device cybersecurity throughout the device’s entire lifecycle.
- When evaluating a medical device’s cybersecurity, consider a broad range of quality information and focus on cybersecurity threats that may compromise a device’s essential functions.
Components of an Effective Cybersecurity Risk Management Program
The new guidance exhorts manufacturers to create a cybersecurity risk management program that will address a device’s cybersecurity from the drawing board to the dustbin.
Premarket, manufacturers should account for cybersecurity by designing cybersecurity-related inputs for their devices and incorporating a cybersecurity management approach that determines (A) assets, threats, and vulnerabilities; (B) how threats and vulnerabilities may affect device functionality and end users/patients; (C) the likelihood of threats and exploitation of vulnerabilities; (D) risk levels and suitable mitigation strategies; and (E) residual risk and risk acceptance criteria. (The FDA gave the same recommendations in its guidance 2014 premarket guidance.)
Adequate postmarket cybersecurity management requires a program that is systematic, structured, documented, consistent with the Quality System Regulation (21 C.F.R. Part 820), and incorporates the National Institute of Standards and Technology’s (NIST) Framework for Improving Critical Infrastructure Cybersecurity (cybersecurity guidelines the NIST created pursuant to a presidential executive order and with input from public and private stakeholders). Key components include:
- monitoring quality cybersecurity information sources—such as complaints, service records, and data provided through cybersecurity Information Sharing Analysis Organizations (“ISAOs”)—for identification and detection of cybersecurity vulnerabilities and risk;
- establishing, communicating, and documenting processes for vulnerability intake and handling;
- understanding, assessing, and detecting the presence and impact of vulnerabilities;
- clearly defining essential clinical performance to develop mitigations that protect, respond, and recover from the cybersecurity risk;
- adopting a coordinated vulnerability disclosure policy and practice; and
- deploying mitigations that address cybersecurity risk early and prior to exploitation.
Assessing Postmarket Cybersecurity Vulnerabilities
Acknowledging that not all vulnerabilities threaten patient safety and that manufacturers may not be able to identify every threat, the guidance advises manufacturers to identify a device’s “essential clinical performance” and focus on identifying and resolving risks to that performance. Manufacturers should define a device’s essential clinical performance by considering the conditions necessary for the device to operate safely and effectively. Manufacturers should assess a vulnerability’s risk by evaluating its exploitability and health dangers resulting from its exploitation. The draft guidance recommends tools for each evaluation: the Common Vulnerability Scoring System v3.0 for exploitability and the standards in ANSI/AAMI/ISO 14971: 2007/(R)2010: Medical Devices – 442 Application of Risk Management to Medical Devices for health dangers caused by exploitation.
The guidance divides risks into two groups and recommends manufacturers do the same. Low or “controlled” risk exists when, after accounting for existing controls, there is an acceptable amount of risk that the device’s essential clinical performance could be compromised by a cybersecurity vulnerability. High or “uncontrolled” risk exists when insufficient controls and mitigations create an unacceptable amount of risk that the device’s essential clinical performance could be compromised by a cybersecurity vulnerability.
A risk’s classification affects whether a manufacturer may address the risk without reporting the risk and its remediation to the FDA under 21 C.F.R. Part 806, which obligates manufacturers to report to the FDA when they repair, modify, or adjust a device to reduce the device’s health risk. Manufacturers may ameliorate controlled risks without reporting the risk or enhancement under Part 806. (But for Class III devices, manufacturers must disclose the risk and the remediation in its periodic report to the FDA under 21 C.F.R. § 814.84.) Uncontrolled risks are a different matter: manufacturers must report them and their remediation unless (A) there are no known serious adverse events or deaths associated with the vulnerability; (B) within 30 days of learning of the vulnerability, the manufacturer identifies and implements device changes and/or compensating controls to bring the residual risk to an acceptable level and notifies users; and (C) the manufacturer participates in an ISAO.
What the Draft Guidance Means for Device Manufacturers
Device manufacturers should not delay assessing the strength of their cybersecurity management program. The U.S. Department of Health and Human Services, Office of Inspector General identified cybersecurity of medical devices as one of its priorities for 2016. And the draft guidance explains that the FDA may consider devices with uncontrolled risk to violate the FDCA and be subject to enforcement action.
To see how their program measures up to what the draft guidance describes, device manufacturers should start by ask themselves these key questions:
- Is our cybersecurity management program addressing cybersecurity throughout each device’s lifecycle?
- Is our program proactive?
- Are there quality data security sources, such as ISAOs, we have not used but should?
- Do we need to develop and deploy new training or messaging to colleagues about cybersecurity?
- Are we using good cyber hygiene?
When deciding how to move forward with strengthening a cybersecurity program, manufacturers will want to keep in mind the need to safeguard devices against malicious and non-malicious attacks. Vulnerable devices may become infected by malware that cannot tell the difference between a personal computer and a pacemaker. That example is not farfetched: J.M. Porup recently reported for Slate that malware designed to steal credit card information infected and disabled vulnerable fetal heart monitors.