We celebrated National Cybersecurity Awareness Month a few weeks ago by bringing you the FDA’s newly published Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, with a promise to cover the Agency’s promised update on its Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which was first
Did you know that October is National Cybersecurity Awareness Month? Neither did we, until we started poking around the FDA’s recent press release announcing that it intends to update its guidance on medical device cybersecurity within the next few weeks. We also learned that National Cybersecurity Awareness Month has been observed each October since its…
We were not affected by the recent ransomware attack that disabled computers worldwide, including in multiple public hospitals in the UK. At least not yet. For those who have never had the pleasure or who otherwise do not follow cybersecurity news closely, “ransomware” refers to an attack on a computer system that encrypts the user’s…
The FDA released its final Guidance on Postmarket Management of Cybersecurity in Medical Devices during the week between Christmas and New Year. You can link to a full copy here, and we gave you our detailed take on the draft Guidance here. You can also click here to see what our data privacy and security colleagues wrote about the final Guidance on Reed Smith’s Technology Law Dispatch, as they beat us to the presses.
The final Guidance resembles the draft, with a few refinements. We see two guiding principles in the final Guidance. First, the final Guidance continues to follow a risk-based approach. As we observed before, the FDA could not have taken a different tack. Medical devices always present both benefits and risks, and the goal of regulators when it comes to cybersecurity is to assess and mitigate risks without overly compromising a device’s benefits. Second, the FDA recognizes that managing medical device cybersecurity takes a village. Or, in the Agency’s words, “FDA recognizes that medical device cybersecurity is a shared responsibility among stakeholders including health care facilities, patients, providers, and manufacturers of medical devices.” Guidance, at 12.
The final Guidance therefore recommends the implementation of cybersecurity risk management programs. Such programs would include monitoring reported adverse events under current regulations. The FDA also recommends incorporating elements consistent with the National Institute for Standards and Technology’s Framework for Improving Critical Infrastructure Cybersecurity. Guidance, at 14. We commented in our prior post that the FDA was combining familiar medical device elements with others borrowed from the cybersecurity world. The citation to NIST’s Framework is a perfect example of the wedding between those two worlds.
More specifically, a cybersecurity risk management program would include:
- Monitoring cybersecurity information sources for identification and detection of cybersecurity vulnerabilities and risk;
- Maintaining robust software lifecycle processes;
- Understanding, assessing and detecting presence and impact of a vulnerability;
- Establishing and communicating processes for vulnerability intake and handling;
- Using threat modeling to define clearly how to maintain safety and essential performance of a device by developing 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.
We have been tracking the issue of medical device cybersecurity for quite some time now. We wrote here on how medical device hacking is both the stuff of Hollywood storytelling and also a genuine concern to which the FDA and medical device manufacturers are paying attention. In June 2013, the FDA issued a Safety Communication entitled “Cybersecurity for Medical Devices and Hospital Networks,” and the agency finalized a guidance document in October 2014 on how to address cybersecurity in medical device premarket submissions. In that guidance the FDA set forth a risk-based model, under which device manufacturers are to identify and assess both risks and strategies to mitigate the risks in preparing their premarket applications. To complete the backstory, the FDA took the unusual step in July 2015 of issuing a Safety Communication regarding a specific cybersecurity vulnerability in a network-connected pain pump. We wrote about that in our prior post, too.
The new development is the FDA’s release on January 15, 2016, of a draft guidance on postmarket management of cybersecurity in medical devices. You can link to the draft guidance (which actually bears today’s date, January 22, 2016) here. Again, the FDA is taking a risk-based approach, i.e., guiding manufacturers to identify, assess, and mitigate risks that emerge after a product has been introduced to market. Come to think of it, the agency could hardly take a different approach, given that all medical devices present both benefits and risks and that risks cannot be complete mitigated in any device. The draft guidance puts it this way: “Because cybersecurity risks to medical devices are continually evolving, it is not possible to complete mitigate risks through premarket controls alone. Therefore, it is essential that manufacturers implement comprehensive cybersecurity risk management programs . . . .” (Draft Guidance, at 11)
We have been meaning for a while to write about LabMD’s epic data privacy fight against the FTC. We’re sure you have read about the action, and particularly about the administrative order dismissing the government’s Administrative Complaint in November 2015. The noteworthy part of the order is its holding that the government has to prove actual injury to consumers, not merely a theoretical “risk” of future harm, in data privacy enforcement actions. We like the sound of that. It reminds us of the old days of medical monitoring class actions, otherwise known as “money for nothing,” where uninjured plaintiffs would claim compensation for future medical surveillance, even though they had never experienced any actual complication. We don’t see those much anymore, but a similar battle has gone on in the context of data privacy. The vast majority of data security breaches result in no tangible harm to anyone, but plaintiffs still sue, and they still want money for the theoretical risk that someone, someday might use their private information to cause them harm—fraud, identity theft, and the
But back to LabMD. The FTC has gone after many companies for allegedly lax data security practices, and in almost every case, the target comes to a negotiated resolution, usually involving a fine and a consent decree requiring certain measures to better protect private information. What makes LabMD different is that, once it found itself in the FTC’s crosshairs, it fought back. That decision was bad for business—the company announced in 2014 that the government’s action essentially closed it down—but it resulted in a complete win at the administrative level and a landmark order pinning back the government’s ears. The action has been going on for years, but here is what you really need to know:
Why do we care? The issue is data privacy and security, and the drug and device industry holds reams of private information—employee data, customer data, consumer data, patient data, etc. The FTC remains the biggest bully in the schoolyard when it comes to data privacy, and the LabMD order is a landmark in delimiting the FTC’s usually unchallenged regulatory prerogative.
Dick Cheney famously disclosed a few years ago that he had the wireless function of his pacemaker disconnected while he was Vice President because he was concerned that hackers might fiddle with the device remotely and do him harm. We at the Drug and Device Law Blog can’t help but wonder whether the Veep placed himself ahead of or behind the risk-benefit curve. Sure, he mitigated the risk that some malicious and very clever hacker would successfully target him. But he also disabled an important feature of a device that was intended to protect and extend his life.
Was he better or worse off? We don’t know. We do know that when we first learned about wirelessly connected implanted medical devices, we were amazed by technology that appeared straight out of Star Trek. You know, like when Bones would treat some befallen Enterprise crew member in a color-coded T-shirt by waving a handheld device over his or her clothed skin. That’s how we pictured connected devices like cardiac defibrillators—capable of transmitting telemetry, issuing warnings, accepting software upgrades, taking commands, and otherwise treating human frailty—remotely and without the need for any invasive procedure.
The potential benefits to health are tremendous, and wireless connectivity is now common in numerous types of medical devices, implanted and not. But what about the potential risks? We are told that Cheney’s paranoia became the basis for an episode of Homeland, a show we have never seen, but that apparently involved a fictional Vice President harmed by pacemaker hackers with malice aforethought. (Although we have never watched Homeland, we have seen every episode of Veep, which stars Julia Louis Dreyfus as a different fictional Vice President (and later President) and is wickedly funny, but so profane that our mother-in-law elected to leave the room rather than watch it. But we digress).