Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available through these devices, their connectivity as part of the Internet of Things (IoT) ecosystem also introduces significant potential risks to patient safety and data security. In the health care industry, concerns about potential cyberattacks and data breaches are ongoing, and the enforcement of cybersecurity laws and standards, with associated penalties for violations, continues to increase.
In this hoganlovells.com interview, Hogan Lovells senior associate Paul Otto identifies the greatest risks to connected medical devices and the processes that companies are putting into place to address them. Cybersecurity threats can be mitigated with initiatives such as risk analysis and management, training and awareness, and incident response planning. Product engineers can address cyber threats by considering potential risks and vulnerabilities throughout the product lifecycle, starting with design and development. And legal counsel plays a critical role when companies must respond to a potential security incident or vulnerability.
What should companies in the life sciences and health care space know about the risks of connected medical devices?
Otto: Organizations are becoming more data driven, even if they weren’t previously thinking of themselves as data organizations. Increasingly in the health care space, a lot of manufacturers that have traditionally been manufacturing implants or other devices, pills for prescriptions, and other products that enter our health system — those manufacturers may have been in the business for decades, and yet have not historically had much involvement beyond the point of sale, so they haven’t been part of the continuing patient-provider relationship.
Now we’re in this phase where those companies — and other new start-ups and tech innovators — are entering the health care space with devices that have internet-connected capabilities. The same devices they made five or ten years ago are now connected to other networks and systems, pulling data out and providing great benefits for the health care profession, in terms of deriving insight about outcomes, patient health, and effective delivery of care.
But the flip side is that this increased connectivity carries a lot of risk. Organizations that have not had a large team of software developers focused on IoT or network security issues face more data exposure than ever before, and a continuing role in the health care ecosystem that they may have never enjoyed.
They may have sold devices and then never seen any further output, except perhaps a summary report of effectiveness from a hospital. But now they can get minute-by-minute data from individual patients indicating whether, for example, a pacemaker is functioning correctly, or a knee implant is showing signs of wear — all sorts of tremendous insights. But with that comes infinitely larger cyberattack exposure and more data being collected that’s subject to attack, compromise, and manipulation by bad actors with malicious intent, and by people inadvertently making mistakes that may cause patient harm or impact data confidentiality.
How would you describe the oversight enforcement environment right now? Is it increasingly aggressive?
Otto: It is, and this is an area where the intersection of all these different components means there is not just one regulator that owns this space. A large number of government entities either have regulatory enforcement authority, oversight authority, or are issuing guidance and standards for connected medical devices.
Traditional regulators include the U.S. Food and Drug Administration (FDA), which has primary oversight over medical devices generally. Different elements come into play when we’re talking about connected devices, however. The U.S. Federal Trade Commission (FTC) generally oversees consumer protection issues and views privacy and cybersecurity as within its purview. The FTC expects companies to have reasonable privacy and security practices in place and inform consumers of their rights and responsibilities as well as how their data is being used. That’s a different enforcement arm than many medical device manufacturers may historically have focused on. Being a direct data recipient may create obligations for connected medical device manufacturers under HIPAA, which is enforced by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights.
And it goes on. If you’re a publicly traded company, the U.S. Securities and Exchange Commission (SEC) has expectations about disclosing cybersecurity-related risk. Many branches of law enforcement are actively investigating threats, vulnerabilities, and potential or actual attacks on networks and systems, including connected medical devices. All that adds up to a lot of cooks in the kitchen — a lot of different agencies and regulators that are paying attention in this space. They’re staffing up with expertise internally to effectively look at these devices and analyze whether companies are employing reasonable security, both before the fact and increasingly after the report of an incident or vulnerability.
How does the European Union’s General Data Protection Regulation (GDPR) play a role in this context?
Otto: The focus in the United States is naturally on U.S. laws and regulations, but this is increasingly a global impact. What’s happening in Europe with the GDPR is a new regime coming into force this year, which carries with it a much larger potential penalty, from a regulatory perspective, for violations of data protection principles, expectations, and requirements.
Starting in May 2018, we’re in a regime where European authorities may have previously expressed interest in investigating a reported vulnerability in a connected medical device, but the penalties and fines that they had underlying their statutes, regulations, and directives weren’t anywhere near what they will be. With that comes a spotlight on companies that are operating globally to look at how they’re complying with the regulatory schemes abroad, as well as the interconnected complex regulatory environment in the United States with various laws, regulations, and regulators in play. The GDPR is a prime example of how an international focus is necessary and equally primary for a U.S.-based company or one that’s operating in the United States.
You’ve discussed several initiatives to manage risk for connected medical devices. What are the best practices for risk analysis?
Otto: In light of the sheer volume of laws and regulations and the many entities issuing guidance, our goals as legal advisors in this space are to help distill down the compliance requirements as well as the core principles that anyone tasked with managing this risk in their organization should consider.
When managing privacy- and cybersecurity-related risks for connected medical devices, there are certain buckets that the compliance or legal staff of a company should think through and confirm that they have appropriate policies, procedures, and practices in place. At a high level, the most important ones are, at the beginning, risk analysis and corresponding risk management. The foundational principle that permeates most regulations, security standards, and frameworks these days is that the organization has a principled approach to identifying potential threats and vulnerabilities at the start, so throughout the design, development, and maintenance of the connected medical device, they’re evaluating the risks to the data and patient safety associated with that device. What controls do they have in place to mitigate or address risks?
Sometimes that means re-architecting a device, building in additional safeguards, or layering other controls on top of the use of that device. For a pacemaker, for example, you can only make but so many changes after you’ve implanted it. You can connect wirelessly and push software updates, but you might think more about the design elements: what type of data transfer do you anticipate needing? And can you limit your attack potential by closing off other avenues for connectivity, or adding more complex authentication requirements?
That kind of risk analysis process at the outset informs every stage of a product’s lifecycle. And corresponding risk management involves being attentive to the changing threat landscape over that product’s lifetime. Over time, new threats and vulnerabilities will present themselves. Five years ago, no one was talking about ransomware as a major attack vector, and yet in the last year, we’ve seen a wave of ransomware attacks that included medical devices being impacted. That’s the kind of risk that an organization ought to consider as part of their risk analysis now.
Another component of risk management is training. Can you expand on that?
Otto: Training and awareness is an area where an overall understanding of privacy and cybersecurity is important at every level, both within the device manufacturing company and with the hospitals, providers, and others in the health care system that interact with a connected medical device. Sometimes that means confirming the materials you provide with the device will help users — patients and physicians — know how to safely and effectively use the device in a way that manages cybersecurity and other risks.
It also means informing your developers and product engineers about best principles for designing privacy in, thinking about cybersecurity early on, and continuing to identify over time when there’s something they should be responding to or acting upon. Many organizations remind people about suspicious e-mails and not to click on links. That’s an easy example, but just one of the many ways in which training and awareness is a continuous process of responding to IoT-related issues that could threaten the privacy and security of data and the device.
How are two of the risk management components, vulnerability management and incident response planning, interrelated?
Otto: Vulnerability management for devices is a crucial component of a broader incident response and crisis management plan. This is the recognition that product and software design is never without flaws, and an important aspect of product design, development, and maintenance is to continually be prepared, assess the potential impact and severity of a new vulnerability when it’s identified, and then act upon it as appropriate. Determine whether some change is needed to the product or whether additional compensating controls could be put into place. Perhaps an additional instruction goes out to physicians to warn them not to configure the device a certain way, or in some cases, actually change the software on a connected medical device, even if it’s implanted.
That vulnerability-managing process necessitates being ready to promptly review and decide whether to change something, and then act. Security researchers are constantly pushing, probing, and prodding devices on the market, looking for ways to demonstrate their strength and highlight how companies are not effectively managing risk. Then there are potential bad actors who are doing the same thing, but we might not learn about them until they’re successful.
And that last part leads to the incident response planning component: having a plan and process in place to deal with suspected or actual cyberattacks or data breaches. For example, let’s say there’s some indication that there’s been a compromise either on the devices themselves or leveraging those devices. An incident might involve someone trying to steal patient data off devices, and that could raise very serious concerns from a privacy and data protection perspective about whether those patients need to be notified or if there is potential harm to patients from the theft of that information.
Another potential incident would be a device being compromised and then used for another purpose. That could be a connected medical device sitting in a hospital, which may be used as a gateway into the hospital’s network, or used as part of a network of compromised devices in a botnet or denial-of-service (DoS) attack. Those devices might be compromised not because a bad actor wants anything off them, but just to use them for some other purpose. All those incidents ultimately need to roll up into a process that a company has to act on in case of an incident, to evaluate what their response should be, how they can contain that incident, what obligations they might have legally, contractually, and otherwise to act upon and notify affected individuals and customers.
What is the lawyer’s role in advising a company in these matters?
Otto: This is an area in which you need a lot of coordination. There are going to be product engineers who have primary responsibility for thinking about privacy and cybersecurity, and a support team and maintenance team managing the lifecycle of that device. You might have people in the field interacting with those devices. You have regulatory compliance folks supporting that device’s certification, review process, and government approvals.
All these elements of a company have a role to play in privacy and cybersecurity. The role of the legal team is to help throughout the process. You design a process to meet legal obligations and on the back end, to advise on how to respond to identified vulnerabilities or an incident that has arisen. We commonly see a vulnerability come to light, and a company then takes stock internally as to whether they responded adequately and what that vulnerability means for their company in terms of the associated exposure. Those are sensitive conversations, and having legal direction can help shape the inquiry or internal investigation about what the response should be as well as how it was managed historically. Perhaps the vulnerability was known for some period of time and hadn’t yet been acted upon or there were internal debates about whether and how to respond.
Most acutely, an incident presents a lot of potential liability to a company, not the least of which is any immediate risk to patient safety. Decisions about how quickly to send out notifications to inform the patient or physician, how accurately you’re conveying information about the potential risk to affected stakeholders in the health care system as well as assessing, investigating, and navigating the process of determining what happened, how bad it was, what type of exposure is related to that incident — all that benefits from the guidance of legal counsel.