The Maturity Paradigm

In healthcare we have an insatiable appetite to adopt new technology

Should we be worried

About state-sponsored attacks against hospitals?

Security and the Board Need to Speak the Same Language

How security leaders speak to thier C-Suite and Board can make all the difference

Who'd want to be a CISO?

Challenging job, but increasingly well paid

Medical Tourism - Growing in Popularity

Safe, fun, and much, MUCH more cost-effecitive

The Changing Face of the Security Leader

The role is changing, but what does the future hold?

Cyber Risk Insurance Won't Save Your Reputation

Be careful what you purchase and for what reason

Building AI-based cybersecurity solutions

Richard Staynings, chief security strategist at Cylera, discusses the difficulties involved in being a cybersecurity professional, tackling bad actors and how AI can both improve and hinder strategies to ensure healthcare system security. (7m 14s).


ResonanceFM PassWord - The Security of IoT

Peter Warren host of 'PassW0rd' part of Future Intelligence (Fi). 

Join Richard Staynings and Peter Warren, host of 'PassW0rd' as they discuss the growing problem of the cybersecurity of IoT - the internet of things.

Future Intelligence (Fi) produces PassW0rd, its monthly hour long radio programme from London and Leipzig for broadcast on Resonance FM, London’s oldest independent radio station.


Been Vished Lately?


By Jon Taylor
Director and Principal of Security, Versa Networks

A lot of vendors lately have been talking about how they can help companies be “less hackable” through the implementation of advanced technology, reducing the attack surface, etc. One item you don’t hear security vendors talking much about is how companies can implement some basic security awareness policies that can also drastically reduce the chances of being compromised, or at least make it a bit harder for bad actors to gain access to the network.

One example that we can discuss in detail was an event that happened at the Defcon Social Engineering Village this year. One such opportunity was thoroughly demonstrated, although I honestly couldn’t believe my eyes (and ears!). On Day One they were having a vishing competition, where teams were placed into a sound booth with a phone dialing system, and they cold-called different businesses to probe for sensitive information on how these companies secured their environments. Now, one might say that there’s no way that someone doing this would really gather anything useful, but the results will absolutely surprise you, as they did me.

Vishing meets supply chain

Now, these vishers weren’t trying to call and gather information from the IT departments of major companies, but instead they were calling franchisees of large companies that we know (and love!). The competing teams were tasked with gathering some key pieces of information, and to do so were calling the individual franchises and acting as if they were from corporate parent company posing at the IT department, franchise relations, or even another franchisee. What’s interesting about this information is that it would have given these vishers the ability to backdoor and compromise not just the franchise, but also gain access to the corporate system as well. The information they were gathering ultimately centered around the franchise-accessed resources provided by the parent company, including technologies such as VPN/ZTNA services and secure websites published to the internet as examples. Some of the resources they were probing for were corporate ordering, timecard/revenue entries, other types of inventory control, etc. They would also ask questions about the type of antivirus/anti-malware being used on the machines, especially the point-of-sale terminals.

If the above sounds bad, it was actually worse. During the exercise, at some point they would have the "mark” go to a mocked-up website from a point of sale (POS) terminal that would self-install a piece of malware, which allowed them to gain access to the computer. Now imagine what would happen if this POS terminal became compromised in some way. Just the amount of credit card information alone would be incredibly valuable on the dark web if it was to be sold. Also, if this terminal had any type of access to the parent network, then the payload could allow the malicious actor to enter the parent corporate system and do anything from planting ransomware to exfiltrating sensitive data. During one call, an employee even offered to share her computer screen and show the visher how they logged into each system using a VPN service and offered up usernames and passwords. If this had been a real malicious actor gathering this information, then this would have been disastrous for both the parent company as well as the franchise as the incident response, public disclosure, and loss of reputation could cost millions.

Now one might say that this is an example of a small business being targeted so of course there isn’t going to be security awareness training, and as long at the parent company has the right security tools they will not be breeched. Well, the latest example of this is the MGM incident. The exact same thing happened to a major corporate brand where someone was able to perform a vishing exercise and ultimately gained access to the corporate environment.

Make people aware

So, what kind of “low-hanging fruit” items should any organization be doing? First off, there should be policies in place for any employee within the company to be able to accurately identify any other employees from the company. There should also be mandatory security awareness trainings for all employees including IT, and it should be renewed within one year of the initial training. In the case of a franchise model and because of the supply chain risk, the franchise parent company should implement these mandatory security awareness trainings as part of their franchise agreement.


What is the Cost of Loss?


Join Richard Staynings on The Segment: A Zero Trust Leadership Podcast as he explores the questions of 'Why is Resiliency so important?' 'What is Zero Trust?' and 'What is the Cost of Loss?' following a breach.

Tune in to this 45 minute podcast as Richard Staynings and host Raghu Nandakumara discuss very topical cybersecurity issues and concerns for healthcare and other industries.





The Maturity Paradox

Figure 1 The Maturity Paradox. Credit: Shaun Van Niekkerk

The Healthcare industry has undergone a dramatic technological transformation over the past decade. From our frustrating interaction with a provider’s voice menu systems before we can speak with a human, to script-reading near-useless overseas calls center staff that attempt to sort out medical billing problems, we have finally entered the digital era. Gone are the days of calling a provider, simply jump on the online provider web portal or open the mHealth app on your smartphone and get what you need – well almost!

Long gone are the days of fat manila files full of medical records that no one ever looks at (unless there is a problem) and welcome-in the days of the electronic medical record (EMR) with seamless interoperability across primary, secondary, and tertiary health providers. The EMR that prevents 10 different nurses asking you the very same question on each visit (yeh right!)

Gone are the days of the suited elderly stoic medical doctor with his leather doctor’s bag and personalized stethoscope, and in are the days of the guy or girl dressed in sneakers and scrubs who looks barely old enough to have graduated high school let alone medical school.

Today’s doctor’s office is now a showcase in medical technology. Absent are the bookshelves full of leather-bound medical journals and in their place are a gadgets, gizmos, and computers that all report dutifully to the almighty EMR. The average hospital bed has between 8 and 12 medical devices. The average ER or ICU bed can have upward of 30 connected medical devices per bed.

But the hospital room of today is not just stuffed with medical devices but the room itself is connected and smart. It turns off the lights when the room is empty, it knows when to tell the HVAC that it needs negative air pressure for (infectious patients) or positive air pressure for immune-compromised patients. It also contains CCTV cameras that display at the nearby nurse station to identify when a patient is in need of attention and a whole heap of patient telemetry systems that report all kinds of vitals to those whose job it is to know. Healthcare of the 2020s is now highly technology dependent and full of advanced equipment, and the pace of change is evolving at an almost exponential rate.

Medical technology has transformed our ability to quickly diagnose medical conditions, to treat ailments, often by non-invasive means, and to quickly restore a patient back to a fully functioning member of society. Genomics-based personalized medicine may one day prevent the onset of disease and the breakdown or wearing out of the body’s components, and this may render all of us perfectly fit and mentally healthy well into our nineties and for some, even beyond.

Digital interoperability between discrete medical, public health, insurance, and population health systems is now driving the meaningful exchange of public health information (PHI). So, when you need to see a doctor while on vacation hundreds of miles or kilometers away from your home, that doctor will have access (with your permission) to your complete medical records and be able to prescribe the best possible course of treatment for you.

In Europe a German tourist can visit a Portuguese doctor while on vacation and be able to access their complete medical history. In the United States, we are not quite there yet, but other OECD countries have deployed a fully functional national medical record. In Australia, ‘My Health Record’, even allows the patient, to upload their fitness and other consumer medical data to their electronic patient record (EPR) from consumer devices like an Apple Watch or an iPhone. The technological enablement of healthcare has helped to contain costs and to drive provider efficiency by removing the need for duplicate tests and providing information at each physician’s fingertips. AI-based diagnostics is leading to targeted rather than broad treatments, this in turn leads to improved patient outcomes and reduced morbidity and mortality. However, digital transformation has come at a cost.

The fortress citadel of healthcare payers, providers and life sciences organizations is no longer able to secure healthcare data as it once did. That data is now extensively shared with patients, used for research to help drive better pharmaceuticals, healthcare tools and applications. This has greatly expanded the threat surface and healthcare data now spreads far beyond the walled confines of a doctor’s office or a hospital. Web portals where patients can check their insurance coverage, make appointments with providers, review test results, or chat with a physician are now widespread. So too are mobile health applications and a ubiquitous rise in the use of medical wearable sensors such as a Fitbit or an Apple Watch. These monitor patient activity, pulse and heart rate, and no doubt many other things in versions yet to be released. The medical data on all of us is steadily increasing. So too is the aggregate largely de-identified medical dataset used for training of artificial intelligence (AI).

Indeed, rising use of AI based machine learning (ML) is helping to drive clinical decision support and evidence-based medicine. AI has facilitated much safer low-dose radiological imaging and is driving the development of personalized medicine. But AI requires vast amounts of data for model development and training and so presents risks if not properly secured alongside its obvious benefits.

Healthcare IoT (HIoT) and the rise of the Internet of Medical Things (IoMT)

The same is true for medical devices and other healthcare IoT which are growing each year at a staggering 16% compound growth rate. These are connected to medical networks, communicate directly with critical healthcare IT systems such as the EMR and create, store, or transmit large amounts of PHI.

Without even considering their alarmingly rapid growth, these systems all present a huge cybersecurity risk. This is because most were never designed with security in mind. Nor have most been able to be patched when security vulnerabilities are discovered in their underlying operating code. What’s more, many have an amortized life span measured in decades rather than years as an inexpensive Windows PC might be, so these IoT systems will be with us for many years to come.

HIoT includes an array of typically large diagnosis machines – CT, X-Ray, PET, MRI, ultrasound; treatment systems such as ventilators, infusion pumps, defibrillators, radiotherapy, and chemotherapy devices; and a multitude of systems for patient monitoring and management. They also include a rising use of pharmacy and surgical robotic systems, as well as hospital building management systems for managing HVAC which provides hospitals with negative airflow to contain pandemic disease and clean rooms for surgery. These systems include a wide array of laboratories, CCTV, elevators, door locks, and other building systems critical to hospital workflow and safety.

The trouble is that most HIoT devices were built with very narrow design parameters, so they lack the hardware to run newer operating systems, or the storage to support a patched application if that increases the size of the application footprint. Many manufacturers refuse to spend money on developing or testing patches or security fixes because that cost was never built into their business model. Instead, they tell their customers to purchase a newer more secure device, even though there may be many years left on the amortization schedule of the existing system - a device which probably works perfectly, other than to present security risks to the medical network and safety risks to patients. Hospitals and their clinical engineering and cybersecurity teams are faced with the prospect in such cases of retiring early, perhaps millions of dollars in capital assets, patching these devices outside of vendor warranties, or implementing compensating security controls that will pass audit and allow the continued use of these devices till they can be fully written off. None of these options were until recently easy or appealing to healthcare leaders.

Medical devices are connected to the medical network on one side, and often a patient on the other side. They present one of the greatest patient safety and cybersecurity risks of all innovative new healthcare technology. They also present an open back door to hackers with the skills to compromise these simple devices.

Cybersecurity Risk

As healthcare data continues to become ever more valuable, its theft and sale on the dark web can command high prices. So too is the rising value of cyber-extortion where hospitals and other healthcare providers are held to ransom by mafia-like criminals. A closed hospital is one unable to treat patients in-need, and this has major implications for patient morbidity and mortality as well as to the community served by a ransomed hospital. Consequently, and because of lack of preparedness and under-funding in cybersecurity resiliency, healthcare providers tend to pay ransoms at a rate far higher than other industries and this is fueling the growth of an extortion industry that targets healthcare.

All of these factors - digital transformation, growth of AI, rapid expansion of HIoT / IoMT, and shortsightedness by healthcare executives and their government overseers responsible for fueling ransomware are all leading to declining security as the rapid pace of adoption for new healthcare technology far outpaces the cybersecurity needed to keep patients safe and hospitals secure.

Cybersecurity can be a very effective enabler of new riskier opportunities for patients and their care teams to engage together via technologies. But without a corresponding improvement in cybersecurity, new technologies just add risk to an already highly risky industry.

As we continue to introduce new technology to hospitals, so the digital maturity of health IT is outpacing the cybersecurity maturity of healthcare providers, and this leads to a technical debt, gaps which adversaries are easily willing and able to exploit and monetize. This is the Maturity Paradox.



"Health care has traditionally underinvested in information technology," claims Dr. John Halamka, chief information officer of Beth Israel Deaconess Medical Center in Boston. Halamka, who has been a CIO since the 1990s, says just a decade ago, pretty much all health records were paper. Then, in a period of a few years, hospitals switched to electronic records. But the security of digital health data has not kept up with its growth. Other industries, like financial services and the federal government, have devoted more than 12 percent of their IT budgets to cybersecurity. Health care averages just half that.

New Cybersecurity Testing Lab Opens in Cheltenham

A new cyber security laboratory has recently opened close to Cylera's UK offices in Cheltenham, and near GCHQ, the UK’s intelligence agency. The 5,200 sq ft lab plans to test IIoT, IoT, OT, ICS, SCADA and embedded devices which now make up a surprising percentage of connected endpoints. These devices are largely regarded by the profession as being inherently insecure and rarely patched against security vulnerabilities by their owners. The greatest problem however is that vulnerabilities are usually unknown by either owners or manufacturers.

The lab’s prime goal is to test vulnerability of vehicles, private jets, and aircraft engines. With this, the laboratory aims on strengthening industrial systems against malicious cyber activities.

This was the subject of my radio interview with BBC Radio Gloucestershire this morning. Listen to the 7 minute discussion below.


NewsTALK

Today I had the privilege to fly to Dublin, Ireland and come into the studio at 6am for a strong cup of coffee with Joe Lynam, host of newsTalk Breakfast Business and to share a few thoughts on the growing problem of cyber-crime and the security of the Irish Health Services Executive.Its been two years since the Saint-Petersburg-based Wizard Spider / Trickbot attack that crippled the HSE resulting in severe disruption of health services across Ireland and a backlog of elective procedures for many patients.

Listen in to our 6 minute conversation where we discuss the challenges of securing the internet of medical things (IoMT) and the broader healthcare life sciences industry. We also discuss the growing threat surface and who the greatest threats are to security.



Joe Lynam & Richard Staynings



FDA Implements New Rules


The March 29th FDA rule changes for the acceptance of new medical devices is a long awaited and major step in the right direction towards improving the security of medical devices. Finally, after more than a decade of pressure from cybersecurity leaders and healthcare providers, manufacturers of medical devices are to be held to a much higher standard of security design, manufacture, and support, of the devices they produce and sell, or lease to providers.

This includes the broader sharing of security information including a Software Bill of Materials (SBoM) of the components within each device and the testing and disclosure of any known vulnerabilities. No longer can manufacturers simply produce devices and move onto the next innovation. They now have a legal duty of care to support those devices they produce from now on. This change goes into effect on Oct 1st and sets a new standard of acceptance by the FDA. Devices submitted that do not adequately demonstrate adherence to the new requirements will likely be refused acceptance and will not be cleared for use.

The fact that the rules were published on the last Friday in March on the very last day that Congress stipulated in its Consolidated Appropriations Act of 2023, (signed into law on Dec. 29), shows just what a herculean task these rules must have been for the FDA and the very small team tasked with the security of medical devices. The size of that team looks to be expanded over coming months, but the government is not renowned for moving quickly so these rules were likely framed by the existing small team headed by Dr. Suzanne Swartz in the Office of Strategic Partnerships & Technology Innovation at CDRH. This is a group with a long history of dialog with manufacturers and healthcare cybersecurity leaders, with in-depth knowledge of both medical and cybersecurity concerns.

"I would expect there to be many more changes to the rules published by FDA over the next year or two as requirements are refined and clarified more definitively,” claimed Richard Staynings, Chief Security Strategist with Cylera and Adjunct Professor of Cybersecurity and Health Informatics at the University of Denver, who has been following these changes closely.

“The manufacturing industry has a long history of claiming not to understand many years of voluntary FDA Pre-Market Guidance, and so avoided making changes. I suspect that some will try the same approach now that the rules are mandatory,” suggested Staynings. “This reluctant approach to change, combined with I suspect, some real ambiguities despite the hurried best efforts of the FDA, will manifest itself in minor changes becoming necessary to the rules.”

Indeed, the FDA final guidance recently published, only impacts new devices being submitted for approval. The new rules fail to address those medical devices that are already approved and in use by medical providers. With a lifespan between 8 and 20 years, legacy medical devices will be a feature of hospitals and other providers for many years to come. They number in the millions, and many are considered a security risk in today’s already vulnerable connected digital healthcare networks.

Hospitals have proven time and time again that amortization schedules on medical and IT equipment are not to be overwritten by gaping security vulnerabilities unless severe patient safety risks can be demonstrated. This means that providers will need to continue to employ compensating IoMT security controls and widescale use of micro-segmentation of at-risk medical devices using network access control (NAC) and software defined networking (SDN), capabilities they already own though may not realize they do.

“I would suspect that in 2024, we will see additional FDA rules that provide increased security guidance on legacy devices and introduce new requirements for manufacturers.” Claimed Staynings. “At the very least this will need to include publication of SBoMs for legacy devices and vulnerability disclosures. It ideally should also require manufacturers to test and make security patches available for legacy devices, though mandating this retroactively on already approved devices may be difficult. Furthermore, the legal mandate behind rule changes, may need some level of amendment to the Protecting and Transforming Cyber Health Care (PATCH) Act of 2022.”

The Importance of an SBoM

Despite being a vital step in the security of medical devices, publication of SBoMs is not a panacea, nor are SBoMs foolproof, they merely provide security teams with a better understanding of vulnerabilities when a component in a device is found to be vulnerable elsewhere. Given the widespread re-use of hardware and software components, and software libraries by developers and systems manufacturers today, this will be useful to some providers. Smaller providers, and those with less mature security teams will be unlikely to benefit from published SBoMs since they lack the depth and breadth of capabilities to do much about known vulnerabilities already. Small and ill-equipped hospital security teams are slowly going away however as health systems merge or take advantage of outsourced security specialists. “Knowing that a number of security vulnerabilities exist, and being able to do something about those vulnerabilities are two separate things,” claimed Staynings.

The New Manufacturer Paradigm

Over the next six months manufacturers of ‘cyber’ connected medical devices will need to evaluate the security of the devices they have in development to consider each’s overall security protections, to test each device for security vulnerabilities and to build and maintain improved security documentation including an SBOM and develop improved capabilities to support new requirements around security vulnerabilities disclosure. “This should not be ‘news’ to any of them given the passage of the PATCH act on March 15th 2022, over a year ago, or years of FDA guidance preceding the act. In fact, all manufacturers have seen the writing on the wall for quite some time”, claimed Staynings. “Manufacturers should examine the new FDA rules very closely and seek immediate clarification if they don’t understand fully, so that their devices are not refused acceptance come October.”

A Welcome Reset

“The passage of the new rules is a welcome reset for medical device security,” claimed Staynings during an interview with SCMedia. This has been one of several open backdoors to securing healthcare for quite some time, and with the growth in medical devices hitting 18% per annum in 2022 this is both a growing concern and gaping risk, that is now finally after much effort, being addressed by new FDA rules.

New FDA Rules Go Into Effect


Yesterday the FDA gave notice that as of Oct 1st it will “refuse to accept” medical devices and related systems unless they meet its new cybersecurity requirements which went into effect March 29th, 2023. These requirements are embodied in new FDA final guidance on its Refuse to Accept (RTA) policy relating to cybersecurity in medical devices, specifically for “Cyber Devices” as defined in the newly-amended FD&C Act (Section 524B).

These powers come out of the Protecting and Transforming Cyber Health Care (PATCH) Act of 2022 and the provisions which were funded under the Consolidated Appropriations Act of 2023 signed into law on Dec. 29. Given the passage of both acts last year, and growing demands for improved medical device cybersecurity going back at least a decade, this should come as no surprise to manufacturers.

Indeed, pre-market FDA security guidance prior to the new law has stipulated increased security requirements, though many manufacturers have not yet implemented this guidance. Under the new powers, improvements in the cybersecurity and ongoing support of medical devices is now mandatory.

This means that if you’re a company building a medical “cyber device”, it is now a requirement that you build your device to be secure by design, develop strategies to monitor and maintain the security of that device post-market and for the life of the device, generate and maintain a software bill of materials, and generate the requisite documentation proving you’ve done so as part of your FDA regulatory submission.


A New Era in Medical Device Security

The days of build, sell, and forget, are now over. While some manufacturers were better than others about cybersecurity and ongoing patch support, others were plainly borderline negligent. The refusal to patch known highly vulnerable medical devices resulted in the FDA issuing its first ever medical device recall in 2017 following the very public disclosure of critical security vulnerabilities from the hacking of a St Jude Medical cardiac defibrillator. St Jude Medical had a long history of refusing to patch its insecure medical devices, and shortly after the disclosure, the company was sold to Abbott Labs reportedly at a big discount.

Submissions to FDA need to include a software bill of materials, which must contain all commercial, open-source, and off-the-shelf software components, while complying with other FDA requirements “to demonstrate reasonable assurance that the device and related systems are cybersecure.” This allows healthcare provider security teams to immediately understand and react to their exposures when CVEs are published for individual software components rather than wait for medical device manufacturers to assess and publish their own vulnerability disclosures.

Device manufacturers will need to submit plans to monitor, identify and address in a "reasonable timeframe" any determined post-market cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosures and plans. “While the language here is vague and not specific, it’s a big improvement over current arbitrary disclosure practices” claimed Timur Ozekcin, CEO of Cylera.

Developers must now design and maintain procedures able to show, with reasonable assurance, “that the device and related systems are cybersecure” and create post-market updates and patches to the device and connected systems that address “on a reasonably justified regular cycle, known vulnerabilities,” according to the guidance.

If discovered out-of-cycle, the manufacturer must also make public “critical vulnerabilities that could cause uncontrolled risks,” as soon as possible. “This appears to be weaker requirements than the originally proposed 30-day patch availability requirement, as is common for other software when critical vulnerabilities are discovered, but it’s a lot better than the current situation,” added Ozekcin.

“These changes mark a much-needed improvement to the security of connected medical devices, but they don’t cover the millions of legacy devices currently in use in our hospitals and clinics. Unless the FDA introduces rules to address these legacy devices then it may take many years before the security of the healthcare industry is significantly impacted,” claimed Richard Staynings, Chief Security Strategist with Cylera. “Medical devices have an expected lifespan of between 8 and 20 years in some cases, so the security of these systems will more than likely be an issue till 2043 and that’s too long,” he added.

While not all connected medical devices will develop security vulnerabilities, many will over the course of their lifetime and amortization schedule. What is needed is a way to better identify medical and other healthcare IoT connected devices, understand their risks and accurately profile devices so that software defined networking (SDN) tools like network access control (NAC) can be used to segment and isolate potentially at-risk systems. AI based tools like Cylera MedCommand now automate this entire process leading to seamless orchestration of security policy across the healthcare network.

For more information on how Cylera solves the problem of cyber-securing legacy medical devices, please contact us to request an overview and demo. 

This story was first posted here

What Security Professionals Need to Know About Safeguarding Medical Devices and Hospital IoT


 
Medical devices are becoming increasingly interconnected and vulnerable to cyber-attacks. As a security professional, it’s crucial that you understand the risks and how to safeguard these devices. Episode S5E3 of the Brilliance Security Magazine Security Podcast will provide an overview of the medical IoT landscape and critical considerations for protecting these devices.

Listen in as Richard Staynings, Chief Security Strategist at Cyleraand Steve Bowcut, Editor at Brilliance Security Magazine discuss what security professionals need to know about the ever-increasing threats against IoT devices in the medical environment. They cover the vulnerable devices, the information threat actors seek, the types of attacks they launch, and effective mitigation strategies.

Click on the image below to take you to the Brilliance Security Magazine Podcast where you can listen on Spotify or your favorite podcast application or just listen in from the web page directly.