Medical IoT devices operate in care facility environments that encompass care giving, case management, customer service, and clinic management. As such, the risk of data gathered and managed by medical devices extends beyond the device itself. A compromise of clinic management services can propagate to IoT device command and control, allowing compromise of devices in attacks that do not directly touch the device at all. This is clearly the major driver for the emerging category of “Medical IoT (IoMT) Cyber Security ”

A large hospital for examples could be home to as many as 85,000 connected devices. While each of these devices has a significant role in the delivery of care and operational efficiency, each connected device also opens the door to a malicious cyberattack. A recent report from Irdeto, found that 82 percent of healthcare organizations’ IoT devices have been targeted with a cyberattack within the last year.

Going over the players in this industry, it is clear that the Medical IoT security category includes a number of different approaches with the common target to provide the customer with a clear assets discovery and timely alerting on security breaches and attacks on its Medical environment.

Although many large security players are addressing this niche too, CyberDB identified a number of emerging players that are focusing on this industry and as such we expect them to benefit from the growth in this market. These players are (in alphabetical order):

Due to the clear use case and the growing awareness and need in this market, we can see general-purpose IoT security players moving towards the Medical IoT security market.

According a recent report by BisResearch, the overall Medical IoT Cyber security market has been witnessing a steady growth. The market is expected to continue to grow with a double digit CAGR of 41.38% during the forecast period 2019-2028.

CyberMDX

CyberMDX is a pioneer in medical cyber security, delivering visibility, threat prevention and analytics for medical and IoT devices and clinical assets. It is a best of breed product built from the ground up for healthcare delivery organizations. CyberMDX is established in 2017, acts globally and raised so far $10M of funds. Its headquarters reside in Tel Aviv & New York City

CyberMDX counters and prevents growing cyber-threats against hospitals, ensuring its critical assets operational continuity as well as patient and data safety. CyberMDX delivers endpoint visibility, network threat prevention and operational analytics for medical, IoT, and OT devices. The agentless solution automates the most granular, context-aware device profiling available on the market and combines it with healthcare tailored risk assessment and remediation capabilities.

Using CyberMDX, healthcare teams can easily:

Audit devices for software vulnerabilities and prioritize patching

Detect malicious activity and behavioral anomalies, triggering responses accordingly

Manage risks proactively via smart micro-segmentation planning and automation

Streamline clinical compliancy programs

Report device-relevant FDA recalls

Optimize device allocation and procurement decision based on usage insights

Track and manage medical asset lifecycles

Provide rich reports in support of HIPAA and corporate compliance efforts

Seamlessly integrate with existing cyber and IT solutions to enrich data sets, enhance workflows, and enable operational excellence

Differentiators

Interdepartmental HDO functionality and true workflow enablement: CyberMDX takes a holistic, 360° view of healthcare organizations and understands that only by building a common frame of reference and cross-departmental synergies can wholesale progress be achieved. Beyond mere security, CyberMDX provides security, IT, clinical engineering and compliance teams with a platform for data-driven workflow enablement and collaboration. Unmatched, context-aware visibility: CyberMDX delivers deep visibility into medical devices, protocols, and connected things of all sorts — along with a clear-eyed view of their clinical context. This deep and contextual visibility drives prevention, incident response, risk mitigation, and lifecycle management (including patch availability notifications). The solution covers medical devices, IoT, and OT across the entire network — providing a single pane of glass from which to view all connected healthcare assets. Superior depth and breadth of risk reporting around clinical and critical assets: CyberMDX has a dedicated research team focused solely on connected healthcare and IoMT. The team works with medical device manufactures and regulatory bodies such as CISA, ECRI, MITRE and the FDA to spot and lock down cybersecurity hazards and vulnerabilities before they can be exploited by malicious actors.

Back

Cynerio

Cynerio was established in 2017 by a versatile team with expertise in cybersecurity, medical devices, and healthcare IT. Headquartered in New York City, Cynerio works with leading Healthcare Delivery Organizations (HDOs) worldwide and delivers the only medical-first cybersecurity solution clinical ecosystems require to stay secure and operate with the peace of mind they need to put their focus where it’s needed most: on patient care.

The Problem

The IoT is an emerging space with a broad sphere of challenges that gets even more complicated when placed in the healthcare context. Hospitals and other HDOs have limited visibility into which devices exist on their networks, device behavior, and vulnerabilities. This limited visibility and understanding impairs IT personnel’s ability to remediate without interrupting patient care.

Securing the healthcare IoT poses the multifold challenge of securing medical devices developed without security in mind. Many of these devices run on outdated operating systems and can’t be patched. Hospital staff often has limited knowledge of the scope of security risks and vulnerabilities introduced to the network by unprotected devices. This is further complicated by traditional security solutions that are ineffective in dealing with connected devices in general.

Hospitals also rely on various non-traditional medical devices to help deliver essential care, such as elevators used to transport patients and smart refrigerators used to store sensitive biological material and medications. These devices are connected to the clinical ecosystem and are involved in medical workflows but are often not given the proper priority when evaluating the security strategy.

The Solution

Cynerio’s holistic medical-first approach to healthcare / Medical IoT cybersecurity management provides HDOs with a one-stop shop they can rely on by prioritizing patient care and privacy above all else while contextualizing risk and remediation within the framework of healthcare business goals. This approach to security allows HDOs to gain control over their clinical assets and helps achieve immediate security goals and meet strategic, long-term objectives.

Cynerio’s agentless and nonintrusive solution analyzes device communications and behavior to provide ongoing, accurate, and contextual assessments of risk and security posture. This enables swift remediation without impacting operations.

Back

Medigate

Medigate is a comprehensive platform for IoT cybersecurity. Distinguished by powerful capabilities driving use-cases that have revolutionized expectations around what clinical visibility can mean, Medigate is successfully partnering with health systems across the world to monetize risk reduction practice.

Not unlike other industries, Healthcare’s vaunted digital transformation is based on unprecedented, new levels of visibility. Although having the ability to identify connected endpoints represents a step forward, it is not the game-changer. Rather, it’s the device-specific, detailed attribution and utilization metrics passively captured by Medigate that competitively separates its offering. Made even more real by meaningful and fully operationalized integrations to the systems that can naturally benefit (e.g. NAC, firewalls, SIEM, CMMS and emerging applications in supply chain, procurement and finance), Medigate’s excellent track record with some of the nation’s largest health systems is easily verified.

It is not “magic” and Medigate’s engineering-heavy company profile reflects it. Medigate has done the heavy lift required to passively fingerprint all connected assets, including serially connected modules and/or devices “hidden” behind legacy and modern integration points. The approach is known as deep packet inspection (DPI). Having invested in the engineering talent required to effectively parse the transmission flows between devices, nested modules, integration points and their payload destinations (e.g. EMRs), Medigate delivers the most detailed and accurate baselines available, while also providing continuously monitored, dynamic views of the entire connected ecosystem.

Emboldened by widely publicized and successful attacks, the FDA’s changing guidance, Joint Commission directives and the recognition by acute care providers that ultimately, it’s a patient safety issue, risk capital has poured into the problem space. Validating Medigate’s approach, competitors use deep packet inspection (DPI) when they can and rely on probabilistic methods (i.e. behavioral models promoted as AI) when they cannot. For DICOM and other protocols packaged in the HL7 framework, all vendors use DPI, but that’s as far as they go, and that’s a seminal difference. Solution evaluators should investigate that difference and make up their own minds.

Medigate’s deterministic approach relies on its proven ability to resolve more than one hundred unique medical device protocols encompassing thousands of common devices that would otherwise go uncovered. The skillsets required to do that, and the resulting superior data quality, have fueled far more meaningful system integrations, non-traditional cross functional collaborations and numerous new use-cases that are turning risk reduction into a more strategically diverse, revenue creation practice. In terms of clinical network visibility, Medigate-powered “views” of what’s now possible are strengthening IT’s ROI mission to the enterprise.

Back

Sternum

Sternum, the multilayered cybersecurity solution offering real-time, embedded protection for IoT devices, was founded in 2018 in Tel Aviv by a team of highly experienced R&D and business leaders. Sternum has a profound understanding of embedded systems and deep insights into the dynamics of today’s threats, offering a new standard of cybersecurity for medical IoT devices. In accordance with the FDA’s pre-market cybersecurity guidelines (which included our commentary), and with unique technology that is ensuring the security of all connected medical devices, Sternum is protecting patients’ lives.

The result: Robust defense of lifesaving devices such as pacemakers and insulin pumps by mitigating known threats while simultaneously adapting to and combating new ones.

The company has developed two holistic solutions:

Sternum’s Embedded Integrity Verification (EIV) identifies and blocks cyberattacks in real time. This integrity-based attack prevention can be deployed to any medical device, including distributed and unmanaged IoT devices. EIV operates like an on-device firewall, validating each operation within the device. EIV only needs to be deployed once. Once EIV is installed, every new piece of code (including 3 rd party) receives protection automatically, fitting into the low resource environment of medical devices and providing security throughout the device’s lifecycle.

identifies and blocks cyberattacks in real time. This integrity-based attack prevention can be deployed to any medical device, including distributed and unmanaged IoT devices. EIV operates like an on-device firewall, validating each operation within the device. EIV only needs to be deployed once. Once EIV is installed, every new piece of code (including 3 party) receives protection automatically, fitting into the low resource environment of medical devices and providing security throughout the device’s lifecycle. Sternum’s Real-time IoT Event Monitoring System (RIEMS) provides first-of-its-kind visibility from within IoT devices (including operating systems and other 3rd party components) so that OEMs who manufacture the devices, enterprises who implement them, and consumers who use them are immediately alerted to indications of any cyber breach, including prevented attack attempts. RIEMS also continuously monitors devices outside managed networks, enabling OEMs to maintain control of product security for all distributed devices.

How is Sternum’s software-only product suite revolutionary in the medical IoT world?

Sternum, as a high-diversity and platform-agnostic solution, is the only on-device, real-time cybersecurity solution supporting all types of real-time operating systems (RTOS) and homegrown OS.

Sternum’s solution operates during runtime with exceptionally low overhead of 3%.

Because it operates in real time, the solution thwarts zero-day attacks.

While network security solutions fail to adequately secure today’s distributed medical devices, Sternum provides real-time monitoring of devices outside managed networks.

Cyberattack prevention is near-perfect when utilizing Sternum’s EIV solution; for over 170 cyberattacks, 96.5% were prevented when benchmarked with RIPE (Runtime Intrusion Prevention Evaluator).

Sternum’s unique, flexible cyber security solution for the Internet of Medical Things (IoMT) can be seamlessly integrated with any medical device’s operating system and development process.

Back

VDOO

Founded in 2017 by serial cybersecurity entrepreneurs Netanel Davidi and Uri Alter, VDOO has raised $45 million from top-tier investors including 83North, Dell Technology Capital, WRVI Capital, GGV Capital, NTT DOCOMO Ventures and MS&AD ventures. The company currently has more than 65 employees at our offices in the US, Japan and Israel, and dozens of well-known customers around the globe including Medtronic, Stanley Healthcare, NTT and MS&AD.

With device security quickly becoming a strategic imperative for the healthcare market, product security teams that work on medical devices cannot keep making long-term decisions based on a partial picture of possible vulnerabilities at a single stage of the device lifecycle. In order to scale their ability to provide optimal security, they must replace the time- and resource-intensive point solutions they are using today with a single integrated platform.

This is where VDOO comes in. Our Product Security Platform for Connected Devices is the only automated security solution that is integrated across the entire medical device lifecycle – from design and development all the way to deployment, post-deployment and legacy. The end-to-end platform includes modules for security analysis, gap resolution, regulatory compliance, embedded protection, operations monitoring, executive insights and threat intelligence.

VDOO’s unique approach to providing optimal security for medical devices is based on the combination of our patented technology with advanced binary analysis and highly sophisticated machine learning capabilities. This is augmented by our research team, which includes some of the world’s leading embedded security experts, that has built the most comprehensive device security database available today based on the thorough analysis of hundreds of millions of binaries and tens of thousands of connected products.

The VDOO platform’s key differentiators and benefits:

Contextual and focused device-specific security – Speed up time-to-market and reduce the risk of attacks by cutting out the noise and focusing on the right threats Automated security processes for the entire device lifecycle – Improve the efficiency of SDLC processes, reducing operational resource requirements across the board Verified compliance with leading standards and regulations – Increase product sales while improving customer adoption by ensuring that all devices are compliant Full visibility into the software supply chain – Reduce dependency on third parties by owning your security, thus lowering legal, monetary and reputational risks Comprehensive end-point security visibility and analytics – Monetize security as a business model by offering monitoring and protection services to end-users

Back