September 27, 2019

Toby Gouker • VP and CISO

Interoperability, meet Security

Among its many benefits, interoperability provides a more cohesive view of patient data that can improve the quality and value of care. When healthcare data can flow between providers and be presented in universal fashion, clinicians can more quickly access patient information, use that information to inform their diagnosis, and allow them to provide the best possible care in a timely fashion. Unfortunately, when healthcare data flows freely, there is the potential for malicious activities to also flow freely. Breaking down communications barriers can also break down many of the defense-in-depth practices that cybersecurity professionals undertake to protect the confidentiality, integrity and availability of patient care information.

Healthcare stakeholders are continuously adding new technologies to assist with their interoperability objectives. Unfortunately, the rush to complete new integrations or build new apps may lead to application interface gaps and system vulnerabilities. With regard to medical devices in particular, the FDA recently released a position statement: “Including an electronic data interface on a medical device may have an impact on the security and other risk management considerations for the medical device, the network, and other interfaced devices.” The FDA also wrote that “analysis of risks due to both the intended and unintended access of the medical device through the interface should be considered.” The CHIME organization has also weighed in on cybersecurity concerns when it comes to interoperability. “As we increase interoperability, additional threats to data integrity will arise,” CHIME President and CEO Russell Branzell and Board Chair Shafiq Rab told the HELP committee, “Without proper safeguards, the safe and secure transmission of sensitive data will continue to be a challenge and will hinder efforts to care outcomes.”

For organizations investing in and enabling interoperability initiatives, First recommends a number of items be taken into consideration. Interoperability affects infrastructure, access and communication flows across a healthcare enterprise. Ensuring that security and privacy requirements are embedded into every layer of the infrastructure is critical to maintaining the integrity of defense-in-depth principals that are so important to an enterprise’s cybersecurity. This includes mechanisms to validate the practices and standards of third-party apps and APIs that allow more flexible sharing of data.

Beyond ensuring a sound infrastructure, First recommends that healthcare systems include a mechanism for providers to verify that all access requests for information are authorized, and each entity with access to individuals’ data be responsible for appropriately securing and using that data. In addition, clinical owners should be identified for all data repositories so that cybersecurity personnel can form a partnership in deciding how data is handled.

Since interoperability is all about data in motion, First recommends that extra attention be given to the proper transmission of healthcare data. More than any other data transmissions, healthcare system data must end up in the correct location 100% of the time, be 100% complete, and 100% secure. By design, interoperability system components must communicate with each other securely. First recommends working with all service providers or vendors to establish a standard security exchange protocol, such as HTTPS, LDAP or SAML otherwise, systems have inherent vulnerabilities that can be exploited.

More on information blocking and privacy (consent) in the next post as First anticipates news on the interoperability final rule and these key issues in the near future. 

May 17, 2019

Jack Wagner • VP of Advisory Services

Cybersecurity for Medical Devices – Pitter Patter Let’s Get At ‘Er

Okay, maybe I watch too much of the Canadian sitcom Letterkenny, and while it may be considered inappropriate for younger viewing audiences, there is one saying in there that I have tried to apply to my everyday life and that is “Pitter patter, let’s get ‘er.” 

What exactly does that mean?  Basically, let’s do it already, get it done, chop chop, right now.

What do we need to get done, you ask?  Well, cybersecurity of our medical devices, of course. 

Some of you have been watching the trends for years.  Unfortunately, many more wait for a problem to occur elsewhere before taking action. Even worse, others standby and just let a problem grow until it turns into a catastrophe that was completely avoidable.

An automobile is a good example.   It requires basic maintenance to stay in top running condition.  Things like oil changes, tire rotation and other basic maintenance ensure that when you cross the 100,000-mile mark on the odometer, your car is there with you for the long haul.  If you ignore that maintenance, then you could end up with a burdensome towing and mechanical repair bill.

Ignoring medical device cybersecurity, is much worse.  If you never change the oil in your car, the engine will eventually seize, possibly leaving you stranded. 

When lack of security maintenance to medical devices occurs, well, everyone gets hurt. 

In healthcare, we care for patients.  That is what we do.  It is our entire mission.  When our healthcare networks get breached, our patients suffer the most.  After all, it is their health and personal information that are at greatest risk due to vulnerabilities that exist in the health care market.

Now, back to “Pitter patter, let’s get ‘er.” How should we proceed to remediate our vulnerabilities?

If you listen to many of the vendors in the burgeoning field of healthcare cybersecurity, the initial answer to your question is, “You need an assessment.  It will tell you everything that is wrong, and we are great at assessing stuff!” 

Okay, I paraphrased a little bit, but that is a popular answer.  Let me be clear, it is not necessarily the wrong answer.  Nevertheless, is it the best answer? 

Going back to the oil change — oversimplified, I get it — analogy.  Do you want a mechanic to spend two hours with your car to come back and tell you every single reason why you need an oil change?  Such as, the oil has broken down, seriously impacting your engine’s lubrication abilities.  If you do not change it, the friction in your engine will build up heat until the metal warps, which will surely destroy it. 

By the way, that information costs $200, because I interviewed you, ran diagnostics and performed in-depth analysis of the oil in your car.

That is all good information to have no doubt, but at this point has the mechanic told you anything that has actually fixed your problem, or have you just paid someone for a good reason to change your oil?

I would like to touch upon a different approach for Cybersecurity of your medical devices in the now buzz-worthy world known as the Internet of Medical Things (IoMT)

This approach is to fix the problems before they become bigger problems.

I get it.  Your next thought is, “how do I know what my problems are so I can fix them?”

The answer can be derived by answering some basic questions:

  1. Do you have medical devices, such as CT Scanners, X-Ray machines, MRIs, Infusion Pumps, etc. connected to your wired/wireless networks? 
  2. Are many of those vendor-maintained?
  3. Do you have a process in place that monitors the operating systems they are running, and the last time they’ve been updated for the latest patch releases? 
  4. Does this process not only identify vulnerabilities, but provide guidance to resolve them?
  5. Does the process work with the device vendors during the remediation process to ensure the gaps are mitigated or closed?

If the answer to the first two questions is yes — You’re in healthcare, right? — and the answers to the follow-up questions are closer to “Ummm, Meh,” then you do not need to pay someone to tell you that again in a 100+ page report with painstaking detail.

Is not that like the mechanic giving you a 10-page diagnostic report explaining the chemical breakdown of the oil in your car over time?

Instead, we should have a conversation on the top items that all healthcare entities need to be doing to protect themselves.  Afterward, you could use those valuable, and oft constrained, budget dollars to address those elements.

A typical assessment could cost anywhere from $20,000 to $100,000, depending on the size and complexity of your organization and the scope of the assessment.  I am sure some of you have seen them cost more.

Instead of paying for that assessment, you could apply those dollars to actual remediation of those devices, while also gaining an understanding of the weaknesses that exist.

Interested yet?  I hope so.  Please bear with me a little longer.

Another question: Do you have a Security Information and Event Management (SIEM) system in place?

Your answer is likely accompanied by an eye-roll and is similar to, “Yes, yes, we do.  Since the 90’s, in fact, or at least the turn of the 21st Century.”

The truth is, many of us do have them already.  They monitor networks, servers, workstations and numerous other things that have been the target of threats for years.  Also true is that many of them have done a good job of it. 

The concern is not around them protecting those devices they were made to monitor, but is around the blind spots they may have, especially in the medical device arena.

Next set of questions: Do you have any products that specifically monitor all the medical devices on your network, identifies when they are working out of the norms, and tells you how to remediate them? Do they perform all that passively, as to not impact the critical patient health traffic on the network?  Do they report all that information to your current SIEM, complementing your current environment rather than replacing it?

If most of the answers are, “No.”  Why not then use some of your budget dollars to remediate that situation now?  The right system could not only tell you everything an assessment could, but also help you track them real-time and give instructions for gap closure.

Final set of questions: What if you could get a pilot of this system, with the cybersecurity expertise to ascertain its best placement, set it up, monitor it and report out the findings, for less than the cost of the typical assessment? 

That would be much better than just a report.

There are several vendors with products in this field of expertise and they claim everything from signature-based vulnerability identification to machine-learning and Artificial Intelligence (AI) concepts.  The truth is, that some of these are much more mature than others and are no longer proof of concept (POC) exercises, but legitimate contenders to help you close the gaps in your medical device vulnerability area.

Additionally, you need a good partner.  Not one that provides an assessment and promises to come back in a year to see how you have done closing the gaps, but rather, one that works through the entire process of system selection, implementation, monitoring and remediation.  A partner that also provides education to your staff, works with them to mitigate gaps, and can also provide 24×7 Security Operations Center (SOC) services to spot, isolate and remediate any brand-new vulnerabilities that the malware community cooks up next. 

It all starts with an honest conversation around Cybersecurity and how best to protect the assets providing the most important tenet of all healthcare organizations, taking care of patients.

Pitter patter, let’s get at ‘er.

May 6, 2019

Carter Groome • Chief Executive Officer

Medical Device Risk Management – Provider Side Takeaways from the Joint Security Plan


The Health Sector Coordinating Council (HSCC) released the Joint Security Plan (JSP) in January with a goal of creating easy to follow guidance for increasing the security and resilience of medical devices and medical technologies.  While the report focus leans toward pre-market medical device themes such as design controls, complaint handling, and maturity evaluation, there are several areas that health delivery organizations (HDO’s) can and should leverage to bolster their risk management strategy.  

Rob Suarez and Kevin McDonald, Task Group Co-Chairs of the JSP, more recently highlighted the plan in an AEHIS webinar, curating the best practices that can be applied to gain more insights into your risk profile.  Here are key areas that stand out from the consumer, or HDO side of the JSP.

  1. Alignment of Expectations: Adopting common languages – CVSS and ISO 14971 for example –  and understanding of process between all stakeholders. Aligning the expectations of the manufacturers and the consumers in purchasing is a strong building block to effective collaboration. When considering the device lifecycle, utilization and decommissioning medical devices, understanding process and communication preferences up front is a powerful planning tool for managing devices in your organization.
  2. Procurement and Supply Chain Processes: As your organization looks to purchase and negotiate for new devices, are you incorporating key questions, RFP criteria and supply chain management into the process.  The JSP provides questions to ask prospective vendors that address structure, governance, risk registers and more (Section VIII) that you can pull right into your own process, facilitating quicker responses and information that will inform decisions through the entire lifecycle of your devices.  
  3. Medical Device Management Plan – The JSP provides the tools to incorporate a Medical Device Management Plan into a more comprehensive Cybersecurity Management Plan.  From vulnerability reporting and prioritization to patch management requirements, access controls and pen-testing documentation, communication and planning on how to deal with the risk is articulated in the JSP.  
  4. Incident Response Planning – Processes for notification, your vendor standards for getting incident information and timeliness in addressing vulnerabilities are all items that need to be addressed in advance.  These actions may lead to additional training and ultimately, more streamlined incident response. The JSP helps to incorporate medical device specifics into a more comprehensive IRP, building special use cases and decision trees for potential incidents throughout your device population.  Pulling in the right people by defining their roles and getting the necessary info to them and the vendor is ideal in assessing the impact of an incident.

The JSP is a great guide to help your team bridge the divide between device manufacturers and all of your stakeholders.  The JSP will be revised on a yearly basis and should be considered in your overall Enterprise Risk Assessment. If you are able to leverage what you currently have in place for assessments and Supply Chain Management Processes, you will be well on your way to improved communication and planning on how to more efficiently address medical device risks within your organization.

September 14, 2018

Carter Groome • Chief Executive Officer

Hurricane Phishing – Awareness of Disaster Scams

As we watch the news from Hurricane Florence (or experience it first hand), here is a timely, and timeless reminder from DHS to be careful in times that we are most inclined to give.  Phishing scams in times of disasters are some of the most lucrative for bad actors.  See the release from NCCIC below and share with those that may not be in the IT or Cyber world.

NCCIC warns users to remain vigilant for malicious cyber activity seeking to exploit interest in Hurricane Florence. Fraudulent emails commonly appear after major natural disasters and often contain links or attachments that direct users to malicious websites. Users should exercise caution in handling any email with a subject line, attachments, or hyperlinks related to the hurricane, even if it appears to originate from a trusted source. NCCIC advises users to verify the legitimacy of any email solicitation by contacting the organization directly through a trusted contact number. Contact information for many charities is available on the BBB National Charity Report Index. User should also be wary of fraudulent social media pleas, calls, texts, donation websites, and door-to-door solicitations relating to the hurricane.

NCCIC encourages users and administrators to review the following resources for more information on phishing scams and malware campaigns:

June 8, 2018

Toby Gouker • VP and CISO

Medical Device Security Starts With An Accurate Inventory

You can’t protect what you don’t know. Getting a handle on the security of your medical and other connected devices in your healthcare facility starts with getting a handle on the inventory. Simple concept, yet why are so many healthcare organizations struggling to get a real accounting of what is being used to serve their enterprise? Many institutions feel they have a grasp on the inventory because they can point to accounting records for purchases. Once their project begins though, they are surprised to learn how inadequate accounting inventories tend to be. Historically, an organization decides to bring in a team of individuals to walk the facility and get an actual physical count of the equipment and its location along with age, operating parameters, and security features.

Today, the path forward to an accurate inventory count can be different. With the advent of big data analysis techniques and machine learning algorithms, vendors are taking advantage of the reams of data that network traffic sniffing tools can deliver and are discerning volumes of information from the data collected on their intranets. Working with small appliances placed on your network, typically at Layer 2, these appliances inspect large volumes of packet communications and run it through a deep machine learning algorithm to discern equipment type, manufacturer, model, operating system and many other factors of interest to clinical engineering and security professionals.

From AWS, BlueFlow and CloudPoint all the way to ZingBox, there are already many vendors who can provide you with an inventory discovery tool to include as part of you medical device security management program. Here are five quick questions you may want to ask to help you find your solution from this rapidly growing list of options:  1) How long have you been providing this solution? 2) How many healthcare deployments have you made? 3) Can you interface with my SIEM and other security management tools? 4) How many appliances will I need to install? 5) Can the solution augment network security architecture?

First is here to help you get answers to these questions and many more as you develop and/or improve your medical device security management program. We can even help you get answers to non-security aspects of these connected asset discovery tools. Given that they are always on and always monitoring device operations, many of these tools can also be put to use by your clinical engineering teams for resource leveling studies, new purchase planning and even reconfiguring maintenance schedules and equipment SLAs.

1 2 3