A lot continues to happen in the cybersecurity field and here are a few things I think are worth highlighting, plus some notes on my current activities.

– As of the writing, the situation in Ukraine is awful and still could have cybersecurity implications for the U.S., as well as Ukraine. See DHS bulletin at https://publicintelligence.net/dhs-ukraine-invasion-cyber-attacks/.

– federal Cybersecurity and Infrastructure Security Agency (CISA) (https://www.cisa.gov) continues to generate advice, including a series of insights at https://www.cisa.gov/insights

– ECRI Top 10 Health Technology Hazards for 2022 – https://www.ecri.org/top-10-health-technology-hazards-2022-executive-brief. (Number 1 is “Cybersecurity Attacks Can Disrupt Healthcare Delivery, Impacting Patient Safety”)

– I’m assisting a medical software startup with setting up its cybersecurity program for its Software as a Medical Device (SaMD) product. 

– I’m doing program management work related to Public Key Infrastructure for a large Silicon Valley technology company. Lots to do to maintain compliance with WebTrust and CAB Forum requirements.

– RSA Conference (https://www.rsaconference.com/usa) and BSidesSF (https://bsidessf.org) in San Francisco are deferred from February to June 2022. I’ll probably volunteer again at BSidesSF, assuming it is reasonably safe with respect to COVID-19. Maybe hang out on the exhibit floor at RSA for a day.

This Spring and Summer there’s a lot going on relative to cybersecurity for medical devices. Check these out…

FDA Document Details Cyber Expectations for Device Makers – https://www.govinfosecurity.com/fda-document-details-cyber-expectations-for-device-makers-a-18863

Senators Introduce PATCH Act to Ensure Medical Device Security – https://healthitsecurity.com/news/senators-introduce-patch-act-to-ensure-medical-device-security

Model Contract-Language for Medtech Cybersecurity (MC2) – https://healthsectorcouncil.org/model-contract-language-for-medtech-cybersecurity-mc2/

CyberMed Summit: Policy Prescriptions & Pandemic Lessons Learned (April 14) – https://www.cybermedsummit.org

Defcon 30 Biohacking Village – is targeted for August 11-14 in Las Vegas. We’ll see whether that actually happens and how risky it may be to attend, depending on the status of COVID-19. https://www.villageb.io

It’s been a whirlwind week and it’s not over, yet. Defcon29 (aka “hacker summer camp”) was August 5-8 in Las Vegas. HIMSS21 (the Health Information Management Systems Society’s global conference) started August 9 and runs through August 13, also in Las Vegas. Temperatures have been as high as 108 degrees F. Both have been hybrid conferences with some online and some in person.

I volunteered with the Biohacking Village at Defcon29, which this year mainly involved monitoring the online discussion boards in case there was any inappropriate behavior. The in person things included villages regarding IoT Hacking, Car Hacking, Voting Machines, Cryptocurrency, Satellite Hacking, and a new group called Security Leaders. There were also some good sessions on Public Policy pertaining to cybersecurity.

I co-authored and co-presented a short talk at HIMSS21…

This talk was based on the paper posted elsewhere on this web site.

Key takeaways…

• equally important with designing, implementing, and maintaining online systems securely is the need to anticipate and expect failures and malicious attacks that will require response and recovery. Sure, cyber defense, but plan for cyber resilience [recover quickly]. Offline backups, emergency contact lists, contingency plans, legal and technical consulting standby contracts, and table top practice session are essential.
• there is a shortage of trained cybersecurity professionals, so start investing in training for your existing staff while continuing to seek the expertise you need
• <probably more – I may edit the to add items…>

More and more RPM devices are being introduced for healthcare providers to use in managing post-acute and chronic care patients. The diagram below shows the variety of ways in which these devices may transmit information from the patient’s home to the clinician. Other posts on this site discuss cybersecurity relative to RPM.

Cybersecurity risk management for supply chains with multiple vendors is complicated. Each vendor is clearly responsible for its own system, but who minds the overall end-to-end concerns? This article asserts that coordination across organizational boundaries is needed to assess and mitigate cybersecurity risks in remote patient monitoring (RPM) systems.

Examples of network-connected RPM devices include wearables (e.g., smart watches), glucose monitors, pacemaker monitors, blood pressure cuffs, pulse oximeters, continuous positive airway pressure (CPAP) machines, scales, and more. Such devices are part of the family of the Internet of Things (IoT).

A 2019 survey of physicians showed “Two in three, or 68 percent, of physicians surveyed strongly intend to use remote patient monitoring technology…” However, the survey report also indicates “Health care professionals view data security as the main barrier to technology uptake.”^[1]

The majority of recent cybersecurity analysis for medical devices has focused on devices used within hospitals and clinics. Cybersecurity for RPM is different in a number of ways.

RPM is a “system of systems” – a physical and digital chain consisting of devices connected to networks, connected to other networks. Typically, there are multiple stakeholders involved in the provision and operation of these systems These include device manufacturers that depend on a supply chain for software and hardware components, communications networks, data integrators, and the clinicians who are the ultimate users of the data (Figure 1). Also, various interfaces with humans, including patients, caregivers, developers, network engineers, and system administrators. 

Attacks on healthcare delivery organization (HDO) networks via device or interim partner vulnerabilities are a bigger concern than attacks on individual devices. This is because more harm can be done if a healthcare delivery organization network is compromised. Attacks on these networks can not only result in theft of personally identifiable information, but also interruption of service, such as what occurs in a ransomware attack. 

In a RPM digital supply chain with multiple vendors involved, it is necessary to take a “trust, but verify” approach. Clauses can be put in a contract or a “Business Associate Agreement” to require a supplier/partner (vendor) to maintain a good cybersecurity posture, but it is unlikely that the vendor can absolutely guarantee protection. When only written assurances of “best efforts” to prevent cybersecurity incidents are provided, it behooves the buyer/user to perform due diligence and monitor whether these efforts are effective.

One possible solution is for the healthcare delivery organization that is the receiver of the data to oversee the end-to-end process. Alternatively, the data platform vendor that consolidates, analyzes, and formats the data may be in a position to provide the needed coordination. On the other hand, it is difficult to imagine how device manufacturers could coordinate all of the stakeholders.

As a final thought, remember that the ever-changing cybersecurity landscape means it may not be possible to anticipate and mitigate all threats. In the event an incident occurs, there needs to be a plan to respond and recover. In an environment with multiple vendors, response coordination has to be planned and rehearsed before something happens. The objective is to make sure the entire remote patient monitoring system is resilient.

If you work for a health care delivery organization that is on the receiving end of a remote patient monitoring system, what are you doing to make sure all of the components in that system are secure and that you are ready to respond to problems?

If you are one of the vendors in remote patient monitoring system, what are you doing to make sure your upstream and downstream partners in the system are secure?

If you are not sure how to do this, you’ll probably want to obtain assistance to reach out to each of the organizations that comprise the end-to-end system and figure out an approach to make sure a holistic security framework is conceived and implemented.

* * *

David Snyder is a cybersecurity professional experienced at facilitating discussions among ecosystem members, analyzing complex processes, and orchestrating cross-functional and cross-organizational efforts.

Inquiries: https://42tek.com/contact/

^[1] CTA Survey Finds High Demand for Remote Patient Monitoring Devices, 11 April 2019, https://www.cta.tech/Resources/Newsroom/Media-Releases/2019/April/CTA-Survey-Finds-High-Demand-for-Remote-Patient-Mo#/

An updated and shorter online version of my well-received December conference workshop. Noon (Pacific) on May 12, 2020.

Factors driving increased adoption of RPM. RPM as a “system of systems” requiring coordination among stakeholders. Cybersecurity best practices.

A version of the slides is posted at https://www.42tek.com/RPM_Cybersecurity.pdf. Video at https://www.youtube.com/watch?v=iZ-QUo8XTPA&feature=youtu.be

This 3-hour workshop on December 10, 2019 in San Francisco explored similarities and differences between network-connected medical devices in clinical settings versus residential environments, relative cybersecurity challenges, and best practices throughout the lifecycle of remote devices.

See https://connected-devices-summit.com.

Several trends are driving increased interest and adoption for using network-connected medical devices outside the clinical environment to diagnose, monitor, and treat patients. These include an aging population living longer, often with multiple chronic illnesses, looming shortages of doctors and nurses, and incentives to reduce hospital readmissions.

“88% of health systems and hospitals surveyed have invested or plan to invest in remote patient monitoring solutions to support their organizational transitions to value-based care.” (Spyglass Consulting Group)

The FDA, hospitals, researchers, and device manufacturers have been working hard to define best practices for cybersecurity for network-connected medical devices in hospitals. Attend and see what you need to consider.

Longer description at https://42tek.com/Cybersec_RPM.pdf.

8-11 August 2019 – Las Vegas, Nevada
Planet Hollywood

This is where hackers had a chance to explore medical devices to discover potential cybersecurity vulnerabilities and, hopefully, how to defend against them. Read more at

https://www.villageb.io and https://www.defcon.org

I volunteered at the Biohacking Village and was able to network with some excellent people about developing and maintaining network-connected medical devices securely. Ten medical device manufacturers provided approximately 40 devices for hackers to examine and explore. There were about 30 workshops, presentations, and panels, including some of the premier security researchers in this space and representatives from the FDA.

Connected Devices: Cybersecurity & Compliance Summit

http://connected-devices-summit.com

December 11-12, 2018 at the Hotel Kabuki in San Francisco.

On December 11^th, I was joined by a great team to conduct a 2.5-hour workshop entitled “Cybersecurity for Medical Devices is a “Team Sport.” Assisting with the workshop were:

• Jason Johnson, Information Security Officer, Marin General Hospital
• Matthew Jones, Clinical Engineering Security Specialist, Intermountain Healthcare
• Deb Muro, Chief Information Officer, El Camino Hospital
• Christine Sublett, President & Principal Consultant, Sublett Consulting, LLC

The workshop focused on how device developers can collaborate with hospitals and clinics to help make sure medical devices are set up and managed to protect patients’ privacy and safety.

The highly interactive session was conducted by a team with diverse backgrounds, including a hospital CIO, a clinical engineer, a hospital information security officer, and two neutral cybersecurity consultants to facilitate and moderate. Topics covered included:

• Considerations during procurement, integration and operations
• Defining best practices for device inventory management and monitoring device behavior and network traffic for potential cybersecurity attack indications
• Ways of thinking about the issues in terms of people, process, and technology
• Views on how connected medical device cybersecurity can be approached as a ‘team sport’ involving collaboration among manufacturers, regulators, providers (hospitals and physicians), supply chain, and patients
• Understanding how hackers plan their attacks
• Ideas for ways potential risks may be mitigated

Group exercises and case studies were included.

There are over 5,000 hospitals in the U.S. and I’ve seen the number 6,000 as the number of medical device manufacturers. Medical devices are increasingly built with network connectivity. Examples include heart monitors, infusion pumps, glucose monitors, and assorted other treatment and diagnostic devices.

Cybersecurity has traditionally been concerned with Confidentiality, Availability, and Integrity of data. However, in medical devices and critical infrastructure (such as the electric power grid), the potential for harm means we have to include Safety when we think about cybersecurity.

On December 11, 2018, I’ll be leading the INTERACTIVE WORKSHOP: Cybersecurity For Medical Devices Is A “Team Sport” at the Connected Devices: Cybersecurity & Compliance Summit in San Francisco at the Kabuki Hotel. See http://connected-devices-summit.com. This interactive workshop will focus on how device developers can collaborate with hospitals and clinics, who purchase network-connected medical devices and need to operate them in their complex networks. This highly interactive and hands-on session will be conducted by a team with diverse backgrounds, including a hospital CIO, a clinical engineer, a hospital information security officer, and two neutral cybersecurity consultants to facilitate and moderate.

My collaborators for this workshop include:

• Deb Muro, Chief Information Officer, El Camino Hospital
• Jason Johnson, Information Security Officer, Marin General Hospital
• Matthew Jones, Clinical Engineering Security Specialist, Intermountain Healthcare
• Christine Sublett, President & Principal Consultant, Sublett Consulting, LLC

If you’d like to read more on the subject, see the following or contact me for more references.

• Click Here to Kill Everybody: Security and Survival in a Hyper-connected World (2018)
  A Book by Bruce Schneier https://www.schneier.com/books/click_here/
• Report on Improving Cybersecurity in the Health Care Industry https://www.phe.gov/Preparedness/planning/CyberTF/Documents/report2017.pdf

Free Sneak Preview Event:

Network-Connected Medical Devices: What Could Possibly Go Wrong?

A presentation at Triple Ring Technologies’ MedTech Frontiers the evening of March 1, 2018. See http://www.tripleringtech.com/march-1-2018-network-connected-medical-devices-possibly-go-wrong-examining-iot-security-blockchain-technologies/

The Main Event:

The Symposium on Securing The Internet of Things (http://securingthenet.com) took a deep dive on what it will take to protect the billions of devices on which we depend for critical infrastructure, healthcare, and our homes. I led a panel discussion on Security for Network-Connected Medical Devices.

The event was March 5 – 7, 2018 at the Crowne Plaza Hotel in Burlingame, CA (near San Francisco Airport). [See agenda at https://42tek.com/STIOTAGENDArev6.pdf] 
My session addressed security topics in medical device design and manufacturing, usage in hospitals, remote monitoring, and related legislative, regulatory, and standards initiatives. Bill Saltzstein of Code Blue Communications, Peyton Paulick Kochel, Ph.D. of Proteus Digital Health, and Eric Pancoast of Medcrypt participated in the panel and May Wang of Zingbox gave a keynote presentation.

Please use the contact form if you would like to request the slides.

Some references on the medical devices topic may be found here.