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“Every time you make another connection, you create another attack vector. There’s another way that things can be hacked.”
– Florence D. Hudson, Executive Director, Northeast Big Data Innovation Hub at Columbia University’s Data Science Institute
Today’s healthcare industry faces a double dilemma regarding technology. As medical data becomes increasingly digitized, medical staff and IT professionals must ensure interoperability across systems and devices while maintaining their organization’s network security. This task has become even more difficult due to the ever-evolving landscape of medical tech and the uniquely sensitive nature of managing patient information and its potential vulnerability should improper access be granted.
When we first explored this topic with Christopher Gates, director of product security at Velentium, in 2023, he drew a clear distinction between the two sides of the problem: “There is IT cybersecurity, and then there’s OT cybersecurity, information technology versus operational technology,” he explained.
IT systems are designed to manage data and information, while OT systems control the physical processes of medical devices. Integrating these two technologies enables medical devices to collect, store, and analyze data, giving healthcare professionals greater insight into patient care.
But that integration has grown considerably more complex in the years since. What was once a matter of connecting a handful of hospital systems has evolved into something far more sprawling. An implanted medical device might now communicate through a patient’s phone to a cloud-based app, which connects to an EHR, which a physician can access from anywhere in the world. “Every time you make another connection, you create another attack vector,” says Florence Hudson, founder and CEO of FDHint and executive director of the Northeast Big Data Innovation Hub at Columbia University. “There’s another way that things can be hacked.”
Not all medical devices communicate with each other or with a particular EHR system, making it difficult for healthcare providers to access and analyze patient data, leading to gaps in patient care and missed opportunities to improve outcomes. The lack of interoperability is a major challenge in integrating medical devices with electronic health records, and any potential solutions must address IT and OT security issues to ensure patient health records are secure, not only for privacy reasons but also because HIPAA requires it.
The stakes of getting this wrong are high. According to Hudson, a medical record is far more valuable on the dark web than a stolen credit card, containing enough personal data to cause serious, lasting harm. Unfortunately, as best as manufacturers and software engineers try, keeping health information safe when using medical technology is incredibly complicated. As Gates put it in 2023, “I want them to stay ignorant of the risks they’re taking if their devices are interoperable today because if they were aware of it, they wouldn’t be using these devices. At the end of the day, our lives improve with these devices, and they markedly improve patient outcomes, but they come with a huge risk.”
Keep reading to examine the challenges in more depth, explore emerging standards and solutions available for organizations looking to manage their resources while keeping patient data secure, and find actionable steps to address these issues effectively.
Meet the Expert: Florence Hudson
Florence D. Hudson is the founder and CEO of FDHint, LLC, a global advanced technology and diversity and inclusion consulting firm, and executive director of the Northeast Big Data Innovation Hub at Columbia University’s Data Science Institute. She chaired the IEEE/UL 2933 working group on Clinical IoT Data and Device Interoperability with TIPPSS, a framework she helped create to address trust, identity, privacy, protection, safety, and security across connected medical devices and systems, and now leads the IEEE TIPPSS Roadmap Task Group to develop new TIPPSS standards across additional cyber-physical domains.
Hudson brings a rare cross-disciplinary perspective to the field, having trained as a mechanical and aerospace engineer at Princeton University before serving as vice president and chief technology officer at IBM and as senior vice president and chief innovation officer at Internet2. She also serves on the IEEE Engineering in Medicine and Biology Society Standards Committee. Her work spans industry, academia, and government, with collaborations including the Department of Energy, Brookhaven National Lab, and the FDA.
Hudson spoke to MedicalTechnologySchools.com in 2026.
Meet the Expert: Christopher Gates
Christopher Gates has over three decades of experience developing and securing medical devices for various industry leaders. Currently, he serves as the director of product security at Velentium, an engineering firm specializing in designing and manufacturing therapeutic and diagnostic medical devices.
He actively collaborates with regulatory and standard bodies such as NTIA, MITRE, Bluetooth SIG, IEEE, U.S. Department of Commerce, and FDA to design and formalize tools, techniques, and processes that facilitate the development of secure medical devices. He holds a BS in computer science from California State University Northridge and has worked as a software engineer, project manager, and cybersecurity architect.
Gates spoke to MedicalTechnologySchools.com in 2023.
2026 Update: The Expanding World of Medical Device Interoperability
Everything Is Connected Now
When the interoperability challenges facing medical technology were first explored here in 2023, the concern was already significant. In the years since, the landscape has changed considerably. What was once a matter of getting a handful of hospital systems to communicate has evolved into something far more complex.
“You can have an implanted medical device, and that could be communicating through your phone into an app in the cloud, and that connects your EHR, and then, your doctor’s on vacation in Jamaica and he can see it,” says Hudson. “The connections have increased; the ability for interoperability is increasing.”
New devices enter the market constantly, software-as-a-medical-device is expanding rapidly, and patients are increasingly interfacing with their own health data in real time. Each new connection brings genuine clinical value. It also brings new risk. “Every time you make another connection, you create another attack vector,” Hudson explains. “There’s another way that things can be hacked.”
Introducing TIPPSS: A Framework for the Whole Picture
Hudson’s response to this growing challenge is a framework called TIPPSS, which stands for trust, identity, privacy, protection, safety, and security. The IEEE/UL 2933 standard, which she chaired, puts all of these elements under one umbrella for clinical IoT devices and systems. The idea wasn’t to reinvent the wheel. “This isn’t meant to replace anything,” she says. “This is meant to kind of harmonize everything… including when you’re decommissioning a device and getting all the data off of it. Everything from soup to nuts.”
The impetus for the standard stemmed from a recurring gap she saw in the field. “We have had pieces of it,” she says. “But it’s all connected, and people aren’t thinking about that. You think about it this way: here is my device, and I know this is locked down. But it communicates with the glucose meter. How’s that protected? Or when you’re in China, how’s that protected?”
The decision to focus on clinical IoT first was deliberate. “We decided we were going to work on clinical internet of things first, because if you had an implanted medical device, you can immediately kill a human,” she says. “So, let’s keep the humans alive. Rule number one.”
Trust, Identity, and Security: The Elements That Need the Most Work
Of all the components in the TIPPSS framework, Hudson is most emphatic about two. “Trust and identity are number one, because if they can’t get in, they can’t mess up everything else,” she says. “Whether it’s a thing, a robot, or a human, or whatever it is.”
The question of identity in connected medical devices is more complicated than it might seem. “How do you validate something’s or someone’s identity? Therefore, you know if you should trust them,” Hudson explains. “How do you revalidate their identity all the time, like the way you always get multi-factor authentication to get into your bank?” Most people take that kind of verification for granted on their phones and laptops. Applying the same rigor to medical devices is a different challenge entirely.
Security, she says, is the other element that demands constant attention, precisely because it never stands still. “Security is changing all the time. What are all the attack vectors? How are they changing? Who am I connected to now?” she asks. “A patient has a phone, so they made a connection from their glucose meter to their phone. Now, how am I going to protect them?”
Privacy rounds out the trio of areas she feels the industry needs to grapple with more seriously, though she notes it is at least well regulated. Safety, too, has significant existing oversight. It is the trust, identity, and security pieces where she sees the biggest gaps and the greatest urgency.
The Stakes: What a Breach Actually Means
The risks of poorly secured medical devices are not abstract. “If you look on the dark web, a medical record is a lot more valuable than a credit card,” Hudson says. “Now we were all worried about, oh my god, they got my credit card. Wait till they get your medical record, because that has everything in it, and so many things they can do to ruin your life if they have all that information.”
And the threat is not coming from unsophisticated actors. “These are not just cute little kids with a hoodie on in their mother’s basement,” she says. “These are big brands we know and respect, and they’ve been worrying about it for years.”
The FDA has been tracking and responding to cybersecurity vulnerabilities in medical devices since around 2017, issuing recalls on hundreds of thousands, even millions, of devices. Hudson sees their work as essential, and her framework as complementary to it. As one FDA official put it in a recent conversation with Hudson, the stakes could not be clearer: “Cybersecurity is patient safety.”
What Students and Professionals Can Do Right Now
For students entering the field, Hudson has a clear message: start asking questions: “Ask if they know about the TIPPSS standard, and if their devices are going to be TIPPSS compliant,” she says. “Start getting them talking.”
The standard itself is publicly available and easy to find. Searching “IEEE TIPPSS” will bring up the IEEE/UL 2933 standard directly. Those interested in getting more involved can visit the TIPPSS initiative page on the Northeast Big Data Innovation Hub at Columbia University, where students can complete a participation form to join the TIPPSS Roadmap Task Group. IEEE is also currently running a TIPPSS hackathon specifically for students, which can be found by searching “IEEE TIPPSS hackathon.” Hudson’s books on the framework are available through Springer Nature and can be downloaded for free by students whose universities have a SpringerLink connection.
Her vision for where all of this leads is simple and memorable. “I want there to be a little girl at the doctor with her mom, and the doctor’s going to try to give one of them an insulin pump,” she says. “The little girl is going to look up at the doctor and say, ‘Does it have TIPPSS?’ That’s what I’m looking for.”
Her advice for everyone in the meantime: “Always be vigilant.”
From the Archives: What Christopher Gates Shared About Health Tech in 2023
The primary ways that medical technologies interface with each other while maintaining security are through standardized communication protocols and interfaces that enable secure data exchange between medical devices and EHR systems. These protocols are designed to meet industry-specific security and regulatory standards, ensuring that patient data remains confidential and protected against cyber-attacks.
“Generally, what these devices utilize for security is what is called a ‘challenge response.’ There is a shared key, and if it matches between devices, then they can share data,” explained Gates in 2023. “Here’s the problem with interoperability. You may have a device sending a challenge response, and the other device it wants to talk to doesn’t know it is being addressed. There are no shared keys. Another option would be to use a certificate authority, where a device presents a 509 certificate, which is confirmed with a certificate authority. Still, you have to have something pre-shared between these devices so they can communicate.”
Here is a list of the biggest challenges in the interoperability and security of medical technology.
Processing Power
Because medical devices are often inherently small, the amount of processing power that can be built into them is limited: “Key infrastructure that we use, like certificate authorities and the network of trust relationships, takes a lot of computational and physical power. You may not have those cognitive resources on a small device. There are limits to what you can do,” explained Gates.
In the past few years, there have been significant advancements in this technology’s capabilities, but running encryption software remains an ever-present hurdle.
Lack of Standardization
Arguably the biggest challenge in medical tech interoperability is a significant need for more standardization. In fact, the ISO, a non-governmental organization that has created thousands of international standards for numerous industries, lists over 50 different standards for medical devices. “The vast majority of devices are patchwork quilts that use proprietary software. Manufacturers don’t want to disclose their interface, so they’re not creating application programming interfaces (APIs), making interoperability really hard,” explained Gates.
But patients want access to the data from their medical devices: “Some software companies have reverse-engineered the wireless connection so users can interface to it. That’s how companies have come about like Tide Pool, which did just that for the diabetics,” said Gates. “Now you can monitor yourself with standard tablets that were never intended to work with your medical equipment because white hat hackers have figured out these interfaces and now use them to help you. But we can’t let those systems be insecure.”
Age of Technology
Medical devices, particularly those that may be implanted into a patient, can last for a very long time. In fact, the oldest pacemaker worked for an incredible 26 years. The age of some of the technology still in use presents significant challenges for interoperability as the software or hardware may become obsolete: “Manufacturers tend to create a device, hold that basic platform for decades, and only do slight upgrades and changes to it. It is not uncommon for me to see processors that are 20 or 30 years old,” said Gates. “Those devices don’t have the code space or the microcontroller to do cryptographic operations. They’re too small and too old and can’t do it.”
Data Privacy
What makes interoperability challenging at the end of the day is that all PHI must be protected under HIPAA. Bluetooth is widely used for all kinds of devices to communicate with each other and is used in many medical technology applications as long as there is an added layer of privacy. “What we have to do in medical devices, again, is have a challenge response mechanism between the device and your smartphone. Somehow they have to have a shared key again.”
One way that developers are solving this problem is actually through the use of bar codes: “We are seeing companies use a barcode on devices that you can read with the camera on your smartphone. That can serve as a challenge-response mechanism, where the barcode now indicates you have physical possession of this device. Even if you have a bunch of them in the same room with you, you’re not connecting to those. You’re just connecting to the one you have scanned,” said Gates.
“This is important for a physician in an office. If they are talking to a patient with a device in front of him but 20 feet away in the waiting room, there are another ten patients. This ensures they are getting the data from the right device,” he adds.
Keeping data private and secure is not just about protecting people’s sensitive health data but is also about ensuring that the data is accurate. Hackers have targeted hospitals and EHRs in many different ways. “Everybody always thinks a denial of service attack is a complete shutdown. What if I just delay the data? So now the data is stale. For something like a glucose reading, the data would now be minutes old, and pumps deliver medication based on old, out-of-date information. That can actually be very harmful to patients,” said Gates.
Solution: Third-Party Certification
A fairly simple solution that Gates sees to the interoperability and security of medical technology is to require a third-party security certification. Third-party certification is an independent evaluation of a medical technology product to assess its security measures and interoperability against industry-specific standards.
Achieving certification can improve patient safety, reduce cybersecurity risks, and provide a competitive advantage for manufacturers by demonstrating compliance with established standards.
“If these devices are supposed to work together, they would have to work with an independent third party and get credentials to allow them to do that. That would be your security, but also, it would be tested at that time to ensure it works,” said Gates. “The interoperability needs to be tested as well and verify that even though these two devices were never intended to work together, they can now communicate data in a secure way.”
