PHI Is Everywhere. Are Medical Devices Ready to Handle It?

If you’re building a connected medical device today, you’re handling protected health information (PHI)—in ways both explicit and hidden. As devices collect patient-specific information and feed it into hospital networks, cloud platforms and EHR systems, they’ve become a working part of the healthcare data ecosystem.  

Patient-specific data enables personalized therapy, real-time monitoring and seamless workflow integration, but it also raises the stakes around privacy, compliance and patient safety. When PHI is involved, medical device cybersecurity and data privacy expectations are higher, and healthcare providers increasingly rely on manufacturers to support their compliance obligations. That’s why manufacturers of connected medical devices need to understand the risks of handling PHI and manage them from the very start. 

PHI and Medical Devices: A Double-Edged Sword 

Protected health information (PHI) might sound like something that only hospitals or insurers worry about, but for today’s connected medical devices, it’s central to how the technology works. At its core, PHI is any information that can identify a patient, combined with anything that describes their health. That can be a name paired with a diagnosis, but it can just as easily be a glucose value attached to a device serial number, an image with patient metadata or a data packet that includes both a reading and a patient ID. 

As devices have become smarter, more networked and more integrated with clinical systems, they now interact with PHI in ways that weren’t even on the radar a decade ago. Devices routinely: 

• Use PHI to tailor therapy or guide clinical decision-making—adjusting insulin, timing medication, triggering safety alerts or monitoring trends unique to each patient. 
• Store PHI in local memory, logs, error reports, audit trails and temporary caches, often without manufacturers realizing how long that data persists. 
• Transmit PHI across hospital networks, wireless channels and into cloud platforms where clinicians access dashboards, analytics engines process readings, and EHRs absorb structured data. 

This expanding role of PHI is what makes connected devices so powerful. It enables personalized therapy, real-time oversight, remote patient monitoring, interoperability with clinical workflows and postmarket performance insights. In other words, PHI is the fuel behind many of the capabilities that clinicians, patients and manufacturers now rely on. 

But it’s also the source of some of the biggest risks we see in the field. When PHI isn’t protected from the start, it becomes a privacy liability, a regulatory hazard and, in some cases, even a patient safety concern.  

The Problem with PHI 

As medical devices become more connected and more central to patient care, the stakes surrounding PHI are rising fast. What used to be a hospital IT concern is now squarely a device manufacturer’s challenge. Here’s why medical device manufacturers need to care:  

• Privacy: Patients expect their health data to stay confidential, no matter where it travels. When a device captures or transmits PHI, it becomes part of that trust equation. Any mishandling—whether through leftover data, unexpected storage or exposure during routine use—can erode confidence not just in the device, but in the broader care ecosystem around it. 
• Compliance: Even though manufacturers aren’t covered entities under HIPAA, their products directly affect a hospital’s ability to remain compliant. If a device collects, stores or passes PHI between systems, customers rely on it to meet HIPAA, HITECH and FDA cybersecurity expectations. A device with unclear or risky data behavior can create regulatory headaches and real liability for healthcare providers—and that makes it a harder product to buy, deploy and trust. 
• Patient safety: Privacy and safety are no longer separate issues. A device that exposes PHI is often a device that can be accessed, altered or disrupted in ways that impact patient care. If PHI is accessed or manipulated improperly, it can compromise therapy accuracy, monitoring reliability or clinical decision-making. 

For manufacturers, this creates a new reality: If a device touches PHI, even indirectly, it inherits a set of expectations around safeguarding that data. Those expectations shape customer decisions, regulatory reviews, postmarket obligations and long-term market trust. At the same time, because much of the use and transfer of PHI happens automatically and invisibly, it’s easy for manufacturers to underestimate how much PHI their device actually handles. 

Protecting PHI by Design 

Connected healthcare will only become more data-driven. Protecting PHI is now foundational to good medical device design.  

The most effective way to manage PHI isn’t to react to problems—it’s to prevent them. And prevention only works when security is built in from the very beginning. At Battelle, we work with medical device manufacturers to help them understand how PHI flows through their system and how to protect it across the entire product lifecycle. 

From early architecture decisions to verification, validation, deployment and postmarket support, our teams work alongside medical device manufacturers to ensure their devices align with FDA guidance, NIST frameworks and the evolving expectations for medical device cybersecurity. That means understanding where PHI is created, where it persists, how it moves and how those data pathways intersect with real clinical environments. 

We’re working to help shape medical devices that are secure-by-design, defensible at audit and ready for market. By addressing PHI considerations upfront, manufacturers can avoid costly late-stage redesigns, reduce regulatory friction, and deliver products that healthcare providers can deploy with confidence. 

In Part 2, we’ll look at how secure-by-design practices, informed by FDA and NIST expectations, help manufacturers build devices that keep PHI safe throughout their lifecycle.