PHI And Medical Devices: What Device Manufacturers Need To Know

The transformation of medical technologies into connected devices has dramatically expanded how health data is collected and used, introducing new responsibilities for manufacturers in safeguarding Protected Health Information (PHI). As devices collect, transmit, and analyze sensitive patient data for diagnosis and care, compliance with regulations like HIPAA is no longer optional—it's integral to safety and performance.

PHI includes individually identifiable health information linked to data elements like names, dates of birth, or medical records. Electronic PHI (ePHI) is governed by HIPAA's Security Rule, which mandates administrative, physical, and technical safeguards. Manufacturers must recognize where their product's data falls on the increasingly fluid boundary between regulated PHI and non-regulated wellness data.

PHI is embedded in nearly every function of modern connected devices, from real-time patient treatment adjustments and remote monitoring to system interoperability and post-market support. Protecting PHI must be a systematic approach built into the device’s design, operation, and maintenance from the outset, not an afterthought.

Dive deeper into the critical data flows and compliance requirements for medical devices.