When most people think of HIPAA compliance, they picture hospitals, clinics, or insurance companies. However, with today’s connected technologies, medical device manufacturers are increasingly part of the compliance discussion. Devices that collect patient data, connect to clinical networks, or communicate with cloud platforms are subject to both HIPAA requirements and FDA cybersecurity expectations.
The FDA’s 2025 cybersecurity guidance makes clear that device safety now includes strong cybersecurity practices. For manufacturers, that means understanding whether your organization is a Covered Entity or a Business Associate and how cybersecurity plays a direct role in HIPAA compliance.
Covered Entities vs. Business Associates
Covered Entities are healthcare providers, health plans, and clearinghouses that directly create, transmit, or store protected health information (PHI). Business Associates are organizations or vendors that process PHI on behalf of a Covered Entity.
For medical device manufacturers:
- If your device stores, transmits, or manages PHI and you maintain that data on behalf of a healthcare provider, you are acting as a Business Associate.
- Even if you never directly handle PHI, security weaknesses in your device could still expose healthcare providers to HIPAA violations.
Cybersecurity as a Core Part of HIPAA Compliance
The HIPAA Security Rule requires administrative, technical, and physical safeguards to protect electronic PHI. For device manufacturers, this means cybersecurity practices must align with both HIPAA and FDA requirements. Key safeguards include:
- Access controls to ensure only authorized users access PHI
- Encryption for data in storage and transmission
- Logging and audit trails to detect suspicious activity
- Patch and update management to address vulnerabilities
The FDA recommends using a Secure Product Development Framework (SPDF) to reduce vulnerabilities, manage cyber risks, and protect PHI throughout the total product lifecycle. These processes mirror HIPAA’s expectations for securing health information.
Shared Responsibility Across the Ecosystem
Cybersecurity is not the responsibility of one party alone. The FDA emphasizes that device makers, healthcare providers, and patients all share responsibility for securing medical devices and PHI.
For manufacturers, this includes:
- Building cybersecurity into device design through threat modeling and secure coding
- Providing labeling and deployment instructions for secure use in healthcare environments
- Maintaining postmarket monitoring and vulnerability management programs to ensure continued protection
How Blue Goat Cyber Supports Manufacturers
Blue Goat Cyber helps medical device manufacturers navigate the intersection of HIPAA compliance and FDA cybersecurity requirements. Services include:
- Cybersecurity risk assessments aligned with HIPAA and FDA expectations
- Implementation of Secure Product Development Frameworks
- FDA premarket submission preparation with cybersecurity documentation
- Postmarket monitoring, vulnerability management, and incident response
Led by Christian Espinosa, a nationally recognized cybersecurity expert, Blue Goat Cyber provides proven strategies for protecting PHI, reducing compliance risks, and strengthening patient trust.
Learn more: Medical Device Cybersecurity Services
FAQs on HIPAA and Medical Device Cybersecurity
Are medical device manufacturers Covered Entities under HIPAA?
Generally no. Manufacturers are typically considered Business Associates if they process or store PHI on behalf of healthcare providers.
How does FDA cybersecurity guidance relate to HIPAA compliance?
Both require protecting PHI and ensuring secure devices. The FDA focuses on device safety and lifecycle security, while HIPAA governs PHI protection across systems.
What cybersecurity measures are required to protect PHI in medical devices?
Access control, encryption, logging, secure software updates, and continuous vulnerability management are essential.
Key takeaway: Even if you are not a HIPAA Covered Entity, your role as a Business Associate and the cybersecurity posture of your device can directly impact HIPAA compliance. Strong cybersecurity is now fundamental to both regulatory approval and patient trust.