Cyber Essentials Plus for Healthcare Manufacturers: The Missing Piece in Your AI Compliance Strategy
The Compliance Gap Healthcare Manufacturers Can’t Afford to Ignore
Following the response to our NHS AI Voice Technology Compliance Guide, healthcare manufacturers across the UK have been implementing robust clinical safety frameworks to meet NHS England’s July 2025 requirements. However, here at ETHOS, we have discovered the critical gap of cybersecurity certification.
While clinical safety addresses patient welfare and regulatory compliance, the underlying technology infrastructure requires equally rigorous security validation. For AI Ambient Voice Technology (AVT) and other digital health systems, this means achieving Cyber Essentials Plus Certification; a requirement that is becoming increasingly mandatory for NHS procurement processes.
Why Clinical Safety Isn’t Enough
NHS England’s July 2025 guidance mandates MHRA Class 1 device status and DCB0160 compliance for AI summarisation systems. Our Clinical Safety Assurance guide addresses these requirements comprehensively, yet healthcare manufacturers implementing these systems face an additional challenge: protecting the digital infrastructure that supports these AI capabilities.
Consider the risks:
- Data breaches affecting thousands of patient records
- System compromises that could manipulate AI outputs
- Network intrusions disrupting critical healthcare services
- Ransomware attacks targeting AI-dependent workflows
These cybersecurity threats can undermine even the most robust clinical safety frameworks, putting both patient safety and manufacturer compliance at risk.
The ETHOS Advantage
At ETHOS, we understand the unique challenges healthcare manufacturers face when implementing cybersecurity frameworks alongside clinical safety requirements. Our team combines:
- 15+ years of NHS experience across clinical and technical domains
- Deep understanding of healthcare regulatory requirements
- Proven track record supporting digital health implementations
- Comprehensive expertise in both clinical safety and cybersecurity frameworks
It isn’t just certification support that we can provide. We team up with healthcare manufacturers to build sustainable security practices that complement their clinical safety initiatives.
Take Action: Secure Your AI Healthcare Implementation
The convergence of clinical safety and cybersecurity requirements means healthcare manufacturers can no longer treat these as separate entities. AI systems require both robust clinical governance AND comprehensive security validation.
Download our complete Cyber Essentials Plus Certification Guide below to discover how your organisation can achieve this critical certification while supporting your clinical safety objectives.
Ready to Get Started?
Contact ETHOS today for a consultation with our friendly Clinical Safety and Cybersecurity Officers. Our team can help you to navigate both of these requirements, ensuring your AI healthcare implementations meet all regulatory standards while protecting patient safety and data security.