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7.  Zero Trust Architecture

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Cybersecurity [AI / ML in Devices](/ecosystems/ai-ml)[Connected & Cyber-Physical Devices](/ecosystems/connected-devices)ZTA 

# Zero Trust Architecture

A security model that authenticates and authorizes every access, regardless of network location.

Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 

## Definition

Zero Trust Architecture (ZTA) is a cybersecurity model - formalized by NIST SP 800-207 (2020) - that assumes no implicit trust based on network location and instead requires every access decision to be authenticated, authorized, and continuously validated. ZTA's tenets include: every resource is treated as a resource to be accessed, all communications are secured regardless of network location, access is granted on a per-session basis, and policies are dynamic and enforced at fine granularity. 

What the regulation says

Zero Trust is the federal direction (Executive Order 14028, OMB M-22-09) and is increasingly expected by hospital security teams. FDA's 2023 cybersecurity guidance does not mandate Zero Trust by name but expects modern security architectures, of which ZTA is the consensus expression. 

## What this means in practice

Connected medical devices challenge classical Zero Trust assumptions because they are often resource-constrained, long-lived, and deployed on segmented OT networks. Practical MedTech ZTA usually means strong device identity (per-device certificates), mutual TLS for every service interaction, and centralized policy enforcement at the gateway or service mesh - not full ZTA inside the device itself. 

Common pitfalls

-   • Treating Zero Trust as a product purchase rather than an architectural decision. 
-   • Forgetting that legacy medical devices cannot meet ZTA requirements without compensating controls. 
-   • Implementing mutual TLS without a credible certificate-rotation and revocation story. 

## Frequently asked questions

Is Zero Trust a product? 

No. ZTA is an architectural pattern. Vendors sell components (identity providers, policy engines, microsegmentation) that support ZTA, but adoption is an organizational program, not a purchase. 

Does ZTA work for medical devices? 

What's the FDA position on Zero Trust? 

## Related terms

Grouped by theme 

### Editor's picks

· Hand-selected related concepts 

[

Cybersecurity

IEC 80001-1

International standard for risk management of IT networks that incorporate medical devices.





](/terms/iec-80001)[

Cybersecurity

NIST Cybersecurity Framework(NIST CSF) 

A risk-based framework of cybersecurity functions and outcomes published by NIST and widely used to organize MedTech security programs.





](/terms/nist-csf)[

Cybersecurity

Premarket Cybersecurity Submission

The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device.





](/terms/premarket-cybersecurity)[

Cybersecurity

Section 524B of the FD&C Act(524B) 

The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices.





](/terms/section-524b)

### More in Cybersecurity

· Same category 

[

Cybersecurity

AAMI SW96

AAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle.





](/terms/aami-sw96)[

Cybersecurity

AAMI TIR57

AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management.





](/terms/aami-tir57)[

Cybersecurity

AAMI TIR97(TIR97) 

AAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57.





](/terms/aami-tir97)[

Cybersecurity

Brainjacking

Unauthorized remote control of an implanted neurostimulator (e.g., DBS) to alter stimulation parameters and harm a patient.





](/terms/brainjacking)

Cited by

Where this term appears across MedTech Terms.

Ecosystems (2)

-   [AI / ML in Devices](/ecosystems/ai-ml)
-   [Connected & Cyber-Physical Devices](/ecosystems/connected-devices)

## Primary references

3 sources 

Link health:  3 verified · last checked 2026-06-20 

NIST· 1 OMB· 1 CISA· 1 

1.  [1 
    
    NIST SP 800-207 Zero Trust Architecture
    
    Verified 
    
    NIST · csrc.nist.gov 
    
    
    
    ](https://csrc.nist.gov/publications/detail/sp/800-207/final)
2.  [2 
    
    OMB M-22-09 Federal Zero Trust Strategy
    
    Verified 
    
    OMB · whitehouse.gov 
    
    
    
    ](https://www.whitehouse.gov/wp-content/uploads/2022/01/M-22-09.pdf)
3.  [3 
    
    CISA - Healthcare and Public Health Sector
    
    Verified 
    
    CISA · cisa.gov 
    
    
    
    ](https://www.cisa.gov/topics/critical-infrastructure-security-and-resilience/critical-infrastructure-sectors/healthcare-and-public-health-sector)

Inline markers like \[1\]  jump to the matching reference above.

Sponsor note

### Working on medical device cybersecurity?

Blue Goat Cyber specializes in MedTech cybersecurity - threat modeling, SBOMs, penetration testing, and FDA premarket submissions.

[Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session)

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MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor.

On this term

Category

Cybersecurity

Acronym

ZTA

Sources

3

Updated

5/5/2026

[Compare with another term](/compare?a=zero-trust)

Learn in 60 seconds

Card Lesson Quiz

A security model that authenticates and authorizes every access, regardless of network location.

-   · Connected medical devices challenge classical Zero Trust assumptions because they are often resource-constrained, long-lived, and deployed on segmented OT networks. 

Remember this

Watch out: Treating Zero Trust as a product purchase rather than an architectural decision.

Related terms

-   [NIST Cybersecurity Framework(NIST CSF) ](/terms/nist-csf)
-   [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity)
-   [Section 524B of the FD&C Act(524B) ](/terms/section-524b)
-   [IEC 80001-1 ](/terms/iec-80001)

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    MedTech Cyber Tips 
    
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