Secure-by-Design (Devices)
Engineering principle of building security in from initial architecture rather than bolting it on.
Definition
Secure-by-design products eliminate entire classes of vulnerabilities through memory-safe languages, least-privilege design, default deny, and threat modeling at architecture phase. CISA promotes secure-by-design as a manufacturer responsibility. For medical devices, FDA's 2023 premarket cybersecurity guidance builds this into the Secure Product Development Framework (SPDF), expecting security architecture views, threat models, security risk management and an SBOM in submissions. Section 524B of the FD&C Act, in force since March 2023, makes these expectations legal requirements for cyber devices. The EU MDR's general safety and performance requirements also require state-of-the-art security.What this means in practice
Increasingly an expectation in FDA premarket cyber feedback and a procurement criterion for hospital IT.Examples
- A medical device manufacturer uses a memory-safe programming language for a new implantable device to eliminate common buffer overflow vulnerabilities.
- During the design of a connected infusion pump, threat modeling identifies potential unauthorized access vectors, leading to the implementation of strong authentication and encrypted communication protocols.
- A software update mechanism for a diagnostic imaging system is designed with a default-deny policy, only allowing signed and verified updates from authorized sources.
- •Failure to conduct thorough threat modeling early in the design process can lead to overlooked vulnerabilities and costly retrofits.
- •Relying solely on post-market patching rather than integrating security into the initial design is a common pitfall.
- •Assuming that general IT security practices are sufficient for medical devices without considering their unique safety and efficacy requirements is a mistake.
- •Neglecting to implement least-privilege principles can lead to excessive access and expanded attack surfaces if a breach occurs.
- •Failing to continually update and assess the security posture throughout the device
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsA documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle.
A structured analysis that identifies how an attacker could compromise a medical device and what controls mitigate each threat.
More in Software & AI
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Resilience of an ML model to inputs deliberately crafted to cause misclassification.
Medical device that uses artificial intelligence or machine learning to perform its intended use.
Historical FDA AI/ML change-control terminology, now reflected in the PCCP Modification Protocol.
Where this term appears across MedTech Terms.
Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1CISA Secure by DesignTier 2 VerifiedCISAcisa.gov
- 2IMDRF - Software as a Medical DeviceTier 2 VerifiedIMDRFimdrf.org
- 3MDCG Software GuidanceTier 2 VerifiedMDCGhealth.ec.europa.eu
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