Glossary

    All MedTech Terms

    513 sourced definitions covering the regulatory, quality, software, and cybersecurity vocabulary of modern medical devices.

    Showing 1–24 of 61

    Cybersecurity

    AAMI SW96

    aka Standard for medical device security

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

    Cybersecurity

    AAMI TIR57

    aka Principles for Medical Device Security - Risk Management

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

    Cybersecurity

    AAMI TIR97(TIR97)

    aka AAMI TIR97:2019/(R)2023 · Postmarket risk management for device manufacturers

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

    Cybersecurity

    Brainjacking

    aka Neural device hijacking · DBS hijacking

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

    Cybersecurity

    CISA Known Exploited Vulnerabilities Catalog(KEV)

    aka CISA KEV · Known Exploited Vulnerabilities

    CISA catalog of vulnerabilities exploited in the wild, with risk-prioritization requirements for covered federal systems.

    Cybersecurity

    Code Signing

    Digital signatures used to verify software or firmware integrity and signer authorization.

    Cybersecurity

    Common Vulnerabilities and Exposures(CVE)

    A globally unique identifier for a publicly disclosed cybersecurity vulnerability.

    Cybersecurity

    Common Vulnerability Scoring System(CVSS)

    An industry-standard 0–10 score that quantifies the severity of a software vulnerability.

    Cybersecurity

    Common Weakness Enumeration(CWE)

    Community-maintained list of software and hardware weakness types, the underlying defects that cause CVEs.

    Cybersecurity

    Coordinated Vulnerability Disclosure(CVD)

    A documented process for receiving, triaging, and responsibly disclosing security vulnerabilities reported by external researchers.

    Cybersecurity

    Cryptographic Agility

    The designed-in ability to replace cryptographic primitives over a device's supported lifetime.

    Cybersecurity

    CycloneDX

    A lightweight, OWASP-maintained SBOM format designed for application security and supply-chain use cases.

    Cybersecurity

    De-Identification of Health Data

    The HIPAA-defined process of removing identifiers from PHI so the resulting data is no longer subject to the Privacy Rule.

    Cybersecurity

    FedRAMP(FedRAMP)

    aka Federal Risk and Authorization Management Program

    U.S. government-wide program that standardizes security assessment, authorization, and continuous monitoring for cloud services sold to federal agencies.

    Cybersecurity

    Hardcoded Credentials

    Secrets - passwords, API keys, certificates - embedded in firmware or source code shipped on every device.

    Cybersecurity

    Hardware Root of Trust(HRoT)

    aka Root of Trust · RoT

    Hardware-enforced trust anchor for selected security functions, subject to implementation and threat assumptions.

    Cybersecurity

    Health Industry Cybersecurity Practices(HICP)

    aka HHS 405(d) HICP

    Voluntary HHS healthcare cybersecurity practices that can support recognized-security-practices evidence in HIPAA enforcement.

    Cybersecurity

    Health Information Sharing and Analysis Center(H-ISAC)

    aka Health-ISAC · NH-ISAC (legacy name)

    Member-driven nonprofit that operates the trusted sharing community for cyber and physical threat intelligence across the healthcare sector.

    Cybersecurity

    Healthcare and Public Health Cybersecurity Performance Goals(HPH-CPG)

    aka HPH Cybersecurity Performance Goals · HHS CPGs

    HHS's sector-specific list of essential and enhanced cybersecurity goals for healthcare, derived from HICP and the NIST CSF.

    Cybersecurity

    HIPAA(HIPAA)

    aka Health Insurance Portability and Accountability Act

    U.S. federal law governing the privacy and security of protected health information.

    Cybersecurity

    HITECH Act(HITECH)

    U.S. law that strengthened HIPAA enforcement and introduced breach-notification requirements.

    Cybersecurity

    HITRUST CSF(HITRUST)

    aka HITRUST Common Security Framework

    Healthcare-focused certifiable security framework that consolidates HIPAA, NIST, ISO 27001, and other authorities into a unified control set.

    Cybersecurity

    HSCC Joint Security Plan(HSCC JSP)

    An industry-developed reference framework from the Healthcare Sector Coordinating Council for end-to-end MedTech cybersecurity.

    Cybersecurity

    ICS Medical Advisory(ICSMA)

    aka CISA Medical Device Advisory · ICS-MEDICAL-ADVISORY

    CISA's official vulnerability advisories for medical devices, the public record of disclosed device cybersecurity issues, indexed as ICSMA-YY-DDD-NN.