EmberKat

Glossary

The acronyms on your desk, in one sentence each

This field runs on acronyms, and most of them are used as if everyone already agreed what they mean. Nothing here assumes a technical background. If a definition needs another term to make sense, the definition is wrong.

A visual lexicon groups dense technical concept markers into a small set of clear connected families.

European law

What the obligation is, and who it lands on.

NIS2 Directive (EU) 2022/2555

An EU law that holds organisations in important sectors — health, finance, energy, transport, digital — responsible both for their own security and for checking their suppliers.

Article 21(2)(d) is the supplier part. It is the reason hospitals and banks now send security questionnaires to the companies that sell them software.

Where you meet itAs a questionnaire or a contract clause from a customer.

Read the source
CRA Cyber Resilience Act, Regulation (EU) 2024/2847

An EU law that puts security requirements on the product itself — effectively anything containing software that is sold in the EU.

You have to know what is inside your product, handle vulnerabilities in it, and report the ones being actively exploited. Reporting duties start 11 September 2026; the rest apply from 11 December 2027.

Where you meet itAs a deadline, whether or not any customer has asked yet.

Read the source
AI Act Regulation (EU) 2024/1689

The EU law on artificial intelligence. It sorts uses by risk and attaches obligations to the higher-risk ones.

Where a product is already regulated — a medical device, for instance — the AI Act applies on top rather than instead. Its application dates were deferred by the Digital Omnibus agreement of 7 May 2026, so check them against the published text before planning around them.

Where you meet itWhen a product gains a model and the existing approval no longer covers it.

Read the source
ISO 27001

An international standard for how an organisation runs its information security — the management side, not the product.

Certification is what customers most often ask for as proof, which is also its limit: it says a system for managing security exists, not that any particular product is sound.

Where you meet itAs a certificate a customer asks to see, or asks you to obtain.

GDPR General Data Protection Regulation

The EU law on personal data. Its security duties mean a breach is not only a technical failure but something the organisation has to account for.

Where you meet itUsually after something has already gone wrong.

ENISA European Union Agency for Cybersecurity

The EU’s cybersecurity agency. Under the CRA, actively exploited vulnerabilities are reported to it.

CSIRT Computer Security Incident Response Team

The national body a serious security incident gets reported to. Every EU country has one.

Medical devices and health software

The strictest reference system, and the vocabulary that comes with it.

MDR Medical Device Regulation, Regulation (EU) 2017/745

The EU law covering medical devices, including software that is a medical device in its own right.

Annex I sections 17.2 and 17.4 are the security requirements: build to the state of the art, and protect against unauthorised access.

IVDR In Vitro Diagnostic Regulation

The equivalent of the MDR for diagnostic tests and the software that runs them.

MDCG 2019-16

The European Commission’s guidance on how cybersecurity should be handled for medical devices.

Not law in itself, but what an auditor expects to see followed — across the whole product life, not only before launch.

IEC 62304

The international standard for how medical device software is developed and maintained.

It defines the stages and the records each stage has to leave behind.

IEC 81001-5-1

The security companion to IEC 62304: which security activities belong in each stage of a health software product’s life.

Auditors treat the European version as the practical route to satisfying the MDR’s security requirements.

notified body

The independent organisation that audits a medical device and certifies it before it can be sold in the EU.

Where you meet itAs the party whose questions decide whether a release can ship.

post-market surveillance

The duty to keep watching a product after it has been sold, and to act on what that watching finds.

DICOM

The standard format and network language for medical images and the information attached to them.

Anything that stores, moves or displays a scan speaks it — which also makes it a route into a hospital network.

PACS Picture Archiving and Communication System

The hospital system that stores medical images and serves them to clinicians.

Often the oldest system in the building and the one holding the most data — decades of it, on patients who cannot be asked again.

SaMD Software as a Medical Device

Software that is itself the medical device, rather than a component inside a physical one.

What you get asked for

The documents and statements a buyer or an auditor wants to see.

SBOM Software Bill of Materials

A list of every component inside a piece of software — an ingredients label, in a form a machine can read.

The CRA requires a manufacturer to have one. It does not require publishing it: it belongs in the technical file and goes to authorities on request. When a customer asks for a copy, that is procurement, not law.

Where you meet itAs a line in a customer’s security questionnaire.

VEX Vulnerability Exploitability eXchange

A statement of whether a known flaw in a component actually affects your product.

Most published flaws in a dependency are not reachable in the way a given product uses it. VEX is how that is said in a form the customer’s tooling can process, instead of being argued over email.

Where you meet itThe first time a customer asks about a flaw that does not affect you.

CVE Common Vulnerabilities and Exposures

A public reference number for a known security flaw — like a case number that anyone can look up.

Once one is published for a component you ship, customers can find it themselves and will ask what you are doing about it.

coordinated disclosure

The agreed process for handling a reported security flaw: who is told, in what order, and by when.

Having it written down before it is needed is the difference between a controlled week and an improvised one.

provenance

Where a software component came from, and whether that can be shown rather than assumed.

conformity assessment

The formal check that a product meets its legal requirements before it is placed on the market.

Engineering terms

Words used loosely elsewhere, defined here.

technical due diligence

The examination a buyer or investor runs before a deal, to test whether what they were told about the technology holds.

Its job is to surface what would change the price, the plan, or the decision to proceed.

Where you meet itWeeks before a transaction, usually with an immovable deadline.

technical debt

Shortcuts inside a system that still work, but make every later change slower and riskier.

Like a loan: useful when taken, with interest charged on every release afterwards.

architecture drift

The gap that opens between how a system was designed and how it actually behaves after years of changes.

Nobody decides to have it. It accumulates from reasonable decisions taken without a current picture.

DevSecOps

Building security checks into the ordinary process of shipping software, rather than testing at the end.

In practice the hard part is not which tool runs the check, but who owns it when the check fails and the release is due.

CI/CD continuous integration and continuous delivery

The automated pipeline that builds, tests and releases software every time it changes.

trust boundary

The line where information or control passes between parts of a system that do not trust each other equally.

Most serious findings live on one of these lines rather than inside a component.

remediation

Actually fixing what an assessment found — as opposed to recording it.

Next step

If one of these arrived with a deadline

Bring the situation, the affected system, who owns the outcome and the deadline.

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