Glossary

Algorithm

A precise set of instructions or rules followed by a computer to solve a task. Used, for example, to support diagnostics or data analysis.

Anonymization

The process of removing personal data from a dataset so that individuals can no longer be identified.

API (Application Programming Interface)

A programming interface that enables different systems to exchange information with each other.

Artificial Intelligence (AI)

The ability of a computer to learn, reason, and perform tasks intelligently. Used, for example, in diagnostics and automated monitoring.

Assistive Device

A medical device that supports a user’s functional ability, especially when limited by injury, illness, or aging.

Audit

An external assessment to verify whether an organization or product complies with specific requirements, such as those related to quality management systems.

CE Marking

A label indicating that a product meets EU requirements. Mandatory for medical devices intended for the market.

Clinical Evaluation

A process used to assess the safety and performance of a medical device.

Clinical Validation

An evaluation process that demonstrates the functionality and benefit of a new device or method in a clinical setting.

Commercial Terms

Contract terms that apply to the procurement of health technology and ensure safe use.

Conformity

Compliance with applicable standards and regulations.

Data-Driven Development

The development of solutions based on the analysis and use of existing health data.

Directive

EU legislation that sets goals for member states but allows them to determine how to achieve them.

E-Health Services (Telehealth)

Health services provided remotely using technology.

Ethical Guideline

An ethical framework for collaboration in health technology and social and healthcare services. Aims to improve patient safety.

FHIR (Fast Healthcare Interoperability Resources)

A standard that enables interoperability between healthcare information systems.

GDPR (General Data Protection Regulation)

The EU’s data protection regulation, which also governs the handling of personal data in health technology.

Health Technology

Medical and diagnostic devices used in healthcare for prevention, diagnosis, treatment, and rehabilitation.

In Vitro Diagnostics (IVD)

Tests performed outside the body, analyzing samples taken from the human body.

IPR (Intellectual Property Rights)

Rights such as patents and copyrights that protect innovations.

IVD Regulation

EU Regulation 2017/746 governing the market placement of in vitro diagnostic devices.

Machine Learning

A subset of AI where algorithms learn from data without explicit programming.

Market Placement

Before placing a health device or product on the market, it must meet applicable requirements. The manufacturer must issue a declaration of conformity and attach CE marking to demonstrate compliance. The manufacturer must also provide required documentation and prove the intended use meets the legal definition of a medical device.

MD Regulation

EU Regulation 2017/745 on the requirements for medical devices (Medical Device Regulation, MDR).

MDR (Medical Device Regulation)

Synonym for the MD Regulation; the current EU legislation on medical devices.

Medical Device (Health Technology)

A device or software used for diagnosis, treatment, or monitoring of disease.

Notified Body

An independent organization designated by an EU member state to assess medical device compliance with relevant requirements.

Patient Data

Data collected from patients, such as treatment records and test results, which can be used anonymously for research and development.

Pilot / Piloting

Testing a product or service in a real-world environment before full-scale implementation.

Post-Market Surveillance (PMS)

A monitoring system for gathering information about a product’s performance after it has been placed on the market.

Pseudonymisation

A data processing method where personal data is replaced with identifiers (e.g., codes), making the individual unidentifiable without additional information. This process reduces privacy risks and is commonly used in health research and development. The identifiable key is stored separately and securely.

Quality Management System (QMS)

A system that ensures product and service quality and compliance with regulations throughout the product life cycle.

Registry Study

Research based on existing patient registry data without direct contact with patients.

Regulation

Mandatory laws and rules issued by authorities that must be followed.

Risk Management

A systematic approach to identifying, assessing, and mitigating risks related to devices or processes.

Secondary Use

The use of data for purposes other than direct patient care, such as research or product development.

Sensor Technology

Devices that measure physiological parameters such as heart rate or physical activity.

Specificity and Sensitivity

Metrics describing the accuracy of a diagnostic method. Specificity indicates correct identification of healthy individuals; sensitivity indicates detection of diseases.

Standard

A documented and agreed method or guideline based on research and best practices.

User-Centered Design

A development approach based on end-user needs and their real-life environment.

UX/UI (User Experience / User Interface)

Design elements focused on user interaction and experience – essential in designing usable health technology.

Value-Based Healthcare

A model that focuses on patient-centeredness and treatment effectiveness in relation to costs.

Wellbeing Technology

Technological solutions that support individual wellbeing but are not classified as medical devices. Important to distinguish from regulated health technology.