Glossary

Glossary of Health Technology

This glossary compiles key terms used in the operations of CleverHealth Network (CHN) and in the development of health technology.

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

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

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

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

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

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

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

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

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

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

Compliance with applicable standards and regulations.

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

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

Health services provided remotely using technology.

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

A standard that enables interoperability between healthcare information systems.

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

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

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

Rights such as patents and copyrights that protect innovations.

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

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

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.

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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