Glossary

Acronyms and terms used throughout the SHAIPED platform and survey.

A

AI

Artificial Intelligence
General term covering machine learning, deep learning, and related techniques.

AI Act

EU Artificial Intelligence Act
Regulation (EU) 2024/1689 establishing harmonised rules on artificial intelligence in the EU.

C

CA

Competent Authority
National authority responsible for MDR/IVDR oversight in each EU Member State.

CE

Conformité Européenne
CE marking confirms that a product meets EU safety, health, and environmental requirements.

CED

Coverage with Evidence Development
Conditional reimbursement scheme where funding is tied to ongoing evidence generation.

E

EC

European Commission
The executive branch of the European Union responsible for proposing legislation and implementing decisions.

EHDS

European Health Data Space
EU initiative enabling secure cross-border sharing of health data for care, research, and policy.

G

GDPR

General Data Protection Regulation
Regulation (EU) 2016/679 on the protection of personal data and privacy in the EU.

H

HDAB

Health Data Access Body
National or regional infrastructure body responsible for granting access to health data under EHDS.

HTA

Health Technology Assessment
A multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The dimensions of value for a health technology may be assessed by examining the intended and unintended consequences of using a health technology compared to existing alternatives. These dimensions often include clinical effectiveness, safety, costs and economic implications, ethical, social, cultural and legal issues, organisational and environmental aspects, as well as wider implications for the patient, relatives, caregivers, and the population. (INAHTA)

HTAB

Health Technology Assessment Body
National or regional organisation responsible for conducting HTA and informing reimbursement decisions.

HTAR

Health Technology Assessment Regulation
Regulation (EU) 2021/2282 establishing a joint clinical assessment framework across EU Member States.

I

IVDR

In Vitro Diagnostic Regulation
Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

M

MDAI

AI-based Medical Device
A medical device whose principal mode of action relies on an AI/ML algorithm.

MDR

Medical Device Regulation
Regulation (EU) 2017/745 establishing rules for placing medical devices on the EU market.

MEA

Managed Entry Agreement
A contractual arrangement between a payer and a manufacturer for a health technology under conditions of uncertainty.

N

NB

Notified Body
Conformity assessment organisation designated under MDR/IVDR to carry out third-party evaluation of medical devices.

P

PMS

Post-Market Surveillance
Ongoing systematic process for collecting and analysing data on devices already placed on the market.

R

RWD

Real-World Data
Routinely collected data relating to patient health status or the delivery of health care from a variety of sources other than traditional clinical trials (EMA definition).

RWE

Real-World Evidence
Clinical evidence derived from analysis of real-world data.

S

SHAIPED

Supporting Health Data Access Bodies to establish AI Pathways Enabling Deployment of AI as medical device tools

SPE

Sandbox for Privacy-preserving Experimentation
A controlled environment allowing experimentation with sensitive data under privacy safeguards.