Investigational Device Exemption
An investigational device exemption (IDE) is a US FDA permit to test an unapproved medical device in a clinical study, often to support premarket approval.
Explore comprehensive, evidence-informed explanations of key health economics concepts, including their development, application and relationships to other concepts. Published entries are validated through human expert review.
A concept page is a published entry on the wiki. Some concepts also have a full encyclopaedia article. The Health Economics Ontology (HEO) holds every concept, including dictionary terms without an article, so it is larger than the list of published pages. The knowledge graph shows how concepts relate to each other.
An investigational device exemption (IDE) is a US FDA permit to test an unapproved medical device in a clinical study, often to support premarket approval.
Knowledge brokering is work by people or organisations that link researchers with health decision makers so that research evidence is used in decisions.
A knowledge graph is a graph of data whose nodes stand for entities and whose edges stand for named relations, used to link trial, drug and coding data.
A large language model (LLM) is a deep learning model trained on vast text to predict the next token, used in HTA work to screen studies and extract data.
Life expectancy is the average number of further years people of a given age would live under stated death rates, a core input to health economic models.
Living HTA is a health technology assessment planned from the start to be updated at set intervals or triggers as evidence, comparators or prices change.
A managed access agreement is a time-limited NHS England deal funding a promising but uncertain medicine while data are collected for a NICE reappraisal.
MCDA in HTA uses multi-criteria decision analysis to appraise health technologies on explicit, often weighted, criteria such as health gain and severity.
The medical loss ratio (MLR) is the share of a health insurer's premium income spent on medical claims and quality improvement, with a US legal minimum.
Medical malpractice is injury to a patient caused by a health professional's negligent care, for which the law allows a claim for compensation.
The Model Context Protocol (MCP) is an open interoperability standard that connects AI applications to outside data and tools, such as health records.
A mortality rate is deaths in a population over a period divided by its mid-period size or person-time at risk, used in burden studies and economic models.
The moving target problem arises when a device, software or procedure changes during HTA, so evidence on it may be out of date by the time of the decision.
Multi-criteria decision analysis (MCDA) is a set of methods that compare health care options on several explicit criteria, often with weighted trade-offs.
Named entity recognition (NER) is a natural language processing task that finds and labels names such as drugs or diagnoses in clinical notes and papers.
A near miss rate is a patient safety indicator counting incidents stopped before they reach a patient per unit of care, such as per 1,000 medication doses.
Occupancy rate (bed occupancy) is the percentage of a hospital's available staffed beds that hold inpatients, averaged from daily bed counts over a period.
An ontology is a formal, explicit specification of a domain's concepts and their relations, used in health economics to code, pool and reason over data.
A patient information leaflet (PIL) is the approved leaflet in a medicine's pack telling users how to use it safely, based on the official product summary.
Premarket approval (PMA) is the FDA review a high-risk Class III medical device must pass before US sale, on evidence of its safety and effectiveness.