International HTA Glossary
NIHR HSC Glossary – additional terms
Conformité Européene = European Conformity. European mark of approval for medical devices.
Early awareness and alert system (EAAs)
A stable unit with reliable connections and sources which aims to:
- identify new and emerging health technologies,
- filter and prioritise those technologies most likely to have a significant future impact and
- make an assessment of either potential impact or clinical and cost effectiveness.
An early awareness and alert system and early assessments are an integral part of the prioritisation process for health technology assessment (HTA) activities.
Generally a technology that is not yet adopted by the health care system:
- pharmaceuticals – will usually be in phase II or phase III clinical trials or pre-launch,
- medical devices – will usually be prior to marketing, or within 6 months of marketing, or marketed but <10% diffused or localised to a few centres.
The Food and Drug Administration. This is the counterpart of the EMA (European Medicines Agency) and the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency), in the USA.
Premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device and is therefore not subject to premarket approval (PMA).
Health care technology
Encompasses all methods used by health professionals to promote health, prevent and treat disease, and improve rehabilitation and long-term care. These methods include pharmaceuticals, devices, procedures, programmes, settings, and public health activities.
Is the identification phase of an early awareness and alert system.
A procedure that is used for diagnosis or treatment that involves incision, puncture, entry into a body cavity, acoustic energy or electromagnetic radiation (e.g. radiotherapy).
A technology in the phase of adoption that has only been available for clinical use for a short time and will generally be in the launch or early post-marketing stages.