Early awareness alert system (also known as early warning system, horizon scanning system; EAA system)
A system that aims to identify, filter and prioritise new and emerging health technologies, or new uses of existing interventions; to assess or predict their impact on health, health services and/or society; and to disseminate information.
Filter: a process to remove technologies that are not relevant to the early awareness and alert system from a list of technologies originating from the identification process.
Prioritise: a process to determine the significance of, or order for dealing with, filtered technologies according to their relative importance to the aims of the early awareness and alert system.
Emerging health technology
A health technology that has not yet been adopted within the healthcare system. Pharmaceuticals are in the Phase II or III clinical trial, or pre-launch stage; medical devices are in the pre-marketing stage.
The systematic identification of health technologies that are new, emerging or becoming obsolete and that have the potential to effect health, health services and/or society.
New health technology
A health technology that is in the launch, early post-marketing, or early diffusion stages.
Other relevant definitions include:
Advanced Therapy Medicinal Product (ATMP)
According to Article 2(1)(a) of Regulation (EC) No.1394/2007 an ATMP is any of the following medicinal products for human use:
A gene therapy medicinal product
A somatic cell therapy
A tissue engineered product
A combined ATMP where the ATMP product is an integral part of a medicine device.
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.
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).