Health technology: the equipment, devices and drugs and the medical and surgical procedures used in prevention, diagnosis, treatment and rehabilitation of disease, as well as the organisational and support systems used in the delivery of health care.
Health technology assessment: is a multidisciplinary process that summarises information about medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased and robust manner. Its aim is to inform the formulation of safe, effective health policies that are patient focused and that seek the best value.
New health technology: is a technology in phase of adoption, which has been available for clinical use for only a short time and is generally in the launch period or early post-marketing stage.
Emerging health technology: any technology not yet adopted by the health care system; pharmaceuticals will usually be in phase II/III of clinical trials or in the pre-launch period, devices devices will be prior to marketing, or within 6 months of marketing, or marketed but with a diffusion of under 10% or localized to a few centres.
Health product/medical device: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software for its proper application intended by the manufacturer to be used in human beings for the purpose of: a) diagnosis, prevention, monitoring, treatment or alleviation of disease, b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, c) investigation, replacement or modification of the anatomy or of a physiological process, and d)control of conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its functions by such means.
Monitoring system: set of tools for generating and collecting data on health technologies for their assessment from the stage of introduction into the health care system until de stage of broader diffusion.
monitorised use: proposed mechanism for systematically generating and collecting data on new technologies for which there is insufficient information on safety, efficacy and efficiency to inform decision making on general funding by the public health care system
Surveillance system: process of systematic collection, analysis and interpretation of health data essential to public health to be used in the planning, implementation and assessment of programmes, including, as a basic element, the dissemination and application of such information.
Post-introduction observation of new technologies system organised system of collection, analysis, interpretation and dissemination of data on new technologies once they have been financed/approved and are used in standard clinical practice. The main goals are to provide essential information on diffusion, accessibility, adequacy of use and identify important deviations in effectiveness, safety or investments.
Adverse effects: any injury, damage and/or complication deriving from the use of a given technology, as well as diagnostic errors (FP, FN) that have led to an alteration in the health status of patients, end-users or the environment.
Severe adverse effect: any injury, damage and/or complication deriving from the use of a given technology, as well as the diagnostic errors that have led to death or major deterioration in the health status of patients, end-users or the environment.