This section explains the reasons for drawing-up the methodological guideline for post-introduction observation of new technologies.
In view of the fact that systematic, prioritised observation of new health technologies following their introduction into the health system, as set forth in this document, is a relatively new initiative, not only in Spain but also in neighbouring countries, there is no standardised methodology for establishing an observation of health technologies after their introduction into the health system.
The systematic observation of all health technologies after their approval is unviable in financial and organizational terms. It is necessary to identify and classify in order of importance the health technologies that may require a post-introduction observation. A structured protocol should be available for prioritisation or there is a risk that this process will be biased due to different pressures and conflict of interests.
This guideline is also needed to identify valid and reliable data-collection instruments, as well as to establish outcome indicators to measure relevant aspects of the diffusion and use of new technologies once they are adopted and used in general clinical practice.
The existence of this guideline would enable health care to be delivered with greater quality, by enhancing patient safety and identifying possible inequities in the health system.