1.- Post-introduction observation of new technologies is a strategy which can complement the procedures implemented to regulate the incorporation and introduction of new technologies.

2.- The current methodological guideline is the first document published that sets forth a standardised methodology for post-introduction observation of new technologies. It is thought that it can serve as a reference for any institution/body, national or international, which may be planning to and/or are carrying post-introduction observation activities.

3.- The methodological guideline provides specific procedures and strategies for planning, implementing and evaluating the utilisation of new technologies.

4.- At present, post-introduction observation could be undertaken by means of clinical registries, using questionnaires completed by clinicians for collecting data of an administrative and clinical nature at the time of short-term intervention/treatment and telephone surveys of patients for medium/long-term follow-up. In the near future, electronic medical records could be the tool of choice for post-introduction observation.

5.- The outcome indicators proposed are valid to identify and measure important deviations in the utilization of new technologies once they are diffused within the health care system and identify effectiveness and safety problems.

6.- The methodology of post-introduction observation put forward is a preliminary proposal which will gradually be redefined with the implementation of these systems in different local, national and international settings.

7.- We recommend that the methodology be adapted to the respective context prior to its application. It is further advisable that a pilot test be conducted in the various health systems to assess the functioning of these procedures in line with each individual setting (public, private, specialised care, primary care health systems, etc.).