5. Patient involvement in different phases of HTA

The safety (including potential risks) of a health technology is equally important to patients as are the probable benefits. Safety is relevant both for pharmaceutical products and for medical devices. Positive as well as negative effects will nearly always be attached to the use of a technology, and the risk scenario should always be examined. You can find more information about ‘Therapeutic window’ in Non-Clinical Development module.

The HTA risk analysis should always include both the patients and the staff or caregivers who are to use the technology. As more and more health technologies are intended for patients' self-management the focus on safety aspects that are important to patients should be thoroughly assessed. Patients can contribute by pointing to the most patient relevant risks and their acceptability for further examinations.

The following safety aspects can provide examples for patients who help formulating safety questions to be included in the HTA assessment:

• Safety requirements for the application of the technology - what are the requirements for marketing authorisation or certification?
• Terminology and definitions - how is “safety” defined when it comes to the technology in question? Do patients, developers and regulators use the same benefit-risk preferences?
• Identification of risks - which adverse effects can be expected? How do patients evaluate or manage these adverse effects? 
• The importance of the adverse effects - how frequent and serious are the adverse effects? Are they associated with increased mortality and morbidity?
• Are other safety concerns important for patients evaluated (e.g. safety issues related to alternative interventions)?
• Patient acceptance of adverse effects - how do patients accept the adverse effects? Patients should pay attention to which groups have been asked about tolerance of adverse effects because the tolerance threshold is very low when the technology is used for patients with less serious diseases or conditions.