1731-7398 Health technology assessment of medical devices Kawalec Paweł author Mrożek-Gąsiorowska Magdalena A. author Stawowczyk Ewa author Instytut Zdrowia Publicznego, Wydział Nauk o Zdrowiu, Uniwersytet Jagielloński Collegium Medicum, Kraków Instytut Zdrowia Publicznego, Wydział Nauk o Zdrowiu, Uniwersytet Jagielloński, Collegium Medicum, Kraków Uniwersytet Bielsko-Bialski Correspondence to: Paweł Kawalec pawel.kawalec@uj.edu.pl Correspondence to: Magdalena A. Mrożek-Gąsiorowska magdalena.mrozek-gasiorowska@uj.edu.pl Correspondence to: Ewa Stawowczyk 28 12 2018 Tom 16, Numer 3 2018 187 194 Copyright © 2018 2018 <p>The current challenge for healthcare systems is to assess the clinical and economic value of non-drug technologies. Attempts have been made to use Health Technology Assessment, a standard method used in many countries to assess and make decisions regarding the reimbursement of medicines. The use of health technology assessment for non-drug technology can be a challenge because of the lower availability of high-quality scientific evidence in comparison with drugs. In several European countries attempts were made to develop guidelines for the clinical and economic evaluation of non-drug technologies; we presented specific guidelines prepared by British and French HTA agencies: NICE and HAS, respectively. In the case of Poland, the role of the Agency for Health Technology Assessment and Tariff System (<em>AOTMiT</em>) is to assess and appraise all medical technologies and services claiming public money funding; most of these assessments concern drug technologies. Only 103 of 1,550 orders (6.6%) issued by the Ministry of Health, from 1^st January 2012 to 1^st July 2018, were related to non-drug technologies. The health services assessed by the <em>AOTMiT</em> include different non-drug medical technologies, both specialized medical devices as well as surgical interventions or diagnostic procedures or screenings. Orders for non-drug technologies issued by the Ministry of Health vary in scope and type of assessment.</p> 1 Keltie K., Bousfield D.R., Cole H., Sims A.J., Medical Technologies Evaluation Programme: A review of NICE progression decisions, 2010–2013, “Health Policy and Technology” 2016; 5: 243–250. 2 Campbell B., NICE medical technologies guidance: Aims for clinical practice, “Perioperative Medicine” 2013; 2: 15. 3 Campbell B., Campbell M., NICE Medical Technologies Guidance a Novel and Rigorous Methodology to Address a New Health Technology Assessment Challenge, “Appl. Health Econ. Health Policy” 2012; 10 (5): 295–297. 4 Campbell B., Dobson L., Higgins J. et al., A new health technology assessment system for devices: the first five years, “International Journal of Technology Assessment in Health Care” 2017; 33 (1): 19–24. 5 Ustawa z dnia 27 sierpnia 2004 r. o świadczeniach opieki zdrowotnej finansowanych ze środków publicznych (Dz.U. 2004 Nr 210 poz. 2135 z późn. zm.). 6 Agencja Oceny Technologii Medycznych i Taryfikacji, Zlecenia MZ 2012–2015; http://bipold.aotm.gov.pl/index.php/zlecenia-mz-2012–2015 (accessed: 10.10.2018). 7 Agencja Oceny Technologii Medycznych i Taryfikacji, Zlecenia MZ 2016; http://bipold.aotm.gov.pl/index.php/zlecenia-mz-2016 (accessed: 10.10.2018). 8 Agencja Oceny Technologii Medycznych i Taryfikacji, Zlecenia MZ 2017; http://bipold.aotm.gov.pl/index.php/zlecenia-mz-2017 (accessed: 10.10.2018). 9 Agencja Oceny Technologii Medycznych i Taryfikacji, Zlecenia MZ 2018; http://bipold.aotm.gov.pl/index.php/zlecenia-mz-2018 (accessed: 10.10.2018). 10 Medical Technologies Evaluation Programme, Methods guide, NICE, April 2011. 11 Fournel I. et al., Methodological Choices for the Clinical Development of Medical Devices, “Medical Devices” (Auckland, N.Z.) 2014; 7: 325–334.  12 AOTMiT, Wytyczne oceny technologii medycznych (HTA, ang. health technology assessment), wersja 3.0, Agencja Oceny Technologii Medycznych i Taryfikacji, Warszawa sierpień 2016.