Biomedical Robotics and Biomicrosystems Lab

Course of Health Technology Assessment and Management

 

Obiettivi formativi

Provide students with the skills pertaining to the regulations, the procedures for testing and certification and safety aspects of a new technology in the biomedical field. Such knowledge will develop skills in preparation for the aspects related to the Health Technology Assessment (HTA) aimed at analyzing the medical-clinical, social, organizational, economic, ethical and legal implications of a new biomedical technology, through the evaluation of various factors such as efficacy, safety, costs and social impact.

The skills acquired will also enable the understanding of issues related to the innovation management of the technology park hospital within the health services.

 

Contenuti del corso

The first part of the course is focused on learning methodologies that allow getting from the prototype to the placing on the market of the product and its use in clinical practice, including policies of intellectual property protection, regulatory issues, procedures for approval of the clinical trial and the subsequent CE marking of the biomedical device, the safety aspects of the technology to be analyzed (e.g. in terms of dependability, safety/security, integrity, confidentiality, availability).

The second part of the course is devoted to the study of elements of economics and health management, namely the identification of methodologies for the economic analysis of technologies, both from a microeconomic point of view (e.g. cost-benefit , cost-utility , cost-effectiveness) and from the macroeconomic point of view (e.g. systems of financing and reimbursement of health benefits, control policies of healthcare spending).  At the conclusion of the second part of the course, the dimensions of analysis to be considered for assessing the organizational impact on the introduction of new technologies in the health sector (eg market analysis, strategies for the management and renewal of the technology park) will be presented.

Finally, the third part of the course focuses on case studies presented by: i) public bodies with expertise in the field of biomedical technology (AGENAS - National Agency for Regional Health Services , National Institute of Health) , ii) companies, including Siemens, Johnsons & Johnsons, abmedica (trading partner of Intuitive surgical Inc., a world leader in the field of minimally invasive surgery robot assisted and producer of the robot, "da Vinci") , MASMEC (producer of a system for interventional radiology assisted), iii) university spin-offs.

At the end of the course there will be the possibility for internships in biomedical companies and for experimental thesis in close collaboration with companies or at the Hospital of the University Campus Bio -Medico.

Textbooks:

Teaching materials and handouts provided by the teacher.

Further reading:

-) Kotler P., Shalowitz J., Sevens R. J., Turchetti G., “Marketing per la Sanità, logiche e strumenti”, Mc Graw Hill, 2010.

-) Turchetti G., “La Politica degli Acquisti di Beni e Servizi in Ambito Pubblico: le Tendenze in atto nel Settore Sanitario”, Franco Angeli, Milano, 2005.

-) Turchetti G., “L’Health Technology Assessment. Riflessioni sulla dimensione e sulle implicazioni organizzative”, in L. Mantovani (a cura di), “L’Health Technology Assessment. Principi, Concetti, Strumenti Operativi”, Il Sole 24ore Libri, Milano, 2011.

-) Ricciardi W., La Torre G., “Health Technology Assessment: principi, dimensioni e strumenti”, SEED srl, 2010.

-) Turchetti G., Labella B., “L’innovazione nelle tecnologie biomediche tra rischio, incertezza, precauzione e gestione”, in Comandè, G. (a cura di) “Gli strumenti della precauzione: nuovi rischi, assicurazione e responsabilità”, Giuffrè 2006.

-) Health Technology Assessment (AA.VV. I quaderni di monitor 4° supplemento al n. 23 – 2009 – ed. Agenas.

 

Other:

-) Turchetti G., I. Palla, F. Pierotti, A. Cuschieri, “Economic evaluation of da Vinci-assisted robotic surgery: a systematic review”, Surgical Endoscopy, Vol. 26, pp. 598-606, 2012.

-) Turchetti G., E. Spadoni, E. Geisler, “Health technology assessment. Evaluation of biomedical innovative technologies”, IEEE Engineering in Medicine and Biology Magazine, May/June, vol. 29, n. 3, pp. 70-76, 2010.

-) Turchetti G., B. Labella, S. Bellelli, S. Cannizzo, I. Palla, S. Mazzoleni, S. Petroni, S. Sterzi, E. Guglielmelli, “Innovation in rehabilitation technology: technological opportunities and socio-economic implications”, International Journal of Healthcare Technology and Management, Vol. 10. Nos. 4/5, pp. 245-261, 2009.

-) Goodman C., “Introduction to health care technology assessment”, National Library of Medicine: National Information Center on Health Services Research & Health Care Technology (NICHSR), 1998.

-) Velasco Garrido M., Busse R., “Health technology assessment. An introduction to objectives, role of evidence, and structure in Europe”, WHO regional office for Europe 2005. European observatory on health system and policies, 2005.

-) Kristensen F.B., Sigmund H., Health Technology Assessment Handbook Copenhagen: Danish Centre for Health Technology Assessment, National Board of Health, 2007.

-) Battista R.N., Hodge MJ. The development of health care technology assessment. An international perspective. Int J Technol Assess. Health Care, Spring;11(2):287-300, 1995.

-) Battista R.N., Expanding the scientific basis of health technology assessment: A research agenda for the next decade. International Journal of Technology Assessment in Health Care, 22, pp. 275-280, 2006.


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