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Expert Rev Med Devices. 2009 May;6(3):251-7. doi: 10.1586/erd.09.2.

Health Technology Assessment: managing the introduction and use of medical devices in clinical practice in Italy.

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AGE.NA.S., Agenzia Nazionale per i Servizi Sanitari Regionali, Sezione ISS-Innovazione, Sperimentazione e Sviluppo, Via Puglie, 23, 00187 Rome, Italy.


Technology assumes a key role in current clinical practice. A number of innovative or improved products are constantly being launched on the market and offered directly to the users (i.e., clinicians) or even to the patients. However, in most cases, the regulation for admission to commerce is slower than the innovation process and may be inadequate for assessing the real clinical effectiveness and safety of medical devices in the premarket phase. Health Technology Assessment (HTA) can be used as a tool for the evaluation of clinical effectiveness, cost-effectiveness and risk to patients of medical devices. HTA products (e.g., periodic reports) may aid healthcare payers to make informed choices regarding the appropriate use, coverage and reimbursement of medical devices. We present the strengths and limitations of the first three Italian HTA reports we coauthored and critically explore some of the aspects related to the introduction, adoption and use of medical technologies in clinical practice.

[Indexed for MEDLINE]

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