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“Apps” for the patient – Medical devices or toys?

Editoriale di Giuseppe RecchiadaVi DigitalMedicine srl, Verona – Fondazione Smith Kline, VeronaTendenze Nuove n.2 – 2021; 13-20: DOI: 10.32032/TENDENZE202102Editoriale.PDF Digital technologies for patient health represent an emerging area of medicine. The possibility of improving health outcomes with these technologies – standalone, in addition or in combination with other treatments, such...

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Tendenze nuove – Special Issue 4/2021 – Volume completo

DIGITAL THERAPEUTICS:AN OPPORTUNITY FOR ITALY, AND BEYOND Executive SummaryWhy a volume on digital therapeutics, and not just for ItalyHow to manage regulatory aspects for digital therapeuticsTechnical validation of digital therapeuticsData protection and cybersecurity in digital therapeuticsClinical evaluation of digital therapeuticsAccess/reimbursement policies for digital therapeutics already in use in national health...

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Digital Therapeutics: an opportunity for Italy, and beyond – Executive Summary

Gualberto GussoniDepartment for Clinical Research “Centro Studi” FADOI(Italian Scientific Society of Internal Medicine), MilanoTendenze nuove, Numero Speciale 4 2021; 3-8: DOI: 10.32032/TENDENZENUOVENS042021EXECUTIVESUMMARY.PDF Executive Summary Digital therapeutics (DTx) can be defined as technologies that “offer therapeutic interventions driven by high-quality software programmes, based on scientific evidence obtained through methodologically rigorous confirmatory clinical...

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Why a volume on digital therapeutics, and not just for Italy

Lucio Da Ros1, Giuseppe Recchia1, 2, Gualberto Gussoni31Smith Kline Foundation, Verona2daVinci Digital Therapeutics, Milano3Department for Clinical Research “Centro Studi” FADOI (Italian Scientific Society of Internal Medicine), MilanoTendenze nuove, Numero Speciale 4 2021; 9-15: DOI: 10.32032/TENDENZENUOVENS04202101.PDF Defining digital therapeutics In recent years, terms and expressions like “digital health”, “digital medicine”, “telemedicine”, “virtual...

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How to manage regulatory aspects for digital therapeutics

Alice Ravizza1, Enrico Caiani2, Eugenio Santoro3,Silvia Stefanelli4, Federico Sternini1 1Use-Me-D, Torino2Politecnico di Milano, Electronics, Information and Biomedical Engineering Department 3Laboratory of Medical Informatics, Mario Negri Institute for Pharmacological Research, Milano4Stefanelli & Stefanelli Legal Chambers, Bologna-MilanoTendenze nuove, Numero Speciale 4 2021; 16-36: DOI: 10.32032/TENDENZENUOVENS04202102.PDF 1. Regulatory framework 1.1. Definition of a medical device...

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Technical validation of digital therapeutics

Alice Ravizza1, Federico Cabitza2, Enrico Caiani3, Eugenio Santoro4, Federico Sternini11Use-Me-D, Torino2Department of Informatics, Systems and Communication, University of Milano-Bicocca3Politecnico di Milano, Electronics, Information and Biomedical Engineering Department4Laboratory of Medical Informatics, Mario Negri Institute for Pharmacological Research, MilanoTendenze nuove, Numero Speciale 4 2021; 37-50: DOI: 10.32032/TENDENZENUOVENS04202103.PDF 1. Foreword As is the case...

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Data protection and cybersecurity in digital therapeutics

Emiliano Casalicchio1, Sebastiano Filetti2, Sabrina Grigolo3,Luigi V. Mancini1, Alessandro Mei1, Giulio Pagnotta1,Alice Ravizza4, Angelo Spognardi1, Silvia Stefanelli51Computer Science Department, Sapienza University, Roma2School of Health, UnitelmaSapienza, Roma3European Patients’ Academy/EUPATI Non-Profit Organization4Use-Me-D, Torino5Stefanelli & Stefanelli Legal Chambers, Bologna-MilanoTendenze nuove, Numero Speciale 4 2021; 51-70: DOI: 10.32032/TENDENZENUOVENS04202104.PDF 1. Data protection profiles in digital...

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Clinical evaluation of digital therapeutics

Alice Ravizza1, Oriana Ciani2, Antonio Ferrari3Sabrina Grigolo4, Francesco Perrone5, Elisabetta Ravot6Eugenio Santoro7, Federico Sternini11Use-Me-D, Torino2CERGAS, SDA Bocconi School of Management, Milano3IQVIA Ltd, Durham, NC, United States4European Patients’Academy / EUPATI Non-Profit Organization5Clinical Trials Unit, IRCCS National Cancer Institute “Fondazione Pascale”, Napoli6Healthware Group, Milano7Laboratory of Medical Informatics, Mario Negri Institute for Pharmacological...

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Access/reimbursement policies for digital therapeutics already in use in national health systems

Elisabetta Ravot1, Roberto Ascione11Healthware Group, Milano-SalernoTendenze nuove, Numero Speciale 4 2021; 105-116: DOI: 10.32032/TENDENZENUOVENS04202106.PDF The development of a business model and access policy for digital therapeutics (DTx) is becoming a recognized need and a matter of discussion in many countries, which can benefit from examples already in place in other...

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Digital therapeutics, HTA and reimbursement in Italy

Nello Martini1, Silvia Calabria1, Giuseppe Recchia2, 3, Gualberto Gussoni4, Oriana Ciani51Fondazione ReS (Ricerca e Salute) – Research and Health Foundation, Casalecchio di Reno (Bologna)2Smith Kline Foundation, Verona3daVinci Digital Therapeutics, Milano4Department for Clinical Research “Centro Studi” FADOI (Italian Scientific Society of Internal Medicine), Milano5CERGAS, SDA Bocconi School of Management, MilanoTendenze...

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