Masotti Cassella

by Kristina Dedi, Elena Carrieri, Anne Moutardier, Masotti Cassella.   To respond to the growing demand for secure digital identities at the European level, the EU has updated the eIDAS regulation, introducing new rules for electronic identification (eID): the eIDAS 2 Regulation. This regulation came into effect on May 20, 2024, but the publication of the implementing […]

eIDAS 2: an ambitious project to revolutionize digital identities and trust services across Europe. By Masotti Cassella To respond to the growing demand for digital identification solutions, the European Union has issued a supplementary update of the eIDAS Regulation: the eIDAS Regulation 2. This legislation entered into force on 20 May 2024, but the publication […]

A definition of digital therapy can be found in the December 2023 ISO standards, which state that it is “health software intended to treat or alleviate a disease, disorder, condition or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on the patient’s health.” (ISO/TR 11147:2023). Each DTx can […]

Critical points and reflection. By Luca Masotti We have deliberately chosen not to comment “hot off the press” on the well-known sentences 139 and (above all) 140 issued in recent days by the Constitutional Court on the well-known and thorny issue of medical device payback. We could have, but it seemed useless, delved into a […]

The Constitutional Court’s Rulings on Payback – Critical and Food for Thought We have deliberately chosen not to comment “on the spot“ on the well–known judgments 139 and (especially) 140 issued in recent days by the Constitutional Court on the well–known and thorny matter of the Medical device payback. We could, but it seemed useless, […]

The Bill on Cyber Security and Computer Crimes has been definitively approved in the Senate on 19 June 2024. This bill proposes new measures to strengthen the resilience of the IT infrastructures of Public Administrations and financial institutions, modifying the regulations on computer crimes and the related sanctions provided for by the Criminal Code, and […]

 In December 2023, the MDCG 2021-27 (concerning the obligations of importers and distributors of medical devices) was updated to respond to questions that have arisen in the market over the past two years. The guideline begins with a definition of “importer” and “distributor,” clarifying that an “importer” is “any natural or legal person established within […]

On 9 February 2024, the Ministry of Health published the criteria and procedures for the collection and allocation of resources pertaining to the so-called “Fund for the Governance of Medical Devices” (pursuant to Articles 28 of Legislative Decree no. 137/2022 and Article 24 of Legislative Decree no. 138/2022 implementing Regulations (EU) 2017/745 and 2017/746) as […]

Quello della responsabilità medica resta uno dei settori più appetibili nell’ambito legale. Un ambito che però presenta ancora luci e ombre e che richiede sempre più una maggiore specializzazione. C’è da dire che dall’introduzione della legge 24/2017 ci sono stati sicuramente degli effetti positivi, come la riduzione dei costi della cosiddetta «medicina difensiva». A rivelarlo […]

Main features of the regime 1. Foreword On 31 May 2022, the Italian Parliament approved Law 62/2022, also referred to as the Sunshine Act to regulate dealings “between manufacturing companies, subjects operating in the health sector, and health organisations”. The Act (published in the Official Gazette no. 135 of 11 June 2022) came into force […]

Italy continues with the harmonisation of its system with the MDR and IVDR. Previous measures (commencing with Legislative Decrees 137/2022 and 138/2022) established the categories of devices for which advertising is prohibited: i.e. (i) custom-made MDs; (ii) MDs requiring the mandatory assistance of a doctor or other health professional for use; (iii) MDs requiring a […]

On September 13 2022, Legislative Decrees on medical devices (137/2022) and in vitro diagnostics (138/2022) were published in Italy’s Official Gazette. These measures harmonize Italian law with the new EU Regulations 745/2017 and 746/2017 (“Regulations”) – amending and repealing (with specific timelines) the previous decrees – and introduce a new legislative framework consistent with the […]

I DL n.17/2022 (“Decreto Energia”) e DL 21/2022 (“Decreto Ucraina”) hanno introdotto alcune agevolazioni fiscali per il contenimento dei costi sostenuti per l’acquisto dell’energia elettrica e del gas naturale e per contrastare gli effetti economici e umanitari della crisi ucraina. Il DL n.17/2022 (Decreto Energia), prevede le seguenti agevolazioni fiscali: – all’articolo 4, un credito […]

Introduction The pandemic has made some critical aspects of a structural nature even more evident in the health sector, which in the future could be aggravated by the increased demand for care resulting from the ongoing demographic, epidemiological and social trends; in particular: (i)   significant territorial disparities in the provision of services; (ii)  inadequate synchronisation […]

Prior to the innovations introduced by Article 7 of the Medical Device Directive 2017/745 (the “MDR”) there was little uniformity of approach or guidance on the issue of advertising and what statements could be made in relation to medical devices (“Advertising). There was no reference to Advertising in the Medical Device Directive 93/42/EEC of 14 […]