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Portolano Cavallo Life Sciences Blog  / Ministry of Health
6 Jul
News on the reorganization of Ethics Committees: Latest updates
In the past few months great strides have been made to establish the national ethics committees envisaged by Law No. 3 of 2018 (the “Lorenzin Law”), which were supposed to be identified by the Ministry of Health within sixty days of the Lorenzin Law taking effect.
21 Mar
Published Decree of Health Ministry identifying the ethics committees of national significance for clinical trials of medicinal products and medical devices
Published Decree of Health Ministry providing measures to enhance no-profit clinical trials and to regulate transfers of data and results of no-profit studies for registration purposes
4 Feb
Medical Devices Regulation: Note issued by the Ministry of Health to regulate the transition period
On November 12, 2021, the Ministry of Health published a note providing guidance on the provisions of Legislative Decree No. 46/1997 that shall still be considered applicable following the date of the application of Regulation (EU) 2017/745 on medical devices and the issuance of the legislative decrees envisaged by Article 15 of Delegation Law No. 53/2021.
15 Dec 21
New national guidelines on telerehabilitation
Last October, the State-Regions Conference approved a document submitted by the Ministry of Health containing national guidelines for the delivery of telerehabilitation services by healthcare professionals.
15 Nov 21
The Consolidated Act on Rare Diseases is finally approved
After three years, Italy has finally adopted its first law on rare diseases. On November 3, 2021, the Italian Senate unanimously approved the Consolidated Act on Rare Diseases, or “Testo Unico sulle malattie rare”.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
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Our highly-ranked team of professionals will provide newsinsights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

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July 19, 2022
Guidelines for the implementation of the Electronic Health Record (EHR) to ensure dissemination, uniformity and accessibility of the EHR at national level now published in the Official Gazet...
June 6, 2022
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
April 27, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation...
April 5, 2022
Electronic prescriptions: the current modalities of transmission from doctors to patients and from patients to pharmacies are extended until 31st December 2022
March 24, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on appropriate surveillance of devices covered by certificates according to the MD Directives, under the transitional prov...
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