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14 Jan 22
Medical devices and artificial intelligence: FDA issues first guidelines for developing Good Machine Learning Practices
On October 27, 2021, the U.S. FDA, in collaboration with the Canadian regulatory agency, Health Canada, and the United Kingdom’s MHRA, released a document containing 10 guiding principles to promote the development of Good Machine Learning Practice.
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.
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the operational and practical implementation of Articles 13&14 and other related obligations for importers and distributors under MDR and IVDR Regulations
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17 Nov 21
Preliminary guidance on the requirements and provisions of the MDR applicable to legacy devices
The devices known as “legacy devices” should be subject to the application of only some of the provisions and requirements set forth by the MDR, as better clarified and identified by the Medical Device Coordination Group report issued on October 21, 2021 (“MDCG 2021-25”).
16 Nov 21
Draft competition bill: New rules for the healthcare sector?
On November 5, 2021, the Council of Ministers approved the draft law on competition. The Competition Bill is now under review by Parliament, which will discuss the draft in the coming weeks.
15 Nov 21
AGCM finds no abuse in diagnostic imaging device manufacturers’ refusal to provide downstream competitors access to information for maintenance services
On March 30, 2021, the Italian Competition Authority closed an investigation it had opened in 2018 against three manufacturers of high-end diagnostic imaging devices.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the Life Sciences-Healthcare industry.
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Our highly-ranked team of professionals will provide news, insights 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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October 6, 2023
CBD products: the Administrative Court suspended until October 24 the recent Decree of the Italian Ministry of Health listing cannabidiol for oral use among narcotic drugs, due to the lack o...
October 4, 2023
The Guidelines for regulating contractual relations between universities and research institutes and private sponsors were adopted by the relevant Italian Ministries following the amendment ...
September 21, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
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