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12 Nov 21
Health data and digital healthcare: MedTech Europe Recommendations
On June 16, 2021, the European trade association representing the medical technology industries named MedTech Europe published a document containing recommendations for maximizing benefits from use of health data collected via medical devices.
1 Mar 21
E-prescriptions now available also for drugs not reimbursed by the NHS
On December 30, 2020, the Ministry of Economy and Finance adopted a decree (“Ministerial Decree”) that provided the possibility for doctors to issue e-prescriptions for drugs not reimbursed by the National Health Service (“NHS”).
18 Feb 21
Telemedicine: The New National Guidelines
Healthcare services provided remotely are officially a part of the National Healthcare Service (“NHS”), now that the State-Regions Conference has approved the document entitled “National guidelines for the provision of telemedicine services,” drafted by the Ministry of Health (hereinafter the “Guidelines”).
Dematerialization of prescriptions: Ministerial Decree allowing e-prescriptions for drugs not reimbursed by the NHS has been published in the Italian Official Journal.
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Telemedicine: Italian State-Regions Conference issues "National indications for the provision of telemedicine services" to implement telemedicine services in Italy
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1 Dec 20
Toward the digital transformation in healthcare: The Garante’s FAQs on electronic health record and online reports
In recent months, the Italian Data Protection Authority (“Garante”) has again addressed the implementation of technological solutions in the healthcare sector.
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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December 13, 2021
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 f...
October 27, 2021
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the applicability of MDR requirements to 'legacy devices' and 'old' devices
October 19, 2021
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the classification of medical devices
September 29, 2021
EU pharmaceutical strategy: today the Commission launched a public consultation on the revision of the EU general pharmaceuticals legislation (open until December 21, 2021)
August 4, 2021
Clinical Trials Regulation: EMA and European Commission confirmed that the Clinical Trials Information System (CTIS) will go-live on January 31, 2022
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