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11 Jun 21
The role of the DPO in the public sector: New guidance from the Italian Data Protection Authority
On May 24, 2021, the Italian Data Protection Authority published on its website “Guidance on designation, position and tasks of the Data Protection Officer in the public sector”.
7 Jun 21
EU regulations on medical devices and the GDPR: first step forward a necessary coordination
In the wake of application of the European medical device regulation (EU Regulation No. 745 of 2017), occurred on May 26, Italy is taking its first steps toward adjusting its national regulatory framework.
The Italian Data Protection Authority published guidelines on the role of the Data Protection Officer in public entities: important news for hospitals and healthcare facilities
25 Feb 21
Italian Data Protection Authority approved the first code of conduct in the public sector regulating the use of health data for educational and scientific publication purposes
The Italian Data Protection Authority (“Garante”) approved the first code of conduct (Decision No. 7 of January 24, 2021, doc. Web 9535354) on how to use personal data concerning health for educational and scientific publication purposes; the code of conduct was submitted by the Veneto Region (“Code of Conduct”).
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.
14 Oct 20
The Italian Data Protection Authority publishes Frequently Asked Questions and Infographic on the Electronic Health Record
On September 14, 2020, the Italian Data Protection Authority (“Garante”) published on its website a set of Frequently Asked Questions (“FAQ”) and an Infographic on the main characteristics of the Electronic Health Record (“EHR”).
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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