E-commerce of medicinal products: According to the Court of Justice, a foreign pharmacy may be subject to the restrictions in force in Member States where it sells medicines online
With e-commerce becoming more and more widespread, including in the pharmaceutical sector, we are taking a close look at the small but growing number of decisions in both national and European courts that are already providing early indication and some interpretation of the many gray areas left by applicable legislation in this field.
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.
Remote clinical trials: from emergency to new normal
This article first appeared on the website of the Healthcare and Life Sciences Law Committee of the Legal Practice Division of the International Bar Association, and is reproduced by kind permission of the International Bar Association, London, UK. © International Bar Association.
Telemedicine: Lombardia and Piemonte give the green light to televisits
Since this summer, two additional regions have agreed to allow and recognize televisits at the Regional Health System (“RHS”)’s expenses.
COVID-19 emergency: increasingly dematerialized prescriptions
In order to reduce the spread of Covid-19, on March 19 the Head of the Civil Protection Department adopted an ordinance (“Ocdpc 651/2020” or “Ordinance“) allowing a citizen to receive from his/her physician an electronic prescription number (numero di ricetta elettronica – “NRE“), which is necessary to get a prescription drug from a pharmacy, without going to the doctor’s office.
New European Guidance on the qualification and classification of software as medical devices
In October 2019, the European Commission’s Medical Devices Coordination Group (MDCG) published a new guidance on the qualification and classification of software as medical devices (MDSW) under the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR) (the “Guidance”).