3
Apr
Article 22 EUMR is still up in the air: Advocate General’s opinion in the Illumina/Grail saga
Advocate General Nicholas Emiliou advised setting aside the General Court’s judgment and annulling the decision of the European Commission to accept the request from certain Member States to review the transaction under Article 22 of the EU Merger Regulation.
19
Jan
Recent legislative news in the life sciences sector under the Budget Law
The so-called “Budget Law” for 2024 wields significant impact on the life sciences sector, and allocates to the healthcare sector EUR 3 billion for 2024, EUR 4 billion for 2025, and EUR 4.2 billion for 2026.
19
Jan
New Public Procurement Code: Changes as of January 1, 2024
Multiple provisions of the new Public Procurement Code became effective on January 1, 2024, concerning the digitization of the procurement lifecycle. Changes should lead to fully digital management of public procurement, designed to enhance the efficiency of public administrations.
18
Jan
Doctors and the use of social media and electronic communication systems: The new FNOMCeO recommendations
FNOMCeO presented a set of Recommendations for the use of social media, e-mail, and instant messaging in the medical setting and in physician-patient communication, to prevent the potential negative repercussions of improper use of these tools.
17
Jan
Artificial intelligence and health care: News and issues in light of guidance from the Italian Data Protection Authority and the WHO
The use of AI in the healthcare field could facilitate improvement of treatment and prevention, and result in more effective allocation of resources in the field. However, there is trepidation about the consequences of possible errors and incorrect use.
16
Jan
Software medical devices in combination with hardware: The new MDCG guidelines
Medical device softwares (“MDSW”) that work in combination with hardware or hardware components to achieve their medical purposes: this is the topic of the guidelines issued by the MDCG-4, addressing manufacturers directly in an effort to provide regulatory guidance.
