Artificial Intelligence and Machine Learning in Clinical Trials: Regulatory attempts by European and national authorities
In the last few years, use of Artificial Intelligence and Machine Learning systems in the performance of Clinical Trials has increased.
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.
Online sales of counterfeit medicines: AIFA recommendations and actions to combat the issue
On April 9, 2021, the Italian Medicines Agency, or Agenzia Italiana del Farmaco (the “AIFA” or the “Agency”) published a Nota informativa notice containing details regarding risks stemming from online purchases of medicines.
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”).
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”).
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.