Published Decree of Health Ministry providing measures to enhance no-profit clinical trials and to regulate transfers of data and results of no-profit studies for registration purposes
15
Dec 21
New national guidelines on telerehabilitation
Last October, the State-Regions Conference approved a document submitted by the Ministry of Health containing national guidelines for the delivery of telerehabilitation services by healthcare professionals.
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.
Clinical Trials Regulation: EMA and European Commission confirmed that the Clinical Trials Information System (CTIS) will go-live on January 31, 2022
Clinical trials: EMA launches public consultation on draft guideline for using computerized systems and electronic data
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.
