The European Centre of Excellence on the Regulation of Robotics & AI of Sant’Anna in Pisa has published an interesting document, under request of the Legal Affairs Department of the European Commission.
EU
ICT and artificial intelligence to fight cancer in the European Union
Ursula von der Leyen, President of the European Commission, launched a public consultation to define the future strategy to fight cancer. Every year 3.5 million new cases of cancer are diagnosed in the EU. The latest program for cancer prevention and diagnosis dates back 30 years. Continue reading
The patient information leaflet becomes digital
The European Medical Agency (EMA) and the European Commissions launched a public consultation on main principles governing the development of electronic product information (ePI) for medicines distribution inside Europe. Continue reading
The European Market of Telemedicine: where we are
In the last few days the European Union published a study on Telemedicine (link here). The document is very detailed (112 pages) and contains interesting information and a sector wide view, but some aspects create some doubts. Continue reading
Why the medical software certification will revolutionise the market in EU
As foreseen by the new Medical Devices European Rules (UE 2017/45), to be operational from 26 May 2020, and by the Court of Justice sentence of 7 December 2017, medical software shall be certified as medical devices (MD) class IIA (with the exception of software aimed to archive, store and transmit data without any data elaboration and added value). This will have a great impact on the market. Continue reading
Why privacy-by-design in healthcare is a utopia
GDPR introduces the principles of “privacy by default” and privacy by design”, on the base of which all company processes have to be re-designed; a change that deeply impact the healthcare information systems. Easy to say but very hard to realise. Continue reading
Digital-health 