Tag: medical device

Covid-19 mini-series | Legal advice for Switzerland Privacy, Health & Technologies

With Covid-19, the world is facing a huge crisis and the economy will be massively impacted.

New coronavirus, known as “Covid-19“, spreads itself from China (Wuhan province) to Europe, and then to the world leading to unprecedented measures from authorities in various countries, including Switzerland. Public health issues combine health law, protection of personal data & Privacy and the use of new technologies to fight and help during this tough historical time.… Plus...

10 March 2020
No Comments
Gabriel Avigdor
Data privacy, Health law, News, Technology

Abilify connected pill: ethics and privacy aspects of Personal Health Monitoring

ABILIFY MYCITE: A FIRST FDA APPROVAL FOR mHEALTH AND CONNECTED MEDICAL DEVICES

On 13 November 2017, we have probably reached a historical new step in digital health (and mHealth) with this market approval from the FDA for “Abilify MyCite“, the first digital tracking-pill which sends data to your doctor.… Plus...

5 February 2018
No Comments
Gabriel Avigdor
Data privacy, Health law, News, Security, Technology

Prescription support software are considered as medical device

Prescription support software is considered as medical device

On 7 December 2017, the European Court of Justice (‘ECJ’) made an important ruling in the French case SNITEM and Philips vs Premier Ministre des Affaires sociales et de la Santé (Case C-329/16). The Court followed its general advocate advice, who issued a non-binding recommendation on 28 June 2017, and defined for the first time under what conditions should medical software (standalone software) be qualified as a medical device pursuant to Directive 93/42/EEC on medical device.… Plus...