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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
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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...