Solutions to promote compliance, prescription and dispensing assistance software, online medicine, e-health applications, m-health, robots, online drug sales and e-communication: digital and e-health are affecting and revolutionising all health sectors. As a new development player, the pharmaceutical industry is also increasingly equipped with artificial intelligence (AI), both in terms of research and for the optimisation of manufacturing and supply chain activities.
These new technologies constantly raise new ethical, legal and technical issues of interoperability and security, which operators must face. Digital development and e-health thus call for specific expertise and support, to which ELSI's lawyers are committed, involving mastery and knowledge of the law of new technologies andartificial intelligence(AI), the law of personal data protection and health data, as well as an understanding of the technical constraints, in compliance with the regulatory framework specific to each activity or product concerned
Health software publishers, medical device manufacturers, pharmaceutical and biotechnology laboratories, start-ups and project developers can therefore call on a lawyer specialised in pharmaceutical and e-health law to provide tailored support for their projects. This is why ELSI offers a complete, dedicated and specific support to its clients in strategy and securing all processes related to the development, use and marketing of new digital and e-health technologies.
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An investigation by the DGCCRF in 2021 led to the penalization of 6.6 million euros for illegal practices by the URGO group.
Medical device law
An amendment to the WDR has just been proposed by the European Commission to postpone the entry into force of the WDR.