Sensitive to the importance of these issues for the operators they advise, ELSI's partners have chosen to develop a particular expertise in the protection of personal and health data, working as closely as possible to the needs of its clients.
As ELSI's lawyers work exclusively in the health products sector, this expertise is essential and inseparable from the strategy and legal security of all aspects of the life cycle of health products, whether they are commercial or regulatory, at the development stage, the conduct of clinical trials and investigations, software publishing, the setting up of registers, etc.
With its unique expertise in this field, ELSI offers support based on a dual approach combining advice and litigation, integrating risk analysis and anticipation, with the aim of providing a clear and strategic vision of the entire personal and health data policy.
This is why we also offer a service and support dedicated to the development of digital and e-health projects, combining the expertise of the firm's lawyers in regulatory affairs, new technologies, business law and health data.
The entry into force of the RGPD has profoundly changed the normative landscape with the overhaul of the French Data Protection Act (LIL ) of 6 January 1978 relating to information technology, files and freedoms by Order No. 2018-1125 of 12 December 2018, in order to ensure its compliance with the RGPD, and the reform of health data hosting.
The specificity of the pharmaceutical sector and the sensitivity of some of its activities, such as health vigilance, clinical trials, and the development and use of software, has led the CNIL to set up a specific standardisation through specific reference methodologies and specific set of references.
For healthcare manufacturers, the processing of health data has now become inseparable from the marketing of their products, particularly for medical devices, but also for all their economic and development activities, such as clinical research and investigations, the development of e-health, the management of commercial relations or relations with healthcare professionals.
In addition, changes in the criteria for access to reimbursement and evaluation by the HAS, as well as post-marketing studies requested by the authorities requiring the implementation of real-life monitoring and patient registers, lead to the implementation of specific data processing, now facilitated by the opening of the national health data system(SNDS).
Theidentification of the nature of the data collected, its use, its hosting, the purpose of the processing as well as its recipients are all issues that operators need to understand and master, in their legal and regulatory environment, prior to the implementation of their processing, but also to ensure its compliance and security, and for which they may have recourse to a lawyer specialising in health data law.
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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.