In the March 2017 issue of La Tribune de l’Assurance Thomas ROCHE explains the various controversies that will result from the Jardé law Thomas ROCHE, a partner in the "Life Sciences" department, outlines the three major changes brought about by the application of the Jardé law, particularly in relation to risk-inherent interventional research...Read
The “Life sciences” department works with companies involved in health and medical technologies, as well as their partners, at all steps in the lives of their products, as part of their development, pre-clinical or clinical assessment, valuation of innovations, marketing, reimbursement or distribution.
The department’s team also advises health establishments of any form, as well as companies and organisations in this sector, relative to their relations with health professionals. For certain customers, it provides outsourced management of the procedures relative to the implementation of these contractual relations.
The lawyers in the “Life sciences” department are distinguished by the particular assistance that they provide to their clients during inspections performed by health authorities, and as part of the defence of their interests in the event of administrative or judicial disputes.
Moreover, faced with the development of digital technology that’s now leading to a true “datafication” of our societies, the definition of a strategy for optimal data management and exploitation is becoming a major concern for all actors in the health sector.
Knowledge and familiarity with the legal and functional framework by actors and the role that they play in health information systems regardless of the objective – management of medical files, research files, medical-social monitoring, hosting, etc. – are essential for everyone involved in today’s health sector.
The “Life sciences” department works with you on the following subjects :
- assistance with the regulatory framework for projects involving health information systems (tele-medicine, health cooperation consortia, territorial hospital groups, etc.),
- assistance with understanding the new rules for exchanges and sharing of health data within the health sector and within the medical-social sector, drafting of hosting contracts for health data and coordination of the various required authorisations,
- consultations on the conditions for accessing health data (including Big data issues), etc.
The department’s members provide extensive inter- and intra-company training in the areas of clinical research, health data, administrative inspections, the usage of biological samples, health products, the valuation of innovations, regulatory compliance, etc.
Given the cross-disciplinary nature of many files entrusted to the “Life sciences” department, and in order to respond to the range and complexity of issues arising for the actors in this sector, these files are handled in close collaboration with the firm’s other departments, primarily the “Personal data”, “Corporate law – Mergers-acquisitions”, “Non-profit organisations”, “Public law” and “Disputes” departments.
The team works in French or English.
Ranking of the department
Liste des classements parmi les principaux :
- LEGAL 500, 2016
- “Health and life sciences sectors and industries” – Rank 3
- DÉCIDEURS, 2017
- “Regulatory law in health, pharma and medical devices” – Excellent
- “Electronic health” – Excellent
- “Patent disputes in Pharma, Biotech and Life sciences” – Highly renowned
- “Consulting for health establishments / hospital cooperation” – Highly renowned
Thomas ROCHE wrote an article for the April 2016 Expertises des Systèmes d’Information analysing an important change in the law relating to data protection Thomas ROCHE, a partner in the "Life Sciences" department, takes a stand in an article published in the April 2016 issue of Expertises des Systèmes d’Information about the recent merger of...Read