• Thomas ROCHE explique dans La Tribune de l’assurance de mars 2017 les différentes controverses dont la loi Jardé va être à l’origine

  • Thomas ROCHE a rédigé pour le magazine Expertises des systèmes d’information d’avril 2016 un article analysant une importante modification de la loi relative aux fichiers et aux libertés

  • Thomas ROCHE a publié dans le magazine Expertises des systèmes d’information de février 2016 un article portant sur le nouvel encadrement de l’ouverture des données de santé

  • Thomas ROCHE et Renaud-Jean CHAUSSADE sont intervenus pendant la journée « Innovation et achats publics hospitaliers » à Lyon le 30 mars 2015 sur le thème des codes des marchés publics.

  • Thomas ROCHE expose, pour le magazine Tribune de Lyon du 19 mars 2015, les conditions d’opposition qui s’appliquent aux données issues d’un objet connecté

LIFE SCIENCES


blog

In the healthcare products and business market, with its constantly evolving legal framework, the Life Sciences department assists healthcare and medical technology businesses, and their partners, at every stage in their product lifecycle, from development, through preclinical or clinical evaluation, marketing approval, reimbursement and distribution.

The department also advises sector businesses and organisations on their relations with healthcare professionals and, for certain clients, provides outsourced management of procedures relating to the implementation of contractual relations.

The department is noteworthy for the particular assistance it offers clients during health authority inspections and audits and for defending their interests in administrative litigation.

Healthcare products, be it medicines, tissues and cells, medical devices, prescription assistance software, cosmetics, in vitro diagnostic medical devices (IVDD), food supplements biocides, phytopharmaceutical products, etc., are central to the activities of the Life Sciences department, which is involved primarily in the following issues:

- authorisation of establishments or activities - preclinical or clinical evaluation
- marketing approval - pricing and reimbursement
- promotion and advertising
- distribution/purchasing - liability
- contractual relations
- intellectual property
- processing of personal data
- animal health inspections
- administrative, legal or commercial litigation
- patronage and sponsorship.

In addition, as the digital realm expands, resulting in what has become the “datification” of our societies, defining a strategy for the optimal management and use of data is becoming a major concern for all concerned.  

E-health, i.e. the use of information and communication technology in the healthcare and medico-social fields, offers a formidable lever for quality, safety and efficiency of care that is now widely acknowledged by all involved.

Knowledge and experience of the legal and functional framework by the players concerned and of the role they play in healthcare information systems, whatever their purpose - medical records management, research files, medico-social monitoring, hosting, etc. - is vital for any organisation seeking to position itself in today’s healthcare sector.

The Life Sciences department is equipped to provide assistance in the following areas in particular:

- regulatory framing of healthcare information systems (telemedicine, health cooperation groups, regional hospital groupings, etc.)
- implementation of information systems in accordance with the benchmarks applicable to the sector
- grasping the new rules for exchanging and sharing healthcare data in the health and medico-social fields
- drawing up healthcare data hosting contracts and coordination of the various authorisations required
- consultations on conditions of access to healthcare data (including Big Data issues) - completing the requisite preliminary formalities with the CNIL and INDS.
- any issue relating to personal data as previously defined for the healthcare sector
- training regarding the legal and functional framework applicable to the healthcare sector.

Widely recognised for its expertise, the Life Sciences department is headed by two partners:

 BOSSI

Jeanne Bossi Malafosse and Thomas Roche, and staffed by:

- 4 associate attorneys:
 
Christine CHAURAND
Axelle Louis
Cécile Gleysteen
Lucille Romestin

- 1 legal expert:

Claire Lauria

The department works closely with the firm’s other departments, in particular the Data Protection, Company Law - M&A, Non-Profits, Public Law and Litigation departments, in order to respond effectively to the plurality and complexity of the issues facing those operating in the sector.

The team is equally at home working in French or English.