Digital health and
health data

The regulatory environment for digital health and data protection is constantly changing, which means it is necessary to constantly rethink development strategies and business models. Our permanent regulatory watch allows us to provide appropriate assistance for the deployment and implementation of your digital projects.

  • Qualification and classification of health applications
  • Validation of innovative digital and organisational projects
  • Compliance audit of data protection policies
  • Drafting and review of general terms and conditions of use
  • Drafting and review of licences, general subscription conditions
  • Data Protection Officer (DPO) mandate
  • Performance of data protection impact assessments (DPIA)

Pre-clinical and clinical research

The research and development phases of health products and solutions require appropriate supervision, in order to ensure performance and legal security. Life Avocats assists you in identifying the most appropriate regulatory and contractual means of carrying out and optimising your research programmes.

  • Qualification of clinical research (clinical trials, clinical investigations, RIPH, etc.)
  • Drafting and review of clinical research contracts, translational research contracts, financial support contracts, legal representative contracts
  • Advice on the collection, storage, preparation and disposal of biological samples
  • Drafting and review of biological and clinical data transfer agreements (MTA/DTA)
  • Protection and enhancement of intellectual property rights
  • Drafting and review of consortium agreements

Health products and market access

Although essential, the marketing of health products and digital solutions is only one step in their life cycle. Their access to the market, their distribution, their management in real life terms are equally important stages during which Life Avocats will assist you.

  • Qualification of health products
  • Drafting and review of manufacturing or contract production agreements
  • Review of promotional materials
  • Drafting and review of health product distribution agreements
  • Challenge against refund refusal
  • Pre-litigation and commercial litigation

Compliance and inspections

Life Avocats has developed particular expertise in assisting companies which face health inspections and which need to challenge administrative policy decisions. In order to prepare you for possible inspections, Life Avocats carries out audits, proposes action plans and assists you in their implementation in order to guarantee your compliance with the applicable regulations.

  • Compliance audit, reasonable effort
  • Advice on the application of transparency and anti-gift schemes
  • Assistance during inspections (ANSM, CNIL, DGCCRF, etc.) or audits of notified bodies
  • Challenging of draft policy decisions
  • Administrative litigation following refusal of a marketing authorisation or health policy decisions

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