What are the rules for protecting medical data? What is the legal framework for setting up a telehealth activity? What are the new modes of practice for health professionals and the social and medico-social sector? What are their responsibilities when using digital tools?
As public and private players contributing to the production or use of health data, you are all concerned by the need to legally secure the exercise of your professions and activities.
Regulatory compliance is a guarantee of the trust that can be placed in the activity, product or service made available as part of a public policy or for commercial purposes. These issues of trust are particularly important in the health and digital sector.
Secure the exercise of your activity as care professionals
To help you practise your profession in complete serenity in a rapidly changing healthcare context, we provide support to help you comply with the conditions for accessing and exercising your activities (healthcare professionals and establishments, EHPAD, MDPH, SESSAD, healthcare centres and homes, networks, medical imaging centres, biology and pharmaceutical laboratories, etc.):
We also address our services to:
The increasing use of digital technology is creating real opportunities for economic development (connected medical devices, "Artificial Intelligence" (AI), connected objects and mobile applications for health and well-being, pharmacovigilance, online medical appointment scheduling, etc.). At the same time, it is necessary to provide legal certainty in the projects.
Your health digitalisation project designed in a secure environment
For those of you who design, supply or host these devices (software for the administrative management of staff, practices, patient records, etc.) and associated services (instant messaging, secure health messaging, data-sharing servers, development of data processing algorithms, etc.), the integration of a legal site from the project design stage is a guarantee to avoid subsequent compliance costs and, where applicable, pre-litigation management costs.
Confidence cannot be decreed, it is acquired, in particular through legal security from the design stage of projects.
With the support of our mastery of the institutional and legal context of digital health and our experience as corporate lawyers, we are able to understand your needs and work in collaboration with the various trades involved in this type of project (manager, engineer, project manager, IT department, CISO).
Ensuring that the legal and normative framework is complied with, right from the design stage of your project, whatever your legal status, means that you avoid costly backtracking!
We support you at all stages of your project by carrying out a legal feasibility study including our recommendations concerning, on the one hand, the most efficient legal set-up (e.g. modification of your company's articles of association, improvement of the contractual clauses binding you to your partners/clients, confidentiality clause, registration of trademarks, patents, etc.) and, on the other hand, the rules applicable to your project:
Whenever is necessary to carry out your project, we will work hand in hand with your teams.
If you're looking to add new functionalities to your software or device, if you have new prospects for the development of your activity requiring the reuse of personal health data or you encounter difficulties in complying with the rules applicable to your activity, we are here to provide you with our legal support any time along the way.
We help to put together applications for funding (grants, other types of aid) and to respond to calls for projects (national or European).
Indeed, there are many grants to support public and private initiatives that respond to a political will to accelerate dematerialisation and digital development, particularly in the health sector (ERDF grant, grants from BPI France, incubators, call for projects from the Ministry of Health for experiments in health innovation, for example under Article 51 of the Social Security Financing Act launched in August 2018, etc.).
The constitution of these files requires legal support to differentiate your offer and win the bid.