Health and digital health

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.

Operating conditions in the health and medico-social sectors


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.):

  • conditions for exercising regulated professions (decree of competence, cooperation between professions, etc.),
  • legal aspects of the structuring of organisations and their health and medico-social activities: authorisation, cooperation, etc,
  • relations with health insurance, MCAs (invoicing rules, agreements, etc.),
  • liability of professionals (ordinal litigation, liability of the establishment).

We also address our services to:

  • structures in charge of coordinating all these players (DAC, CLIC, etc.);
  • structures representing professionals in the field of social and medico-social care and monitoring;
  • authorities in charge of implementing public health policy (regional health agencies and bodies such as regional e-health development support groups, territorial support platforms, etc.) or representing the interests of the above-mentioned professionals and structures (e.g. regional unions of liberal professions, orders, federations, unions, etc.);
  • intermediate structures acting for the promotion and development of innovation (scientific cooperation foundations, associations);
  • structures that produce or re-use personal data, including health data, for the purposes of activity monitoring, research, or in related fields such as insurance;
  • we also advise you on how to secure the use of digital technology in your daily professional practice or in the context of a particular project.
Legal framework for digital health projects and feasibility studies

image02The 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).


enlightenedEnsuring 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:

  • Sectoral security standards: national health identifier, evidentiary force, identification and authentication of professionals, essential service operators, etc.
  • Interoperability standards,
  • Rules on the exchange and sharing of health data, respect for the rights of the persons concerned,
  • Hosting of health data,
  • Legal framework for digital health activities: e-prescription, dematerialisation of patient records, use of devices incorporating artificial intelligence, distribution of roles and responsibilities,
  • Research projects in the field of health (CNIL reference methodologies, rules on the use of Health Data Hub data, etc.),
  • Authorisations, contracts,
  • You can also refer any question to us on a specific subject requiring legal advice.

Whenever is necessary to carry out your project, we will work hand in hand with your teams.

Legal monitoring of the implementation of your projects

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.

Applications in response to calls for projects, funding applications

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.