The Digital Health team at Lerins & BCW, led by Marguerite Brac de La Perrière and Mathilde Croze, offers to its French and foreign clients an extensive and recognized expertise in Digital Health in France matters ranked as “Excellent” (Leaders League), specifically in the following areas:
- Processing of personal health data in France
- Regulatory matters in the field of Digital Health in France: health data hosting, exchange and sharing of health data, medical confidentiality, software and digital medical devices, online consultations / digital health services telemedicine / telecare, giftware, health data warehouses
- Cybersecurity in France
- Massive data and Artificial Intelligence (Big data and AI in France), data valuation, data anonymization / data pseudonymization
- Contracts: IT Agreements, Partnership Agreements, Cooperation Agreements and Commercial and Distribution Agreements.
- Intellectual Property aspects
The Digital Health team at Lerins & BCW law firm has a cutting-edge knowledge of the digital health sector, and advises all categories of players in order to provide a practical, pragmatic, holistic and forward-looking vision:
- Health data hosting companies
- SaaS and On Premise Health software / IT companies
- Manufacturers of medical devices / connected objects (IoT)
- Public and private health hospitals
- Health Cooperation Groups and Hospitals Groups (GCS and GHT)
- Health professional corporations and unions of health professionals / practitioners
- Insurance companies
- Health industries / innovation labs
- Sectoral authorities
- Private equity funds and investors in relation to Tech M&A transactions
The Digital Health team is particularly involved in the following activities:
- Compliance with GDPR and regulations from the design stage
- Distribution of digital health products / devices and/or digital health online services
- publishing / marketing / commercial distribution (Finder fee model to traditional distribution including VAR agreements) for complex IT solutions, software and on-premise applications, Saas, B2B and B2C
- Collaboration, Partnerships and Consortium Agreements
- POC, pilot and MVP on digital health services or products
- Relations with public authorities / lobbying
- Data Regulatory Authority in France controls, audits and inspections
- Pre-litigation / litigation / mediation / IT expertise
The activity of the Digital Health team at Lerins & BCW law firm comprises the following services relating to:
- Artificial intelligence (AI): strategic advice, legal opinion, PoC Agreements, Partnership Agreements and Consortium Agreements, Cooperation Agreements, patient information, terms and conditions of use and services, liability, medical device qualification/classification, Ethical Policies, etc.
- Health Data Warehouses and Anonymized Databases: legal structuring, support in the conditions relating to the anonymization and/or pseudonymization of data, Data Sharing Agreements, software and database licenses, relations with the French Data Regulatory Authority in France (CNIL)
- Telehealth, telecare: technical and legal prerequisites, practitioner and patient General Terms and Conditions, social security aspects.
- Health Data Hosting: legal support for required HDS certification in France, Hosting Agreements, Sub-contracting Agreements and Services Agreements
- Health GDPR matters: qualification of actors and their responsibilities, definition of implementation conditions, requests for authorizations from the French Data Regulatory Authority in France (CNIL), accountability documentation (policies and procedures), processing registries, Sub-processing Agreements , support in the event of control, information and rights of individuals, Data Processing Schedules and GDPR addendum to existing agreements.
- Cybersecurity: technical and legal prerequisites for each project, Policy for the use of information systems, security documentation, support for the implementation of the information security policy or security measures, impact analyses, etc.
- Data breaches concerning Health Data
- IT subject matters in France: IaaS Agreements, PaaS Agreements, SaaS Agreements, Sub-processing Agreements and services and consultancy Agreements health data related
- Qualification and classification of medical devices (MD), distribution of MDs in France, 3D print issues, connected objects (IoT)
- Anti-gift regulation in France
Our Digital Health team acts as a day-to-day partner for many of its clients:
- As a Data Protection Officer (DPO) for software, services or hosting companies and public players, or in support of their DPO.
- As an outsourced legal counsel
Our Digital Health team also carries out training sessions as LERINS & BCW has the official training certification: in-house, on catalogue for training organizations (Dii, Les Echos Formations), bespoke trainings depending on clients’ needs. Our team also participates in numerous conferences and round tables on digital health in France legal matters.
The Digital Health team at Lerins & BCW law firm is led by Marguerite Brac de La Perrière and Mathilde Croze who share the same technicity, dynamism and enthusiasm in their work, and the same solid values:
- Marguerite Brac de La Perrière is famous in the French Digital Health ecosystem in France thanks to her agility in highly technical matters, such as Health Data Hosting, Cybersecurity, Data Anonymisation and AI, and regulatory issues, associated with a major lobbying activity.
- Mathilde Croze, French-American, is a leading expert in IT Agreements and Data Privacy matters as well as Technology M&A deals, performing – in the context of shareholding, asset or equity buyouts – IP and IT due diligence (contracts and licenses), Data Privacy audits, and the drafting of related legal documentation, offering her clients her in-depth expertise and a perfect understanding and management of risks, of complex IT and data matter in particular in an international context.
The Digital Health team at Lerins & BCW is appreciated for its pragmatism and its forward-looking vision, based on a perfect knowledge and understanding of the Digital Health sector, and an ability to move the lines in order to provide innovative and constructive legal solutions.
The Digital Health team is leading and highly involved in Digital Health in France, in particular as a member of APSSIS (Association for Health Security IT systems), as partner of start-up incubators such as (Le Village by CA), and as a contributor or a speaker at Syntec numérique (Software companies union).
The Digital Health team at Lerins & BCW law firm regularly publishes articles and opinions in the field of Digital Health:
- 2021-03: “Cybersecurity in the health field, what is the current situation in France? “an opinion article published in Les Echos.
- 2021-01: Marguerite Brac de La Perrière is interviewed by Chrystèle Bazin on “The legal issues of AI in health“, and in particular the anonymisation of data.
- 2020-06: Marguerite Brac de La Perrière is interviewed by DII Drive Innovation Insights on the development of digital uses in health, and the changes brought about by the Covid 19 crisis: Drive Insight Innovation interview “Health crisis and artificial intelligence“.
- 2020-05: Marguerite Brac de La Perrière is questioned by the Argus de l’assurance on the development of online medical consultation uses during the Covid 19 crisis, more precisely on the current regulatory situation, the conditions for more flexible treatment, the consequences for complementary health care, and the prospects for perpetuation ” Teleconsultation: crisis effect or future service “.
- 2020-05 : Marguerite Brac de La Perrière writes on “Can the law be deactivated by a state of emergency” for Village de la justice
- 2020-04: Vincent Trély of APSSIS questions Marguerite Brac de La Perrière on the current state of digital health, in particular the new obligations of the players resulting from the HOP’EN program, from sectoral reference systems including the PGSSI-S, and from the health system transformation strategy materialised in Ma Santé 2022.
- 2020-04 : Virtual and augmented reality in the health services: Marguerite Brac de La Perrière participates in the Virtual and augmented reality special health dossier published by Laval Virtual, “Virtual or augmented health reality from a legal perspective”.
- 2020-06 : Marguerite Brac de La Perrière is the author of 2 Lamy (Wolters Kluwer) studies ” GDPR in the health field ” and ” Health connected objects “.
- 2020-06: “AI and health: what are the legal and ethical issues” Marguerite Brac de La Perrière speaks in Planet Robot
- 2020-01: Marguerite Brac de La Perrière speaks at the Journées de l’Innovation en Biologie (JIB) on the theme “GDPR – New code of conduct and governance“
- 2019-04 : Marguerite Brac de La Perrière speaks at the “Data Managers’ Meetings” on GDPR and the reuse of data in the context of research.
- 2019-06 : ” What responsibility for AI? “Marguerite Brac de La Perrière gives an update for DSIH magazine on the liability regimes applicable to AI (Part 1 – Part 2)
- 2019-05 : Marguerite Brac de La Perrière interviewed by APSSIS proposes a “News update on the certification of health data hosting provider“.
- 2019-03: SFIL round table on “Health data: from property … to user rights” by Marguerite Brac de La Perrière
- 2019-01: Marguerite Brac de La Perrière proposes to the APSSIS a news on “The hosting of personal health data” in the SSI Santé Collective Work
- 2018-03 : Marguerite Brac de La Perrière intervenes with DM Experts on “Data protection in the health sector: what specificities”.
- 2018-05: round table “Healthtech and uberisation” organised by the Esprit Service Institute & MEDEF
- Marguerite Brac de La Perrière explains the main principles of GDPR for DSIH « Faithfulness to the founding principles of our law on information technology»
- 2017-10 : Marguerite Brac de La Perrière speaks in Archimag on the protection of personal medical data, legal news, hosting of health data
- 2017-10: Marguerite Brac de La Perrière, invited by URPS Ile-de-France “Data sharing: regulatory precautions“.