Digital health / e-health

Lerins&BCW’s Health Team has been awarded the Gold Trophy for Health and Pharma for the year 2021 by a professional Jury as part of the Trophées du Droit organized by Leaders League.

The Digital Health team at Lerins 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
• Anti-gifting devices and transparency
• Digital Therapeutic: support for the implementation of the platform (GDPR regulations, partnership contracts, research, anti-gifts), research, partnership contracts with institutions

The Digital Health team at Lerins 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 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.
• Medical websites and Health Services: audit and compliance, GTCs, Terms of Use, legal notices, Privacy Policy, Cookie Policy and banner, online medical content publications
• 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 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 law firm 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.

The Digital Health team at Lerins 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).