#Digital Health Lawyer in France (E-Health)

Areas of work	Details
Regulatory compliance and data protection	- Audit of health data collection and processing practices. - Setting up GDPR-compliant data management policies. - Drafting legal notices and privacy policies. - Data breach management protocols to respond effectively to cyberattacks.
Developing and launching health software	- Support with the conformity assessment of software qualifying as a medical device (CE marking). - Regulatory validation of health and telemedicine apps. - Drafting subcontracting agreements. - Protection of intellectual property rights (copyright, trade marks, patents where applicable).
Managing legal risks and disputes	- Amicable resolution of contractual disputes. - Representation before the courts in litigation. - Risk management protocols to make contractual relationships legally sound. - Assistance with cybersecurity and incident management.
Building partnerships and negotiating contracts	- Structuring and negotiating public-private partnerships. - Drafting terms of use for health platforms. - Subcontracting agreements for e-health services (hosting, maintenance). - Managing contractual relationships with healthcare professionals and service providers.
Assistance with cyberattacks and data protection	- Creating crisis management protocols for cyberattacks. - Notification to the CNIL (French data protection authority) and other competent authorities. - Setting up cybersecurity policies. - Training teams to strengthen the security of health data.
Innovation and development strategy	- Assessment of the legal feasibility of e-health projects. - Structuring the development strategy for ongoing compliance. - Help in obtaining funding for digital health projects. - Recommendations on integrating AI and new technologies.

Hashtag Avocats, located in the heart of Paris, assists companies and organisations in the digital health sector. We offer end-to-end legal support, covering every stage of your e-health projects. Our team helps you navigate the complex regulatory framework governing digital health, combining regulatory compliance solutions with health data protection.

Our services are varied and designed to meet the current challenges of the digital transformation of healthcare. If you are developing mobile health apps, telemedicine software or connected medical devices, we act on the main legal issues raised by digital health. We help you anticipate risks and strengthen the compliance of your projects, while protecting your users’ sensitive data.

• GDPR compliance and health data: bringing you into compliance, data management, security audits.
• Drafting and negotiating contracts: subcontracting, public-private partnerships, terms of use.
• Protecting intellectual property rights: copyright in software, patents, trade marks, licences.
• Risk management and dispute resolution: assistance in litigation or in the event of a data breach.

What is e-health (digital health)?

E-health, or digital health, covers a range of digital practices and technologies applied to the medical sector. It is transforming healthcare by making care easier to access, improving the effectiveness of treatment and enabling remote patient monitoring. This transformation includes telemedicine, connected devices, health management platforms and many other innovations.

E-health also raises major challenges in terms of personal data security, regulatory compliance and legal liability. Every digital solution involving health data must meet strict data protection standards, which calls for dedicated legal support to anticipate and manage risks.

E-health innovations and services

• Telemedicine: remote consultations that reduce waiting times and improve access to care.
• Health apps: prescribing support software, real-time monitoring tools.
• Management platforms: solutions for managing patient records, prescribing and dispensing treatments.
• Connected devices: sensors and monitoring devices for real-time tracking of vital signs.
• AI in healthcare: use of artificial intelligence for diagnosis and personalised treatment.

When do you need a digital health lawyer in France?

E-health is subject to strict and constantly changing regulation, which calls for vigilance and in-depth legal expertise. The support of an e-health lawyer is indispensable to anticipate legal risks and strengthen the compliance of your projects.

Regulatory compliance and data protection

With the large-scale collection of sensitive health data, every e-health business must comply with the requirements of the GDPR and the specific regulations on health data. Failure to comply with these standards can lead to financial penalties and damage the company’s reputation. An e-health lawyer provides comprehensive support to:

• Audit data collection and processing practices in order to identify non-compliance risks.
• Set up personal data management policies that meet GDPR standards and the specific requirements of the health authorities.
• Draft legal notices and privacy policies, which are essential to inform and protect users of digital health services.
• Prepare data breach management protocols in order to respond quickly and effectively in the event of a cyberattack.

Developing and launching health software

Health software and connected medical devices must meet strict standards of security, reliability and data protection. The assistance of an e-health lawyer helps you navigate this complex legal framework:

• Support with conformity assessment procedures for software qualifying as a medical device, required before it is placed on the market (Article 52 of Regulation (EU) 2017/745).
• Legal advice on the regulatory validation of mobile apps and telemedicine platforms.
• Drafting subcontracting and partnership agreements with software publishers, so that liability is clearly defined and shared between the various parties.
• Assistance in managing the intellectual property rights in health software: copyright, which protects software (Article L. 112-2 of the French Intellectual Property Code (Code de la propriété intellectuelle) (in French)), licences and trade marks; a patent does not cover a computer program “as such” (Article L. 611-10 of the same code (in French)).

Managing legal risks and disputes

E-health involves complex interactions between different parties (developers, healthcare professionals, patients), creating potential legal risks. In the event of a dispute, the e-health lawyer plays a key role in protecting the client’s interests:

• Negotiation and amicable resolution of contractual disputes, avoiding costly court proceedings.
• Representation before the competent courts to defend the company’s interests in litigation relating to data protection or the safety of medical devices.
• Setting up risk management protocols to minimise exposure to litigation and make contractual relationships legally sound.
• Advice on cybersecurity and incident management to limit the damage caused by cyberattacks or data breaches.

Building partnerships and negotiating contracts

Developing e-health projects often involves partnerships between public and private players. These collaborations require well-defined contracts and clear commitments to avoid conflicts of interest. An e-health lawyer acts to:

• Structure and negotiate public-private partnerships, ensuring a fair allocation of responsibilities and benefits.
• Draft terms of use for health platforms, with a view to transparency and legal compliance.
• Draft and negotiate subcontracting agreements for e-health services, including data hosting, maintenance and cloud services.
• Support you in managing contractual relationships with healthcare professionals, suppliers and end users.

Assistance with cyberattacks and data protection

With the growing use of digital technologies in healthcare, the risk of cyberattacks has become a major issue. As health data is particularly sensitive, prompt and effective handling of any breach is necessary to protect patients and limit the legal consequences:

• Drawing up crisis management protocols to respond effectively to a cyberattack or data theft.
• Support with notification to the CNIL (French data protection authority) and other competent authorities in the event of a data leak.
• Designing cybersecurity policies to strengthen the security of digital health systems and minimise the risk of breaches.
• Training teams in data security to prevent incidents and raise awareness of good practice in managing health data.

Innovation and development strategy

Start-ups and innovative companies entering e-health benefit from strategic support to carry out their projects while meeting legal requirements. An e-health lawyer can give targeted advice to:

• Assess the legal feasibility of projects, taking account of the regulations in force in the digital health sector.
• Structure the development strategy to maintain ongoing compliance, from product design through to commercialisation.
• Help obtain public and private funding for digital health projects, by supporting the administrative and legal formalities.
• Provide recommendations on good practice for integrating artificial intelligence and new technologies into health solutions that meet ethical and legal standards.

How can a digital health lawyer assist you?

Regulatory compliance and data security

Regulation in the e-health field is constantly changing, with strict standards governing the collection, processing and storage of health data. The GDPR imposes specific rules to protect users’ sensitive information. Our lawyers carry out compliance audits and help you put in place data management policies that meet legal requirements.

Drafting and negotiating specific contracts

Contracts play a central role in e-health, whether for partnerships between companies, subcontracting agreements or terms of use. We help you structure these documents so that they protect your company’s interests and comply with legal requirements. This includes drafting IT contracts, managing relationships between developers, users and service providers, and negotiating distribution agreements.

Protecting intellectual property

Digital health innovations often involve the creation of unique software and medical devices. Their protection relies on copyright for software, on trade marks and, where the invention has a technical character, on patents; licences then govern how they are exploited. Our lawyers work to protect your creations and advise you on intellectual property rights.

Managing risks and disputes

As healthcare becomes increasingly digital, disputes and the risk of cyberattacks are multiplying. In the event of a contractual conflict or a data breach, our firm acts to defend your interests, either through amicable resolution or before the competent courts. We put crisis management strategies in place to limit financial and reputational impact.

Strategic support

A digital health project is more than a technological innovation. It requires a solid strategy that integrates legal, technical and ethical aspects. Our e-health lawyers work with your teams to assess the legal feasibility of your projects, anticipate obstacles and structure lasting, well-protected solutions. We also act on the implementation of telemedicine solutions, health management platforms and robust cybersecurity systems.

Contact Hashtag Avocats about your e-health project

The firm’s Contractual IP/IT practice handles the legal issues raised by digital health projects: qualification of the product as a medical device, hosting of health data, contracts with healthcare professionals and institutions, information of data subjects. Every situation is different, and the analysis starts with a review of your project.

To protect your e-health project and obtain quality legal support, contact us on 01 85 73 56 66 or visit our offices at 51 Avenue Franklin Delano Roosevelt, 75008 Paris. We will be pleased to discuss your specific needs and offer you tailored support.

Every situation is different: the information on this page is general and does not replace legal advice tailored to your case. The firm makes no promise of outcome; it commits to the means it deploys.