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Artificial Intelligence & Healthcare

Ensuring compliance and governance of AI projects in healthcare

AUMANS AVOCATS advises healthcare stakeholders on the design, governance, development and deployment of their projects integrating artificial intelligence systems.

The development of artificial intelligence in the healthcare sector opens up new opportunities in research, diagnosis, decision support, personalised care and the use and valorisation of health data.

However, these projects operate within a particularly demanding and constantly evolving regulatory environment, characterised by the combined application of the European Artificial Intelligence Regulation (AI Act), the GDPR and, depending on the project, European regulations relating to medical devices, health data, clinical research and cybersecurity.

In this context, compliance constitutes a governance issue and an element of the development strategy for AI solutions in healthcare.

AUMANS AVOCATS therefore works alongside legal departments, DPOs, senior management, medical, scientific, Data and IT teams in order to identify the applicable regulations, anticipate their developments and integrate regulatory constraints into the project’s key structural choices.

Compliance
CRO support
Health Data Warehouses
Training

Dedicated expertise in AI in the healthcare sector

The firm advises healthcare companies, pharmaceutical laboratories, medical device manufacturers, MedTech and HealthTech companies, healthcare institutions and professionals, research organisations and digital solution providers.

The firm notably advises on projects relating to:

diagnostic and clinical decision-support systems;

medical devices and software integrating artificial intelligence functionalities;

tools supporting care and patient monitoring;

generative artificial intelligence applied to healthcare;

AI systems used in research and clinical trials;

the use of health data for the development, training, validation or evaluation of AI systems;

AI projects developed using health data warehouses;

tools for the analysis and valorisation of health data.

Coordinating the AI Act and the GDPR

Where an AI system involves the processing of personal data and, in particular, health data, its compliance cannot be assessed solely in light of the AI Act. The firm assists its clients in ensuring coordinated compliance with the AI Act and the GDPR.

  • qualification of the AI system and identification of the relevant actors: provider, deployer, importer or distributor;
  • classification of the AI system and identification of the applicable obligations;
  • qualification of data processing activities, their purposes and their legal bases;
  • framework for the use of health data for training, validation and testing;
  • privacy by design and data protection by default;
  • carrying out and coordinating risk assessments and DPIAs;
  • information and transparency vis-à-vis patients, healthcare professionals and other data subjects;
  • framework for automated decision-making and human oversight;
  • security, anonymisation and pseudonymisation;
  • compliance documentation and governance of data and AI systems.

High-risk AI systems and medical devices

The firm advises on projects requiring consideration of the provisions of the AI Act and the provisions applicable to medical devices. Indeed, where an AI system constitutes or is integrated into a medical device, its development and placing on the market may require the requirements of the AI Act to be coordinated with those of Regulation (EU) 2017/745 on medical devices (MDR) or Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

In this respect, the firm advises on the following aspects:

  • qualification and classification of the AI system;
  • identification of high-risk AI systems;
  • risk management and documentation;
  • data governance and quality;
  • documentation, traceability and transparency;
  • human oversight;
  • accuracy, robustness and cybersecurity;
  • coordination of risk management and quality management systems;
  • system monitoring, incident management and allocation of responsibilities.

The objective is to build a coherent compliance pathway and avoid the juxtaposition of separate approaches for each of the applicable regulatory frameworks.

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Health data, model training and research

AUMANS AVOCATS has developed dedicated expertise in personal data and data matters. In this respect, data constitutes an essential element in the development and evaluation of artificial intelligence systems in healthcare. Its use, sharing or interoperability may raise specific issues where datasets include health data or originate from research, clinical trials, health data warehouses or databases established by healthcare institutions.

The firm assists its clients with the following services:

  • determining the conditions for data reuse;
  • providing a legal framework for the creation of training, validation and testing datasets;
  • analysing the conditions for access to and sharing of data;
  • providing a framework for anonymisation and pseudonymisation, in accordance with the guidelines of the EDPB and European data protection authorities;
  • securing data transfers and making data available;
  • drafting and negotiating data access, sharing and transfer agreements;
  • analysing the use of data originating from research or health data warehouses;
  • anticipating the interaction with the future European Health Data Space (EHDS).

Governance, regulatory strategy and anticipation

The regulatory framework applicable to artificial intelligence in healthcare is evolving rapidly. Beyond the AI Act and the GDPR, stakeholders must take into account existing sector-specific regulations, their evolution and European legislative initiatives likely to affect their projects.

AUMANS AVOCATS assists its clients in defining a legal and regulatory strategy adapted to the lifecycle of their artificial intelligence projects, in order to provide the following services:

  • mapping the applicable regulations and their interactions;
  • qualifying AI systems, actors and their responsibilities;
  • identifying at an early stage regulatory constraints having an impact on technological or organisational choices;
  • integrating compliance requirements from the design stage of projects;
  • structuring internal governance and defining responsibilities between legal, Data, IT, medical and business teams;
  • establishing AI governance committees, policies and procedures;
  • organising documentation and the traceability of decisions;
  • anticipating European regulatory developments and analysing their impact on current or future projects;
  • supporting trade-offs between innovation, access to data, risk management and compliance;
  • securing relationships with partners, suppliers, healthcare institutions and other project stakeholders;
  • supporting projects over time, from their design to their deployment and monitoring.

An integrated and strategic approach to compliance

AUMANS AVOCATS favours a cross-cutting and forward-looking approach to the compliance of AI systems in healthcare. Our support aims to determine the requirements currently applicable, but also to anticipate developments in the European framework and integrate these parameters into strategic decisions taken throughout the project.

This approach enables healthcare stakeholders to have a comprehensive view of their regulatory environment, secure their choices and support the development of their projects over time.

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