Digital Twins in Healthcare: Legal Challenges, GDPR Implications and the Future of Personalised Medicine

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Digital Twins: A Technological Revolution for E-Health

The Health Division team at DPO Consulting has closely followed the major e-health trends for 2026 and has examined the growing use of digital twins in the healthcare sector.

Today, digital technologies enable the continuous collection of data, which can then be used for analytical and predictive purposes. This data—originating from medical records, imaging, connected medical devices, or healthcare information systems—feeds models capable of anticipating medical developments and guiding clinical decision-making.

In this perspective, each individual could ultimately have their own digital twin, designed to predict and personalise medical care through dynamic modelling.

In France, the government actively supports the development of these digital models in order to assess the spread of certain diseases, virtually test treatments before their implementation, and assist healthcare professionals in their decision-making processes.

However, current developments mostly involve partial digital twins, focused on a specific organ, pathology or care pathway, rather than a complete digital twin of a patient.

Several French projects illustrate this trend:

  • Digital heart twins are being developed to better understand heart rhythm disorders and support interventional cardiology.
  • Other initiatives focus on the brain, particularly for epilepsy management and neurosurgical planning.
  • Digital lung models are also being studied for chronic respiratory diseases.

At the European level, “Virtual Human Twins” (VHTs) are also being developed. These are digital models of patients or populations that make it possible to simulate diseases, assess treatments and anticipate the impact of public health policies.

The ultimate objective is to promote more personalised medicine, accelerate research and reduce reliance on heavy clinical trials.

Digital twin technology should not be confused with other technological tools that may appear similar:

  • Synthetic data: artificially generated fictional data based on statistical models and anonymised real datasets, used to simulate fictitious patient groups for research or algorithm testing purposes, without any link to real individuals.
  • Patient avatars: visual or interactive representations sometimes used in therapeutic education or treatment settings. They are generally educational in nature and do not have predictive or direct decision-making functions. They do not provide real-time personalisation.

What Is the Legal Qualification of Digital Twins in Healthcare?

What is the legal status of this innovative healthcare technology?

  • Should digital twins be considered copyright-protected works, databases subject to a specific legal regime, software, or a combination of these categories?

The answer to this question is crucial, as it will determine the applicable legal framework and the nature of the rights attached to these digital objects.

To date, there is no unified legal regime specifically dedicated to digital twins.

This situation requires a cross-disciplinary legal approach, combining intellectual property law, data protection law and contract law. Case law specific to these technologies is gradually emerging but remains under construction.

From a comparative law perspective, Singapore has adopted pioneering legislation through the “Digital Twin Act”, explicitly recognising digital twins as distinct legal objects. This initiative could serve as a model for other States facing the current legal vacuum.

Digital Twins and GDPR: Data Protection Challenges

What about data protection rules?

To fully operate and deliver value, digital twins generate, process and analyse considerable volumes of data, raising crucial privacy concerns.

When a digital twin models an individual or processes information relating to identifiable persons, the GDPR in Europe—or its international equivalents—fully applies, imposing strict obligations on data controllers. Significant technical measures will also be required to ensure the security of this digital solution.

This massive data collection inevitably clashes with the principle of data minimisation. This fundamental principle of data protection law requires that only strictly necessary information be collected. Yet the effectiveness of a digital twin often relies on the richness and completeness of data, creating a legal tension.

This new digital tool also raises particularly sensitive issues. In healthcare, digital twins may incorporate highly comprehensive data, such as genetic profiles, medical history or patient predispositions. Such information qualifies as special categories of data under Article 9 GDPR and therefore benefits from enhanced protection.

The issue of patient consent also arises: can such a solution truly rely solely on the data subject’s consent?

In particular, would it be possible to achieve the intended objectives—especially in terms of public health—if patient consent constitutes the primary or even exclusive legal basis, particularly in cases where data processing continuously evolves?

In this regard, the French Data Protection Authority (CNIL) recommends implementing dynamic and granular consent mechanisms.

It may therefore be appropriate to question whether consent is the most suitable legal basis for this type of digital solution, especially when its purpose is to serve a public health objective.

Once a clear legal and technical framework is established—integrating data protection, security, dynamic consent and best practices in intellectual property—digital twins will be able to be fully deployed.

They will offer the opportunity to develop more preventive medicine by anticipating disease progression and improving the quality of care through increased personalisation of treatments and enhanced public health strategies.

Conclusion

Digital twins represent a major technological advancement for the healthcare sector. However, their deployment cannot be envisaged without rigorous legal structuring, particularly in terms of data protection, cybersecurity, intellectual property and governance.

Far from hindering innovation, a clear and secure framework will enable these technologies to develop sustainably and ethically, serving a more personalised and more efficient form of medicine.

Are you developing or planning a digital twin project in healthcare?

DPO Consulting’s Health Division supports healthcare institutions, e-health stakeholders and innovative companies in structuring compliant, secure and sustainable digital projects.

Contact our experts: https://dpo-consulting.com/contact-us

To learn more about digital health twins: https://esante.gouv.fr/actualites/decryptage-jumeaux-numeriques-en-sante

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