Medico-social sector compliance: GDPR & AI Act

Why the 'Medico-social' sector is concerned

The medico-social sector processes health data (dependency, disability, care) and highly sensitive social data (family situations, child welfare services, addiction treatment). This data often concerns vulnerable individuals — minors and protected adults — which calls for maximum vigilance.

The sharing of information between professionals and organisations — essential to the provision of care — must be strictly governed: professional secrecy, need-to-know principle, traceability. The hosting of health data is subject to enhanced requirements.

The use of AI (planning, assessment, guidance) remains emerging, but when it serves to evaluate access to essential social benefits, it may fall under high risk within the meaning of the AI Act.

GDPR — health, social, vulnerability

Organisations act as controllers for highly sensitive health and social data. They must identify a valid exemption for processing health data, govern sharing among professionals, implement robust security measures, and adapt retention periods and information notices to the vulnerability of the individuals concerned.

Health data hosting is subject to enhanced requirements.

Key obligations

• Legal exception for health data.
• Framework for information sharing (confidentiality, need-to-know basis).
• Enhanced security and suitable hosting.
• Vigilance regarding vulnerable individuals.

AI Act — access to services

AI used to assess eligibility for essential social benefits may fall under high risk, as in the public sector. Planning or administrative support use cases generally fall under limited risk.

Human oversight and non-discrimination are essential when dealing with vulnerable audiences.

Key obligations

• Qualifying AI uses (access to benefits = potentially high risk).
• Human oversight and bias control.
• Transparency tailored to audiences.
• DPIA where applicable (relevant deployers).

Comparative overview of regulations

How these regulations interact

The social and healthcare sector pushes GDPR requirements to their maximum: health and social data, vulnerable individuals, multi-stakeholder sharing. Professional secrecy and GDPR reinforce each other to protect confidentiality.

When AI is used to assess access to benefits, the combined GDPR/AI Act framework resembles that of the public sector: sensitive data (GDPR) and high-risk system (AI Act), with FRIA and human oversight.

Application timeline

• 1GDPR. In force; maximum requirements on sensitive data.
• 2AI Act. High risk: From 2 August 2026 for access to benefits.

Applicable penalties

GDPR provides for up to €20M or 4% (specific public-sector caps for certain bodies); the AI Act up to €35M or 7%. A breach involving data of vulnerable individuals is particularly serious, both humanly and legally.

Compliance roadmap

• 1Map. Inventory health and social data processing and data sharing between stakeholders.
• 2Maximising security. Health exception, adapted hosting, enhanced security.
• 3Frame data sharing. Formalise confidentiality, need-to-know, and traceability.
• 4Protect vulnerable individuals. Adapting information and safeguards for minors and protected adults.
• 5Governing AI. Qualify use cases and conduct FRIAs if access to services is involved.

How Data Comply One supports the sector

Data Comply One covers GDPR and AI Act on a single platform, with an outsourced DPO, and supports medico-social organisations on sensitive data, governed data sharing and AI for access to services.

DCO offers tailored templates (health data DPIA, data-sharing frameworks, information notices adapted to vulnerable audiences).

Frequently asked questions