The processing of health data has always been one of the most sensitive areas of personal data protection. With the application of Regulation (EU) 2016/679 (GDPR) in 2018, the European Union introduced a model based on accountability, a risk-based approach, and strengthened security measures.
Several years on, the GDPR is neither being replaced nor rewritten, but is entering a phase of regulatory maturity. Operational experience, case law, and guidance from supervisory authorities are progressively shaping how existing rules must be interpreted and applied, particularly in the healthcare sector.
This evolutionary path will lead to a more structured and integrated framework, with a key point of consolidation expected from 2027 onwards, in the context of European initiatives dedicated to health data.
What Changes in 2026: Increased Regulatory Scrutiny and Stronger Enforcement
In 2026, the focus shifts to a stricter application of GDPR principles: expectations rise for organisations handling health data, which must demonstrate tangible controls and effective risk management.
Supervisory authorities, also in light of growing cyber risks and the increasing complexity of healthcare information systems, require a more concrete and demonstrable application of GDPR principles. Compliance is no longer assessed solely on documentation, but on an organisation’s actual ability to manage risk over time.
Areas under increased scrutiny
Already today, and even more so throughout 2026, healthcare organisations are required to demonstrate:
- effective access controls, with granular role management and full traceability of operations;
- documented periodic reviews of security measures, internal processes and suppliers;
- up-to-date business continuity and disaster recovery plans, aligned with the current cyber threat landscape;
- practical, evidence-based staff training supported by operational procedures;
- substantive accountability, ensuring that what is defined in policies is effectively implemented and verifiable.
This therefore represents an evolution in the application of the GDPR, rather than a formal regulatory change.
Why 2027 will be the real turning point
The year 2027 represents a key milestone, as it coincides with the transition to a more operational phase of the new European framework for health data, particularly in the context of the European Health Data Space (EHDS) and new procedural rules supporting GDPR enforcement.
These initiatives do not replace the GDPR, but complement it and make it more structured for the healthcare sector, strengthening in particular:
- traceability of processing activities and data access;
- continuous documentation of organisational and technological decisions;
- data protection impact assessments (DPIAs) for high-risk processing;
- cooperation between data controllers, technology providers and supervisory authorities;
- the obligation to continuously update systems, software and security measures.
From 2027 onwards, health data management will increasingly move beyond a narrow “privacy” issue and become a core element of governance, cybersecurity and digital strategy.
Why preparing now makes the difference
Many healthcare organisations today believe they are GDPR-compliant. Often, however, this perception is based on predominantly formal compliance or on technological assets that are no longer adequate for the current context.
The real risk is not the sudden introduction of new rules, but the inability to demonstrate, over time, the effective application of GDPR principles in an environment of constantly evolving threats, systems and organisational models.
Organisations that begin aligning today with a more structured and substantive approach will be naturally better prepared to face the regulatory framework that will consolidate from 2027 onwards, reducing exposure to sanctions, incidents and operational disruptions.
The regulatory evolution towards 2027 confirms an increasingly clear direction: protecting health data requires an integrated security culture that combines technology, organisation and accountability.
It is no longer sufficient to “be compliant” at a given point in time.
Preventing, verifying, documenting and continuously updating systems becomes an essential requirement for operating within an increasingly mature and demanding regulatory environment.
Today’s compliance does not automatically guarantee tomorrow’s conformity: preparing now is the real enabler for approaching 2027 with awareness and resilience.