Italy’s data protection authority fined IQVIA Solutions Italy S.r.l. €7 million after finding that patient records in a database built from general-practice data were not anonymous. The authority said persistent patient codes and detailed health and location information could distinguish people and make re-identification reasonably possible. The dollar figure sometimes reported as $7.8 million is an approximate currency conversion; the order specifies €7 million.
What did Italy’s regulator decide?
The Garante per la protezione dei dati personali issued decision 710 on 23 September 2026 and announced it on 2 October. It fined IQVIA Solutions Italy S.r.l. €7 million over its processing of information drawn from general practitioners’ records. The Garante’s order sets out the legal findings and required actions; its press release gives the public summary.
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The database covered about one million patients from 800 family doctors. Its fields included a patient code, birth year, sex, diagnoses, symptoms, prescriptions, tests, vaccinations and location data. The patient code enabled records to be linked over time.
Why did the regulator say the data were not anonymous?
Removing names or replacing them with codes does not by itself make health data anonymous. If records remain linkable or distinguishable, and identifying someone remains reasonably possible using available information or methods, the data may still be personal data.
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The Garante’s concern was the combination of a persistent code and detailed clinical and contextual attributes. That combination could allow patients to be singled out and re-identified by reasonable means. The authority did not say that every patient was identified, nor that the database was openly published.
How is anonymized data different from pseudonymized data?
Pseudonymized data have direct identifiers replaced or separated, often using a code. The code and detailed records can still allow data about one person to be connected over time; the information therefore remains personal data when re-identification is reasonably possible.
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Anonymized data cannot reasonably be used to identify or single out a person, including by linking records or combining attributes. The Garante’s findings show why a coded longitudinal health record may fail that standard even when names are absent.
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What other compliance failures did the Garante identify?
The decision also found shortcomings beyond the anonymization claim:
- No adequate legal basis for the processing.
- Insufficient information for patients.
- No defined data-retention period.
- Inadequate security measures.
- Missing arrangements governing processors.
- An incomplete data protection impact assessment (DPIA).
The authority also recorded that identifying details relating to about 3,370 patients were present in the database. Of those, 3,080 also had health data that were communicated to SIMG. These figures describe a subset noted in the decision, not the database’s roughly one million-patient population.
What must IQVIA do if processing continues?
The order sets out two possible paths for the examined processing:
- Continue the processing with the required safeguards: establish a legal basis, provide patients with information, complete the DPIA and appoint participating doctors as processors.
- Have doctors anonymize the data: the doctors must carry out anonymization subject to the safeguards specified by the Garante.
IQVIA must provide the authority with a documented response on compliance within 120 days of notification of the order.
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The authority’s materials establish that the decision provides a right to challenge it before the ordinary courts within the applicable statutory period. They do not establish whether IQVIA has appealed, paid the fine or completed the required remediation. Those outcomes remain unconfirmed in the available official materials.
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