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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 information were not anonymous. Persistent patient codes and detailed health and location attributes could make people distinguishable and, by reasonable means, identifiable again. The order is dated 23 September 2026; the Garante announced it on 2 October. The often-repeated $7.8 million is an approximate currency conversion, not the amount specified in the order.
What the Garante found
The Garante per la protezione dei dati personali, Italy’s data protection authority, examined a longitudinal database assembled from information provided by about one million patients of 800 general practitioners. It imposed a €7 million fine on IQVIA Solutions Italy S.r.l. in decision 710, dated 23 September 2026. The authority’s 2 October 2026 announcement summarizes the decision; the full order sets out its findings and required action.
The database included a patient code that enabled records to be connected over time, alongside fields such as birth year, sex, diagnoses, symptoms, prescriptions, tests, vaccinations, and location information. The Garante concluded that this combination could distinguish patients and permit re-identification using reasonable means. It therefore rejected the claim that the information was anonymous. This finding does not mean every patient was identified, or that the database was publicly released.
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Why coded health records may still be identifiable
Anonymization is not achieved merely by deleting names or replacing them with codes. A dataset may remain personal data if records can still be linked to the same person over time, or if a combination of attributes makes a person distinguishable and re-identification is reasonably possible.
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In this case, the persistent code made longitudinal tracking possible, while detailed clinical and contextual information added identifying clues. As the Garante put it in its announcement, “Il codice associato a ciascun paziente consentiva, infatti, di seguirlo nel tempo.” The authority’s concern was the risk arising from the dataset’s structure and attributes—not proof that all records had been matched to named individuals.
Other compliance failures identified
The order also identified shortcomings beyond the disputed anonymization. The authority found that IQVIA lacked an adequate legal basis for the processing, provided deficient information to patients, had not set a retention period, and had inadequate security. It also cited missing arrangements governing processors and an incomplete data protection impact assessment (DPIA).
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The decision separately records 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 order, not the roughly one million-patient population of the broader database.
What IQVIA must do if processing continues
The Garante’s order sets out different compliance routes, depending on whether the examined processing continues:
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- If IQVIA continues the processing: it must establish a legal basis, inform patients, complete the DPIA, and appoint participating doctors as processors.
- Alternatively: the doctors must carry out anonymization, subject to the safeguards specified by the authority.
IQVIA must provide a documented response on compliance within 120 days of notification of the order.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What the fine does—and does not—establish
The amount in the order is €7 million. The $7.8 million figure in some coverage is an approximate conversion into U.S. dollars; it is not the fine as stated by the Garante. The official materials establish the penalty and the compliance requirements, but do not establish whether IQVIA has appealed, paid the fine, or completed remediation. The order provides a right to challenge it before the ordinary courts within the applicable statutory period; the outcome is not established by the cited official materials.
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