[ SOLUTIONS ] / [ HEALTHCARE SOFTWARE GDPR ]

Software for clinics and outpatient centers, GDPR Article 9.

For software handling health data (electronic health records, bookings, SSN billing). Compliance with the reinforced safeguards for special-category data (GDPR Art. 9), integration with Tessera Sanitaria, FSE, SOGEI, conformity with the Electronic Health Record Guidelines.

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[ THE PROBLEM ]

What happens today.

Health data is special-category data under GDPR Article 9: it requires reinforced safeguards (strong encryption, segregation, immutable log, mandatory DPIA) and specific legal bases. Building healthcare software that passes Garante audits is non-trivial.

In addition, integration with the Italian digital-health ecosystem (Tessera Sanitaria, Fascicolo Sanitario Elettronico, SOGEI for SSN billing, regional ones like ESF Lombardia or Marche) requires specific technical skills and frequently updated official interfaces.

Health data is not ordinary data. The software handling it can't be either.

[ HOW IT WORKS ]

The solution, broken into parts.

  • GDPR Art. 9 architecture

    End-to-end encryption of clinical data. Segregation of identifying data (registry) from clinical data via pseudonymization. Immutable log of every health-data access. DPIA kept versioned.

  • Healthcare ecosystem integration

    Integration with Tessera Sanitaria (TS-CNS), Fascicolo Sanitario Elettronico (regional FSE), SOGEI for SSN billing, specific regional integrations. Official interoperability tests run.

  • EHR Guidelines conformity

    AgID/AGENAS Guidelines on the Electronic Health Record integrated into the design. Digital signature of documents, compliant archiving, integration with the company document repository.

[ WHO IT'S FOR ]

The typical profiles who benefit.

  • Private clinics and outpatient centers

    Private healthcare facilities with electronic health record, appointment management, mixed billing (private/SSN). Need for custom software where generic systems are not enough.

  • Specialist medical and dental practices

    Specialist practices with vertical needs (orthodontics with complex treatment plans, ophthalmology with diagnostic images). Custom software where the standard EHR is insufficient.

[ WHAT WE NEED ]

Transparency on what the client does.

Before we start we need a few accesses and decisions. All reasonable, no surprise asks.

  • Healthcare scoping

    • DPO/privacy consultant as mandatory interlocutor
    • Medical director for clinical choices
    • Specific regional accreditations if any

  • Technical decisions

    • Type of facilities covered (clinics, outpatient, specialist practices)
    • Healthcare-ecosystem integrations (regional FSE, TS, SOGEI)
    • Possible integration with medical devices (DICOM, HL7 FHIR)
[ TIME AND COST ]

Indicative numbers, not quotes.

TIME
Typically 6-12 months for medium healthcare software. Art. 9 compliance + FSE integrations add 25-35% to the time of an equivalent non-regulated project.
COST
Range €80,000-400,000 depending on complexity and integrations.
MODEL
Fixed milestones with DPIA, privacy threat model, and interoperability tests as separate deliverables.

Indicative numbers. For an accurate quote, let's talk.

[ FREQUENTLY ASKED ]

Answers to the most common questions.

Do you integrate with the FSE / Electronic Health Record?

Yes, we handle integration with FSE 2.0 and with regional platforms (variable per region: ESF Lombardia, Sole Toscana, Marche regional, etc.). Official interoperability tests run pre-release. FSE technical specs change over time; we keep the integration up to date during evolutionary maintenance.

Do you have experience with DICOM or HL7 FHIR systems?

Yes, on both. DICOM for diagnostic-image management, HL7 FHIR for structured clinical-data exchange. For complex integrations with hospital PACS/RIS systems we work alongside system integrators specialized in healthcare.

Hosting: are Italian data centers mandatory?

For health data, Italy/EU hosting is almost always required by regional policies and DPIA. We typically work with AgID-qualified clouds (for PA-facing) or Italian ISO 27001-certified data centers. US cloud is discouraged even with Standard Contractual Clauses for Art. 9 data.

[ LET'S TALK ]

Recognize your case?

Write a couple of lines about your context. We'll reply within 24-48 hours with an initial assessment and a first orientation on time and cost.

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[ RELATED SOLUTIONS ]
[ WHERE IT WORKS BEST ]
[ PARENT PILLAR ]
Custom software for regulated industries Custom software for those who can't afford to get security wrong.