Un Health Information System (HIS) è l'ecosistema socio-tecnico che cattura, gestisce, trasmette e analizza dati clinici, amministrativi, finanziari e di ricerca per supportare cura, gestione, salute pubblica e innovazione. Non è solo software: include governance, standard, workflow, persone, dispositivi.
Acquisiscono dati clinici dettagliati, strutturati, ad alta frequenza per specifico dominio. Alimentano EHR via interfacce (HL7 v2 ORU^R01, MDM^T02, DFT^P03, FHIR DiagnosticReport/Observation/Procedure).
| Sistema | Acronimo | Dati chiave | Standard interfaccia |
|---|
| Laboratorio | LIS (Laboratory Information System) | Ordini, campioni, risultati (LOINC), valori riferimento, flag, regole interpretative | HL7 v2 ORU^R01, FHIR DiagnosticReport/Observation, LIS2-A2 (analizzatori) |
| Radiologia / Imaging | RIS (Radiology IS) + PACS (Picture Archiving) | Scheduling, worklist, referti (RADLEX, SNOMED), immagini DICOM, dose tracking, AI findings | HL7 v2 ORM^O01/ORU^R01, DICOM MWL/Storage/Query, FHIR ImagingStudy/DiagnosticReport |
| Farmacia | Pharmacy IS / Pharmacy Management System | Ordini, verifica, dispensing, compounding, inventory, formulary, CDS (interazioni, dosaggio, renale), MTM | HL7 v2 RDE^O11/RAS^O17, NCPDP SCRIPT (eRx), FHIR MedicationRequest/Dispense |
| Percorso operatorio / Sala operatoria | OR Management / Anesthesia IS | Scheduling, checklist (WHO), documentazione intraop, anestesia record, conteggio strumenti, implant log | HL7 v2 SIU/SRU, MDM, FHIR Procedure/ServiceRequest |
| Terapia intensiva / Monitoraggio | PDMS (Patient Data Management System) / Clinical Information System | Segnali fisiologici ad alta freq (waveforms), trend, calcoli emodinamici, ventilatore, bilancio fluidi, scoring (APACHE, SOFA) | IEEE 11073, HL7 v2 PCD, FHIR Observation (vital signs), MIMIC/physionet per research |
| Emergenza / ED | EDIS (Emergency Department IS) | Triage (ESI), tracking, documentazione rapida, order sets, throughput metrics, boarding | HL7 v2 ADT/ORM/ORU, FHIR Encounter/ServiceRequest |
| Cardiologia / Elettrofisiologia | CVIS (Cardiovascular IS) / EP Lab System | ECG, Eco, Cateterismo, EP study, device implant (PM/ICD/CRT), follow-up device remote | DICOM SR, HL7 v2, FHIR, Device communication (MERLIN, CareLink, LATITUDE) |
| Patologia Anatomica | AP LIS / Digital Pathology | Accessioning, gross, microscopy, diagnosi (CAP protocols, WHO), synoptic reporting, WSI (Whole Slide Imaging) | HL7 v2 OML^O21/ORU^R01, DICOM WSI, FHIR DiagnosticReport |
3. Accesso via Internet / Portali Paziente e Telemonitoraggio
Patient Portal (Tethered PHR)
- Funzioni: visualizzare record (visite, referti, farmaci, immunizzazioni, allergie, problem list), messaggistica sicura (secure messaging), prenotazione/rinnovo appuntamenti, richiesta rinnovo ricette, pagamenti, completamento questionari (PHQ-9, GAD-7, PROMIS), proxy access (genitori/tutori), scaricare CCDA/FHIR bundle (Blue Button 2.0).
- Standard: HL7 FHIR (Patient/Observation/DocumentReference/Communication), SMART on FHIR per app di terze parti, OpenID Connect / OAuth2 / SMART App Launch per autenticazione.
- Efficacia evidence-based: pazienti cronici (diabete, HTN, HF, trapianto) → ↑ aderenza, ↑ self-efficacy, ↓ accessi PS/ricoveri, ↑ soddisfazione (studies: Kaiser, Geisinger, VA, UC Denver). Digital divide: accesso broadband, alfabetizzazione digitale, lingua, disabilità → barriere equità.
Remote Patient Monitoring (RPM) / Telemonitoraggio
- Dispositivi: wearables (Apple Watch, Fitbit, Garmin, Withings), patch ECG (Zio, BioTelemetry), spirometri Bluetooth, glucometri connessi, BP cuff cellulari, scale impedenziometriche, pulse ox, sensori ambientali (temp, umidità, qualità aria).
- Architettura: Device → BLE/WiFi/Cellular → Cloud Gateway (HIPAA-compliant) → FHIR Observation / DeviceMetric → EHR / Clinician Dashboard / Alerting Engine.
- Codici rimborso USA (CPT): 99453 (setup), 99454 (device supply 30gg), 99457/99458 (management 20+ min/mese), 99091 (physician review 30+ min).
- Use cases validati: HF (peso, BP, sintomi → ↓ readmission 30-50%), HTN (BP home → controllo migliore), COPD (SpO2, sintomi → early exacerbation detection), Diabete (CGM → Time in Range ↑), Post-op (recupero precoce), Oncologia (sintomi chemo → ↓ ED visits).
4. Sistemi Amministrativi e di Supporto Decisionale
Revenue Cycle Management (RCM) / Practice Management (PM)
- Registrazione, verifica eleggibilità (270/271), autorizzazioni (278), claim submission (837P/I), remittance (835), denial management, patient statements, collections, contract modeling, price transparency (MRF - Machine Readable Files).
Clinical Decision Support (CDS) & Analytics
- CDS integrato nell'EHR: alert farmaci (interazioni, allergie, dosaggio, renale), best practice advisories (BPAs), order sets, calcolatori rischio (CHA₂DS₂-VASc, ASCVD, CURB-65), screening reminders (USPSTF), precision medicine (genomica, farmacogenomica).
- Analytics / BI / Population Health: Data Warehouse / Lake (EDW, Epic Clarity/Cogito, Cerner HealtheIntent, IBM Watson Health, Health Catalyst, Arcadia). Strati: Operational → Analytical → Predictive/Prescriptive. KPI: HEDIS, STAR ratings, MIPS, readmissions, LOS, cost per episode, equity dashboards.
- Clinical Research Informatics: CTMS (Clinical Trial Management), EDC (Electronic Data Capture), EHR-to-EDC (FHIR-based), IRB management, biospecimen tracking, RWE generation (OMOP CDM, OHDSI).
5. Public Health & Interoperabilità Nazionale
- HIE (Health Information Exchange): regionali/statali (es. CRISP, HealthInfoNet, Indiana HIE, Manifest MedEx). Servizi: query-based exchange (Patient Lookup), event notification (ADT alerts), direct messaging (secure email), public health reporting (syndromic surveillance, immunization registry, cancer registry, lab reportable conditions).
- TEFCA (Trusted Exchange Framework and Common Agreement): ONC-led, QHINs (Qualified Health Information Networks: Epic Nexus, eHealth Exchange, Kno2, Health Gorilla, Konza, MedAllies, CommonWell) → nationwide interoperability "network of networks".
- USCDI (US Core Data for Interoperability): versione annuale (v1-v4) definisce data classes/elements minimi per scambio (Allergies, Medications, Clinical Notes, Labs, Vitals, Procedures, Goals, Problems, Immunizations, Devices, Demographics, Narratives, SDOH).
Governance, Sicurezza, Privacy
- HIPAA Privacy/Security/Breach Notification Rules: fondamento legale USA.
- 42 CFR Part 2 (SUD records): consenso specifico per disclosure.
- FERPA (student health): scuole/università.
- NIST Cybersecurity Framework / HITRUST CSF / SOC 2 Type II: framework sicurezza adottati da vendor/organizzazioni.
- Information Blocking (21st Century Cures Act): divieto pratiche che interferiscono accesso/use/scambio EHI (eccezioni: privacy, security, infeasibility, IP, health IT performance).