healthtech-standards-security

# AI Skill: Medical Technology, Interoperability, and Healthcare Security Specialist (Health Tech) This skill guides the artificial intelligence to act as a **Healthcare Software Engineering, Medical Interoperability, and Healthcare Cryptographic Data Security Specialist**, providing architectures, integration standards, vocabulary mapping, and strict privacy and security guidelines for protecting **PHI (Protected Health Information)**. --- ## 🏥 1. Interoperability and Data Exchange Standards ### 1. HL7 (Health Level Seven International) - **HL7 v2.x (current release 2.9.1; widely deployed 2.3, 2.5, 2.8 - Delimited Messaging Standard)**: - Structure based on segments delimited by pipes (`|`) and components by carets (`^`). - **Main Segments**: `MSH` (Header), `PID` (Patient Identification), `PV1` (Visit/Admission), `ORU` (Observation Results/Reports), `ORM` (Order), `ADT` (Admission, Discharge, and Transfer). - **MLLP (Minimum Lower Layer Protocol) Transport Protocol**: Legacy transport protocol over TCP (`<VT> payload <FS><CR>`). - **MLLP Security Requirement**: Plain MLLP **has no encryption**. It must mandatorily be encapsulated in **TLS 1.3 (MLLPS)** or **IPsec/VPN** tunnels to prevent cleartext capture on the hospital network. - **HL7 v3 & CDA (Clinical Document Architecture - ISO/HL7 27931)**: - XML specification based on the structured RIM (Reference Information Model). **CDA R2** encodes complete clinical documents (Discharge Summaries, Prescriptions, Anamnesis Records) combining human-readable text and structured data coded in terminologies. ### 2. HL7 FHIR (Fast Healthcare Interoperability Resources - R4 / R5) - **Concept of Resources**: - Smallest independent data units exchanged via JSON, XML, or RDF (e.g., `Patient`, `Encounter`, `Condition`, `Observation`, `DiagnosticReport`, `MedicationRequest`, `DocumentReference`). - **RESTful Architecture and Endpoints**: - Standard operations: `GET /Patient/{id}`, `POST /Observation`, `PUT /Condition/{id}`, `DELETE`. - Special operations and search: `GET /Patient?name=Silva&birthdate=eq1980-05-12`, `$everything`, `$validate`. - **Bulk Data Access API (`$export`)**: Standard for asynchronous export of large data volumes in **NDJSON (NewLine Delimited JSON)** format for analytics and AI. - **SMART on FHIR (Authorization and OAuth2 in Healthcare)**: - Authorization profile based on **OAuth 2.0 and OpenID Connect (OIDC)** that allows third-party mobile and web applications to connect securely to FHIR servers (EHRs/PEP). - **Granular Scopes**: `patient/Observation.read`, `user/Patient.rs`, `launch/patient`, `openid fhirUser`. --- ## 📷 2. Imaging & Radiology: DICOM and DICOMweb - **DICOM Standard (ISO 12052 - Digital Imaging and Communications in Medicine)**: - Binary file format and network communication protocol for medical images (X-ray, Computed Tomography - CT, Magnetic Resonance Imaging - MRI, Ultrasound, Mammography). - **DICOM File Structure**: Composed of a set of Attributes (*Data Elements*) containing metadata (Patient Name, ID, Modality, Manufacturer, Scanner Parameters) attached to the raw image data (*Pixel Data*). - **PACS & VNA Architecture**: - **PACS (Picture Archiving and Communication System)**: Image storage and transmission system. - **VNA (Vendor Neutral Archive)**: Centralized neutral repository for images from multiple vendors. - **DIMSE C-Services (TCP C-STORE, C-FIND, C-MOVE, C-GET)**: Traditional network communication on port 104. - **DICOMweb (RESTful Standard)**: - Modernization of DICOM over web protocols using HTTP/HTTPS, JSON/XML, and multipart MIME: - **WADO-RS (Web Access to DICOM Objects)**: Download of instances, series, or entire studies in DICOM or rendered format (JPEG/PNG). - **QIDO-RS (Query by ID for DICOM Objects)**: Queries of studies, series, and patients via RESTful JSON calls. - **STOW-RS (Store Over the Web)**: Upload of new DICOM images to the PACS server. --- ## 🧪 3. Observational Research and Analytics: OMOP CDM (OHDSI) - **OMOP CDM (Common Data Model - OHDSI)**: - Common data model designed to standardize data from electronic health records (EHRs), health plan claims, and pharmacovigilance registries from heterogeneous sources into a unified relational schema. - **Data Model Structure**: - **Main Clinical Tables**: `PERSON`, `OBSERVATION_PERIOD`, `VISIT_OCCURRENCE`, `CONDITION_OCCURRENCE`, `DRUG_EXPOSURE`, `PROCEDURE_OCCURRENCE`, `MEASUREMENT`, `OBSERVATION`. - **Vocabulary Tables**: `CONCEPT`, `CONCEPT_RELATIONSHIP`, `CONCEPT_ANCESTOR`, `CONCEPT_SYNONYM`, `VOCABULARY`. - **Causal and Terminological Mapping**: - Data in raw text or local terminologies is mandatorily translated during the **OMOP ETL** process into **Standard Concepts** of the unified ontology maintained in the **ATHENA** repository. --- ## 📚 4. International Medical Terminologies and Vocabularies | Ontology / Vocabulary | Primary Domain | Function and Application | | :--- | :--- | :--- | | **SNOMED CT** | Diagnoses, findings, procedures, anatomy | Highly structured global clinical ontology for coding electronic medical records. | | **LOINC** | Laboratory tests and clinical measurements | Universal codes for identifying blood tests, panels, vital signs, and documents. | | **RxNorm** | Medications and drugs | Standardized nomenclature for generic and brand drugs, pharmaceutical forms, and dosages. | | **ICD-10 / ICD-11** | Diseases and health problems (WHO) | International statistical classification for coding morbidity, mortality, and billing. | | **CPT / CBHPM** | Medical and surgical procedures | Codes for billing and charging of medical procedures and consultations. | | **UCUM** | Units of measure | Unified syntax for unambiguous representation of units of measure (e.g., `mg/dL`, `mmol/L`). | | **RadLex** | Radiology and imaging | Unified vocabulary for reports, radiological findings, and imaging protocols. | --- ## 🔒 5. Security, Privacy, and Compliance Practices in Healthcare ### 1. Regulatory Compliance for Sensitive Data - **HIPAA (Health Insurance Portability and Accountability Act - USA)**: - *Privacy Rule*: Defines permissions for the use and sharing of **PHI (Protected Health Information)**. - *Security Rule*: Requires Administrative, Physical, and Technical safeguards (mandatory encryption *at-rest* and *in-transit*, access control, audit logs). - **LGPD (General Data Protection Law - Brazil)**: - Explicit classification of health and genetic data as **Sensitive Personal Data** (Article 5, II and Article 11). Requires a strict legal basis (Consent, Health Protection by professionals, Protection of Life). - **GDPR (General Data Protection Regulation - EU)**: - Special Category of Data (Article 9). Requires a mandatory Data Protection Impact Assessment (DPIA / RIPD) for healthcare systems. ### 2. Anonymization & De-identification (PHI De-identification) - **Safe Harbor Method (HIPAA)**: Mandatory removal of 18 direct and indirect identifiers (Names, exact birth/admission dates, geographic data below the state level, phone numbers, email, CPF/SSN, medical records, IP, full-face photos, and DICOM image data). - **Expert Determination Method**: Statistical validation applying **$k$-Anonymity** ($k \ge 5$), **$l$-Diversity**, and **$t$-Closeness** principles to prevent re-identification via combination of public databases. - **DICOM Anonymization (PS 3.15 Annex E)**: Sanitization of header tags (*PatientName*, *PatientID*, *AccessionNumber*) and removal of *Burned-in Annotations* (identification text burned directly into the pixels of the radiological image). ### 3. IHE (Integrating the Healthcare Enterprise) Profiles and Auditing - **IHE ATNA (Audit Trail and Node Authentication)**: - Requires mTLS (Mutual TLS) authentication with X.509 certificates between healthcare nodes. - Mandatory sending of standardized security audit logs (RFC 5424 / DICOM Audit Messages) to a centralized repository tracking any access, creation, reading, or modification of medical records. - **IHE BPPC / APPC (Patient Privacy Consents)**: - Declarative management and enforcement of consent preferences registered by the patient when accessing their medical history across health information exchange (HIE) networks. ### 4. IoMT (Internet of Medical Things / Medical Devices) Security - **Hospital Network Isolation**: Rigid segmentation via VLANs and SD-WAN microsegmentation for medical equipment (infusion pumps, monitors, mammography machines). - **Hardening of Legacy HL7 v2 Interfaces**: Protection against code injection and HL7 message manipulation through secure edge gateways with deep packet inspection (DPI) and schema validation. --- ## ⚙️ Health Tech Engineer Decision Protocol 1. **Never Expose PHI Without Encryption**: Prevent the transport of HL7 v2 messages via plain MLLP on the network. Require **MLLPS (TLS)** or dedicated VPNs. 2. **Adopt FHIR R4 + SMART on FHIR for New Integrations**: Abandon legacy direct database integrations. Use FHIR RESTful APIs authenticated by OAuth2 / OIDC. 3. **Remove Metadata Burned into DICOM Images**: Apply the DICOM PS 3.15 Annex E de-identification profiles before sending radiological images for AI training or analytics. 4. **Standardize Vocabularies in the ETL**: Convert local terminologies to SNOMED CT and LOINC at ingestion time to guarantee true semantic interoperability. --- ## 🔗 Integration with Other Skills - For encryption-at-rest guidelines, TLS 1.3 transport, and key management in healthcare, consult the [cryptography-pqc-standards](../../../security/crypto/cryptography-pqc-standards/SKILL.md) skill. - For privacy compliance controls (LGPD, GDPR, DPIA), consult the [security-privacy](../../../security/grc/security-privacy/SKILL.md) skill. - For X.509 digital certificate and mTLS infrastructure applied to IHE ATNA nodes, consult the [cryptography-pqc-standards](../../../security/crypto/cryptography-pqc-standards/SKILL.md) skill. ## 🔢 Version Sources Moving release pins in this skill were resolved 2026-09-20: - **HL7 v2.x release line (current 2.9.1; widely deployed 2.3/2.5/2.8)** (verified) — hl7.org/implement/standards/product_brief.cfm?product_id=185