# HIPAA Interoperability — Workflows ## Workflow 1: Information Blocking Exception Assessment ``` Request for EHI Access, Exchange, or Use Received │ ├── Step 1: Determine if Actor is Subject to Information Blocking Rules │ ├── Health IT developer of certified health IT? → YES, subject │ ├── Health information exchange (HIE)? → YES, subject │ ├── Health information network (HIN)? → YES, subject │ ├── Healthcare provider? → YES, subject │ └── None of the above? → Not subject to information blocking rules │ ├── Step 2: Is the Practice Likely to Interfere with Access/Exchange/Use of EHI? │ ├── NO → No information blocking concern; proceed normally │ └── YES → Evaluate whether an exception applies │ ├── Step 3: Evaluate Applicable Exceptions (45 CFR Part 171) │ │ │ ├── Privacy Exception (§171.202)? │ │ ├── Is the practice required by HIPAA Privacy Rule? │ │ ├── Is the practice permitted by HIPAA Privacy Rule and tailored to privacy risk? │ │ ├── Does the practice satisfy all sub-requirements of §171.202? │ │ └── If YES to all → Exception applies; document rationale │ │ │ ├── Security Exception (§171.203)? │ │ ├── Is the practice directly related to safeguarding C/I/A of EHI? │ │ ├── Is the practice tailored to specific security risks? │ │ ├── Is it implemented consistently and not discriminatory? │ │ └── If YES to all → Exception applies; document rationale │ │ │ ├── Preventing Harm Exception (§171.201)? │ │ ├── Is there a reasonable belief that the practice will prevent harm? │ │ ├── Is the practice no broader than necessary? │ │ └── If YES to all → Exception applies; document rationale │ │ │ ├── Infeasibility Exception (§171.204)? │ │ ├── Is fulfillment segmented, technically infeasible, or infeasible due to uncontrollable events? │ │ ├── Has the actor made reasonable efforts to fulfill? │ │ └── If YES → Exception applies; document rationale │ │ │ └── No exception applies? │ └── Practice constitutes information blocking; must cease or modify │ └── Step 4: Document Exception Determination ├── Record the request, the practice, the exception invoked ├── Document the factual basis supporting the exception ├── Retain documentation per organizational retention policy └── Periodically review whether the practice remains justified ``` ## Workflow 2: Patient Access API (FHIR) Privacy Compliance ``` Patient Requests API Access to Health Data │ ├── Step 1: Identity Verification │ ├── Authenticate patient using NIST IAL2/AAL2 standards │ ├── Methods: patient portal credentials + MFA, or in-person identity proofing │ ├── If identity cannot be verified → Deny access; offer alternative (in-person request) │ └── Log authentication attempt and outcome │ ├── Step 2: Determine Scope of Access │ ├── Right of access per §164.524 → Entire designated record set │ │ ├── INCLUDE: clinical notes, lab results, imaging reports, claims data │ │ └── EXCLUDE: psychotherapy notes (§164.524(a)(1)(i)), info compiled for litigation │ ├── Minimum necessary does NOT apply to individual access (§164.502(b)(2)(v)) │ └── Map FHIR resources to designated record set content │ ├── Step 3: Third-Party App Authorization │ ├── Patient selects third-party app to receive data? │ │ ├── YES → Present disclosure notice: │ │ │ ├── "Once shared with [App Name], your data may no longer be protected by HIPAA" │ │ │ ├── "Review the app's privacy policy before authorizing" │ │ │ └── Obtain patient confirmation to proceed │ │ └── NO → Data delivered directly to patient portal │ │ │ ├── SMART on FHIR authorization flow: │ │ ├── App requests authorization with defined OAuth 2.0 scopes │ │ ├── Patient reviews and approves requested scopes │ │ ├── Access token issued with scope-limited permissions │ │ └── Token expiration set per policy (recommended: 1 hour with refresh) │ │ │ └── Log: app name, scopes authorized, timestamp, patient confirmation │ ├── Step 4: Data Delivery │ ├── Serve FHIR R4 resources over TLS 1.2+ │ ├── Format per USCDI data classes and elements │ ├── Include provenance metadata │ └── Respond within 1 business day per §164.524(b)(2) where feasible │ └── Step 5: Audit and Accounting ├── Log all API access in audit system (§164.312(b)) ├── Maintain accounting of disclosures for third-party app access (§164.528) └── Retain logs for minimum 6 years ``` ## Workflow 3: TEFCA Health Information Exchange ``` Health Information Exchange Request via TEFCA │ ├── Step 1: Validate Exchange Purpose │ ├── Treatment → Verify requesting provider has treatment relationship │ ├── Payment → Verify payer/plan relationship and coverage │ ├── Healthcare Operations → Verify operations relationship │ ├── Public Health → Verify requesting authority status │ ├── Individual Access → Verify patient identity and authorization │ └── Benefits Determination → Verify plan participant relationship │ ├── Step 2: Consent and Authorization Check │ ├── Does state law require specific consent for this data type? │ │ ├── 42 CFR Part 2 (substance abuse) → Patient consent required │ │ ├── State-sensitive categories (HIV, mental health, genetic) → Check state law │ │ └── Standard PHI → HIPAA TPO basis sufficient for treatment/payment/operations │ │ │ ├── Is consent on file? │ │ ├── YES → Proceed with exchange │ │ └── NO → Request consent or apply consent exception if applicable │ │ │ └── Apply consent directives (opt-in, opt-out) per organizational policy │ ├── Step 3: Apply Minimum Necessary │ ├── Treatment purpose → Exception applies; provide full clinical information │ ├── Payment/operations → Limit to minimum necessary for stated purpose │ └── Individual access → Exception applies; provide full designated record set │ ├── Step 4: Execute Exchange │ ├── Route through QHIN (Qualified Health Information Network) │ ├── Apply TEFCA Common Agreement security requirements │ ├── Encrypt in transit (TLS 1.2+) │ ├── Include digital provenance and source attribution │ └── Confirm receipt by receiving QHIN participant │ └── Step 5: Post-Exchange Documentation ├── Log exchange: purpose, parties, data types, timestamp ├── Update accounting of disclosures (if applicable) ├── Retain exchange records per TEFCA and HIPAA requirements └── Report any exchange failures or anomalies to QHIN ``` ## Workflow 4: Payer-to-Payer Data Exchange (CMS-0057-F) ``` Patient Switches Health Plan and Requests Data Transfer │ ├── Step 1: Patient Request Validation │ ├── Verify patient identity with new plan │ ├── Confirm patient has opted in to payer-to-payer exchange │ ├── Obtain prior plan information from patient │ └── Validate coverage dates with prior plan │ ├── Step 2: Prior Plan Data Assembly │ ├── Prior plan assembles patient data: │ │ ├── Claims and encounter data (minimum 5 years) │ │ ├── Clinical data received via prior authorizations │ │ └── Provider directory information relevant to patient │ ├── Format per FHIR R4 and USCDI standards │ └── Apply HIPAA minimum necessary to payment/operations data │ ├── Step 3: Secure Transfer │ ├── FHIR Bulk Data export from prior plan │ ├── Encrypted transfer to new plan via FHIR API │ ├── Mutual TLS authentication between plan systems │ └── Confirm data integrity upon receipt │ ├── Step 4: New Plan Data Integration │ ├── Ingest and validate received data │ ├── Map to new plan's data model │ ├── Apply access controls per new plan's HIPAA policies │ └── Make data available to patient via Patient Access API │ └── Step 5: Documentation ├── Log transfer: date, data types, prior/new plan identifiers ├── Retain patient consent/opt-in record ├── Update accounting of disclosures at prior plan └── Retain records for 6 years ```