HITECH Act
HITECH 2024-2025 Pipeline: NPRM Security Rule Modernisation, Reproductive Health, Information Blocking, Sectoral Application

HITECH Act HITECH-Implementation-Roles-Compliance-Audit: HITECH Implementation Roadmap, Organizational Roles, Compliance + Audit-Readiness

HITECH implementation roadmap. ORGANIZATIONAL ROLES: (a) PRIVACY OFFICER + COMPLIANCE OFFICER - strategic ownership + HIPAA + HITECH compliance + OCR-relations; (b) SECURITY OFFICER + CISO - HIPAA Security Rule compliance + technical safeguards + cybersecurity + 405d Safe Harbor; (c) GENERAL COUNSEL + LEGAL - statutory + regulatory interpretation + breach response coordination + state law analysis + BAA negotiation; (d) HR + WORKFORCE - training + sanctions + workforce-related HIPAA compliance + HITECH Workforce Development; (e) HEALTH INFORMATION MANAGEMENT (HIM) - PHI custodian + record retention + accounting of disclosures + access requests; (f) IT + EHR ADMINISTRATOR - EHR Certification + Meaningful Use/Promoting Interoperability + Information Blocking compliance + 2015 Edition Cures Update; (g) BUSINESS ASSOCIATE MANAGER - BAA inventory + tracking + sub-BA management + vendor risk; (h) BOARD + EXECUTIVE LEADERSHIP - governance + oversight + breach reporting; (i) BREACH RESPONSE TEAM - cross-functional including Privacy + Security + Legal + Communications + IT + HR; (j) AUDIT + INTERNAL AUDIT - OCR audit-readiness + Phase 3 audits + HSPP documentation. PROGRAM ELEMENTS: (1) RISK ANALYSIS + RISK MANAGEMENT - 45 CFR 164.308(a)(1) ongoing risk analysis + risk management plan + remediation; (2) ADMINISTRATIVE + PHYSICAL + TECHNICAL SAFEGUARDS - Security Rule implementation + HSPP demonstration; (3) BREACH NOTIFICATION PROCEDURE - 4-factor assessment + notification SLA + register + Wall of Shame reporting; (4) BUSINESS ASSOCIATE MANAGEMENT - BAA inventory + tracking + sub-BA + termination; (5) WORKFORCE TRAINING - role-based + annual + breach response + sanctions + cybersecurity; (6) ACCESS + ACCOUNTING - electronic access procedures + accounting of disclosures + minimum necessary; (7) MARKETING/FUNDRAISING/SALE - authorization + opt-out + restrictions; (8) RESTRICTION TO HEALTH PLAN - paid-out-of-pocket + procedures; (9) OCR AUDIT-READINESS - documentation + Risk Analysis + BAA + policies + procedures; (10) ONC CERTIFICATION + INFORMATION BLOCKING + INTEROPERABILITY - certified EHR + Open APIs + Information Blocking exceptions. TOOLING: (a) HIPAA compliance platforms (Compliancy Group + Total HIPAA + HIPAA One + HealthcareITSecurity + Clearwater Compliance + Apgar HIPAA + many); (b) Privacy management (OneTrust Healthcare + TrustArc + Securiti + others); (c) BAA management (Compliancy + HIPAA Vault + Aptible + others); (d) EHR + Health IT certified products (Epic + Cerner/Oracle + Allscripts/Veradigm + Meditech + athenahealth + eClinicalWorks + many); (e) HIPAA-compliant cloud + collaboration (AWS HealthLake + Azure for Healthcare + Google Cloud Healthcare + Microsoft 365 HIPAA + Box for Healthcare + others); (f) Breach response platforms (OneTrust + Resilience + various); (g) OCR Audit-readiness assessment tools. METRICS: OCR audit-history + Compliance Officer + CISO reports + breaches reported (with timeline + Wall of Shame status) + BAA inventory + workforce training completion + Risk Analysis cycle + remediation closures + HSPP demonstration + state breach notifications + Right of Access response time.

Maintained by Gerard BlokdykControl text last updated

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