FHIR Strategy & Compliance Advisory
Helping Healthcare Organizations Align with Regulatory Standards & Optimize FHIR Implementation
Many healthcare organizations struggle with FHIR adoption due to evolving regulations, compliance requirements, and interoperability challenges. Without a well-defined strategy, organizations risk inefficiencies, security vulnerabilities, and non-compliance penalties.
Our FHIR Strategy & Compliance Advisory service provides expert guidance on aligning FHIR implementation with regulatory frameworks, including HIPAA, TEFCA, USCDI, and US Core profiles. We deliver a strategic roadmap tailored to your organization’s compliance needs and long-term interoperability goals.
Scope of Work
What We Deliver
- Comprehensive Regulatory & Compliance - Assessment (HIPAA, CMS, ONC, TEFCA, US Core)
- Strategic FHIR Implementation - Roadmap Aligned with Business Goals
- Risk & Compliance - Gap Analysis with Mitigation Strategies
- Governance & Data Privacy - Best Practices for FHIR Implementation
- Enterprise-Wide FHIR Adoption - Strategy (Including Vendor & Partner Alignment)
- Budget, Timeline & Resource - Planning for Sustainable FHIR Compliance
Who Should Consider This?
Healthcare Organizations (Providers, Payers, Labs, PBMs, ISVs) who:
- Need a structured compliance strategy before implementing FHIR.
- Are uncertain about how upcoming regulations impact their FHIR strategy.
- Want to ensure that their FHIR implementation aligns with HIPAA, TEFCA, and other interoperability frameworks.
- Have multiple data systems and require a unified governance model for FHIR adoption.
- • Seek expert guidance to avoid compliance pitfalls and streamline implementation.
Process & Timeline
Step 1:
Compliance & Stakeholder Discovery (1 Hour)
Goal: Understand the organization’s business objectives, compliance concerns, and interoperability requirements.
Key Activities:
- One-on-one discovery calls with IT, compliance, and business stakeholders.
- Assess existing data governance policies and security controls.
- Understand areas impacting FHIR adoption.
- Map key interoperability challenges and system dependencies.
Step 2:
Regulatory Compliance Assessment & Risk Analysis (1-2 Weeks)
Goal: Evaluate the organization’s readiness for FHIR compliance.
Key Activities:
- Audit FHIR implementation against HIPAA, TEFCA, and US Core standards.
- Identify security gaps in OAuth 2.0, SMART on FHIR, and access controls.
- Analyze existing data governance policies for regulatory adherence.
- Develop a risk mitigation framework to address compliance gaps.
Step 3:
Strategic Roadmap & Compliance Advisory (1 Week)
Goal: Provide a clear action plan for FHIR adoption, regulatory alignment, and interoperability strategy.
Key Activities:
- Define a phased FHIR adoption plan aligned with compliance deadlines.
- Provide an enterprise-wide governance framework for data security and privacy.
- Develop a prioritization framework for high-impact implementation areas.
- Outline budget, timeline, and resource recommendations for long-term sustainability.
- Present a final strategic report with compliance best practices and advisory recommendations.
Why Choose Our FHIR Strategy & Compliance Advisory?
- Regulatory-First Approach: Ensures full compliance with HIPAA, TEFCA, and US Core standards.
- Interoperability Expertise: Deep knowledge of FHIR, HL7, EHR systems, and healthcare IT.
- Customized Strategy: Tailored recommendations based on your organization’s needs and existing IT infrastructure.
- Risk-Reduction Focus: Identifies compliance pitfalls and provides proactive mitigation strategies.
- Accelerated Decision-Making: Clear, actionable steps to fast-track FHIR adoption.
