ONC Health IT Certification (HTI-1)
Readiness assessments, certification criteria mapping, test plan development, and evidence preparation for ONC Health IT certification under HTI-1 requirements.
Healthcare Compliance Consulting Services
Stay CMS, HIPAA & Interoperability Ready Without the Audit Anxiety
ISO 27001 + ISO 9001 certified
Compliance Work We Take Off Your Plate
Compliance problems solved end-to-end.
Interoperability and FHIR API Compliance
Patient access APIs, payer-to-payer exchange, SMART on FHIR patterns, and production validation aligned to CMS and ONC interoperability mandates.
Information Blocking and EHI Access
Policies, workflows, and technical controls that support lawful access to electronic health information and reduce information blocking risk.
HIPAA Security and Privacy
Privacy and security rule assessments, risk analysis, control documentation, breach readiness, and operational alignment across teams handling PHI.
Quality and Payer Reporting
eCQM, QRDA, HEDIS, and payer quality reporting readiness—including measure logic, data mapping, and submission validation support.
Regulatory Readiness and Gap Assessment
Structured reviews of policies, workflows, systems, and evidence against applicable requirements—with prioritized remediation roadmaps.
Policy, Training, and Governance
Compliance policy development, staff training, governance frameworks, and rollout support so teams understand what to do in practice.
Validation, Mock Audits, and Ongoing Monitoring
Testing support, mock audits, evidence preparation, issue tracking, and post-go-live monitoring to keep compliance programs audit-ready.
Not sure where to start?
Book a complimentary compliance assessment and get a prioritized view of your highest-risk gaps.
Schedule AssessmentCompliance Frameworks We Cover
The regulations driving the work right now, with a short explainer behind each.
HIPAA Privacy and Security Rule
Read the explainerHITECH Act
21st Century Cures Act
Read the explainerCMS Interoperability and Patient Access
Read the explainerCMS-0057-F Prior Authorization
Read the explainerTransparency in Coverage
FHIR and USCDI
ONC Certification (HTI-1 and HTI-2)
Read the explainerMeaningful Use and MACRA
Find your compliance gaps before an auditor does.
Get my free gap assessmentHow We Get You Compliant
Seven phases, the same on every engagement. Tap any phase to see what happens, what you walk away with, and roughly how long it takes.
Scoping Call
A 30-minute call to hear which rule is on your desk and what your deadline is.
What you get: A clear scope and a same-week answer on whether and how we can help.
Typical timing: 30 minutes
Current-State Assessment
We map your systems, data flows, integrations, and the exact rules that apply to your organization and segment.
What you get: A documented picture of where you stand today.
Typical timing: 1 to 2 weeks
Gap Analysis and Risk Ranking
We compare current state to what the mandate requires and rank every gap by risk and by what it costs to leave it open.
What you get: A prioritized gap report, with the high-risk items called out first.
Typical timing: 1 week
Remediation Roadmap
We turn the gaps into a phased plan with owners, sequencing, and dates tied to the actual mandate.
What you get: A roadmap your team and ours can both work from, costed and scheduled.
Typical timing: 1 week
Build and Implementation
The work itself. FHIR APIs, certification engineering, encryption and access controls, HL7 to FHIR translation, policy and control documentation, whatever the roadmap calls for.
What you get: A working, compliant system, not a list of recommendations.
Typical timing: Scoped per engagement. FHIR patient access APIs have gone live in as little as six weeks.
Testing, Validation, and Certification
Conformance testing against the relevant suite (Inferno for FHIR and ONC work), evidence preparation, and a mock audit before anything is declared done.
What you get: Validated endpoints, certification where it applies, and an evidence pack ready for a regulator.
Typical timing: 1 to 3 weeks
Go-Live and Ongoing Monitoring
Launch support, post-go-live monitoring, and tracking of new and changing rules so you are not surprised by the next one.
What you get: A program that holds after launch, with us on call.
Typical timing: Ongoing
Industries We Serve
Compliance pressure looks different across the healthcare ecosystem. Nalashaa supports organizations with consulting aligned to the regulatory, operational, and technical realities of each segment.
Payers
CMS interoperability, prior authorization, member access, and reporting readiness
Providers
HIPAA, quality reporting, patient access, and clinical workflow alignment
Health IT Vendors
Certification, FHIR APIs, testing support, and product compliance roadmaps
Clinics & Ambulatory Care
Operational compliance, privacy controls, and scalable documentation practices
Medical Device Companies
Regulatory documentation, data handling, and integration readiness
Digital Health Organizations
Privacy, security, and scalable compliance for digital care models
Healthcare Networks & Systems
Enterprise governance, exchange readiness, and multi-entity alignment
Healthcare Technology Platforms
Platform compliance, API strategy, and cross-product implementation support
WHY Choose Nalashaa
Why Organizations Trust Nalashaa
Healthcare compliance work rarely stays confined to policies alone. It often reaches workflows, systems, APIs, documentation, and the teams responsible for putting requirements into practice.
That is why the right partner needs to understand both the compliance expectation and what it takes to operationalize it.
Built for Regulated Healthcare Environments
Work with a team that understands how compliance pressure shows up across healthcare operations, interoperability requirements, data handling, and implementation planning.
Where Compliance Meets Execution
Compliance efforts often involve more than one team. Nalashaa helps connect policy, data, systems, and delivery so work can move forward with clearer ownership and better alignment.
Beyond Advisory Support
Get more than recommendations. Nalashaa supports the work that follows, from assessments and planning to workflow alignment, technical coordination, and readiness activities.
Compliance Work We've Delivered
Different rules, different starting points, certified either way.
Talk to a Healthcare Compliance Specialist
Preparing for CMS mandates, interoperability rules, or API requirements? Most teams start by checking their systems against the timelines and the gaps. We can map a practical path before the deadline turns into pressure.
Map my compliance path
Frequently Asked Questions
A healthcare compliance consultant helps you assess regulatory obligations, identify gaps, strengthen policies, improve readiness, and plan the actions needed to support compliance across operations and systems.
CMS-focused consulting includes readiness assessments, gap analysis, API and data exchange planning, prior authorization workflow review, and roadmaps that connect regulatory timelines to system and operational changes.
Yes. Many programs require both HIPAA privacy and security controls and interoperability capabilities such as FHIR-based APIs and patient access. An integrated approach reduces duplicate effort across teams.
Health plans can get support for patient access APIs, provider directory requirements, prior authorization automation planning, evidence readiness, and alignment between compliance, product, and technology teams.
Yes. Nalashaa supports payers, providers, clinics, health IT vendors, digital health organizations, medical device companies, and healthcare technology platforms.
A gap assessment reviews policies, workflows, technical capabilities, documentation, and evidence against applicable requirements, then prioritizes findings with phased remediation recommendations.
Preparation includes defining required FHIR resources and operations, assessing API security, mapping source data, validating with testing tools, and aligning product, engineering, and compliance teams on timelines.
Yes. Engagements can cover policy development, training, workflow alignment, FHIR and API enablement, testing support, audit preparation, and post-implementation monitoring.