FAQ: TAP, HTI-1 & Clinical Data Compliance

How TAP engagements scope and start, what a Starter Audit includes, and how we validate FHIR, USCDI, and privacy engineering, plus deep-dive technical questions.

Questions buyers and engineering leads ask
before and during a TAP engagement

Getting started with TAP

TAP is our structured technical audit for health IT teams: we test interoperability and privacy-critical behavior, document evidence, and give you a prioritized remediation backlog plus re-scan verification after fixes (see our one-pager for the full deliverable list, HTI readiness scorecard, evidence packet, board-ready summary, etc.).

TAP produces technical diagnostics and evidence, not legal opinions. ONC certification decisions remain with ONC-ACBs.

Why two steps? Intake captures technical scope without tying it to a card or calendar. Assessment bundles checkout and booking so money and time live in one audited flow. Between them you may have a short intro or email thread, that is normal; you do not need “intake complete” before a conversation, but we need intake before we can quote a Starter Audit or lock scope in a SOW.

Typical flow: Book a Call so we can size the work in writing → optional short intro to confirm fit → we align on a SOW for a Starter Audit or advisory engagement.

Do I need intake before we talk? Reach out anytime if you already know you want to proceed. Intake is the structured artifact we need before fixed-fee quotes and audit scope; separate from optional discussion.

If you are still exploring requirements, skim Regulations for engineering context and Privacy Laws for jurisdictional overview, then come back to intake.

Starter Audit fixed-fee TAP engagements start at $7,500, consistent with our strategic one-pager. Exact scope, assumptions, and deliverables are confirmed in a signed SOW before billable work.

Need a shorter executive snapshot first? The one-pager is the best single artifact to share internally.

Certification & interoperability (HTI, USCDI, FHIR): start with Regulations (engineering context), then deep dives in Regulatory Hubs and the HTI-1 through HTI-4 & USCDI v3/v4 implementation guide.

Privacy statutes & frameworks: see Privacy Laws, US State Laws, and International Laws. MHMDA engineering protocols when Washington consumer health data applies.

Risk & cost context

Healthcare data compliance enforcement is public record. HHS OCR publishes every HIPAA settlement and every breach affecting 500+ individuals. CMS publishes information-blocking disincentive determinations. ONC-ACBs (Drummond, ICSA Labs, SLI Compliance) publish certification surveillance findings. State Attorneys General publish privacy enforcement actions (Washington MHMDA includes a private right of action).

The financial penalty is rarely the largest cost. The published narrative is. Journalists, competitors, and Series B leads all read these lists.

We maintain a sourced reference on what each failure mode actually costs, drawn from public regulator notices. See Cost of non-compliance →

Technical audit vs security audit & regulatory context

SOC 2 and many security audits focus on controls, policies, access, encryption, vendor risk. TAP focuses on whether your clinical interoperability and safety-critical logic behave correctly under HTI/USCDI expectations: FHIR resources, CDS/DSI traceability, clinical workflows, and evidence you can show an ACB or payer.

Think: security auditors stress-test your locks; we stress-test whether your sepsis alert logic and data exchange hold up, not only whether the firewall is on.

No. We provide technical implementation advice: we translate requirements from legal, privacy, and compliance stakeholders into testable checks, pipelines, and AWS/Azure/GCP configurations. We are the how, not the law.

The HTI rules (HTI-1 through HTI-4) set certification and interoperability deadlines for certified Health IT. Applications that connect to certified systems (e.g. Epic, Cerner) must keep pace with US Core and USCDI v3/v4 expectations, or risk failed integrations, blocked deploys, or certification problems. View current ONC certification deadlines.

Privacy engineering & de-identification

Yes, that is a core specialty. We architect NLP-driven pipelines using SQL tooling, Redgate, and Google Cloud Healthcare APIs, and we evaluate Azure Health Data Services and AWS Comprehend Medical where they fit. Compare Azure, AWS, and Google Cloud Healthcare APIs.

Different data types: Redgate and SQL masking excel at structured columns (demographics, billing codes, SSNs). Cloud APIs excel at unstructured clinical text.

Together: Redgate for dev/test copies and referential masking; cloud APIs for note-level de-ID before the lake. We routinely combine SQL, Redgate, and Google Healthcare APIs. Full comparison.

EHR, automation & multi-cloud operations

We audit Decision Support Intervention (DSI) logic so source attributes, training data provenance, and behavior are traceable against federal transparency expectations (including (b)(11)-class requirements).

"At Providence, Terry led validation of Early Warning Systems for Sepsis and MEWS in Epic, mapping clinical triggers to protocols, supporting standard-of-care implementation and over $13M in annual operational savings through improved stability."

Static dummy data misses edge cases. We design automated pipelines that feed lower environments and CRM instances with high-fidelity, de-identified clinical datasets.

"Automated ETL de-identification for Providence and Opala hydrated CRM and non-prod environments daily with Safe Harbor–style datasets, realistic scenarios, zero PHI breach risk."

Yes, we reduce manual regression through structured break-fix analysis and automated E2E coverage for major EHR releases.

"During the Epic ICD-10 migration, ISTQB-style automation validated hundreds of apps, ~20,000 hours of manual testing automated, $2.5M saved, zero downtime through a major US regulatory transition."

Yes, platform choice should not dictate whether you can govern data. We build in-place de-identification and governance patterns that run across all three clouds.

"At Opala, AWS-to-Azure migration work cut infrastructure costs by 55% while maintaining payer–provider interoperability standards."

TAP engagements, pricing & policies

You're not hiring a vendor; you're hiring a coach, mentor, trainer, validator, and best-practices expert who can work with you at the C-suite level or down to engineers and QA. We publish transparent pricing aligned with how lean HealthTech teams actually buy TAP (Technical Audit Protocol) work.

Getting started:

Scoping call with our delivery team: A no-obligation fit check.

TAP Intake: Structured scoping via the intake form so we can size endpoints, constraints, and evidence expectations.

Book a Call: Our team responds within one business day to confirm fit, scope, and timeline. A signed SOW kicks off the engagement.

Fixed-fee TAP (Technical Audit Protocol): Four SKUs, priced per FHIR endpoint. Each SKU is a fixed package confirmed in the SOW. Multi-endpoint engagements multiply the per-endpoint price.

TAP Starter

Fast health check / pre-due-diligence

$7,500 · per endpoint

  • Live FHIR R4 endpoint audit (automated, citation-level)
  • TAP Scorecard with 0-100 conformance score and severity ratings
  • AI-synthesized compliance brief (board, investor, procurement-ready)
  • Penalty exposure quantified in dollar terms
  • Delivered in 24-48 hours
TAP Full Engagement

Procurement, Series A, ONC certification

$75,000 · per endpoint

  • Everything in TAP Corrective Action
  • 24-point HIPAA policy assessment (Security, Privacy, Breach Notification)
  • DSI inventory review against 45 CFR 170.315(b)(11)
  • State law applicability (MHMDA, CPRA, 42 CFR Part 2)
  • Executive debrief call
TAP Monitoring

Fractional compliance monitoring for healthcare data systems

$3,500 · per month

  • We track the regulations so your engineers don't have to
  • Weekly re-audit of in-scope FHIR endpoints
  • Email drift alerts when new failures appear
  • Monthly scorecard snapshot
  • Catches regressions before the buyer does

All fees are fixed-fee per endpoint, listed in the SOW before billable work. Multi-endpoint engagements (for example a payer auditing patient access plus provider directory plus formulary) multiply the per-endpoint price.

Work that involves PHI uses a signed NDA and BAA as appropriate.

vs. large consultancies: You avoid enterprise overhead, long sales cycles, and junior staff doing the work. You get a senior practitioner who has validated 20M+ healthcare records and led compliance at scale, without the big-firm markup.

vs. boutique firms: You get the same deep expertise, but with a fractional model built for startups: milestone-based engagements, no long-term lock-in, and pricing that fits early-stage budgets.

You get direct principal-level access: FHIR pipelines, HTI/USCDI validation, $13M documented cost-avoidance leadership, and zero critical or high defects in production under our QA discipline over 15 years, not a bench of junior analysts.

We typically respond within 48 hours. For active engagements, response expectations are documented in the SOW.

We keep a limited client load so each TAP or advisory engagement gets focused attention. If you need faster turnaround, say so when you Book a Call.

Specific terms, including response-time SLAs, are documented in the signed SOW or engagement agreement.

Yes. If you do not find value in our engagement, or if our audit surfaces no critical findings in scope, we work with you to make it right, including refunds of fees where our agreement allows.

We aim to earn trust through results and evidence, not lock-in. Specific guarantee language lives in your signed agreement.

Specific terms and conditions are documented in the signed SOW or engagement agreement.

Ready to scope your audit?

Starter Audit TAP engagements start at $7,500 fixed fee (see one-pager). Start with an intake call to describe systems and constraints.

Book a Call

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