Checklist: What to Ask an AI Health Vendor Before You Sign

Checklist: What to Ask an AI Health Vendor Before You Sign — a practical contract & security guide for clinics and caregiver organizations (2026)

Hook: You need an AI tool that actually helps clinicians and caregivers — not new headaches from poor integrations, hidden costs, or data risks. In 2026, with more FedRAMP-certified AI platforms, growing regulatory scrutiny, and record rates of tool sprawl, vetting vendors on technical, security and financial grounds is non-negotiable.

Topline summary (what to ask first)

Start with three core truths: security posture (FedRAMP, SOC 2, HIPAA), integration ability (FHIR, SMART on FHIR, device SDKs), and financial stability (runway, revenue trends, indemnity). Below is a prioritized checklist you can use in vendor selection calls, contract redlines and procurement reviews.

Priority checklist — ask these in the first 30 minutes of any demo or procurement call

• FedRAMP status: Are you FedRAMP-authorized? If yes, what authorization level (Moderate or High) and which authorizing agency approved it? Can you provide the ATO package or SSP (System Security Plan) redacted for non-sensitive info?
• HIPAA & privacy compliance: Do you sign a Business Associate Agreement (BAA)? What privacy frameworks do you follow (HITRUST, ISO 27001, SOC 2)?
• Data access & portability: Who owns the data we send? Can we export raw clinical data and model outputs in standard formats on demand? See guidance on architecting data portability and audit trails.
• Integration standards: Do you support FHIR R4, SMART on FHIR, HL7v2, DICOM, and commonly used EHR connectors? Can you demonstrate a sandbox EHR integration? Refer to developer guidance on preparing training and integration artifacts: developer-ready training-data guidance.
• Service Level Agreements (SLA): What uptime, response time, and data-processing SLAs do you guarantee? What are the remediation credits for downtime? Understand the business impact of outages in advance (cost impact analysis).
• Financial health: Can you provide recent audited financials or a summary of revenue, burn rate and cash runway? What is your customer concentration risk?

Why these questions matter in 2026

Late 2025 and early 2026 saw a surge of acquisitions and new FedRAMP-certified platforms — meaning governments and large healthcare organizations increasingly expect cloud and AI vendors to meet federal security standards. At the same time, many clinics are collapsing under tool sprawl: budgets balloon while integrations fail to deliver value. Asking the right, early questions stops expensive mistakes.

"Too many tools add cost, complexity and drag. Confirm technical fit and financial stability before you pilot." — actionable advice based on 2026 market trends

Detailed contract & security checklist (use during legal and technical review)

1. FedRAMP and government-ready security

• Ask for exact FedRAMP authorization: FedRAMP Moderate or FedRAMP High. Verify the agency ATO and the package date. FedRAMP High is increasingly required for clinical data with greater sensitivity.
• Request the vendor’s System Security Plan (SSP), Plan of Actions & Milestones (POA&M) and third-party assessment reports (either full or redacted). For practical security controls and operational expectations, compare vendor artifacts to published security best practices.
• Confirm the vendor’s continuous monitoring cadence and whether monitoring artifacts can be shared under NDA for audits.

2. Privacy, HIPAA and cross-jurisdictional rules

• Require a signed BAA and confirm the vendor’s breach notification timelines (e.g., notify within 48 hours of detection). See practical privacy checklists for counsel and procurement in privacy-focused vendor guides.
• Ask how the vendor handles international data transfers and compliance with GDPR, CPRA/California privacy laws, and other state laws your patients may fall under.
• Get clarity on de-identification: if the vendor claims data is de-identified, ask for the method used and a re-identification risk assessment.

3. Access, ownership & portability of data

• Contract clause to insist on: Customer data ownership — the health system retains ownership of all patient data and derivative outputs.
• Require data export rights in usable, standard formats (FHIR JSON, CSV, DICOM). Include timelines for exports (e.g., 7 business days) and formats. See patterns from teams building paid-data marketplaces and portability plans: architecting a paid-data marketplace.
• Ask for a data escrow arrangement (data & connector configs) that is triggered on vendor insolvency, breach, or failure to meet SLAs.

4. Source code, model provenance & explainability

• Request documentation on model training data provenance, version history, and performance metrics stratified by key demographics (to check bias). Guidance on preparing training artifacts is here: developer guide for compliant training data.
• Ask if the vendor provides local explainability tools (feature attributions, confidence scores), and what level of clinician-facing explanations are available.
• Negotiate rights to audit model behavior and access to logs showing inputs/outputs for a sampled period under strict privacy controls.

5. Security certifications & third-party validation

• Require proof of SOC 2 Type II or ISO 27001, and prefer HITRUST for organizations with high regulatory needs. Check vendor attestations against published security best practices.
• Ask about penetration testing cadence and whether test results can be shared under NDA. Confirm the vendor remediates critical findings within a set period (e.g., 30 days). For hands-on secure-workflow notes, see the TitanVault & SeedVault workflows review.
• Confirm cybersecurity insurance limits and whether the vendor’s policy covers patient harm caused by model errors.

6. Incident response, breach notification & transparency

• Contract requirement: vendors must notify the customer within 48 hours of any security incident affecting customer data, with a remediation plan and timeline.
• Ask how the vendor handles model drift and unexpected performance degradation — include notification obligations and rollback procedures in the contract. These expectations should map back to your model governance plan and provenance documentation (see architecture and audit trail patterns).

7. Integration, connectivity & interoperability

Integration failures are the most common reason pilots stall. Validate real, technical fit before a trial.

• Confirm support for FHIR R4, SMART on FHIR OAuth2 flows, and HL7v2 where relevant. Ask for a demonstration against your EHR in a sandbox. If a local sandbox or lab is helpful, teams often spin up lightweight LLM or dev labs (example: local LLM lab builds) to test connectivity and offline behavior.
• Ask whether the vendor provides a developer sandbox with realistic test data and APIs for end-to-end testing.
• For devices, confirm supported protocols (Bluetooth Low Energy, MQTT, IEEE 11073) and whether the vendor provides device SDKs, SDK licensing, and certification support.
• Clarify responsibilities: who maintains the integration, who supports upgrades, and who pays for ongoing mapping and maintenance?

8. SLA specifics you should never accept verbally

• Uptime guarantee (e.g., 99.9% monthly uptime) and a clear credit scheme for downtime.
• API latency and throughput commitments for both read and write operations (p95 and p99 metrics).
• Support response & resolution times by severity level and dedicated escalation contacts.
• Data recovery objectives — Recovery Time Objective (RTO) and Recovery Point Objective (RPO).

9. Financial health and vendor viability

Recent market activity in late 2025 showed both consolidation and distressed sellers in AI. Before you sign, quantify vendor risk.

• Ask for recent audited financial statements or a summary: revenue, gross margin, cash runway (months), and investor commitments.
• Ask about customer concentration (any single customer >20% of revenue is a risk).
• Require a change-of-control and bankruptcy clause that preserves your data access and provides contractual protections (e.g., immediate data escrow release). Guidance on portability and domain/asset portability is useful here: domain & portability playbooks.
• Red flag: vendors who refuse to disclose basic financial metrics or offer only unaudited snapshot slides.

10. Pricing, hidden costs & tool sprawl

Budget for integration and ongoing maintenance — not just license fees.

• Ask for a full TCO estimate: onboarding professional services, integration engineering hours, expected maintenance costs per year, and costs for model updates or additional features. Use vendor-comparison frameworks (similar to CRM comparison matrices) to capture ongoing costs: comparison & decision-flow patterns.
• Include termination-for-convenience terms with a predictable exit cost and a guarantee of technical handover assistance.
• Ask whether functionality overlaps existing vendors — avoid duplication that adds complexity and cost.

Sample contract language (copy-paste ready prompts for your legal team)

Below are practical clauses you can propose. They’re written to be implementation-ready but should be reviewed by counsel.

Data ownership & portability

Sample clause:

Customer Data Ownership: Vendor acknowledges that all Customer Data and Derivative Data are the sole property of Customer. Upon termination for any reason, Vendor shall export and return all Customer Data in FHIR R4 JSON and CSV formats within seven (7) business days at no additional cost. If Vendor fails to do so, Vendor shall place a copy of all Customer Data into escrow pursuant to the attached Escrow Agreement, with release to Customer upon Vendor insolvency, material breach, or termination for non-performance.

FedRAMP & security artifacts

FedRAMP & Security Reporting: Vendor represents that its services are FedRAMP Authorized at the [Moderate/High] level. Vendor will provide Customer, under NDA, with the System Security Plan (SSP), continuous monitoring summary, and remediation timelines for POA&Ms. Vendor shall provide SOC 2 Type II reports annually and promptly notify Customer of any changes to authorization status.

SLA and remedies

SLA: Vendor guarantees 99.9% monthly uptime. For each 0.1% below 99.9%, Vendor will credit Customer 5% of the monthly fee, up to 100% for outages exceeding 72 hours. Vendor will provide API latency metrics (p95 and p99) and a real-time status page. Vendor will maintain backups with RPO <= 4 hours and RTO <= 8 hours.

Financial protections

Change of Control & Insolvency: In the event of a change of control, assignment, or Vendor bankruptcy, Customer may (a) terminate the agreement for convenience with 30 days’ notice and (b) require Vendor to deposit Customer Data and integration artifacts into escrow within seven (7) business days at Vendor’s expense.

Technical integration playbook — steps to run a safe pilot

1. Run a scoping call with IT, clinical leads and procurement to map data flows and compliance needs.
2. Request a developer sandbox and perform an end-to-end test: write a patient record, call the API, validate latency and output formats. If you need a low-cost local test lab to emulate behavior, consider lightweight dev lab approaches (local LLM lab examples).
3. Perform a security scan and architecture review (VPN/IP allowlisting, mutual TLS, OAuth2 support). Compare vendor claims to published security best practices.
4. Run a small clinical validation with pre-defined success criteria (safety checks, performance thresholds) and a stop/go decision point.
5. Prove your exit path: export data, simulate vendor failure and confirm you can continue operation or switch vendors.

Operational policies & clinician safety

• Define clinical governance: who signs off on model use, how exceptions are handled, and how clinicians can report errors.
• Require regular retraining and performance reviews: vendor must provide quarterly model performance reports and a plan for handling drift.
• Set patient-facing disclosure and consent requirements if AI impacts care decisions.

Red flags — when to pause procurement

• Vendor will not sign a BAA or refuses to be bound by HIPAA-like obligations.
• Vendor denies data export or ownership rights.
• Vendor refuses to provide SOC 2/ISO 27001 or share recent pen-test results.
• Opaque pricing, high professional services needed for basic integrations, or pressure to sign long-term without pilot metrics.

2026 trends to watch — and how they change this checklist

• More FedRAMP-authorized AI platforms: government and large health systems expect vendors to be FedRAMP-ready. Prioritize FedRAMP status if you plan any public-sector partnerships.
• Focus on portability and anti-lock-in: acquisitions and consolidations (some companies reset balance sheets in late 2025) make data escrow and change-of-control clauses essential. See domain & portability playbooks for triggers and escrow patterns: domain portability guidance.
• Tool consolidation: following 2025 reports on tool sprawl, expect procurement to demand TCO and integration readiness up front to avoid redundant subscriptions.
• Regulatory attention on AI explainability: expect auditors and clinicians to ask for provenance and fairness reports as standard deliverables by 2026.

Real-world example — short case study

Clinic network (Midwest, 120 providers): The network piloted an AI medication-reconciliation tool in 2025. They nearly signed a 3-year contract before asking for escrow and a ransomware response plan. After requesting audited financials, SOC 2 reports, and a FHIR sandbox test, the vendor produced a remediation plan and agreed to a 12-month pilot with clear exit and data portability terms. Result: after 6 months they achieved a 22% reduction in reconciliation time; the contract included a data escrow and explicit RTOs, which protected the clinic when the vendor was acquired in early 2026.

Actionable takeaways — your quick 10-question checklist to use on calls

1. Are you FedRAMP authorized? Which level and which agency approved it?
2. Will you sign a BAA and provide SOC 2/ISO 27001/HITRUST reports?
3. Who owns patient data and can we export it in FHIR R4 JSON within 7 business days?
4. Do you support SMART on FHIR and can you demonstrate a sandbox EHR integration?
5. What is your uptime SLA and API latency (p95/p99)?
6. How long is your cash runway and can you provide audited financial summaries?
7. Do you have cyber insurance that covers patient harm tied to model errors?
8. How do you notify customers about incidents and model drift?
9. Will you place data & code/config into escrow on trigger events?
10. What are the total onboarding and annual maintenance costs beyond license fees? (Get a full TCO estimate — see comparison frameworks for guidance.)

Final words — protect clinicians, patients and budgets

In 2026, AI vendors bring real value — but success depends on asking the right questions early: confirm FedRAMP & compliance, validate integration readiness, and quantify financial risk. Use the sample contract clauses and technical playbook above in your procurement, legal and IT reviews to reduce risk and prevent tool sprawl.

Next steps (call-to-action)

Use our downloadable 1‑page checklist (formatted for procurement calls) and the sample contract clauses to accelerate safe piloting. If you want a tailored vendor assessment template for your clinic or caregiver organization, request our 30-minute consult and we’ll adapt the checklist to your EHR, device mix and compliance needs.

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