Build vs Buy

What investors ask about your clinical model, and how to answer

The clinical section of a telehealth diligence process is where good companies lose weeks. The questions are predictable, so the answers can be ready before the first partner meeting. Here is the list, what a strong answer looks like and the documents behind each.

TL;DR

In telehealth due diligence, investors check seven areas of the clinical model: clinical structure, licensure coverage, prescribing oversight, compliance, medication sourcing, data ownership and unit economics. Strong answers are documents: a licensure matrix, signed BAAs, dated protocols, pharmacy agreements, an export clause and a per-visit model. Red flags include “nationwide” coverage with no matrix, missing BAAs and no succession plan. Building on licensed infrastructure moves five of the seven areas into one agreement.

Answer with documents, not descriptions

Telehealth due diligence covers seven areas of your clinical model, and the questions barely change between firms. Answer each with a document and the clinical section moves quickly. Answer with descriptions and it turns into weeks of follow-ups.

Built on licensed infrastructure, five of the seven areas are answered mostly through one agreement. Compliance and unit economics stay yours to prove.

AreaWhat investors askYour own practice: evidenceOn Lithos
1. Clinical structureWho practices medicine, under what entity?PC/MSO agreements, counsel’s memoThe infrastructure agreement
2. LicensureWhich states can you serve?State matrix with modality notesLicensed providers in all 50 states; modality set per encounter
3. Prescribing oversightWho writes protocols and decides each encounter?Dated protocols, escalation policyProvider protocol summaries and escalation process
4. ComplianceWhere are the BAAs; who reviews ads?BAA list, pixel review, ad review, LegitScriptBAA at onboarding; your marketing review stays yours
5. MedicationWhich pharmacies, shipping where?Pharmacy agreementsRouting to your pharmacy or Lithos’s partners, at pharmacy cost
6. Data ownershipCan you export everything and leave?Contract clause, sample exportYou own patients and data; export any time
7. Unit economicsWhat does a visit cost at scale?Per-visit modelPublished per-visit rates; your model stays yours

What a strong answer looks like in each area

Clinical structure. Name the structure in one sentence and point to the agreements. With your own PC/MSO, that is the management services agreement, the succession agreement and counsel’s memo; our guide to PC/MSO structures explains each. On infrastructure, diligence reads one contract.

Licensure. Show a matrix of states, allowed modalities, licensed clinicians and pharmacies that ship there. It should match where your ads run, and intake should screen out states you can’t serve. Our 50-state compliance checklist shows what belongs in it.

Prescribing oversight. Named clinical leadership approves protocols, which carry version dates. A licensed provider in the patient’s state decides every encounter. If AI is involved, it prepares the chart; a licensed provider reviews and makes the clinical decision. Controlled substances follow current DEA telemedicine rules, which are still changing.

Compliance. Investors dig into your own house here, whatever your clinical setup:

  • A signed BAA from every vendor touching PHI: infrastructure, hosting, email and SMS, support, analytics.
  • A documented review of tracking on intake pages. Our post on HIPAA and the marketing stack covers where this goes wrong.
  • A review step for ad and creator claims, and a counsel-approved policy on referral payments.
  • Your LegitScript certification status, which ad platforms commonly require.

Lithos is HIPAA compliant, signs a BAA at onboarding and has SOC 2 Type II in progress.

Medication. Name the pharmacies and show their licensure against your patient states. For compounded medications, show patient-specific prescriptions filled by licensed 503A pharmacies, cleanly documented. That is lawful practice done properly. For branded medications, show how benefits checks and prior authorization work. On Lithos, medication passes through at pharmacy cost, plus a small flat fee on mail-order orders.

Data ownership. Point to the clause: you own the patients and data, can export at any time, and have a defined transition. Portability keeps your pricing negotiable. Read this clause most carefully on any infrastructure contract.

Unit economics. Show cost per visit by type, medication as a pass-through, contribution per patient per month and CAC payback. Our telehealth startup runway model builds this month by month. Lithos is free to start, with no setup, implementation or platform fee: $45 async and $70 sync per completed visit on pay-as-you-go, falling with volume.

What goes in a telehealth data room?

FolderDocuments
StructureFormation documents; PC/MSO or infrastructure agreement
LicensureState coverage matrix; pharmacy shipping footprint
ClinicalDated protocol summaries; escalation policy; clinical lead
ComplianceBAAs; privacy policy; marketing review; LegitScript status
InsuranceYour certificates (general liability, cyber, D&O); malpractice cover for clinicians
SecuritySecurity overview; questionnaire answers
PharmacyPharmacy agreements or routing; compounding documentation
DataOwnership and export clauses; sample export
EconomicsPer-visit model; retention or refill data; CAC by channel

Before your next partner meeting, we’ll go through these nine folders with you and mark which the Lithos agreement, BAA and security materials cover and which stay yours. Book a call.

Eight red flags that slow a round

  1. “Nationwide” coverage with no matrix behind it.
  2. Ads that promise outcomes the protocols don’t support.
  3. Unreviewed tracking pixels on intake pages.
  4. A vendor touching PHI without a BAA.
  5. One pharmacy and no backup plan.
  6. One clinician or physician owner carrying the practice, with no succession plan.
  7. No export right, or an export nobody has tested.
  8. Medication revenue counted as margin.

None kills a deal alone. Four or five add weeks.

Run the clinical call like a demo

Many investors hold a call just for the clinical model, often with an outside clinician listening.

  1. Send a one-page memo the day before. One paragraph per area, each pointing to its data room folder.
  2. Walk one patient through the flow. Intake, provider decision, prescription, pharmacy order, renewal. A sandbox shows every state change without real patient data.
  3. Bring the right people. The founder who owns the clinical relationship, your clinical lead and whoever built the integration.
  4. Answer follow-ups in writing within days, and file them. The same questions come back next round.
One-page memosent before the callData roomnine foldersClinical callwalk one patientWritten answersfiled in the roomeach red flag = another round of questionsno open questions: the round moves forward
Clinical diligence runs as a loop: memo, data room, a call that walks one patient through the flow, then written follow-ups. Each red flag sends you around again, so the fastest rounds are the ones with the fewest open questions after the call.

Be plain about what isn’t done. “SOC 2 Type II is in progress” is a fine answer. Overstating where you are damages trust, because investors check.

Lithos is the licensed clinical infrastructure underneath your own care experience: licensed providers, protocols, prescribing and pharmacy routing, and compliance in all 50 states, behind one API, with a BAA at onboarding and malpractice, general liability and cyber insurance covering clinicians working through Lithos. Raising soon? We’ll walk your investors through the clinical layer, and accelerator companies can claim up to $2,500 in credits via the Lithos Startup Program. Book a call, or read our security overview.

Frequently asked questions

What do VCs ask about a telehealth startup’s clinical model?

Who practices medicine and under what structure, which states you can serve, how prescribing is overseen, how you handle HIPAA and advertising rules, where medication comes from, who owns the patient data, and what each visit costs. Expect all seven in the first diligence request.

What documents should a telehealth startup put in its data room?

Structure documents or the clinical infrastructure agreement, a state licensure matrix, dated protocol summaries, a BAA for every vendor touching PHI, pharmacy agreements, your marketing review procedure and LegitScript status, insurance certificates, security materials and a per-visit unit economics model.

What are red flags in telehealth due diligence?

“Nationwide” coverage without a matrix, ads that outrun the protocols, unreviewed tracking pixels on intake pages, a vendor touching PHI without a BAA, undocumented medication sourcing, and dependence on one clinician or vendor with no transition plan. Each adds a round of questions.

Does building on telehealth infrastructure make due diligence easier?

Usually. Clinical structure, licensure, prescribing oversight, medication routing and data terms sit mostly in one agreement, so diligence concentrates on that contract. Investors still check your marketing, privacy practices and unit economics directly.

How do investors evaluate telehealth unit economics?

They want cost per visit by visit type, medication as a pass-through, acquisition cost against monthly contribution per patient, and refill rates that show patients stay. The strongest models show clinical cost falling as a share of revenue as volume grows.

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