mHealth Platform 2.0
Co-architected the infrastructure that runs remote, multi-site clinical studies across an academic medical center. One platform replaced per-study builds, with the audit trail and data provenance regulators expect.
Accepting new engagements
Fractional CTO & scientific partner
Fractional CTO & scientific partner
for digital health.
Palo Alto Health Labs is the senior technical counterpart teams bring in to get regulated digital health right the first time — a CTO who has shipped clinical software, with a Stanford PhD in clinical epidemiology.
01 · Why us
A CTO who can read the protocol.
Most digital health work falls into a gap. Engineers ship software that doesn't survive contact with clinicians, regulators, or patients. Clinicians design studies that cannot be implemented. We are a single, senior counterpart fluent in both worlds.
i.
Engineering, at depth
Production mobile health apps, regulated data pipelines, EHR integrations, wearable ingestion, and the platform architecture beneath them. Built and shipped — not whiteboarded.
ii.
Science, at the bench
A PhD in computational epidemiology with a neurology focus. Study design, eCOA validation, biostatistics, and a working understanding of how clinical evidence is actually built.
iii.
One senior counterpart
You don't have to translate between vendors. We hold the technical architecture, the scientific design, and the regulatory posture in the same head — and write the spec accordingly.
02 · What we do
Digital health consulting, end to end.
For digital health companies, and for hospitals, practices, and clinics putting AI to work. Each can be scoped on its own or folded into an advisory, fractional CTO, or build engagement, with one senior counterpart holding the engineering, the science, and the compliance posture.
01
AI implementation & integration
For hospitals, practices, and clinics: find the workflows where AI pays off, build and integrate it under HIPAA, and get staff using it.
Learn more 02Mobile health app development
Patient- and clinician-facing iOS and Android apps, HIPAA-compliant from the first commit, with wearable and EHR connectivity.
Learn more 03HIPAA compliance guidance & verification
Gap assessment, technical safeguards, BAA coverage, policies, and verification that what is documented is what is built.
Learn more 04Healthcare architecture design
Platform, cloud, and data architecture for regulated products, with the expensive-to-reverse decisions made deliberately and in writing.
Learn more 05SaMD planning
Intended use, classification, pathway, design controls, and documentation, planned before the architecture locks it in.
Learn more 06Study design
Protocols, digital endpoints, eCOA/ePRO, analysis plans, and the decentralized trial infrastructure that captures the data.
Learn more 07Dataset management, procurement & labeling
Sourcing and licensing clinical datasets, de-identification, governance, and annotation workflows with clinical labelers and quality control.
Learn more 08EHR & wearable interoperability
FHIR and SMART on FHIR, Epic and Oracle Health, HL7 v2, and wearable ingestion that land in a usable data model.
Learn more 09Technical due diligence
Independent review of a product, codebase, or vendor for investors, acquirers, and partners, with a risk-rated report.
Learn more
03 · How to start
Start small. Grow as scope clarifies.
Most founders start with the audit: three weeks, a written deliverable, and a clear view of what to fix before the next raise. Everything after that is optional and builds on it.
Fixed scope · 3 weeks
Initial Audit
A senior-led review of your product across seven readiness domains: regulatory intent, architecture, data and interoperability, evidence, security, quality, and team.
- Risk-rated findings report
- 30 / 60 / 90-day remediation roadmap
- Two-page summary for your board or investors
- Fee credited toward Advisory or Fractional CTO
Monthly retainer
Advisory
A standing seat on your technical leadership. Architecture review, hiring input, vendor selection, and regulatory orientation.
- Two strategic sessions per month
- Async architecture & design review
- Investor / partner diligence support
- 30-day notice, no minimum term
Multi-month embedded
Fractional CTO
Embedded leadership through a defined arc, from architecture through hiring through first production release. The most common engagement for funded startups.
- Two to three days per week, embedded
- Owns architecture & engineering hiring
- Scientific input on endpoints, eCOA, and study design
- Three- to six-month minimum
Scoped delivery
Build
A senior team delivers a defined platform or application. We hold the architecture, the science, and the timeline through release.
- Mobile health apps, dashboards, pipelines
- Fixed scope, fixed timeline
- Senior engineers only — no offshoring
- Optional handoff plan to your team
Not sure which? Book the scoping call and we'll name the smallest engagement that moves you forward.
04 · Who we work with
Built for founders.
Seed through Series B digital health companies whose product has to satisfy regulators, clinicians, and investors at the same time — usually before the first senior technical hire.
i.
Before you build
Deciding what to build: intended use, SaMD classification, and the architecture and data decisions that are expensive to reverse once capital is committed.
ii.
Before you raise
Diligence-ready: a written technical and regulatory position investors and partners can review, and a credible technical voice in the room when they ask.
iii.
After the agency
An inherited codebase or an outsourced build with no senior owner. We take technical ownership and set the bar for whoever writes the code.
We also work with hospitals, medical practices, and clinics on AI implementation, and take a limited number of engagements with pharma innovation groups and research consortia, usually starting with an assessment or the audit.
Building something that has to clear the clinical bar?
Bring the architecture, the science, and the regulatory posture to one senior counterpart. Start with a 30-minute scoping call — we'll tell you the smallest engagement that moves you forward.
05 · Founder
Built by a CTO with a Stanford PhD.
The practice is led by its founder — both as the senior technical counterpart on every engagement and as the person responsible for the work delivered.
“The work I care about lives in a narrow band — software that actually clears the clinical bar and science that actually ships. Palo Alto Health Labs exists to do that work for partners who need a counterpart who has done it before.”
Mike Hittle holds a PhD from Stanford in computational epidemiology with a focus on neurology. Over the last decade, the through-line of the work has been re-engineering how digital health gets built — co-architecting the platform infrastructure for Stanford Medicine, founding open-source infrastructure for regulated health apps, shipping research platforms that link wearable and EHR data, and teaching the next cohort of engineers to that bar. The portfolio below has the specifics.
The unusual profile — a senior engineering leader with first-hand medical and epidemiologic depth — is what Palo Alto Health Labs offers its partners.
Portfolio
Platforms, open-source infrastructure, and courses that shipped — and what each one proved. The practice today is this work on behalf of new partners.
CardinalKit
Founded an open-source foundation for regulated mobile health apps, now used across academic and industry programs. Teams start from a HIPAA-conscious, ResearchKit-based codebase instead of a blank repository.
PHENOMS Platform
Designed and built an eCOA platform pairing a clinician dashboard with a participant app, linking wearable data to the EHR. Research-grade neurology data a biostatistician can use without a cleanup project.
CS342 — Building for Digital Health
Created a project-based course in which engineering teams ship a clinical-grade app in one quarter with real clinical partners. A repeatable method for taking a team from zero to a reviewable product.
EPI 270 — Digital Health
Teaches epidemiologic method applied to digital health at the school of medicine — the same translation between evidence design and software that the practice does for clients.
06 · Free resource
The Digital Health Architecture & SaMD Readiness Checklist
The 60-point checklist we use to pressure-test a digital health product before a line of code is committed — spanning regulatory intent, architecture, interoperability, evidence, security, and quality. Built from shipping regulated clinical platforms.
- Define intended use and SaMD risk classification before you build
- Design the audit trail, versioning, and data provenance regulators expect
- Validate digital endpoints with the V3 framework (verification, analytical, clinical)
- Get FHIR / EHR interoperability and wearable ingestion right the first time
- Pass HIPAA, SOC 2, and design-control review without a rebuild
07 · Questions
Frequently asked.
The questions founders ask before a first call.
How is this different from hiring a dev shop?
A dev shop builds what you specify. We own what gets specified — regulatory intent, architecture, data model, and evidence plan — and then build it or direct whoever does. You get a senior technical owner accountable for the outcome, not a vendor accountable for the hours.
We already have engineers or an agency. Does this still work?
Yes, and it is the usual case. We don't replace your team; we give it a technical owner. We work alongside your engineers and vendors, set the architecture and review standards, and are the technical voice with investors, partners, and clinical collaborators.
How fast can you start?
The Initial Audit starts within ten business days of signature. Advisory usually starts within two weeks. Fractional CTO depends on current load, and the scoping call will tell you honestly.
What does the first month look like?
For the audit: discovery in week one, analysis in week two, findings report, roadmap, and leadership readout in week three. For a fractional CTO engagement: a written architecture and risk review in the first two weeks, then a 90-day plan you and your investors can hold us to.
Do you take equity?
Engagements are cash: a fixed fee for the audit and monthly retainers for advisory and fractional work. Equity is occasionally part of a longer fractional CTO engagement, decided case by case.
What happens when we need a full-time CTO?
That is the goal of most fractional engagements. We help define the role, run the search, sit on the interviews, and hand over a documented architecture and roadmap so the hire starts ahead instead of from zero. Many relationships continue as advisory afterwards.
Do you work on SaMD or FDA-regulated software?
Yes. We architect Software as a Medical Device and other regulated digital health systems so they are built to clear review — data integrity, auditability, and the documentation trail regulators and quality teams expect.
08 · Contact
Tell us what you're building.
Book a 30-minute scoping call, or send a short note — we respond personally within two business days. For sensitive material, ask for our PGP key or a signed NDA before sharing detail.