What do health systems ask in security reviews?

Expect questions about where data is stored and who can access it, encryption, audit logging, single sign-on, incident response, subprocessors and your business associate agreement. We build the product so these answers are true, and prepare the architecture and data flow documents reviewers ask for.

How do you set the scope of a fixed-scope MVP?

On the scoping call we agree the one workflow that proves value, the user type and platform, and what is deliberately left out. That list becomes the fixed scope. New ideas go into the next release instead of delaying this one.

Patient using a digital health app on a phone, with an MVP scope card and a HIPAA-ready checklist for encryption, audit logs and role-based access

Healthcare / Digital Health Startups

Software development for digital health startups

Founders need a product patients and clinicians will use, that passes a health system security review and that does not need rebuilding at the first pilot. Agnotic Technologies builds fixed-scope MVPs with HIPAA safeguards from day one and adds EHR integration when your first customer asks for it.

15-Minute Scoping Call

Fixed scope

An MVP with an agreed feature list

HIPAA-ready

Encryption, access control and audit logs from day one

FHIR R4

EHR integration when your first customer needs it

Trusted by global innovators

Industry Overview

What is software development for digital health startups?

Software development for digital health startups is turning a care or wellness idea into a product that patients, clinicians and buyers can trust: a working app, secure handling of health data and the integrations health systems require. Agnotic Technologies builds this for founders as a services partner, starting with a fixed-scope MVP.

Where you are

Which stage is your digital health company at?

What you need from a development partner changes with each stage. These are the starting points we see most often.

Validating the idea

Before funding or before the first real users.

A clickable prototype to test with patients or clinicians
Synthetic data only, so no PHI is involved yet
A clear list of what the MVP must prove

Building the first MVP

Funded, with first users or a design partner lined up.

One core workflow, built properly
HIPAA safeguards and BAA-covered hosting from the start
Analytics on the actions that show value

Preparing a health system pilot

A buyer is interested and has sent a security questionnaire.

Single sign-on and role-based access
Security evidence for the review
A first EHR data feed through FHIR

Rescuing an existing build

A prototype or AI-generated codebase that cannot go to production.

Architecture that cannot pass a security review
No audit logging or access control
Features that break when real users arrive

Industry Challenges

Why do digital health MVPs stall after launch?

Most early products stall for the same few reasons, and each can be avoided with decisions made in the first weeks.

HIPAA added late: safeguards bolted on after launch slow down the first enterprise deal.
Prototype architecture: the code that won the demo cannot answer a security questionnaire.
Scope creep: every new idea joins the first release, and launch keeps moving.
No path to EHR data: a health system asks for integration and the product has no way to provide it.

Fixed-scope MVP

What goes into a fixed-scope MVP, and what waits?

A fixed scope keeps the first release small enough to ship and strong enough to prove value. Everything else gets a place in a later release.

What a fixed-scope digital health MVP includes and what moves to later releases
Area	In the first release	In later releases
Users	One primary user type, such as patients or clinicians	Additional roles such as caregivers or admins
Workflow	The one job that proves the product's value	Secondary workflows and settings
Health data	Only the data the workflow needs, encrypted and audit logged	Wider data sets and analytics
EHR integration	None, or one read-only feed if a pilot requires it	Write-back and support for more EHRs
Platforms	One platform, web or mobile	A second platform
Security	HIPAA safeguards, BAA-covered hosting, single sign-on if a buyer needs it	SOC 2 readiness when buyers ask for it

Our Approach

How do you get from an MVP to a first health system pilot?

Health systems buy differently from consumers. We plan the product so that pilot requirements are an addition, not a rebuild.

Security review pack

Architecture and data flow diagrams, access control and audit logging design, and draft questionnaire answers.

Enterprise sign-in and roles

Single sign-on with the health system's identity provider and roles that match its teams.

EHR data access

FHIR or SMART on FHIR integration scoped to what the pilot actually needs.

Pilot reporting

Reports on the outcome measures the pilot sponsor agreed to, from day one of the pilot.

Capabilities

What do we build for digital health startups?

Patient and clinician products built on one secure backend, so the second platform is not a second project.

Patient mobile apps

iOS and Android apps for onboarding, care plans, reminders and progress.

Clinician dashboards

Web workspaces for reviewing patients, messages and alerts.

Secure messaging and video

In-app messaging and telehealth visits between patients and care teams.

Device and wearable data

Apple HealthKit, Health Connect and Bluetooth devices feeding one data model.

Care plans and reminders

Configurable programs with tasks, education and nudges.

Admin and analytics

Operations tools and the product metrics investors and buyers ask about.

Engineering Stack

Which technologies do we use for digital health products?

A stack chosen for speed of delivery and for passing enterprise review later.

Apps

React NativeNext.jsSwiftKotlin

Backend

Node.jsPythonPostgreSQL

Standards

FHIR R4SMART on FHIRHL7 v2

Devices

Apple HealthKitHealth ConnectBluetooth Low Energy

Infra

AWSAzureGoogle Cloud

Roles

Who does what on a startup engagement?

Founders keep product direction. We bring the engineering, and a fractional CTO when you do not have one yet.

Roles on a digital health startup engagement
Role	Owns	Where Agnotic helps
Founder	Vision, customers, priorities and fundraising	Turning priorities into a scoped, sequenced plan
Clinical advisor	Clinical accuracy and safety of the workflow	Building review points into the product
Product and engineering	Design, build, testing and releases	Our team, from the first sprint
Technical leadership	Architecture, security and hiring decisions	A fractional CTO for healthcare until you hire one

Measured Impact

What should a digital health MVP measure?

Measures that show investors and buyers the product works. We instrument them in the first release.

Activation

First key action

New users who complete the action that delivers value, divided by sign-ups.

Retention

Week 4 active users

Users still active four weeks after sign-up.

Time to value

Days to first result

Time from sign-up to the first meaningful outcome for the user.

Pilot outcome

Agreed pilot measure

The clinical or operational result your pilot sponsor signed off on.

My Lauren Maternal Health Platform | Built by Agnotic

A HIPAA-ready maternal health platform enabling remote patient monitoring, care coordination, and personalized engagement from pre-pregnancy through postpartum.

Case Study

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My Lauren Maternal Health Platform | Built by Agnotic

LERA Health: Compliant Women’s Health App Platform

A women’s health product experience focused on guided care journeys, education, and compliance-aware workflows to support long-term engagement.

Case Study

Read the case study

Use Cases

What kinds of digital health products do we build?

Product types founders bring to us, from consumer apps to clinician tools.

Virtual care

Telehealth visits, asynchronous consults and follow-up messaging.

Chronic condition programs

Care plans, device data and coaching for long-term conditions.

Women's health and femtech

Cycle, fertility, pregnancy and menopause products.

Mental health and wellbeing

Therapy platforms, check-ins and escalation to clinicians.

Remote monitoring

Home device data reviewed by a care team.

Care navigation

Helping patients find, book and prepare for the right care.

Integrations

Which systems do digital health products integrate with?

Connections founders usually need in the first year.

Devices

Apple HealthKitHealth Connect

EHR

EpicOracle Health (Cerner)

Communication

Video and messaging APIs

Payments

Payment processors

Compliance-First Development Services Backed by Global Standards

We build secure, scalable products designed for privacy, interoperability, and regulatory readiness from day one across every sector we serve.

Health Insurance Portability and Accountability Act

Protect PHI with privacy-first architecture, encrypted storage and transmission, and strict access controls.

Fast Healthcare Interoperability Resources

Enabling standardized health data exchange through standards-based API mappings.

Our Edge

Why Global Leaders Choose Us

We combine deep technical expertise with industry-specific knowledge to deliver solutions that aren't just functional, but transformational.

Enterprise-Grade Security

We implement rigorous security protocols and compliance standards (HIPAA, GDPR, SOC2) across all industrial solutions to protect sensitive data.

High-Performance Scaling

Our architectures are built to handle massive data loads and user bases, keeping performance steady whether you're serving ten or ten million.

Accelerated Time-to-Market

Using our suite of internal tools and proven frameworks, we reduce development cycles and get your product to market 40% faster.

Embedded AI Integration

Beyond simple wrappers, we build deep-learning integrations and predictive analytics directly into the core of your industry-specific workflows.

Engagement Model

How does an engagement with a startup work?

We work in short, fixed-scope stages, so you always know what the next release contains. Timing depends on scope, and we agree it on the scoping call.

Scoping call

We agree the one workflow the MVP must prove, the user and the platform.

Fixed-scope plan

A written scope listing what is in the first release and what waits.

Build with weekly demos

You see working software every week and can adjust priorities between sprints.

Launch

Release to your first users with monitoring and support in place.

Scale and support

Pilot readiness, integrations and the next releases as customers arrive.

Facts and sources

Which rules apply to digital health products?

Short facts on the regulations founders meet first, each linked to its official source.

The HIPAA Security Rule requires administrative, physical and technical safeguards for electronic protected health information.
Source: 45 CFR Part 164 Subpart C (eCFR)
Health apps that are not covered by HIPAA can fall under the FTC Health Breach Notification Rule, which requires notice after a breach of personal health record data.
Source: 16 CFR Part 318 (eCFR)
HIPAA allows health information to be de-identified by removing specified identifiers or through an expert determination, after which it is no longer protected health information.
Source: 45 CFR 164.514 (eCFR)
Section 520(o) of the Federal Food, Drug, and Cosmetic Act excludes certain software functions from the definition of a medical device, such as some functions for maintaining a healthy lifestyle.
Source: 21 U.S.C. 360j (US Code)

Voice of success

We don't just build products; we forge lasting partnerships. See how we've helped industry leaders transform their vision into technical reality.

“I can clearly see how Agnotic has a unique way of handling end-to-end development. They are always active on quick chat and provide support quickly.”

Aaron Phelan

Founder, Benchmark

“Agnotic combines deep technical expertise with strong domain knowledge. They understand the business context, anticipate challenges, and make collaboration smooth and effective.”

John Pasmore

Founder, Latimer

“Agnotic is the best technical team we evaluated. Their engineering excellence made our work dramatically easier and allowed us to stay focused on what matters most for maternal care outcomes. They took full ownership of the technical execution, and we are always happy to continue working together.”

Kim Smith

Founder, My Lauren

Related services

Where can founders start with us?

Detailed pages for the services digital health founders ask us about.

Fractional CTO for healthcare

Technical leadership for founders who have not hired a CTO yet.

Healthcare software scope builder

Plan features, workflows, integrations and security before you talk to vendors.

Fixed-scope MVP

A first release with an agreed scope and weekly demos.

HIPAA compliant software development

Products built with HIPAA safeguards from the first sprint.

Telemedicine platform development

Virtual visit platforms with scheduling, video and EHR integration.

Remote patient monitoring software development

Device data, care team workflows and billing support for RPM programs.

EHR software development

Custom EHR modules and platforms built around clinical workflows.

HIPAA requirements for software teams

The safeguards we build into every healthcare product.

The Same Engineering Patterns, Across Other Industries

The technical patterns behind this platform translate naturally into adjacent verticals.

AI

Apply private LLM and RAG architectures to clinical knowledge bases.

Education

Extend secure platform engineering to medical education and CME workflows.

Gov & Research

Power national health datasets and population health initiatives.

Frequently Asked Questions

Yes, and it is often the right start. A prototype or pilot can run on synthetic or de-identified data while you validate the workflow. We design the architecture so the same product can take on PHI once hosting, access controls and agreements are in place, without a rebuild.

Industries