New to Healthcare Development?

Healthcare software is different. We help developers and startups navigate HIPAA compliance, EHR integration, and the unique challenges of building in this regulated industry.

What Makes Healthcare Different

If you're coming from fintech, e-commerce, or enterprise SaaS, healthcare software will surprise you. The technical challenges are real, the regulatory burden is significant, and the sales cycles are long.

HIPAA isn't optional

If you touch Protected Health Information (PHI), HIPAA compliance is mandatory. This means encryption at rest and in transit, audit logging, access controls, incident response procedures, and Business Associate Agreements with every vendor. Fines range from $50K to $1.5M per violation.

EHR integration is harder than you think

The ONC lists 800+ certified EHR vendors. Epic dominates (50% market), but every Epic instance implements FHIR differently. You'll need site-specific testing, custom field mapping, and ongoing maintenance. Budget 30-40% more time than you estimated.

Standards aren't standard

FHIR has multiple versions (DSTU2, STU3, R4, R5), HL7v2 has countless variants, and vendor implementations vary wildly. What works in Epic's sandbox often fails in production. Integration testing is expensive and time-consuming.

Regulatory burden is real

Beyond HIPAA, you may face FDA regulation (Software as Medical Device), ONC certification requirements, state licensing laws, and payer-specific compliance mandates. Legal review takes months. Security reviews block enterprise sales.

Sales cycles are long

Expect 6-18 month enterprise sales cycles. Every customer requires security review, BAA negotiation, compliance validation, and procurement approval. SOC 2 Type 2 certification is often required before you can even engage with large health systems.

Uptime expectations are 24/7

Healthcare doesn't have maintenance windows. Clinicians work nights, weekends, holidays. Your disaster recovery plan needs to account for data loss (HIPAA requires it), and your SLAs will be scrutinized during security reviews.

Common Mistakes (& How to Avoid Them)

Learn from others who've navigated healthcare development. Here are the most common pitfalls and how to avoid them.

"We'll just use a middleware platform"

Problem: Per-member-per-month fees destroy unit economics at scale. A platform charging $2/patient/month costs $2.4M annually at 100K patients.When it's right: Fragmented market, quick validation, broad EHR coverage needed.When it's wrong: Analytics use case, concentrated market (2-3 EHR vendors), high patient volumes.

"HIPAA compliance is just encryption"

Problem: Encryption is table stakes. You also need audit logging, access controls, incident response plans, employee training, and annual risk assessments.Reality: Technical + organizational + legal requirements. Documentation is as important as code.Cost of wrong: $50K-$1.5M fines per violation, reputation damage, customer loss.

"Epic's FHIR API will work like our sandbox"

Problem: Every Epic instance configures FHIR differently. Sandboxes are idealized. Production has custom fields, missing data, inconsistent formats.Reality: Site-specific testing, custom field mapping, ongoing maintenance required.Budget: Add 30-40% more time than you estimated. Plan for iterations.

"We'll build our own integration platform"

Problem: Underestimating 5-year maintenance cost. New FHIR versions, EHR updates, breaking changes happen constantly.When it's right: 2-3 EHR vendors, 80%+ market concentration, analytics use case, high patient volumes.When it's wrong: Long-tail coverage needed, limited engineering resources, transactional workflows.

"We can skip the security review"

Problem: Blocks enterprise sales, delays revenue. Every hospital system requires security diligence before signing contracts.Reality: 3-6 month sales cycle includes security review, architecture review, penetration testing.Better approach: Get SOC 2 Type 1 early, design for compliance from day one.

"CDS Hooks is just a REST API"

Problem: Testing requires live Epic environment (expensive). Site-by-site configuration. Epic certification process is lengthy.Reality: $80-200K implementation cost, 8-12 weeks development + testing, ongoing maintenance.ROI timeline: 12-18 months minimum. Make sure your use case justifies the investment.

Critical Questions for Healthcare Startups

Before you write code, answer these questions. We help startups think through these decisions with economic modeling and strategic guidance.

Integration Strategy

• Who are your customers? (Hospitals, practices, payers, patients)• Which EHRs do they use? (Epic = 50% market, but what about YOUR market?)• Real-time or batch? (Clinical workflows vs. analytics)• Build vs. buy? (We model the 5-year TCO)

Compliance Posture

• Are you touching PHI? (If yes, HIPAA applies)• Cloud provider? (AWS/GCP/Azure HIPAA compliance)• Need SOC 2? (Most enterprise customers require it)• FDA regulated? (Software as Medical Device = different rules)

Technical Architecture

• Monolith or microservices? (Healthcare favors boring reliability)• Data residency requirements? (Some contracts specify US-only)• Audit logging strategy? (Required for HIPAA, often forgotten)• Disaster recovery? (Healthcare = 24/7 uptime expectations)

Healthcare Developer Resources

Essential tools, documentation, and frameworks to help you navigate healthcare software development.

Getting Started

Epic's FHIR DocumentationComprehensive guide to Epic's FHIR API implementation. Start here if you're building on Epic.
SMART on FHIR TutorialsInteractive tutorials for building SMART apps that launch from EHRs.
FHIR SpecificationOfficial HL7 FHIR spec. Dense but authoritative. Use as reference, not learning material.

Compliance & Security

HHS HIPAA GuidanceOfficial HIPAA rules and guidance from Health & Human Services. Start with the Security Rule summary.
HITRUST CSFComprehensive security framework. Relevant if you're pursuing enterprise healthcare customers.
MedScrub PHI De-identificationOur open-source proxy for safely using LLMs with healthcare data without exposing PHI.

Our Healthcare Case Studies

Practice Rounds: Healthcare Recruiting PlatformBuilt HIPAA-compliant platform connecting healthcare professionals with employers. Includes secure messaging, credential verification, and compliance workflows.
Lexmed AI: Clinical Documentation AssistantAI-powered clinical note generation with PHI protection, EHR integration strategy, and HIPAA compliance architecture.

Common Questions

Answers to frequently asked questions about healthcare software development, compliance, and integration.

How much does it cost to integrate with Epic?

A basic SMART on FHIR read-only app takes 4-6 weeks ($80-200K with an agency). Epic Showroom (App Orchard) listing adds 2-4 weeks. Read/write workflows with CDS Hooks integration cost $50-100K and take 8-12 weeks. The real question is whether you need Epic-specific integration or can use a standards-based FHIR approach that works across multiple EHRs.

Should we build our own integrations or use a middleware platform?

Depends on your use case and market concentration. Middleware platforms (Redox, Healthjump, Particle) charge $1-3 per patient per month, which destroys unit economics at scale for analytics use cases. They make sense for transactional workflows, fragmented markets, or if you need broad EHR coverage quickly. Custom integrations have higher upfront costs but better long-term economics if you're targeting 2-3 EHR vendors that represent 80%+ of your market. We model both approaches based on your projected patient volumes and market concentration.

Do I need to be HIPAA compliant from day one?

If you're handling Protected Health Information (PHI), yes. HIPAA applies immediately when you collect, store, or transmit PHI. Fines start at $50K per violation. The good news: basic technical compliance (encryption, access controls, audit logging) can be implemented in 2-4 weeks if you architect correctly from the start. It's much cheaper to build compliant systems than to retrofit compliance later.

What's the difference between FHIR versions?

DSTU2 (2015) is legacy but still deployed in older Epic instances. STU3 (2017) saw wide adoption and is still common. R4 (2019) is current standard for new implementations. R5 (2023) is latest but not yet widely adopted in production EHRs. Most healthcare organizations run multiple FHIR versions simultaneously. Plan to support both STU3 and R4 for broad coverage. Epic's implementation of FHIR varies by institution even on the same FHIR version.

How long does it take to get SOC 2 certified?

SOC 2 Type I can be achieved in 2-3 months if your security controls are already implemented. Type II requires 3-12 months of audit observation period to prove controls work over time. Budget $30-50K for audit costs, plus engineering time to implement required controls and prepare evidence. Most enterprise healthcare customers require SOC 2 Type II before they'll sign contracts.

Can I use LLMs (ChatGPT, Claude) with patient data?

Not directly with PHI unless the LLM provider signs a Business Associate Agreement (BAA) and you have appropriate technical safeguards. OpenAI and Anthropic offer BAA-eligible APIs but many features (like ChatGPT web interface) are not HIPAA-compliant. Better approach: de-identify PHI before sending to LLMs using tools like our MedScrub proxy, which strips identifiers while preserving clinical context.

Need Help Navigating Healthcare Development?

30-minute discovery call to discuss your integration strategy, compliance requirements, and technical roadmap.