Healthcare App Development
HIPAA compliance is not a feature. It is the architecture.
Healthcare apps that meet regulatory requirements from the first line of code. Telehealth, patient portals, and clinical tools built by a team that understands the stakes.
The global telehealth market reached $177.82 billion in 2025, projected to hit $851.75 billion by 2033. The U.S. telehealth market alone is $52.76 billion. HIPAA compliance adds $45,000 to $300,000 to development costs and $4,000 to $12,000 per year in maintenance. Penalties range from $100 to $50,000 per violation, with maximums of $1.9 million annually per violation type. The average healthcare data breach costs $9.77 million. Getting this right is not optional.
HIPAA compliance from the architecture
We do not bolt HIPAA compliance onto finished apps. We architect for it from day one. AES-256 encryption at rest, TLS 1.2+ in transit, role-based access controls with multi-factor authentication, comprehensive audit logs of all PHI access and modifications, and Business Associate Agreements with every third-party vendor.
The January 2025 HIPAA Security Rule update (the first major revision in 20 years) introduced stricter encryption, risk management, and resilience standards. Vulnerability scanning every 6 months and penetration testing annually are now expected. 67% of healthcare organizations are unprepared for these standards. We build for the new requirements, not the old ones.
EHR integration realities
FHIR and SMART on FHIR cut MVP timelines by up to 40% compared to older HL7 integrations. But EHR integration is still complex and expensive. Simple FHIR integration adds $50,000 to $100,000. Complex multi-system integration can exceed $200,000. Epic alone charges $15,000 to $20,000 to spin up a basic interface before touching real data.
We scope EHR integration during discovery, not as an afterthought. The integration architecture determines your app’s value proposition, data flow, and regulatory posture. Getting it wrong means months of rework. Getting it right means your app works with the systems clinicians already use.
40%
faster MVP with FHIR vs. legacy HL7 integration
FDA considerations for digital health
Apps that qualify as Software as a Medical Device (SaMD) require FDA 510(k) clearance or De Novo pathway. General wellness apps, scheduling tools, and education apps are not medical devices. The line matters. We help you determine your regulatory classification during discovery, before you build something that requires clearance you did not plan for.
The EU AI Act and FDA AI/ML action plan are now in force. If your app uses AI for clinical decisions, the regulatory landscape is more complex. We scope this upfront.
FAQ
Fair questions.
Ask us directlyHow much does HIPAA compliance add to development cost?
Typically $45,000 to $300,000 on top of base development, depending on the scope of PHI handling, number of integrations, and infrastructure requirements. Annual maintenance adds $4,000 to $12,000. This is significantly cheaper than retrofitting compliance after launch or paying $1.9M in penalties.
Can you integrate with Epic?
Yes. We integrate with Epic, Cerner, Athena, and any EHR with a FHIR or HL7 interface. Epic integration requires their development environment ($15K to $20K from Epic) plus our integration engineering. We scope this during discovery.
Does our app need FDA clearance?
It depends on what the app does. General wellness, scheduling, and patient communication apps typically do not. Apps that diagnose, treat, or make clinical recommendations may qualify as SaMD and require 510(k) or De Novo clearance. We help you determine classification during discovery.
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