Integrations
Each EHR, payer, lab or device connection adds mapping, testing and go-live work, more so with write-back.
Custom Healthcare Software
Custom healthcare software development
Off-the-shelf tools rarely fit the way your clinicians and staff actually work. Agnotic Technologies builds custom healthcare software around your workflow, with HIPAA-ready architecture and EHR integration from the first release.
HL7 FHIR R4HL7 v2SMART on FHIRHIPAA Security Rule
Trusted by global innovators
What is custom healthcare software development?
Custom healthcare software development is designing and building software for one organization's clinical or operational workflow, instead of adapting a generic product. Agnotic Technologies builds it for providers and digital health teams: HIPAA safeguards, audit logging and EHR integration through HL7 FHIR are part of the first release, which is fixed in scope.
Custom software makes sense when the workflow is what sets you apart, or when the product has to connect to systems in a way packaged tools do not support.
Which healthcare software do we build?
Most projects start from one of these and connect to the systems around it.
EHR and EMR software
Specialty charting, orders, e-prescribing and FHIR APIs, or modules that extend the EHR you already run.
Telehealth platforms
Video visits, scheduling, intake and follow-up, with the visit record written back to the EHR.
Remote patient monitoring
Device data, alert rules and clinician review workflows for chronic and post-acute care.
Patient apps
Mobile and web apps for onboarding, education, care plans and secure messaging.
Portals
Patient, provider and partner portals with role-based access and audit logging.
Care coordination
Shared care plans, tasks and referrals across teams, settings and organizations.
Clinical workflows
How do we validate clinical workflows before we build?
Software that skips this step gets worked around. These four steps happen before and during the first release.
1.
Shadow the workflow
We map how clinicians and staff do the work today, including the workarounds, with the people who do it.
Observe2.
Prototype the hard screens
We test clickable prototypes of the busiest screens with real users before writing production code.
Test3.
Agree the first release
We fix the users, workflows and integrations the first release covers, and what waits for later.
Scope4.
Review in the clinic
Clinical reviewers see working software regularly, so changes are caught while they are cheap.
IterateCompliance and security
What compliance and security requirements apply to custom healthcare software?
Each requirement becomes an engineering decision. Agnotic claims no certification; we build so your product can pass security reviews and audits.
- HIPAA Security Rule (HHS): access control, audit logging, encryption and backups for every system that holds PHI
- Business associate agreements (HIPAA): a signed BAA with Agnotic and with every hosting, messaging or AI vendor that touches PHI
- Health Breach Notification Rule (FTC): breach notification duties for consumer health apps that HIPAA does not cover
- Standardized FHIR APIs under ONC (ASTP) certification: certified EHRs offer FHIR R4 APIs your software can read from and write to
- Accessibility (W3C WCAG 2.2): accessible screens for patients and staff, tested with assistive technology
Outside the US
What changes when you build healthcare software for the UK, Canada or Australia?
The engineering approach stays the same; the privacy rules and the integrations change.
| Country | Main privacy and security rules | What changes in the build |
|---|---|---|
| United States | HIPAA Privacy and Security Rules, state privacy laws, FTC Health Breach Notification Rule | BAAs, audit logging, US hosting, FHIR R4 and US Core for EHR data |
| United Kingdom | UK GDPR, the Data Protection Act 2018 and, for NHS data, the Data Security and Protection Toolkit | Lawful basis for health data, data protection impact assessment, NHS integration standards |
| Canada | PIPEDA and provincial health information laws | Which law applies depends on the province and the organization; data residency is often a contract term |
| Australia | The Privacy Act 1988 and the Australian Privacy Principles | Health information handled as sensitive information, with consent and disclosure rules |
We do not give legal advice. Your privacy counsel confirms which rules apply to your product in each country.
Scope and effort
What drives the cost and timeline of custom healthcare software?
We do not publish prices. These drivers decide the size of a project.
PHI from day one
Storing PHI in the first release adds security work; an MVP on synthetic data can launch smaller.
Platforms
Web, iOS and Android together cost more than one platform first.
Data migration
Moving records from a legacy system adds mapping, cleansing and parallel running.
Regions
Each country adds its own privacy rules, hosting and integration standards.
Who it is for
Who builds custom healthcare software with us?
We work with health systems and startups, and the first release looks different for each.
Hospitals and health systems
Teams adding apps and workflows the EHR does not cover, with Epic or Oracle Health integration.
Digital health startups
Founders taking a product from fixed-scope MVP to the first health system pilot.
Specialty practices and MSOs
Groups that need specialty workflows, intake and reporting across locations.
Payers and care management teams
Teams building member, provider and care management tools.
Facts and sources
Which rules and facts shape custom healthcare software?
Short facts we design around, each linked to its primary source.
The HIPAA Security Rule requires administrative, physical and technical safeguards for electronic protected health information.
Source: 45 CFR Part 164 Subpart C (eCFR)The FTC Health Breach Notification Rule requires vendors of personal health records and related entities, including many health apps outside HIPAA, to notify consumers after a breach of unsecured health information.
Source: 16 CFR Part 318 (eCFR)In England, organisations that have access to NHS patient data and systems must complete the Data Security and Protection Toolkit, a self-assessment against the National Data Guardian's data security standards.
Source: NHS England, Data Security and Protection ToolkitAustralia's Privacy Act 1988 sets 13 Australian Privacy Principles for how covered agencies and organisations handle personal information.
Source: Office of the Australian Information Commissioner
Compliance-First Healthcare App Development Services Backed by Global Standards
01
HIPAA
Health Insurance Portability and Accountability Act
Protect PHI with privacy-first architecture, encrypted storage and transmission, strict access controls, and traceable audit logs.
02
GDPR
General Data Protection Regulation
Implement lawful consent flows, data minimization, retention controls, and secure processing for sensitive health data.
03
FHIR
Fast Healthcare Interoperability Resources
Enable standardized health data exchange across apps, care teams, and systems through standards-based FHIR APIs.
04
HL7
Health Level Seven International
Support enterprise-grade interoperability with HL7-based integrations for records, events, and clinical messaging workflows.
05
HITRUST
Health Information Trust Alliance
Align security programs to healthcare-specific control and risk management practices trusted by providers and ecosystem partners.
06
HITECH
Health Information Technology for Economic and Clinical Health Act
Design with breach notification readiness, digital record safeguards, and operational controls that support regulated care programs.
07
SaMD
FDA Software as a Medical Device
Plan software quality, traceability, and documentation pathways for products that may require SaMD review and submission.
08
MDR (EU)
Medical Device Regulation (European Union)
Prepare EU market-ready processes for risk classification, evidence tracking, and lifecycle governance under MDR expectations.
09
SAMHSA
Substance Abuse and Mental Health Services Administration
Apply confidentiality controls and consent-aware sharing models for behavioral and mental health data experiences.
Frequently Asked Questions
It depends on the integrations, whether the first release stores PHI and how many platforms it covers. We agree a fixed scope after a scoping call and plan the schedule from it, rather than quoting a number before we know those drivers.
Yes. For startups we usually build a fixed-scope MVP that can pass a health system security review. For health systems we build apps and workflows around the EHR, with the integration and approval steps your IT team requires.
We observe the work with the people who do it, test prototypes of the busiest screens with real users, and have clinical reviewers see working software throughout the first release.
We support the product in production, monitor the integrations and add features and connections in agreed phases. When your own team takes over, we hand over documentation of the architecture and the controls.