A data model built around clinical reality
Using SNOMED CT, LOINC, ICD-10, CPT and RxNorm rather than generic fields that lose meaning at the receiving end.
We build healthcare products that ship on schedule and clear certification. EHR and EMR platforms, revenue cycle systems, telehealth, patient portals and connected device software for US HIT vendors, providers, payers and medical device companies.
Definition
Custom healthcare software development is the process of designing and building clinical, administrative or patient-facing software to a specific organization's workflows, data model and regulatory obligations, rather than configuring a commercial product to approximate them.
The distinction matters more in healthcare than in most industries, because the workflow is often specific to a specialty, the data has to move between systems that each interpret the same standard differently, and the product itself may have to hold up under an ONC certification audit or an FDA review. Whether custom is the right choice at all is a question we take head-on further down. That is custom medical software development when the product sits next to clinical care or a regulated device.
A custom build in this market typically covers
Using SNOMED CT, LOINC, ICD-10, CPT and RxNorm rather than generic fields that lose meaning at the receiving end.
Whether that means HL7 v2 feeds, FHIR R4 APIs, X12 transactions for claims and eligibility, or DICOM for imaging.
Covering HIPAA safeguards, audit logging, access control and, where the product qualifies, 21 CFR Part 11 electronic records and signatures.
If the product will be used as certified health IT under ONC or regulated as a medical device by the FDA.
Our solutions
We have delivered products across the clinical, financial and patient-facing sides of US healthcare. Each area below links to deeper detail where we have it.
Video consultation, scheduling, consent capture, documentation and billing integration, built so the virtual encounter lands in the chart as a structured visit rather than a separate silo.
Learn more →Device data ingestion, threshold alerting, care team workflow and chart integration. We map each incoming metric to a structured entry, which is the difference between usable RPM data and a stream of free-text comments nobody reads.
Records access, secure messaging, appointment self-service, forms and intake. We build portals against the same data classes the certification criteria use, so patient API access is a design input rather than a retrofit.
Cohort identification, care gap tracking, outreach workflow and quality measure reporting, including QRDA Category I and III submission where products support quality programs.
Learn more →Native and cross-platform apps for patients, clinicians and field staff, including wearable and connected-device companions, built against the same data and security model as the platform behind them.
Learn more →Scheduling, registration, eligibility, front-desk workflow and administrative reporting, built to sit alongside the clinical record rather than duplicate it. We have delivered practice management alongside EHR for chiropractic, podiatry and behavioral health specialties.
Charge capture, claim generation, submission, remittance posting and denial management. We build RCM as a product for vendors selling it, and as a module inside a broader platform, with X12 837, 835 and 270/271 handled correctly rather than approximated.
Learn more →We build electronic health record systems from the ground up and extend existing ones, covering clinical documentation, order entry, results review, care coordination and provider workflow. Several of these products have gone through Meaningful Use certification with us.
Learn more →As a custom hospital software development company, we cover admissions, bed and resource management, departmental workflow, order coordination and administrative reporting across inpatient settings. We have delivered inpatient information management systems, including certification work on them.
Imaging workflow, study management, viewer integration and archive strategy, including DICOM and DICOMweb handling for departments consolidating across modalities.
Order and result workflow, specimen tracking, analyzer connectivity and result reporting, with LOINC mapping so results arrive in the chart as coded values.
Medication workflow, formulary handling, prescribing and real-time prescription benefit. This is one of the areas where certification criteria changed most recently, so we build it against the current requirement rather than the one from two years ago.
Alerting, order sets, risk scoring and guideline surfacing, built with the transparency and source attribution that certification criteria and clinical users both expect.
Products that meet the FDA definition of a device, built under a validated development lifecycle so the evidence a submission needs exists as a by-product of the build rather than a retrofit.
More areas we cover
Not sure which of these you need, or whether you need a build at all? Describe the problem and we will tell you which of these fits, or if the answer is none of them.
Get a Scope EstimateWho we serve
We work with four markets in US healthcare. Most of our engineering hours go to the first.
01
Certification cycles keep eating the sprint you planned for the roadmap. We take that engineering on as a delivery team, from criteria work through attestations and Real World Testing, so your own people stay on the product.
A podiatry EHR built from scratch and certified for Meaningful Use Stage 3 in the same engagement.
02
The systems you run were not built around how your practice actually works, so staff close the gaps by hand and the cost shows up in throughput rather than on an invoice. We build the software that closes them, designed to connect to what you already run rather than replace it.
A surgery scheduling platform re-engineered to serve multiple organizations from a single instance.
03
Claims, eligibility and prior authorization systems were built for a slower regulatory cycle than the one CMS-0057-F has put you in. We build and modernize the interfaces and back-end systems that have to carry that load.
Explore this market →04
Your software sits inside a regulated product, so release velocity runs straight into design controls and the evidence a submission will ask for. We work inside that constraint rather than around it.
Real-time medical device data streaming and processing, delivered for a device manufacturer.
Custom vs off-the-shelf
Most healthcare organizations should start by asking whether a commercial platform can do the job, because when it can, it is the better answer. Here is an honest comparison.
| Attribute | Off-the-shelf platform | Configured platform | Custom build |
|---|---|---|---|
| Upfront cost | Lowest | Moderate | Highest |
| Time to first release | Fastest, days to weeks | Weeks to months | Months |
| Fit to your workflow | Whatever the vendor decided | Close, within the product's limits | Exact |
| Integration control | Vendor's connectors only | Vendor's connectors plus custom work | Full |
| Data ownership and PHI custody | Vendor-held, per contract | Vendor-held, per contract | Yours |
| Compliance and audit control | Vendor's roadmap | Vendor's roadmap | Yours |
| Certification path | Vendor certifies, you inherit | Vendor certifies, you inherit | You certify, you control scope |
| Vendor lock-in | High | High | Low |
| Cost over five years | Predictable, rises with seats and modules | Predictable, plus recurring configuration work | Higher at the start, flatter after |
The decision
Custom is worth the investment when at least one of these is true.
Configuring a general product would mean asking staff to work around the software every day.
The product is the business, so a platform's limits become your limits.
Certified health IT and FDA-regulated products both require evidence you cannot inherit from a platform vendor.
If none of those apply, buy the platform. We will say so during discovery.
Certification and compliance
Not the code, but the evidence the code has to produce, and the moving regulatory target it has to produce it against.
Moved the baseline to USCDI v3, US Core STU 6.1.0 and SMART App Launch 2.0.0, and replaced the clinical decision support criterion with decision support interventions in the Base EHR definition.
Updated the e-prescribing criterion, added a real-time prescription benefit criterion, and added certification criteria for electronic prior authorization APIs.
Would remove 34 and revise 7 of the 60 certification criteria, narrow Insights reporting to FHIR usage, and descope Real World Testing in favor of the voluntary Standards Version Advancement Process.
Taking a client product through ONC certification, and keeping it certified through the next cycle, is the work most development firms have never actually done. Below is what we have learned running it.
When your customers are providers who report under Medicare payment programs. The ONC Health IT Certification Program is voluntary on paper, but those providers need certified health IT to participate, so in practice your product has to be certified for them to buy it.
Certification is also modular. You certify a health IT module against specific criteria rather than certifying a whole product in one pass, which makes scope a decision rather than a given. Scoping it well is usually where a certification budget is won or lost.
More preparation than testing. Before an ONC-Authorized Certification Body tests anything, the product has to demonstrate conformant behaviour against every criterion in scope, and your organization has to be ready for the obligations that continue after the certificate is issued.
Those ongoing obligations include:
Teams that treat certification as a one-off project rather than a maintained state are the ones scrambling every cycle.
By keeping production PHI out of development environments wherever possible and governing every exception. Four controls:
On the BAA specifically: any engagement where we create, receive, maintain or transmit protected health information on your behalf runs under one, covering permitted uses, safeguard obligations, breach notification duties and what happens to data when the engagement ends. We expect to sign it, and we would question a healthcare development partner who did not raise it.
Zero reportable HIPAA incidents across 15+ years of US healthcare delivery. That is a function of this discipline rather than luck.
For an engineering team the practical point is that HITECH extended direct liability to business associates, so the consequences of a weak security posture land on the software vendor and not only on the customer. That is why access control, audit logging, encryption and breach detection belong in the architecture rather than in a policy document.
The policy, assessment and program side of that work sits with our healthcare compliance consulting services.
If the software is intended to diagnose, treat or prevent disease on its own, it may be regulated as Software as a Medical Device, and that changes how it has to be built rather than only how it has to be documented. Design controls, traceability from requirement to test, validated system behavior and Part 11 grade audit trails are architectural decisions, not paperwork you add before a submission. Audit trails added late are audit trails with gaps in them, which is why classification belongs in discovery.
Almost every healthcare product has to exchange data with something else, usually several things. We handle HL7 v2 interfaces, FHIR R4 APIs, X12 transactions, NCPDP for pharmacy and DICOM for imaging as part of the build rather than as a separate phase, and we design the product's data model so those exchanges do not require translation gymnastics later.
Integration is a large enough discipline that we treat it as its own practice. If your primary need is connecting systems rather than building a product, our healthcare interoperability services page covers that work in detail.
Before you build
We will map your criteria scope and flag what HTI-5 could change for your roadmap before you build against criteria that may not survive.
Map My Certification Scope41 of the 60 ONC certification criteria could change under HTI-5
Process and engagement
Five stages from discovery to sustenance. Some engagements end at stage one, because discovery shows a commercial product is the better answer.
We map the workflow, the systems the product has to live alongside, and the regulatory scope. You get a written summary covering technical approach, integration and compliance dependencies, and the risks worth resolving before the build starts. Some engagements end here, because discovery shows a commercial product is the better answer.
We design the data model, integration surface and security architecture together, because in healthcare they constrain each other. If the product needs ONC certification or falls under FDA rules, those requirements shape this stage rather than arriving later.
Development runs in sprints with testing inside each one rather than after all of them: functional tests, workflow validation against real clinical scenarios, security testing, and conformance testing against whichever standards the product implements. You see working software each sprint.
Where certification applies, we prepare the product for testing, work with your ONC-Authorized Certification Body through the process, and produce the documentation the program requires. For launches we handle deployment, data migration where relevant, and the cutover plan.
After launch we cover L1 to L3 support, performance monitoring, standards updates as versions advance, attestation and Real World Testing obligations, and ongoing enhancement. Products that stay certified need someone watching the regulatory calendar. Sustenance engineering.
Companies come to us looking for different things: a healthcare software development agency to own a build end to end, a dedicated team alongside their own engineers, or specific skills for a fixed stretch. We work all four ways.
We scope a defined deliverable and commit to it. Best when the requirement is clear and you need budget certainty.
An allocated team working to your roadmap and your process. Best when the work is ongoing and priorities shift, which is the common shape for HIT vendors.
Specific skills added to your existing team, under your management. Best when you have the capability but not the capacity.
Structured around a defined result, most often a certification or a launch milestone. Best when the outcome is unambiguous and the path to it is ours to determine.
We maintain 95% on-time delivery across phased engagements. Where a date is going to move, you hear it when we know, not at the milestone.
Proof
A scheduling platform built for single-organization deployment needed to serve multiple client organizations from one instance without data crossing between them. We re-engineered the tenancy model, data isolation and access control, which is architectural surgery on a live product rather than a feature addition. The platform now supports multi-tenant deployment with tenant-level isolation.
Read Case StudyA podiatry-focused health IT vendor needed a complete EHR product and needed it certified, having no existing platform to extend. We built the system from scratch and carried it through Meaningful Use Stage 3 certification in the same engagement, which meant the certification criteria shaped the architecture rather than being retrofitted onto it. The vendor went to market with a certified product their provider customers could use under Medicare reporting programs.
Read Case StudyDocumentation burden pulls clinicians away from patients, and dictation that has to be transcribed later does not solve it. We built a web-based platform that captures provider dictation, converts it to text in real time, summarizes it into structured notes, and supports downstream integration with EMR, billing and patient-facing systems. Providers using it complete documentation 70% faster.
Read Case StudyA cloud EHR vendor needed claim printing and submission working reliably at scale across their customer base. We delivered three claim submission paths within the cloud platform. The capability now serves more than 7,000 practices.
Read Case Study![]()
Nalashaa's team is an invaluable partner to us. They understood our challenges, questioned ideas, and refined features as product owners. Their approach gave us a smoother system, better coordination, and reliable support as we continue to work together.
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We have trusted the Nalashaa team with complex projects that our senior developers did not have the bandwidth to take on. They take time to understand requirements and approach estimates thoughtfully.
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Nalashaa delivers accurate project estimates from business requirements, and their code reviews reflect strong technical discipline. They have become an indispensable part of our development team.
Why Nalashaa
We do not build healthcare software alongside retail and fintech. Our engineers know why a result is coded in LOINC, what a certification criterion expects, and how a workflow decision surfaces months later inside a claim. It shows up in the questions we ask during discovery.
We have been through the testing, the attestations and the cycle after that one. The value to you is not the certificate on our side, it is knowing where products fail before yours does.
We scope in phases, with a written technical approach, dependency map and risk list from discovery onward. You know what you are committing to before you commit to it.
Audit trail patterns, access control models, conformance test harnesses and documentation templates carried across from earlier certification work. It cuts build time without cutting corners.
Epic, Cerner, Meditech, Athenahealth, Allscripts and eClinicalWorks, on patient, provider and payer-side systems. When we say a product will integrate, it is because we have done it against that system before.
We document as we build and hand over everything: code, architecture decisions, test suites and runbooks. You own the product, and you are not locked into us to keep it running.
There is no honest single answer, because the term covers a scheduling module and a certified EHR platform, and a range that fits both tells you nothing. What we can tell you is exactly what moves the number.
Book a Feasibility ReviewThere is no honest single answer, because the term covers a scheduling module and a certified EHR platform, and a range that fits both tells you nothing. What we can tell you is exactly what moves the number, so you can judge where your own project sits before anyone quotes you.
We start with a free feasibility review: a 45-minute call with our engineering team, followed by a written summary of scope, technical approach, integration and compliance dependencies, and the risks worth resolving first. You get that within five business days and there is no obligation to engage further.
Validating a new product idea, planning a certification cycle, or scaling a platform that has outgrown its architecture? Start with a feasibility review. A 45-minute call with our engineering team, followed by a written summary of scope, technical approach, integration and compliance dependencies, and the risks worth resolving first.
Book a feasibility review
It depends on product scope, integration count, regulatory requirements and data migration volume, which is why we scope before quoting rather than publishing ranges. A focused module and a certifiable EHR platform are different projects by an order of magnitude. Our free feasibility review produces a written scope and technical approach within five business days, which is the point at which a meaningful number becomes possible.
A first release covering core workflow and essential integrations typically takes months rather than weeks. Certification, data migration and device connectivity extend that. The variables that matter most are integration count and regulatory scope, both of which we assess during discovery so the timeline you get is based on your actual dependencies.
Yes. We have taken 15+ client EHR and EMR products through Meaningful Use Stage 2 and Stage 3 certification, in several cases building the product and certifying it in the same engagement. We handle criteria development, conformance preparation, work with your ONC-Authorized Certification Body, and the documentation the program requires. We also support the ongoing obligations after certification, including attestations and Real World Testing.
Yes. We work under Business Associate Agreements, maintain separated environments so production PHI does not reach development or test systems, use de-identified or synthetic test data by default, and apply role-based access with logged sessions where production data access is necessary. We hold ISO 27001:2022 certification and have maintained zero reportable HIPAA incidents across 15+ years of US healthcare delivery.
Yes, on any engagement where we create, receive, maintain or transmit protected health information on your behalf. The BAA defines permitted uses, safeguard obligations, breach notification duties and end-of-engagement data handling.
Through environment separation, de-identified or synthetic test data, BAA-governed access with role-based controls and logged sessions where production data is genuinely required, and time-limited credentials rather than standing access. The same secure development practices we build into the product apply to the delivery environment itself.
Risk classification determines the path. Lower-risk products may be exempt or follow a straightforward route, while higher-risk products need a premarket submission supported by design controls, risk management and verification and validation evidence. The important thing is establishing classification during discovery, because retrofitting that evidence onto a product built without it costs far more than building with it from the start.
Yes. Our teams have worked across Epic, Cerner, Meditech, Athenahealth, Allscripts and eClinicalWorks, on patient, provider and payer-side systems. Integration is handled as part of the build rather than as a separate phase. Our interoperability services page covers the standards and engines in detail.
Yes, and it is a large part of what we do. Modernization rarely means a rewrite. More often it means adding an API layer over a stable core, migrating modules incrementally, or re-engineering a specific constraint such as tenancy, scalability or a certification gap, while the existing product keeps serving customers.
Four. Discovery-led fixed scope for clear requirements and budget certainty. Dedicated team for ongoing work with shifting priorities. Staff augmentation when you have the capability but not the capacity. Outcome-based when the result is unambiguous, most often a certification or launch milestone.
You do. Ownership of the software we build for you transfers to you, and the specifics are set out in the engagement contract. We would encourage you to confirm this in writing with any development partner rather than assume it.
We provide L1 to L3 support, performance monitoring and tuning, release management, standards updates as versions advance, and ongoing enhancement. For certified products that also covers attestation cycles and Real World Testing obligations, which need someone tracking the regulatory calendar rather than reacting to it.
Start with the platform. It is cheaper, faster to deploy, and usually good enough. Custom becomes the better answer when your workflow is specialty-specific, when you are selling the software rather than using it, or when you need direct control of a certification or FDA path, because those obligations cannot be inherited from a platform vendor.
Mostly the terms are interchangeable, and firms offering medical software development services and healthcare software development services are usually describing the same work. Where a distinction is drawn, medical software tends to imply software closer to clinical care or regulated as a device, while healthcare software covers administrative and financial systems too. We build across both.
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