Here are five companies that build HIPAA-compliant software for healthcare, what each one fits best, and the questions that separate them when every proposal claims compliance.
The security review for a patient-facing app that reads from the electronic health record (EHR) and submits prior authorization requests usually opens with one question: “Are you HIPAA-compliant?” While vendors on the shortlist may say yes, the question that decides the outcome comes after launch, when protected health information (PHI) moves through the EHR connection, the payer connection, and every subcontractor in between.
According to IBM’s 2026 Cost of a Data Breach Report, healthcare breaches cost an average of $6.64 million, the highest of any industry for the 15th consecutive year. Custom healthcare software development is where many of those exposures begin because every new integration adds another system that handles PHI.
Key takeaways
- The five companies below can all deliver custom healthcare software development that meets HIPAA requirements. The right choice depends on the type of build and who will operate it after launch
- A "HIPAA-compliant" label carries no regulatory weight because the Department of Health and Human Services (HHS) doesn’t endorse or recognize private certifications under the Security Rule
- The compliance bar for custom healthcare software development is rising in three places at once. Centers for Medicare & Medicaid Services (CMS) prior authorization application programming interfaces (APIs), a proposed HIPAA Security Rule update, and state consumer health data laws are all moving together
- Encryption remains a visible gap, with only 37% of breached organizations encrypting sensitive data both at rest and in transit
IN THIS ARTICLE
Which companies build HIPAA-compliant software for healthcare
We have listed five companies that build HIPAA-compliant software for healthcare: Wizeline, Andersen, Itransition, Kanda Software, and ScienceSoft. Each has a different delivery model and area of healthcare specialization.
Company
Best fit
Healthcare focus
Delivery model
Wizeline
AI-embedded clinical and operational systems
Telehealth, virtual care, and patient data security
Nearshore Agentic Pods that build and stay through support
Andersen
Broad healthcare portfolios
Providers, payers, pharmacies, and contract research organizations (CROs)
Full-cycle development teams
Itransition
Choosing between custom and platform-based builds
Healthcare CRM, patient portals, telemedicine
Custom or platform-based implementation
Kanda Software
Healthcare product companies
Clinical applications and medical device software
US-based project leadership with global engineering
ScienceSoft
Regulated medical device software and software as a medical device (SaMD)
Medical device and care delivery software
Full-cycle development with in-house regulatory consultants
Wizeline
Best fit
AI-embedded clinical and operational systems
Healthcare focus
Telehealth, virtual care, and patient data security
Delivery model
Nearshore Agentic Pods that build and stay through support
Andersen
Best fit
Broad healthcare portfolios
Healthcare focus
Providers, payers, pharmacies, and contract research organizations (CROs)
Delivery model
Full-cycle development teams
Itransition
Best fit
Choosing between custom and platform-based builds
Healthcare focus
Healthcare CRM, patient portals, telemedicine
Delivery model
Custom or platform-based implementation
Kanda Software
Best fit
Healthcare product companies
Healthcare focus
Clinical applications and medical device software
Delivery model
US-based project leadership with global engineering
ScienceSoft
Best fit
Regulated medical device software and software as a medical device (SaMD)
Healthcare focus
Medical device and care delivery software
Delivery model
Full-cycle development with in-house regulatory consultants
Wizeline
Wizeline, a technology services company founded in Guadalajara and San Francisco, builds custom AI systems for healthcare and life sciences through its Healthcare^AI practice. The work centers on the workflows where protected health information (PHI) moves most: prior authorization automation connected to existing EHR and payer systems, revenue cycle management (RCM) AI inside billing and coding, and care coordination that triages patient inquiries, routes cases, and summarizes interactions for physicians while clinicians keep the oversight roles. It also covers telehealth and virtual care platforms and data security controls designed around patient privacy requirements.
Delivery runs through Agentic Pods, cross-functional teams of engineers, QA, product, and data specialists working with AI agents embedded in their workflow, so human judgment stays on decisions that carry clinical or financial risk. The teams work nearshore from Mexico, Colombia, Argentina, and Romania with overlapping US business hours, and they build inside the EHR and cloud tools a client already runs instead of standing up a parallel stack. That matters for compliance because every added platform is another place PHI lives and another party to account for. Wizeline also holds an AWS AI Services Competency with both agentic AI and generative AI specializations.
For the telehealth startup MiSalud, Wizeline acted as an end-to-end design strategy, research, experience design, and engineering partner. The cross-functional team built the service blueprint and provided the security consulting and engineering needed to support HIPAA, SOC 2, and HITRUST requirements. The platform launched on Google Play in October 2021, and Wizeline continues to work on new features with MiSalud.
Best fit: Organizations that want one nearshore team to build AI-embedded healthcare systems inside their existing EHR and cloud tools and stay accountable after launch
Ask them: How documentation, access, and operational ownership are handled if you later change vendors.
Andersen
Andersen provides healthcare software development services for providers, payers, pharmacies, and CROs. Its work spans EHR and electronic medical record (EMR) systems, telehealth, and remote patient monitoring. It also builds Picture Archiving and Communication System (PACS) and Digital Imaging and Communications in Medicine (DICOM) software, plus medical device software.
Best fit: Organizations with several healthcare products or business lines that want one vendor across them
Ask them: Which team members carry over between projects
Itransition
Itransition cites more than 25 years in healthcare IT and builds healthcare CRM, patient portal, and telemedicine software. It offers two routes: custom development, or the Itransition Healthcare Platform, its own product for electronic health records, telehealth, and practice management. Because it owns the platform and does the implementation, the chain of parties handling PHI is shorter, but the buyer’s roadmap depends on one vendor’s product.
Best fit: Buyers still deciding whether a platform or a custom build suits their workflows
Ask them: How compliance controls differ between the two approaches for your use case
Kanda Software
Kanda Software integrates custom builds with the EHR platforms most health systems already run, including Epic, Cerner, Meditech, and Allscripts. It pairs US-based project leadership with global engineering talent, and the technical staff on its healthcare projects have completed HIPAA compliance training.
Best fit: Healthcare product companies that want US-based project management
Ask them: Where engineers who touch PHI are located and how access is controlled
ScienceSoft
ScienceSoft holds ISO 13485, the quality management standard for medical device software, along with ISO 27001 and ISO 9001, and has prepared software for FDA clearance and CE marking, which suits regulated device and SaMD work. It also sells HIPAA consulting as a standalone service, with a PHI security risk assessment, a risk mitigation plan, and, for software companies, an assessment of the development infrastructure against HIPAA requirements.
Best fit: Medical device companies and SaMD builds that need ISO 13485 processes
Ask them: Which regulatory consultants join your project, and at what stage
How to choose a custom healthcare software development company
Choose a custom healthcare software development company by testing whether it can back its answers to four specific questions with evidence, not by trusting a compliance label alone.
- Ask where PHI will travel, including every subcontractor, cloud service, and AI tool under the business associate agreement (BAA)
- Ask how encryption, multi-factor authentication, and asset inventory are handled today
- Ask for a shipped system running under HIPAA requirements, with a reference you can call
- Ask who operates the system after launch, and put that answer in the statement of work
No government body certifies software vendors, and HHS states in its Security Rule guidance that it doesn’t recognize private HIPAA certifications.
Legal accountability comes from the business associate relationship. Under HHS business associate guidance, any vendor that handles PHI on your behalf is a business associate, and so is each subcontractor it passes that PHI to.
Compliance depends on what happens to PHI after launch: how it moves through integrations, subcontractors, and the people operating the system. A vendor evaluated only on the code it delivers leaves most of the exposure unexamined.
The bottom line
All five companies can deliver custom healthcare software development that meets HIPAA requirements. So when deciding, the key question is who will remain accountable for PHI once the system is live, across every integration and subcontractor.
Regulated-device specialists, broad full-cycle vendors, and platform implementers each approach that responsibility differently. Wizeline answers it with one nearshore team that builds Healthcare^AI systems inside the EHR, payer, and cloud tools clients already use and stays through production support.
If your healthcare plans depend on new integrations but your vendors can only show you a compliance badge, the operating model is usually the gap, and it’s worth a conversation.
Frequently asked questions
Is there an official HIPAA certification for software vendors?
HHS doesn’t issue or recognize HIPAA certifications for vendors or software. SOC 2 reports and HITRUST certification are useful evidence of controls, but they don’t transfer compliance responsibility.
Does a software development company need to sign a BAA?
A BAA is generally required when the company creates, receives, maintains, or transmits PHI on your behalf. Each subcontractor handling that PHI needs its own BAA with the vendor.
Should we choose custom medical software development or an off-the-shelf HIPAA-ready platform?
Off-the-shelf platforms arrive with controls in place but can limit workflow fit. Custom builds can fit the workflow more closely but put control design and implementation responsibilities on the build team and the healthcare organization. Many organizations combine the two.
