HIPAA-Compliant Software Development: A Comprehensive Guide
Since 2005, ScienceSoft has been mastering medical software development to design and implement HIPAA-compliant healthcare software.
HIPAA compliance is compulsory for software that stores, processes, or transfers personal health information (PHI) and operates in the US market. The development of medical software according to HIPAA guidelines minimizes the risks of patient data loss, theft, alteration, and potential legal claims and financial reparations.
Time: From 4 months (e.g., for an MVP of a simple application for patient-doctor communication) to 12+ months for a full-fledged remote patient monitoring system.
Team: A project manager, a business analyst, a regulatory consultant, a solution architect, UI and UX designers, front-end and back-end developers, an information security specialist, a QA engineer, and a DevOps engineer.
Cost: Starts from $30,000 for a single-functionality mobile patient app without EHR integration (e.g., medication intake monitoring).
Specifics of a HIPAA-compliant development plan depend on the type of medical software and its functional scope. Below, we provide a generalized plan of HIPAA-compliant medical software development based on ScienceSoft’s 17 years of hands-on experience in the domain.
Step 1: Medical software requirements gathering, compliance requirements engineering and software planning
Duration: from 4 weeks.
- (When you outsource any project activities) Signing of a Business Associate Agreement with a consulting or development partner having access to PHI to ensure their legal obligation to follow HIPAA compliance guidelines on data security, encryption methods, security practices documentation, etc.
- (For product companies) Market and competitors research in the respective medical software niche, identification of target customers, software idea productization.
- (For healthcare organizations) Business needs analysis and elicitation of medical software requirements.
- Gathering compliance requirements for the HIPAA regulation and other applicable federal and local legal acts, standards, and guidelines of appropriate governmental agencies (FDA, FCC, etc.).
- Listing and prioritization of medical software features, outlining main user scenarios (e.g., for patients, doctors), splitting features into subscription plans (for medical software products).
- Designing the architecture and integrations of HIPAA-compliant software and selecting a fitting tech stack. Note: Cloud services in use should comply with HIPAA.
- (For medical software products) Planning configuration capabilities that allow users to modify certain software modules.
- Assessment of usage risks (e.g., potential software misuse) for HIPAA-compliant software and risk mitigation plan design.
- Signed Business Associate Agreement.
- Medical software feature list with traceability between user/business needs and the features.
- Software compliance specification with references to appropriate clauses of standards and regulations (HIPAA, CCPA, etc.).
- Software requirements specification.
- A high-level design of medical software architecture.
- Medical software usage risks description and a mitigation plan.
Step 2: HIPAA-compliant software project planning
Duration: from 2 weeks (may run simultaneously with step 1).
- Project scope identification.
- Choosing a development approach for HIPAA-compliant software.
- Assessment of software development risks (e.g., delays in the development).
- Budget planning.
- Project scheduling (planned development iterations, key milestones, etc.) and KPI planning.
- Budget plan.
- Project schedule and KPI plan.
- Mitigation plan for medical software development risks.
Best practice: ScienceSoft’s project managers plan Agile development (Scrum, Kanban, etc.) for complex medical software development projects to easily accommodate potential project scope changes in later project stages.
Step 3: Design of UX and UI for healthcare software
Duration: from 2 weeks.
- UX design – to visualize key software functionality in the identified user scenarios and plan convenient journeys for medical software users (patients, medical specialists, admins). The user journeys are planned taking into consideration HIPAA compliance and security measures like user session timeout, emergency access to patients’ data, software access control, etc.
- UI prototyping – to visualize software look for different user groups.
- UI design – to create graphic interface elements of healthcare software according to the defined visual accessibility requirements.
- UX wireframes.
- User interface design documentation (all screens, assets, and source files).
Best practice: If a customer needs to cut the healthcare software development time, ScienceSoft launches the UX and UI design stage simultaneously with the software project planning stage.
Step 4: Medical software development
Duration: from 2-6 months for an MVP.
- Back-end software development – to develop the server side of the application and APIs with a focus on PHI security.
- Front-end development of healthcare software – to transform UI design elements into a functioning user side.
- Testing – to detect and fix medical software defects, check software against its functional requirements, verify software stability, security, and HIPAA compliance, validate usability and accessibility for target users.
- Developed software.
- Detailed architecture design.
- Application’s source code.
- Test documentation.
Best practice: ScienceSoft usually starts with creating an MVP for HIPAA-compliant software to quickly present core software functionality with a simple UI design. It allows getting early stakeholder or market feedback on software and adding new features to it based on the feedback analysis.
Step 5: Pre-launch activities and medical software launch
Duration: from 1 week.
- Revision of HIPAA-compliant software usage risks – to identify new usage risks, address them, and update the risk mitigation plan.
- Revision of HIPAA-compliant software documentation – to check if any medical software requirements changed during the development process and update software documentation to ensure documentation cohesiveness for future HIPAA compliance audits.
- Software compliance check according to relevant medical standards (e.g., IEC 82304-1:2016 for software integrated with smart medical devices or sensors).
- Pilot rollout of medical software for a focus group – to present the fully developed app to the focus group (e.g., a group of patients in a hospital), evaluate their satisfaction with the app, get their feedback, and adjust software accordingly.
- Launch of HIPAA-compliant software.
- Deployed medical software.
- Revised healthcare software documentation.
- App setup guide, admin guide, support guide, user guide (for all user groups).
Step 6: Healthcare software maintenance, audit, and evolution
- Medical software support and maintenance – to fix revealed defects, implement security patches, resolve incidents, and ensure uninterrupted work of medical software.
- HIPAA compliance and security audits – to regularly verify medical software and its infrastructure for HIPAA compliance, check PHI security, etc.
- Evolution of medical software – to implement new medical software features according to user feedback.
With over 17 years of hands-on experience in medical IT, ScienceSoft offers end-to-end HIPAA-compliant software consulting and development services.
HIPAA-compliant software consulting
- Healthcare software concept design.
- Development and launch plan for HIPAA-compliant software.
- High-level architecture and integrations design for healthcare software and tech stack selection.
- HIPAA compliance guidelines tailored to your healthcare software specifics.
- Estimation of costs, ROI, and a payback period for your HIPAA-compliant software development project.
Outsourcing of HIPAA-compliant software development
- Creating a concept of HIPAA-compliant software.
- A comprehensive feature set for medical software.
- UX and UI software design.
- Healthcare software development according to the chosen approach to software development (e.g., Agile).
- QA with a focus on security and HIPAA compliance requirements.
- Collection of all required documents for HIPAA compliance audit.
- Healthcare software maintenance, support, and evolution.
- HIPAA compliance audits upon the agreed schedule.
– plans a healthcare software development project, assigns tasks to a project team, supervises the project delivery (including timing and budget), assesses project risks and provides solutions to mitigate them, and facilitates team communication and cooperation.
– elicits medical software requirements and identifies tech limitations, creates the software concept and specification, analyzes healthcare software usage risks, designs software features, defines necessary app integrations with other software (e.g., EHR).
– chooses a HIPAA-compliant technological stack, plans a healthcare software architecture taking into account compliance with HIPAA and other regulations.
Regulatory consultant for HIPAA compliance
– advises on healthcare software architecture components, tech stack, development process, and project documentation management to ensure compliance with HIPAA and other relevant laws and standards.
– conducts UX research and identifies user scenarios, designs experiences of software users (patients, hospital supervisors, etc.) and interactions with software with a focus on usability and accessibility, creates UX prototypes.
– designs an appealing visual interface of healthcare software.
– creates the business logic and the server side of healthcare software with a focus on security and HIPAA compliance.
– develops the user side of healthcare software.
– plans a test strategy, creates and executes test cases, reports medical software defects and vulnerabilities.
Information security specialist
– creates security testing scenarios for HIPAA-compliant software and conducts security testing.
– sets up and maintains medical software development infrastructure, establishes CI/CD pipelines for automated software deployment, selects and configures tools to execute daily monitoring of HIPAA-compliant software, etc.
100% in-house HIPAA-compliant software development
Pros: Full control over the medical software development project.
Cons: High risks of HIPAA compliance and quality issues due to the lack of expertise with regulatory requirements, risk of project delays due to lack of resources and technical capabilities.
A mix of in-house and outsourced consultancy and development
Pros: Access to necessary technical capabilities, highly qualified specialists in HIPAA-compliant software development, opportunity to scale up or down the resources when needed.
Cons: Need for management of the outsourced resources and fast establishment of the communication process with the outsourced team.
Fully outsourced HIPAA-compliant software development process
Pros: Full responsibility for healthcare project management, delivery, and HIPAA compliance lies on the vendor.
Cons: High vendor dependency.
HIPAA-Compliant Clouds We Recommend for Medical Software Development
A cloud that meets all HIPAA requirements is a must in healthcare software development. In the majority of medical projects, ScienceSoft uses the following HIPAA-compliant clouds to ensure data security and integrity.
Best for: hybrid cloud and IoMT
- Cost-effective software development due to a wide array of HIPAA-compliant cloud services (for telehealth, PHI storage, IoMT device management, analytics, data sharing, etc.).
- A Leader in Gartner’s Infrastructure & Platform Services Magic Quadrant for 10 consecutive years.
Best for: IoMT and machine learning
- HIPAA compliance is ensured by the ISO/IEC 27001 certification.
- Offers HIPAA-compliant services for PHI storage, data management, IoMT, etc.
- 2nd place in Gartner Magic Quadrant for Cloud Infrastructure and Platform Services.
Google Cloud Platform
Best for: highly variable software load
- 90+ HIPAA-compliant cloud services for software development.
- 3rd place in the Gartner Magic Quadrant for Cloud Infrastructure and Platform Services.
HIPAA-compliant software development costs vary depending on a solution's functionality. For example, a mobile patient app (e.g., for medication intake monitoring) without EHR integration costs from $30,000, telemedicine software usually costs from $150,000 – $250,000, and costs for a custom EHR system start from $400,000. The costs do not include regular license fees for cloud services.
From ScienceSoft’s experience, each medical software project has specific tech requirements and limitations, so the cost factors vary from customer to customer. Here, we outline general cost factors for HIPAA-compliant software.
Core cost factors
- Medical software functionality scope (e.g., hospital asset tracking, patient rehabilitation).
- Number and complexity of features (e.g., IoT integrations will increase the cost).
- Healthcare software type (web, mobile, desktop).
- Supported mobile platforms (iOS, Android).
- Number of user roles (e.g., patients, doctors, administrators).
- Software scalability needs.
- Medical software performance requirements.
Integration cost factors
- Software integration with remote patient monitoring devices or tracking tags.
- Number and complexity of integrations with medical IT systems (EHR, practice management system, procurement software, etc.).
Operational cost factors
- Necessary data storage capacity.
- License fees for cloud services or ready-made components of HIPAA-compliant software (e.g., data analytics services, messaging services).
- Healthcare software maintenance services.
ScienceSoft is an IT consulting and software development vendor headquartered in McKinney, Texas, US. Being ISO 13485 certified, we design and develop medical software according to the requirements of the FDA and the Council of the European Union and ensure software compliance with HIPAA and HITECH regulations.