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How to Develop a Healthcare App

A Step-by-Step Guide

As an ISO 13485-certified provider, ScienceSoft has been delivering medical software that improves hospital workflows, care management, and patient experience since 2005.

How to Develop a Healthcare App - ScienceSoft
How to Develop a Healthcare App - ScienceSoft

Healthcare Software Development in Brief

Healthcare software development implies designing, architecting, coding, and supporting healthcare administration systems, patient apps, solutions for care management, and other clinical tools.

Healthcare app key development steps

  1. Engineer functional and compliance requirements.
  2. Plan a compliance framework (HIPAA, GDPR, etc.) for sensitive data regulation within the SDLC.
  3. Plan milestones, budget, and risks.
  4. Design a secure architecture.
  5. Determine user personas and design an accessible UI.
  6. Build a minimum viable product (MVP).
  7. Get FDA approval (for medical devices or SaMD).
  8. Perform post-market monitoring and maintenance.

The development process may take from 4 months for an MVP of a simple mobile application (e.g., a patient-doctor communication or medication intake monitoring app) to 12+ months for a full-fledged solution like a remote patient monitoring system.

The costs of custom healthcare app development may range from $40,000 to $2,000,000. The exact pricing will depend on software type, complexity, user roles, platform specifics, etc.

Explore the Diversity of Healthcare Software

Healthcare applications cater to the needs of healthcare organizations, medical professionals, and patients. Below are some of the solutions ScienceSoft delivers:

Health App Development Plan

The specifics of the medical software development process will depend on the app's purpose. This is a generalized plan elaborated by ScienceSoft's healthcare IT consultants based on our 19 years of experience in the field.

1.

Conceptualization and requirements engineering

From 4 weeks; stages 1–3 can run in parallel.

This stage involves defining the software concept and analyzing the market and target audience (for software products). If you are a healthcare startup, you need to set your app apart from competitors to survive and attract investment. So, it would help if you found a niche related to a specific care type or patient group (e.g., easy-to-use apps for geriatric patients).

The next step is to identify the main features to be implemented. Common prioritizing methods, such as the Must, Should, Could, and Won’t (MoSCoW) method, KANO model, or value vs. effort, can help. The SRS should include non-functional requirements for security such as encryption, access controls, and audit trails.

At this stage, it’s also essential to define the regulatory requirements the software must comply with. If it will be used in the US, HIPAA compliance is a must as nearly all healthcare software deals with personal health information (PHI). Software for medical devices or SaMD additionally requires FDA approval.

ScienceSoft

ScienceSoft

2.

Project planning

From 2 weeks

The project plan outlines the budget, resource allocation, timelines, and deliverables. It’s important to allocate substantial time to testing and schedule regular compliance checks and code reviews. Prepare your team to maintain detailed documentation of the development process and create a risk mitigation plan.

ScienceSoft

ScienceSoft

3.

Architecture design

From 4 weeks

When designing the architecture, evaluate the potential options in terms of how well they meet the performance, scalability, security, and other requirements for the software. Most common evaluation approaches, like the architecture tradeoff analysis method (ATAM), might be effort-consuming. So, lightweight methods such as active reviews of intermediate designs (ARID) or pattern-based architecture review (PBAR) can be chosen. ARID, for example, can be used to ensure HIPAA compliance by identifying any potential privacy or security risks early on. With PBAR, the software architecture can be assessed for alignment with the healthcare industry standards.

Integrations are another essential part of architecture design. While this step depends on project specifics, healthcare apps are often integrated with EHR, CRM, PACS, LIS, billing systems, telemedicine platforms, and other software used by providers. For high software interoperability, uniform data exchange standards such as HL7, FHIR, and DICOM should be supported.

ScienceSoft

ScienceSoft

4.

UX and UI design

From 4 weeks

The UX/UI design must be developed to meet the needs of users, in accordance with their user roles (patients, medical staff, etc.) and corresponding user scenarios (e.g., patients can book an appointment or manage medications, doctors can access patients’ medical data, materials managers can order supplies).

It’s crucial to ensure usability for every user role. For example, for the patient interface, possible physical and cognitive restrictions should be considered to adapt the app to cope with them. This can be achieved by using high color contrast, large font sizes, text-to-speech, etc. Intuitive navigation can significantly enhance user engagement. Importantly, there should be easy-to-digest consent forms and a privacy policy for patients outlining data access and usage details to ensure regulatory compliance.

ScienceSoft

ScienceSoft

5.

Development and testing

2–6 months

It’s better to start with developing a minimum viable product (MVP), as it allows you to benefit from an early software launch and quickly adapt the software to user feedback.

Rigorous testing (often in parallel with development) is required to ensure the high quality of the software:

  • Performance testing helps ensure the app can handle stress conditions (e.g., an increased number of users).

  • Integration testing verifies that healthcare software modules or applications (e.g., EHR, patient apps, medical devices, imaging and lab software, etc.) work together smoothly.

  • Security testing is essential to guarantee data protection.

  • Functional testing confirms that the app works exactly as planned (e.g., prescriptions are filled correctly, insurance claims are processed, etc.).

  • Compliance testing verifies the software's adherence to regulatory standards such as HIPAA, IEC 62304, and FDA requirements.

  • Accessibility testing helps ensure usability for different user groups, including individuals with disabilities.

ScienceSoft

ScienceSoft

6.

Pre-launch activities and release

From 1 week to 6+ months

The last stage before the release requires revising the project documentation for consistency and conducting a HIPAA compliance assessment or GDPR compliance audit. In the case of software for medical devices or SaMD, you will also need to submit your product to FDA/MDR. Low-to-moderate-risk devices (e.g., software connected to a glucose monitor) only need premarket notification, while high-risk devices (e.g., medical diagnosis software) undergo premarket approval. Lastly, make sure to carry out the final review of security controls and draw up an incident response plan before launching the app.

ScienceSoft

ScienceSoft

7.

Post-launch activities

Continuous

After releasing the app, it’s important to help the end users incorporate it into their routines. Successful adoption hinges on comprehensive user training and responsive software support, especially during the first few months after launch. It’s advisable to get user feedback to identify major concerns, which can be used to map out the app's next version. With time, software can also be updated to include new functionality. For example, AI can be used for intelligent diagnosing and treatment plan generation, as well as to enhance patient experience with the help of chatbots or virtual assistants.

ScienceSoft

ScienceSoft

Successfully Developed Healthcare Apps

What Our Customers Say About ScienceSoft’s Healthcare Software Development

Our project required a large amount of industry-specific methodology and algorithms to be implemented into our new software connected to EHR/LIS systems, which the team handled well. They are reliable, thorough, smart, available, extremely good communicators, and very friendly.

I’ve had six orthopedic surgeries since playing college football and tried every major digital exercise therapy platform on the market. None of them offer the comprehensive and personalized care they claim. Thanks to ScienceSoft’s practical healthcare IT expertise, we created a musculoskeletal therapy platform that can be fully customized and reflect the needs of each program member.

The team’s flexibility is beyond praise, as any time we brought up new ideas, they quickly adapted to our changing requirements. We also appreciate ScienceSoft’s efforts to reduce the project costs and meet our tight relaunch schedule. They worked expeditiously and even prepared market promotion strategies, proving to us that they cared about TriadXP’s success as much as we did.

During the project flow we were very pleased by the work of ScienceSoft’s business analysts and developers, who demonstrated high level of skills and competence. They made many significant contributions to our products both in terms of functionality and quality. We would definitely recommend ScienceSoft as skilled and trustworthy consulting and development partner.

About ScienceSoft

  • 35 years in software development and 19 years in healthcare IT.
  • 150+ successful healthcare IT projects.
  • ISO 13485, ISO 9001, and ISO 27001 certificates.
  • Hands-on experience with HIPAA, GDPR, FDA, ONC, MDR, SAMHSA, CEHRT, and SAFER regulations.
  • Proficiency in healthcare standards such as HL7, ICD-10, LOINC, CPT, XDS/XDS-I, FHIR, DICOM, Blue Button+, CDA, and CCD.
  • 3-year champion in the Financial Times' rating of Americas’ fastest-growing companies.
  • #1 in Healthcare Software Development, according to the Black Book™ 2023 market survey.
  • 2023 North American Enabling Technology Leadership Award in the medical devices connectivity industry from Frost & Sullivan.
  • Ranked 3rd in the Top Health & Fitness App Development Companies & Healthcare App Developers list compiled by TopDevelopers in 2022.

Sourcing Models for Healthcare Software Development

Technologies ScienceSoft Is Experienced In

Healthcare App Development Costs

Below are some software cost factors to be considered:

  • Scope and software type (telemedicine, RPM, EHR, etc.).
  • Platform (e.g., web, mobile, desktop).
  • Number of user roles (patients, doctors, nurses, etc.) and the expected number of users.
  • Integrations (e.g., with EHR, wearables, etc.).
  • Regulatory compliance requirements (HIPAA, GDPR, FDA requirements, etc.).
  • Performance, security, usability, and accessibility requirements.
  • Required software maturity (an MVP or a fully-featured solution).
  • Sourcing model (in-house vs. outsourcing).

The cost of custom healthcare app development varies from $40,000 for a simple mobile patient app (e.g., medication intake reminder) to $2,000,000+ for a complex EHR system with diverse functionality. Below are some sample cost ranges for popular software types:

From $40,000 to $300,000

for a patient app

From $200,000 to $400,000

for telemedicine software

From $200,000 to $400,000

for remote patient monitoring or medical device software

From $300,000 to $800,000

for a digital therapeutics solution

From $400,000 to $2,000,000+

for EHR software

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Ready to Develop a Healthcare App?

As an ISO 13485-certified technology partner, ScienceSoft delivers secure and compliant medical software for patients, doctors, and hospital staff.