Our Comprehensive FDA Compliance Service

Regulatory Consultation

Regulatory Consultation

HIPAA Privacy Rule is to safeguard patients’ sensitive health data by establishing guidelines that healthcare providers, health plans, and relevant entities must adhere to.

Validation and Verification

Validation and Verification

The HIPAA Security Rule serves as a safeguard against the growing threats to digital health data, including cyberattacks, unauthorized access, and data breaches.

Quality Management Systems Implementation

Quality Management Systems Implementation

This has two objectives: To notify individuals of potential breaches and to ensure that covered entities quickly address and mitigate such breaches.

Audit Preparation and Support

Audit Preparation and Support

HIPAA Omnibus Rule is to enhance the current privacy and security measures for patients’ health data, particularly with the growing use of electronic health records.

Benefits of FDA Compliance Software

FDA compliance software offers several benefits to organizations involved in the development and distribution of medical devices and healthcare software. Some of the key advantages include;

Patient Safety

Quality Assurance

Risk Mitigation

Enhanced Data Security

Streamlined Audits

Improved Traceability

Why We’re Your Greatest Fit

We don’t just deliver solutions we build partnerships that drive transformation. With a proven track record in healthcare technology, we understand the industry’s unique challenges and offer customized solutions to help you achieve breakthroughs.

Our Clients

A Glance of Our Work

Compliance-Driven Services!

Our developers are HIPAA certified and skilled in various healthcare regulations, including GDPR and HITECH. We create HIPAA-ready solutions, ensuring security and compliance with all necessary standards. Trust us to deliver robust, compliant healthcare software that protects patient data.

Our Partner Ecosystem

EHRs

API Platform

Wearables

Cloud

Most Popular Solution Accelerators

Save minimum 40% in development costs and build products in 55% less time with our advanced solution accelerators.

EHRConnect provides a robust API/SDK for effortless integration with major EHR systems such as EPIC and Cerner, ensuring secure data exchange with advanced authentication and authorization protocols. Its support for diverse FHIR endpoints enhances data interoperability, facilitating efficient communication.

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WearConnect is a wearable technology platform facilitating seamless integration between wearable devices and various applications, enhancing user experience and data accessibility. It enables efficient communication and data exchange, empowering users to leverage the full potential of their wearable devices.

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PHISecure is a comprehensive solution dedicated to safeguarding Protected Health Information (PHI) within healthcare systems, ensuring compliance with privacy regulations like HIPAA. Its advanced encryption and access control features offer robust security measures to prevent unauthorized access to sensitive patient data.

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SecureSphere provides a holistic infrastructure management solution, facilitating swift deployment within hours. It prioritises compliance, scalability, and high performance. Additionally, it seamlessly integrates advanced monitoring tools, underscoring a commitment to security and reliability throughout the infrastructure.

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Use Case Areas

Childcare

We offer custom, innovative, and scalable software solutions to streamline childcare management, improving care delivery and administrative efficiency.

We offer custom, innovative, and scalable software solutions to streamline childcare management, improving care delivery and administrative efficiency.

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Dental

We deliver advanced software solutions designed to enhance dental practices, improving patient care, appointment scheduling, and billing management.

We deliver advanced software solutions designed to enhance dental practices, improving patient care, appointment scheduling, and billing management.

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EHR & API Integrations

We provide integration solutions that enable seamless data exchange with EHRs and health systems using FHIR, HL7, and APIs for efficiency.

We provide integration solutions that enable seamless data exchange with EHRs and health systems using FHIR, HL7, and APIs for efficiency.

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e-Prescription

We deliver secure, custom-built e-prescription software to streamline the prescribing process, enhancing healthcare efficiency and accuracy.

We deliver secure, custom-built e-prescription software to streamline the prescribing process, enhancing healthcare efficiency and accuracy.

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Home Healthcare

We provide personalized software solutions for providers to improve patient care, reporting, and management efficiency.

We provide personalized software solutions for providers to improve patient care, reporting, and management efficiency.

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Digital Therapeutics

Develop software-driven therapies that support mental health, chronic disease management, and rehab care.

Develop software-driven therapies that support mental health, chronic disease management, and rehab care.

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Mental Health

We offer advanced technology solutions for mental health professionals to improve patient outcomes through integrated platforms.

We offer advanced technology solutions for mental health professionals to improve patient outcomes through integrated platforms.

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Nursing

We deliver software that optimizes nursing care workflows, enabling better management of tasks, schedules, and patient interactions.

We deliver software that optimizes nursing care workflows, enabling better management of tasks, schedules, and patient interactions.

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Rehabilitation

We provide technology-driven rehabilitation solutions to support providers in delivering efficient, personalized, and scalable care.

We provide technology-driven rehabilitation solutions to support providers in delivering efficient, personalized, and scalable care.

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Telemedicine

We build custom, scalable telemedicine solutions to facilitate secure, seamless remote healthcare consultations, improving access to care.

We build custom, scalable telemedicine solutions to facilitate secure, seamless remote healthcare consultations, improving access to care.

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Urgent Care

We deliver technology-driven, scalable solutions to improve patient management, scheduling, and communication for urgent care facilities.

We deliver technology-driven, scalable solutions to improve patient management, scheduling, and communication for urgent care facilities.

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Fitness

We help you develop custom fitness softwares that help users track their health, fitness goals, and progress, promoting better wellness outcomes.

We help you develop custom fitness softwares that help users track their health, fitness goals, and progress, promoting better wellness outcomes.

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Frequently Asked Questions

What is required for the software to be HIPAA compliant?

Building HIPAA-compliant software should include measures such as access authorization with the appropriate user roles and permissions, regular backups, encryption, and constraints on physical access.

Does HIPAA apply to health apps?

According to the Health Insurance Portability and Accountability Act (HIPAA), the Personal Health Record (PHR) includes almost all health applications that collect user data including apps that track mental health, medications, and fitness.

To what extent are the HIPAA privacy policies used by HIPAA-compliant organizations customized for the application?

It depends. Most policy documents are standardized, so there’s not going to be a ton that needs to be customized. But you must figure out which policies apply specifically to your business model in light of your internal circumstances.

How early should we designate a privacy compliance officer and HIPAA security officer?

As long as a compliance officer is described in one’s job description for an organization, then anyone in the company can work on ensuring a company meets its requirements for being HIPAA (Health Insurance Portability and Accountability Act) compliant. Read the detailed answer here.

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