Ensure Compliance with Seamless Regulatory Solutions

25+

Years of Global Experience

7+

Geographical Locations

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Employees

10000+

Projects Successfully Delivered

Comprehensive Regulatory Compliance Solutions in Australia

Navigating healthcare regulations can be challenging, but staying compliant is crucial. At smartData, we provide expert guidance to help you seamlessly manage complex regulatory requirements across Australia. Our expertise covers a wide range of standards, including HIPAA, CCDA, HL7, FHIR, PIPEDA, SNOMED, and more.

What makes smartData stand out? We go beyond basic compliance—we ensure your organization maintains the highest standards of care for both government-sponsored plans and private payers. Our team specializes in CCDA/HL7/QRDA/EDI file parsing, making data reporting and submissions smooth and hassle-free. We also assist in achieving essential certifications like PCMH and Meaningful Use, aligning with NCQA and CMS guidelines. With smartData, you can confidently meet evolving regulatory demands while enhancing patient care. Let us help you stay compliant, efficient, and ahead in the ever-changing healthcare landscape.

Stay Ahead with Expert Compliance Solutions

Clinical Care Compliance

Ensure uncompromised clinical care compliance with smartData. We specialize in adherence to healthcare regulations, ensuring that clinical practices meet all necessary standards and quality measures.

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Healthcare Interoperability Standards

Facilitate seamless healthcare communication with smartData's Healthcare Communication Platforms. Our solutions ensure secure and efficient information exchange, compliance with healthcare regulations, and improved patient-provider interactions.

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Healthcare Data Security and Privacy

Protect healthcare data with smartData's Healthcare Data Security and Privacy solutions. We specialize in safeguarding patient information, ensuring compliance with data protection regulations, and enhancing the overall security of healthcare systems.

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Regulatory Compliance Audits

Our experts conduct comprehensive audits to ensure that your healthcare business adheres to all regulatory standards, including HIPAA, FDA, and Medicare/Medicaid requirements. We examine your operations, documentation, and policies to identify compliance gaps and provide solutions to resolve them. These audits are critical for avoiding penalties, improving patient care, and maintaining a trusted reputation in the industry.

Risk Management and Mitigation

Healthcare providers face various risks, from patient data breaches to non-compliance with medical regulations. Our compliance experts help identify potential risks and develop strategies to mitigate them. Whether it’s through staff training, securing patient information, or streamlining workflows, we work closely with your team to reduce operational risks and protect both patients and your organization from legal and financial repercussions.

Clinical Trials Compliance

We help healthcare organizations and researchers navigate the complex regulatory landscape surrounding clinical trials. Our experts assist with compliance in the design, execution, and reporting phases of trials. We ensure adherence to local and international standards, including good clinical practice (GCP) guidelines, ensuring the integrity of your clinical data and the safety of trial participants.

Health IT and EHR Compliance

Electronic Health Records (EHR) systems are a key component in modern healthcare, but they must meet regulatory standards to ensure data privacy and security. Our experts help healthcare providers implement and maintain compliant EHR systems that adhere to HIPAA and other regulations. We support the setup, auditing, and ongoing compliance checks for EHR systems, ensuring that your practice’s data management processes are both efficient and secure.

Medical Device Regulatory Compliance

Our experts assist healthcare businesses in the medical device industry by ensuring their products meet local and international regulatory standards, including FDA regulations, CE marking, and other industry-specific requirements. We provide guidance on product testing, documentation, and certification, helping you bring your medical devices to market efficiently and without delay, while maintaining the highest standards of safety and compliance.

Ongoing Compliance Monitoring

Compliance doesn’t end after an audit or assessment. Our experts offer ongoing monitoring services to ensure that your business remains compliant as regulations evolve. We regularly review your operations, assess any new regulations that apply, and make adjustments to your compliance practices, so you don’t have to worry about falling behind.

Compliance Program Development

Developing a robust compliance program is essential for any business, and our experts are here to guide you through the process. We help create customized compliance programs that align with your business objectives while addressing the specific regulatory requirements of your industry. Our team develops policies, procedures, and protocols to establish a solid compliance framework that your organization can follow. With our expert guidance, you can build a program that promotes accountability and ensures ongoing compliance.

Faq's

Expert Regulatory Compliance Solutions for Your Business

Our team of regulatory compliance experts at smartData Inc. helps businesses navigate complex compliance requirements with ease. By offering tailored strategies, up-to-date knowledge, and industry-specific expertise, we ensure your business meets all regulatory standards and stays ahead of changes in laws. Our goal is to minimize risk, streamline operations, and safeguard your business against potential compliance issues.

Our experts provide personalized consultation to assess your business's current regulatory standing. They guide you through the required steps, ensuring that your processes and documentation are fully compliant with local and international regulations.

When working with our experts, you can expect thorough analysis, clear communication, and actionable solutions. They collaborate closely with your team to ensure seamless integration of compliance strategies into your business operations.

Our experts specialize in a wide range of industries, including healthcare, finance, technology, and manufacturing, ensuring that your business complies with the specific regulations of your sector.

Recent Portfolio Projects

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AI IoT based Holistic Wellness App

AI IoT based Holistic Wellness App

An intelligent hybrid of wearable technology, artificial intelligence (AI) through an algorithm based matching helps in selection of right health coaches who in turn help in creating the right health and wellness program . Algorithm feeds on users' health and wellness data through a HRA based questionnaire. Based on the responses, the AI-enabled engine creates a personalised health and wellness plan, along with a closest match with a fully qualified and accountable health coach.The coach validates and amends the plans to ensure the best results. The app also offers integration with popular fitness trackers, medical devices, and smartwatches that help users track their performance, nutrition, and get notifications for guided regimen adherence.

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Clinical Trials Registry Portal

Clinical Trials Registry Portal

A volunteer and researcher data management system that allows researchers to create research projects and get volunteers on board who are willing to be part of research projects. It assists the research institute and its medical researchers and clinicians to uncover the causes of diseases, finding better treatments and providing the best outcome for patients.

The developed solution collects data from volunteers who are willing to share details on their lung & respiratory conditions and sleep disorders for further analysis, clinical care & education. Collected data from volunteers is used for investigating the causes of disease, finding better treatments and translating it into new clinical practice. 

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Behavioural Telehealth Platform

Behavioural Telehealth Platform

Our platform bridges the gap between international workers and students and mental health professionals in their home countries. It offers a culturally sensitive approach to behavioral health by connecting individuals with therapists who understand their unique cultural backgrounds, communication styles, and specific needs. By addressing the challenges that often arise when seeking care abroad, such as language barriers and cultural mismatches, the platform ensures that users receive personalised, empathetic care from professionals they can trust. With seamless virtual consultations, users can access support anytime, regardless of geographic location, creating a supportive and familiar therapeutic environment. This service fosters mental well-being and resilience, making it easier for international communities to maintain strong connections with their home countries while navigating life abroad. 

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Clinical Trial Match MVP

Clinical Trial Match MVP

Clinical Match - helps matching patients to specific trials. Platform where patients, physicians, and principal investigators can come together for trial related education, matching, and physician-driven patient enrollment and retention. Also, assists to identify potential innovative new treatments to diseases and health conditions.

Features:

- Match patients with clinical trials
- Patient/ Participant/ Volunteer enrolment
- Patient CCD import
- Qualification process of patients
- Video conferencing and text chat
- Physician schedule management
- Patient encounters
- Principal investigator and its staff management
- HIPAA compliant

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Roster Management System Two

Roster Management System Two

This system will be used to provide home care to disable patients and provides a fast, easy-of-use, robust solution for the care providers and patient shifts management.

The National Disability Insurance Agency (NDIA) is an independent statutory agency and its role is to implement the National Disability Insurance Scheme (NDIS), which will support a better life for hundreds of thousands of Australians with a significant and permanent disability and their families and carers. NDIS provides grants to disabled patients to take home-care services which help to improve their lives.

We developed this system for the Home care service providers who provide daycare providers to NDIS-approved patients.

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Tele-health Ecommerce(Dermatalogy)

Tele-health Ecommerce(Dermatalogy)

The proposed solution aims to develop a Telehealth E-Commerce Platform that will enable patients to browse listed skincare products. Upon selecting a product and adding it to the cart, the system will prompt patients to register and complete combined questionnaire for intake and product related inputs e.g. few questions to collect their medical history, such as allergies, medications, and medical conditions and others product specific questions.
Once the questionnaire will be complete, the prescription request to be sent to the dermatologist for his review and the patient will be notified about the prescription request accordingly.

The proposed solution will not onboard other providers as of now, it has its own dermatologist to view prescription requests and he can approve or reject prescriptions requests.

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What our clients says about smartData

Gavin

Gavin

CEO and Founder
Peter

Peter

CEO and Founder
Jatin

Jatin

CEO and Founder
Ben

Ben

CEO and Founder
Kawasaki

Kawasaki

CEO and Founder

smartData Benefits

Global Talent Pool

We boast nearly 1,000 highly skilled developers strategically positioned across three offshore locations, enabling us to deliver world-class software solutions. 

Proven Track Record

With a proven track record of delivering over 10,000 diverse software applications worldwide, we have honed our expertise to perfection.

Worldwide Presence

smartData Enterprises boasts a robust global footprint, with a strong foothold in key regions such as the US, Australia, Europe, and Japan.

CMMI/ISO certifications and accreditation

smartData’s CMMI Level 3 and ISO 9001:2015 certifications showcase our commitment to quality and consistency, with a focus on client success. As we aim for CMMI Level 4, we’re driving greater efficiency and innovation.

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