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Regulatory & Security
Regulatory & Security
Navigating Regulations, Protecting Patients
In today’s healthcare landscape, where data security and regulatory compliance are non-negotiable, Citrusbits emerges as your trusted ally. Our solutions are built on a foundation of uncompromising security and compliance, seamlessly integrating HIPAA, GDPR, and other healthcare-specific regulations. This allows you to focus on innovation and patient care, confident that your data is protected against ever-evolving cyber threats.
At Citrusbits, we go beyond checkbox compliance by embedding security and regulatory adherence into every aspect of our design and development process. Our expert teams leverage cutting-edge technology and proactive strategies to ensure that your healthcare technology not only meets but exceeds the highest standards of security and innovation. With us, you’re not just gaining a solution—you’re partnering with a dedicated ally committed to safeguarding your patients’ trust and enhancing your organization’s reputation in the digital health era.
Your Partner in Regulatory and Security Solutions
Certified Compliance and Standards
Adhering to globally recognized certifications and standards to ensure the software and devices we build are safe, effective, and compliant.
Interoperability for Seamless Integration
Building for DICOM standards, HL7 FHIR standards, API integrations, and MIRTH engine setup for streamlined data flow.
Platform Security & Data Protection
Delivering end-to-end encryption, cloud infrastructure security, authentication and authorization, and data protection.
Mature Quality Management System (QMS)
Enhancing patient safety through consistent compliance with regulatory standards and continuous improvement in healthcare processes.
Compliance and Conformance
CitrusBits’ commitment to excellence in healthtech development is underscored by a comprehensive framework of standards that ensure compliance, security, interoperability, and quality management.
We adhere to a wide array of compliance standards, including FCC regulations, FDA 21 CFR Part 820, and the Medical Device Single Audit Program (MDSAP), along with international regulations such as Health Canada Medical Device Regulations and CE Marking.
Additionally, we comply with privacy laws like HIPAA, HITECH, CCPA, and GDPR, ensuring that patient data is handled with the utmost care across various jurisdictions including Australia (TGA Essential Principles), Brazil (ANVISA RDC 16/2013), and Japan (MHLW Ordinance No. 169). Our conformance to industry standards is demonstrated through certifications such as ISO 13485:2016 for quality management systems and IEC 60601 for medical electrical equipment, ensuring our products meet rigorous safety and performance benchmarks.
Our measures strictly adhere to data privacy regulations and industry best practices, ensuring the confidentiality, integrity, and availability of sensitive information.
Interoperability, Security and QMS
In terms of interoperability, we implement DICOM standards for medical imaging and HL7 FHIR standards for seamless healthcare data exchange, supported by robust API integrations.
Our security measures are stringent, featuring TX-RAMP compliance, OWASP ASVS adherence, and advanced data encryption protocols to safeguard sensitive information. Furthermore, we maintain an ISO 27001:2013 certification for information security management.
Our mature Quality Management System (QMS) is adaptable to specific customer processes and requirements, ensuring compliance with various regulations such as ISO 14971 for risk management in medical devices.
By embracing these standards, we not only enhance operational efficiency but also build trust with our clients and stakeholders in the healthcare ecosystem.
