Regulatory & Security
Regulatory & Security
Navigating Healthcare Regulations, Protecting Patients
In today’s healthcare landscape, data security and regulatory compliance are critical. CitrusBits serves as your trusted ally, delivering secure, compliant solutions that empower you to focus on innovation and patient care. Our platforms are designed with uncompromising security, seamlessly integrating healthcare-specific regulations such as HIPAA, GDPR, and other global standards. This ensures your organization remains protected against evolving cyber threats.
At CitrusBits, we go beyond checkbox compliance. We embed healthcare security and regulatory adherence into every phase of design and development, leveraging advanced technology and proactive strategies. Our healthcare technology solutions not only meet but exceed the highest industry standards. By partnering with us, you gain more than a solution—you gain a dedicated ally committed to safeguarding your patients’ trust and enhancing your organization’s reputation in the healthcare sector.
Your Partner in Healthcare Regulatory and Security Solutions
Certified Compliance and Standards
CitrusBits adheres to globally recognized certifications and standards, ensuring that the healthcare solutions we develop are safe, effective, and compliant. Our commitment covers various healthcare compliance frameworks, including HIPAA, HITECH, CCPA, and GDPR for data privacy. We also maintain strict conformance with healthcare-specific standards such as FCC regulations, FDA 21 CFR Part 820, and the Medical Device Single Audit Program (MDSAP). Our expertise extends to international standards, including Health Canada Medical Device Regulations, CE Marking, TGA (Australia), ANVISA (Brazil), and MHLW (Japan). Our quality management practices are further validated by certifications like ISO 13485:2016 for quality management and IEC 60601 for medical electrical equipment, ensuring the highest standards of safety and performance.
Interoperability for Seamless Healthcare Integration
CitrusBits ensures seamless healthcare data exchange through advanced interoperability solutions. Our platforms are designed to support DICOM standards for medical imaging and HL7 FHIR standards for healthcare data exchange. We implement robust API integrations and MIRTH engine setup, ensuring consistent data flow across healthcare systems. These capabilities enhance connectivity, improve data accessibility, and support efficient patient care.
Platform Security and Data Protection in Healthcare
Security is at the core of our healthcare solutions. We provide end-to-end encryption for secure data transmission, robust cloud infrastructure security for safe data storage, and advanced authentication, authorization, and access control measures. Our proactive monitoring strategies help detect and mitigate security threats, ensuring the confidentiality, integrity, and availability of sensitive patient information.
Mature Healthcare Quality Management System (QMS)
Our Quality Management System (QMS) is specifically designed for healthcare, ensuring consistent compliance with regulatory standards while promoting continuous improvement. Our adaptable QMS aligns with ISO 14971 for risk management in medical devices and is tailored to meet specific client requirements. We focus on continuous quality enhancement to ensure patient safety and regulatory adherence.
Compliance and Conformance
CitrusBits is committed to excellence in healthcare technology development, supported by a robust compliance framework that ensures security, interoperability, and quality management. Our approach encompasses:
Privacy Compliance
Adherence to healthcare data privacy regulations, including HIPAA, HITECH, GDPR, and CCPA, ensuring the confidentiality and security of patient information.
International Healthcare Regulatory Standards
Compliance with FCC, FDA 21 CFR Part 820, MDSAP, Health Canada Medical Device Regulations, CE Marking, TGA (Australia), ANVISA (Brazil), and MHLW (Japan), demonstrating our global reach and expertise.
Certified Quality Management
Validation through ISO 13485:2016 for healthcare quality management, IEC 60601 for medical electrical equipment, and ISO 27001:2013 for information security management.
Healthcare Security Excellence
Advanced data encryption, TX-RAMP compliance, and OWASP ASVS adherence, providing robust protection for sensitive healthcare data.
CitrusBits is committed to excellence in healthcare technology development, supported by a robust compliance framework that ensures security, interoperability, and quality management. Our approach encompasses:
Our Healthcare Custom Software Development Process
Interoperability
Our healthcare platforms are designed for seamless data exchange, supporting DICOM standards for medical imaging and HL7 FHIR standards for health data sharing. We ensure secure, real-time connectivity across healthcare systems through advanced API integrations, enhancing patient care and streamlining workflows.
Security Excellence in Healthcare
CitrusBits prioritizes healthcare security at every level. Our solutions are built with advanced data encryption protocols, ensuring secure data transmission and storage. We maintain strict compliance with TX-RAMP and OWASP ASVS, providing robust protection against evolving cyber threats. Our ISO 27001:2013 certification for information security management further demonstrates our commitment to safeguarding healthcare data.
Mature Healthcare Quality Management System (QMS)
Our adaptable QMS is designed specifically for healthcare, ensuring consistent compliance with industry regulations. We align with ISO 14971 for risk management in medical devices and maintain continuous quality improvement, guaranteeing patient safety and regulatory adherence.
