Leading provider of secure, open-source healthcare IT systems, FHIR interoperability, and CDC DIBBs implementations for data-driven disease surveillance and outbreak response.
Empowering public health agencies with secure, open-source healthcare IT infrastructure and interoperable data systems.
We partner with public health agencies to deploy, secure, and maintain critical healthcare information systems. Our expertise in open-source solutions ensures cost-effective, compliant, and interoperable healthcare data infrastructure.
Expert implementation of Fast Healthcare Interoperability Resources (FHIR) standards for seamless health data exchange. We ensure your systems comply with HL7 FHIR specifications for modern healthcare interoperability.
Enable secure, standards-based communication between Electronic Health Record (EHR) systems. We implement open APIs, data exchange protocols, and integration frameworks that ensure your health data flows securely across platforms.
Secure, HIPAA-compliant REDCap (Research Electronic Data Capture) hosting for public health research and data collection. We handle installation, configuration, maintenance, backups, and security hardening of your REDCap instances.
Deployment and customization of open-source healthcare solutions including OpenMRS, GNU Health, OpenEMR, and other FHIR-compliant systems. Cost-effective alternatives to proprietary healthcare IT systems.
Comprehensive security assessments and hardening for healthcare systems. We ensure your infrastructure meets HIPAA, HITECH, and other healthcare-specific regulatory requirements while maintaining data integrity and confidentiality.
Build secure Health Information Exchange networks for regional health data sharing. We implement standards-based HIE infrastructure enabling public health agencies to aggregate, analyze, and share critical health data.
Real-world implementations of CDC's Data Integration Building Blocks for public health data modernization.
Problem: Public health agencies receiving data in multiple incompatible formats, requiring manual data transformation.
Solution: Deployed CDC DIBBs FHIR Converter to automatically transform incoming eCR, ELR, and VXU messages into standardized FHIR format, with automated geocoding and record linkage.
✓ Results: 70% reduction in manual data processing time, improved data quality, and real-time case surveillance capabilities.
Problem: Public health staff spending hours on phone calls and faxes to collect patient health information from healthcare organizations.
Solution: Implemented DIBBs Query Connector with TEFCA QHIN integration, enabling direct FHIR-based queries to healthcare networks for case investigations.
✓ Results: Reduced case investigation time from days to minutes, improved data completeness, and enhanced outbreak response capabilities.
Problem: Electronic Case Reports (eCR) containing entire medical records, making it difficult for public health staff to find relevant case information.
Solution: Deployed DIBBs eCR Refiner and eCR Viewer integrated directly into NEDSS Base System (NBS) to present condensed, disease-specific data views.
✓ Results: Increased eCR adoption rates, improved user satisfaction, and faster case processing times across multiple jurisdictions.
Problem: Manual execution of multiple data processing steps creating bottlenecks and errors in public health surveillance workflows.
Solution: Implemented DIBBs Orchestration service to coordinate automated execution of FHIR conversion, geocoding, record linkage, and data routing in customized sequences.
✓ Results: Fully automated end-to-end data pipelines, 80% reduction in processing errors, and ability to handle 10x data volume during outbreak responses.
Comprehensive cybersecurity solutions tailored for government and non-profit healthcare organizations.
As a non-profit organization, our mission is to enhance security posture regardless of client size or resources.
We provide affordable cybersecurity services tailored to limited budgets and complex regulatory environments.
Ensuring compliance with relevant industry standards and legal requirements for government and non-profit sectors.
Knowledge sharing initiatives, training programs, and awareness campaigns to promote cybersecurity culture.
We employ cutting-edge methodologies and advanced tools to simulate real-world attacks on networks, applications, and infrastructure. Identify vulnerabilities and develop effective strategies to mitigate risks proactively.
Comprehensive security hardening services to assess existing measures, analyze potential weaknesses, and implement robust controls using industry best practices.
Thorough evaluation of your security posture with detailed reports and actionable recommendations to fortify your organization against cyber threats.
Rapid response to security incidents with expert forensics and remediation strategies to minimize damage and restore operations quickly.
Securing data, applications, and infrastructure in cloud environments while ensuring confidentiality, integrity, and availability.
Guidance on PCI DSS, HIPAA, SWIFT, and other regulatory requirements to ensure your organization meets all necessary security standards.
Expert implementation of FDA regulations for electronic records and electronic signatures in healthcare systems.
Title 21 CFR Part 11 establishes FDA regulations on electronic records and electronic signatures (ERES). It defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. This regulation applies to pharmaceutical companies, medical device manufacturers, biotech companies, biologics developers, and clinical research organizations.
Complete validation of electronic systems to ensure accuracy, reliability, and compliance with FDA requirements. We provide documented evidence that systems consistently perform as intended throughout their lifecycle.
Deploy comprehensive audit trail systems that track all record creation, modification, and deletion activities. Secure, computer-generated time-stamped audit trails that cannot be altered or disabled by users.
Implement secure electronic signature systems with multi-factor authentication, unique user IDs, and biometric controls. Ensure signatures are legally binding and linked to their respective records.
Establish role-based access controls, user authentication systems, and authority checks to limit system access to authorized individuals. Implement password management and session controls.
Develop comprehensive Standard Operating Procedures (SOPs) governing electronic record and signature processes. Create validation documentation, training materials, and compliance reports.
Design and deliver training programs to ensure all personnel understand Part 11 requirements, system capabilities, and their responsibilities. Maintain training records and competency assessments.
Systems must be validated to ensure they perform as intended and maintain data integrity throughout their operational lifecycle.
Computer-generated, time-stamped audit trails that independently record date, time, and operator information for all record activities.
Physical and logical security measures to prevent unauthorized access, ensure data integrity, and maintain system availability.
Electronic signatures must be unique, verifiable, and include signer's printed name, date/time of signature, and meaning of signature.
Electronic records must be retained and readily retrievable throughout the required retention period in their original format.
Comprehensive documentation of policies, procedures, system specifications, validation reports, and training records.
Challenge: Public health research institution needed to ensure their REDCap (Research Electronic Data Capture) system met 21 CFR Part 11 requirements for clinical trial data management.
Solution: Implemented comprehensive Part 11 controls including:
✓ Results: Successful FDA audit with zero Part 11 findings, streamlined clinical trial data collection processes, and improved data integrity controls.
Drug development, manufacturing, and quality systems
Design controls, quality management systems, and submissions
Research, development, and production documentation
Clinical trial data management and regulatory submissions
Surveillance systems and health information exchanges
CMO/CDMO production and quality records
Evidence-based support for open-source software in public health from leading research institutions.
Government agencies can benefit significantly from open-source software by taking advantage of work done by others to solve common problems. This saves time, money, and human resources while generating flexibility, transparency, shared best practices, and community support.
Read Full Article →Open source software addresses many challenges in making healthcare more accessible, equitable and resilient in both high and low income settings. Projects like DHIS2, OpenMRS, and GNU Health demonstrate global impact.
Read Full Article →Open source puts purchasers in stronger positions, generates superior software through collaborative development, and facilitates open standards. OSS is particularly suitable for health information systems given significant investment levels and motivated user bases.
Read Full Article →The CDC Data Integration Building Blocks (DIBBs) program provides free, cloud-based tools for public health organizations to clean, transform, and enhance data. All DIBBs tools are open source and available on GitHub.
At Cipher Security, we understand the criticality of maintaining the confidentiality, integrity, and availability of information systems in today's interconnected world. We believe that strong cyber defenses are crucial for fostering public trust, preserving intellectual property, and protecting the privacy of individuals.
By partnering with Cipher Security, organizations can rest assured that their digital assets are in capable hands. Together, we can build a safer digital future, one fortified system at a time.
Ready to strengthen your cybersecurity posture or modernize your public health data infrastructure? Contact us to learn how we can help.