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Health data security & privacy services

Edenlab leads in developing secure software solutions for IT startups, software vendors, and healthcare life sciences organizations. Our team delivers built-in encryption, access controls, audit logging, and consent management tools to ensure compliance with HIPAA, GDPR, ONC, and ISO 27001 across EHRs, HIEs, analytics platforms, and more.

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Expertise you can trust

Proven expertise in secure healthcare system integration at a national scale

Proven track record in secure healthcare system integration at a national scale

Edenlab delivers secure, privacy-focused healthcare integrations at scale. Our team connects high-load platforms, manages anonymized patient data, and implements ABAC-driven security rules to ensure robust interoperability across large medical and payer ecosystems.

Deep knowledge of emerging security frameworks and regulatory mandates

Deep knowledge of emerging security frameworks and regulatory mandates

For example, we implement SMART on FHIR v2 to help FHIR-native products meet ONC Health IT Certification requirements, delivering fine-grained access control, secure authorization, and future-proof interoperability aligned with the latest industry standards.

We provide end-to-end security and privacy implementation

Requirement analysis and risk assessment

  • Analyzing required integrations and processes related to user and third-party data access
  • Mapping data flows and identifying sensitive information
  • Analyzing regulatory compliance needs (HIPAA, GDPR, ONC, and more)
  • Developing a detailed risk matrix and security roadmap

Security and privacy architecting

  • Designing state-of-the-art data encryption and access control systems
  • Planning seamless, secure integration with existing infrastructure if it’s necessary
  • Developing security policies and procedures
  • Validating against industry standards (OAuth 2.0 and OpenID Connect)

Secure solution development

  • Implementing industry-leading secure coding practices
  • Utilizing agile sprint methodology for rapid, secure iterations
  • Integrating continuous security testing throughout development
  • Building in compliance checks at every stage

Security testing and compliance validation

  • Conducting rigorous penetration testing and thorough code reviews
  • Ensuring full regulatory compliance across all relevant frameworks
  • Preparing security documentation

Deployment and monitoring

  • Implementing secure, streamlined deployment procedures
  • Setting up advanced real-time security monitoring systems
  • Establishing proactive incident response protocols
  • Providing continuous security updates and patches

Tailored security & privacy features to safeguard healthcare data

For EHRs and HISs

For EHRs and HISs

  • ONC certification compliance
  • Patient-centric consent management with strict adherence to HIPAA and GDPR
  • Advanced audit logging that facilitates seamless investigations
For HIEs

For HIEs

  • Comprehensive data sharing agreements for clear security responsibilities
  • Identity resolution for
accurate patient matching, preventing breaches
  • Intelligent data segmentation and advanced access controls for multi-tenant environments
For RCM systems

For RCM systems

  • AI-enhanced anomaly detection for identifying suspicious patterns and potential security threats
in real time
  • Multilayered access controls for stringent data protection
  • End-to-end encryption for safeguarding sensitive information throughout the RCM process
For analytics systems

For analytics systems

  • Advanced anonymization techniques to protect patient privacy while enabling analysis
  • Comprehensive data governance tools
  • Controlled data usage practices that ensure HIPAA or GDPR compliance for research and analytics

Custom health data security & privacy services
we deliver

Secure product development

Secure product development

We engineer software solutions with solid security measures. Our specialists deploy encryption, implement attribute-based (ABAC) and role-based (RBAC) access controls, and perform systematic security assessments. We follow OAuth 2.0 and OpenID Connect standards and use secure development methods to build resilient healthcare platforms that protect patient information while maintaining smooth operations.

SMART on FHIR implementation

SMART on FHIR implementation

We empower healthcare software vendors and providers of FHIR-native software with comprehensive SMART on FHIR implementation and ONC certification services. Our team ensures robust security, compliance with relevant regulations, and seamless integration with existing systems to enhance data interoperability and streamline healthcare workflows. 

Data security consulting

Data security consulting

We provide expert consulting to fortify your healthcare data infrastructure. We assess the hospital security software, design secure architectural solutions, and ensure compliance with relevant regulations, such as HIPAA and GDPR. Our team integrates advanced features into your infrastructure and performs regular security audits to maintain the highest protection standards.

Innovate healthcare with SMART on FHIR

Accelerate your project’s growth with Edenlab’s SMART on FHIR expertise. We help you build tailored, interoperable healthtech solutions that improve care delivery, streamline data exchange, and meet the highest security and compliance standards.

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Case study
Payers & TPAs
Hong Kong Hong Kong

Heals.Asia HIE with claim processing

Implementing an FHIR Facade for seamless provider directory access and real-time search by specialty and location. Claim processing optimization with an auto-adjudication engine.

Heals.Asia HIE
Case study
Medtech
USA USA

FHIR backend for Elation Health

Implemented SMART on FHIR, ensuring secure integration, robust data privacy, and compliance, while enabling seamless third-party app connectivity with secure authorization and authentication.

FHIR backend for Elation Health
Case study
Governmental agencies
Ukraine Ukraine

National eHealth system

Building a secure, high-load national E-Health platform with HL7 FHIR, RESTful APIs, digital signatures, blockchain-based data integrity, and privacy-driven control and ABAC over sensitive patient information.

National eHealth system National E-Health system

We address specific health security
& privacy challenges

Data security

Ensuring secure access to sensitive data

Managing proper authorization levels for confidential patient records presents challenges that could result in security breaches. Deploying role-based access control (RBAC) and attribute-based access control (ABAC) following NIST standards and implementing MFA through OAuth 2.0 and/or OpenID Connect frameworks enables secure control of protecting data.

Cyber threat exposure

Cyberattacks constantly endanger healthcare facilities and may compromise data security by means of breaches and manipulation. Regular SOC 2 Type II audits and ISO 27001-compliant intrusion detection and prevention systems (IDPS) help to lower these risks and improve cybersecurity posture.

Legacy system vulnerabilities

Outdated systems can hinder interoperability, increasing security risks due to unsupported software. Upgrading to current, secure platforms that support TLS 1.3 encryption and adhere to the HITRUST CSF can improve data transfer security.

Third-party integration risks

External app connection without sufficient oversight presents security risks, resulting in system vulnerabilities. Implementing stringent security policies and vendor contracts that include OWASP-based penetration testing and HIPAA-compliant security audits helps to mitigate possible security breaches.

Data storage and transmission security

Data security during storage and transmission is critical to avoiding interception and unwanted access. Encryption methods such as HTTPS with TLS 1.3 for transit and AES-256 for stored data offer robust protection against unauthorized access.

Data privacy

Compliance with ethical data use

Protecting patient information confidentiality presents challenges. Following HIPAA standards for data anonymization and de-identification, combined with clear data handling protocols that follow Belmont Report principles, can strengthen privacy safeguards.

Regulatory compliance complexity

Navigating dynamic data protection laws such as GDPR and HIPAA presents significant operational challenges. Implementing privacy-first design principles per GDPR Article 25, and keeping comprehensive audit trails aligned with HIPAA standards, helps maintain regulatory conformity.

Data anonymization for analytics

Utilizing patient data for research and analytics while protecting privacy is complex. Implementing advanced anonymization, pseudonymization, and de-identification techniques ensures compliance with HIPAA, GDPR, and HITECH, while still supporting the effective use of data in analytical models.

Our custom software is built to comply with healthcare data security and privacy regulations

Data security

HIPAA (Security Rule)

  • Requires regular security risk analyses
  • Mandates encryption for data
  • Requires audit mechanisms for systems with PHI
  • Mandates protection against unauthorized alteration or destruction of PHI
  • Requires safeguarding PHI during transmission

HITECH Act

  • Requires encryption or destruction of data at rest
  • Mandates data backup and recovery documentation
  • Requires regular testing of recovery procedures
  • Mandates enhanced security incident reporting
  • Requires robust security controls beyond HIPAA

21st Century Cures Act

  • Mandates standardized APIs for secure health info access
  • Requires no technical barriers for health info exchange
  • Mandates secure exchange of health info for authorized uses

National Digital Documentation Regulations

  • Requires validated digital signature processes
  • Mandates immutable audit trails
  • Requires secure repositories for documentation
  • Mandates robust user authentication

Industry Guidelines

NIST Cybersecurity Framework:

  • Requires managing cybersecurity risks with five core functions: identify, protect, detect, respond, and recover

ISO/IEC 27001:

  • Mandates information security controls with encryption
  • Requires asset management for data protection
  • Mandates comprehensive risk assessments
Data privacy

HIPAA (Privacy Rule)

  • Requires minimum necessary use of PHI
  • Mandates patient access to their health information
  • Sets boundaries on health record use
  • Requires authorization for non-treatment disclosures
  • Mandates clear notices on data usage and protection

GDPR (General Data Protection Regulation)

  • Requires explicit, informed consent
  • Mandates data use limited to consented purposes
  • Requires integrated data protection measures
  • Mandates rights for access, rectification, and erasure
  • Requires 72-hour notification for breaches
  • Mandates documentation for compliance

CCPA (California Consumer Privacy Act)

  • Requires detailed privacy policies
  • Mandates systems for privacy rights requests
  • Requires separate privacy policies for HR data

PIPEDA (Personal Information Protection and Electronic Documents Act)

  • Requires informed consent for personal data collection
  • Mandates accurate and up-to-date personal information
  • Requires access to personal information upon request

We develop custom software that can be adapted to meet any healthcare data security and privacy regulations, without being limited to a fixed list.

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Components of our healthcare data security solutions

Core architecture and deployment

Core architecture and deployment

  • Secure and scalable infrastructure
  • Software compliant with industry standards (HIPAA, GDPR, ONC, etc.)
  • Customizable deployment options (cloud, on-premise, hybrid)
  • Detailed security and privacy compliance documentation
Monitoring, audit, and incident response

Monitoring, audit, and incident response

  • Real-time security monitoring
  • Comprehensive audit trails
  • Automated alerts and notifications
  • Security incident management
Data lifecycle management

Data lifecycle management

  • Version control for critical healthcare record
  • Secure and compliant data retention management
  • Data deletion processes
  • Support for the immutable storage of historical data
Secure data integration modules

Secure data integration modules

  • Secure APIs and data connectors
  • Data transformation and mapping
  • Data validation and cleansing
  • Secure data sharing and exchange
Identity & access management

Identity & access management

  • Identity Providers integration and customization
  • Centralized authentication and authorization services
  • Attribute-based access control (ABAC) and role-based access control (RBAC)
  • Multi-tenant support
  • Customizable user management policies
Data protection and encryption

Data protection and encryption

  • Data encryption in transit
  • Key management and rotation
  • Data loss prevention (DLP)
  • Data masking and tokenization
Data privacy controls

Data privacy controls

  • Consent management and tracking
  • Data subject access requests (DSAR) management
  • Data anonymization and pseudonymization tools
SMART on FHIR

SMART on FHIR

  • Identity provider with OAuth 2.0 and OpenID Connect
  • Authorization server for token issuance and user auth
  • FHIR server enforcing scopes and token validation

Secure your data, unleash insights
with FHIR

Fortify your health data security and privacy measures with Kodjin, our ready-to-implement FHIR-driven solution. Transform sensitive data into actionable insights while maintaining strict compliance and robust security protocols.

Learn more

Our approach to healthcare data security software development

Unparalleled expertise in health data security & privacy

We bring years of hands-on experience in health data security and privacy, empowering you to develop robust, compliant solutions from inception. We transform complex regulatory landscapes into streamlined execution — guiding you from initial discovery through to a secure, privacy-focused solution.

Comprehensive documentation throughout the development

We provide detailed documentation at every stage, ensuring complete transparency and control. From design decisions to security measures and compliance checks, our thorough approach keeps you informed and ensures all requirements are met.

Scalable fortification, evolutionary resilience

We architect dynamic health data security systems engineered to scale seamlessly with your vision. Whether you’re exponentially expanding your user base, integrating complex data streams, or pivoting to address seismic market shifts — your platform remains primed for tomorrow’s challenges.

See how we work

Explore more services and custom solutions we provide

Healthcare integration services

Edenlab connects healthcare systems and data sources to improve workflows and data exchange. We combine industry tools with custom platforms, ensuring robust integrations backed by our expertise.

Clinical data repository development

We create scalable solutions to securely store, manage, and access clinical data. Our custom repositories are tailored to your needs, to ensure seamless integrations, and efficient retrieval to support informed decisions.

EHR/EMR software development

We create EHR/EMR systems that elevate patient care quality. We use FHIR, HL7, and other standards to ensure ONC and HIPAA compliance, delivering innovative and scalable solutions that adapt to your evolving needs.

HIE software solutions development

We offer high-performance HIE solutions that enable secure interoperability and streamline data exchange. Our expertise in regulatory compliance and interoperability standards enhances healthcare efficiency.

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    "In Edenlab, they don’t just follow your technical brief as other outsourcing companies, but care about the final result and are ready to help you find the best way. Their deep expertise in FHIR is impressive. We appreciate it a lot, as many really good solutions were born in this cooperation."

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