Our development processes adhere to ISO 27001 standards for information security management systems, ensuring comprehensive protection of sensitive healthcare data.

Key Implementation Areas:

• Information security policies and procedures

• Risk assessment and treatment

• Security controls implementation

• Monitoring and continuous improvement

• Incident management protocols

For medical device software, we implement ISO 13485 quality management systems to ensure consistent development of safe and effective software.

Key Implementation Areas:

• Quality management system documentation

• Design and development controls

• Verification and validation processes

• Risk management throughout development

• Traceability of requirements and changes

We implement comprehensive measures to ensure compliance with the Health Insurance Portability and Accountability Act for U.S.-focused healthcare applications.

Key Implementation Areas:

• Privacy Rule implementation

• Security Rule technical safeguards

• Breach notification procedures

• Business Associate Agreement compliance

• Administrative and physical safeguards

We build healthcare applications with privacy by design principles that meet the requirements of the General Data Protection Regulation for European data subjects.

Key Implementation Areas:

• Privacy by design and default

• Data subject rights implementation

• Consent management mechanisms

• Data protection impact assessments

• Cross-border data transfer controls

For medical software and applications that qualify as medical devices, we implement development processes that meet FDA requirements and guidelines.

Key Implementation Areas:

• Quality System Regulation (QSR) compliance

• Software as a Medical Device (SaMD) classification

• Design control documentation

• Verification and validation planning

• 510(k) or De Novo submission support

For healthcare applications that process payment information, we implement Payment Card Industry Data Security Standard compliant processes to protect financial data.

Key Implementation Areas:

• Secure network architecture

• Cardholder data protection measures

• Vulnerability management program

• Strong access control measures

• Regular security monitoring and testing

The analysis of the specific regulatory requirements that apply to your healthcare application based on its functionality, target market, and data processing activities.

Here's what happens:

• Regulatory scope determination

• Compliance requirements mapping

• Gap analysis against current state

• Compliance architecture planning

The comprehensive risk assessments to identify potential threats to patient data security and privacy, and develop mitigation strategies.

Here's what happens:

• Threat modeling and risk identification

• Impact and likelihood assessment

• Risk prioritization

• Control selection and implementation planning

Integrating compliance requirements into the design phase ensures that privacy, security, and regulatory considerations are built into the application architecture.

Here's what happens:

• Privacy by design implementation

• Security architecture development

• Technical control specification

• Design review and validation

Implementing secure coding practices and regular security testing to identify and remediate vulnerabilities early.

Here's what happens:

• Secure coding standards implementation

• Regular code security reviews

• Dependency vulnerability scanning

• Static and dynamic application security testing

Conducting comprehensive testing and validation to ensure that all implemented controls effectively meet regulatory requirements and security standards.

Here's what happens:

• Security control testing

• Compliance requirement validation

• Penetration testing

• Documentation review and verification

Preparing comprehensive documentation to demonstrate compliance with regulatory requirements, providing evidence of implemented controls and processes.

Here's what happens:

• Control implementation documentation

• Risk assessment reports

• Test results and validation evidence

• Compliance attestation preparation