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Safe Governance & Compliance

This domain covers the regulatory, ethical, and compliance aspects of operating Secure Data Environments, ensuring systems meet legal requirements and maintain appropriate controls.

Regulatory Compliance

Regulatory Compliance ensures that secure data environments meet legal requirements and standards for handling sensitive healthcare information. This subdomain encompasses information governance frameworks, data protection compliance with laws like GDPR, adherence to healthcare-specific standards such as DSPT and NHS DTAC, implementation of specialised security frameworks, and management of ethics and research approval systems that collectively maintain legal and regulatory adherence across all aspects of data handling.

Information Governance

Establishes and maintains frameworks for managing information assets securely and compliantly. Involves implementing governance controls, conducting assessments, ensuring system compliance, developing enterprise strategies, establishing oversight mechanisms, and leading maturity initiatives that align with organizational requirements and industry standards.

  • Understands basic information governance principles (e.g., data minimization, accountability)
  • Familiar with key information governance frameworks (e.g., Caldicott Principles, ISO 27001)
  • Can follow established information governance procedures
  • Implements information governance controls and processes
  • Conducts information governance assessments (e.g., data flow mapping, risk assessments)
  • Ensures systems comply with governance requirements
  • Develops enterprise information governance strategies
  • Establishes governance frameworks and oversight mechanisms
  • Leads information governance maturity initiatives (e.g., implementing maturity models)

Data Protection Compliance

Ensures adherence to data protection laws and regulations such as GDPR. Involves understanding subject rights and consent requirements, implementing protection controls, conducting impact assessments, developing comprehensive frameworks, establishing governance oversight, and leading enhancement initiatives across the organization.

  • Understands relevant data protection regulations (GDPR, etc.)
  • Familiar with data subject rights and consent requirements
  • Can implement basic data protection controls (e.g., pseudonymization, access controls)
  • Implements comprehensive data protection frameworks (e.g., Data Protection Impact Assessments, privacy by design).
  • Conducts data protection impact assessments
  • Ensures systems comply with data protection requirements
  • Develops enterprise data protection strategies
  • Establishes data protection governance and oversight
  • Leads data protection enhancement initiatives (e.g., organization-wide training, new privacy technologies).

Healthcare Standards Compliance

Ensures adherence to healthcare-specific regulatory standards such as DSPT and NHS DTAC. Involves implementing compliance frameworks, conducting assessments, ensuring systems meet regulatory requirements, developing enterprise strategies, establishing governance programs, and leading standards compliance initiatives.

  • Understands relevant healthcare standards (DSPT, NHS DTAC, etc.)
  • Familiar with healthcare compliance requirements
  • Can implement basic healthcare compliance controls
  • Implements healthcare standards compliance frameworks
  • Conducts healthcare compliance assessments
  • Ensures systems meet healthcare regulatory requirements
  • Develops enterprise healthcare compliance strategies
  • Establishes healthcare compliance governance programs
  • Leads healthcare standards compliance initiatives

Healthcare Data Security Frameworks

Implements specialised security controls required for protecting healthcare data. Involves understanding healthcare-specific frameworks like DSPT and NHS DTAC, implementing compliance controls, conducting assessments, ensuring regulatory requirements are met, developing strategies, and establishing governance oversight specific to healthcare environments.

  • Understands basic healthcare data security frameworks (DSPT, NHS DTAC)
  • Familiar with healthcare-specific compliance requirements
  • Can follow established healthcare compliance procedures (e.g., incident reporting, access reviews)
  • Implements healthcare compliance controls and processes (e.g., encryption, audit logging)
  • Conducts healthcare compliance assessments
  • Ensures systems meet healthcare regulatory requirements
  • Develops healthcare compliance strategies and frameworks
  • Establishes healthcare compliance governance and oversight
  • Leads healthcare standards compliance initiatives

Ethics & Research Approval Systems

Manages systems and processes for ensuring research meets ethical standards and approval requirements. Involves understanding ethical review processes, preparing documentation for submissions, implementing tracking systems, ensuring compliance with approvals, and developing strategies to enhance ethical governance across the research environment.

  • Understands ethical review requirements and research approval processes
  • Familiar with ethics and IRAS documentation requirements
  • Can assist with preparing submissions for ethical approval (e.g., drafting consent forms, compiling supporting documents)
  • Implements systems for tracking ethical approvals and requirements (e.g., electronic tracking tools, spreadsheets)
  • Ensures research activities comply with ethical approvals
  • Conducts ethics compliance reviews and assessments
  • Develops ethical compliance strategies and frameworks
  • Establishes ethics governance and oversight processes
  • Leads initiatives to enhance ethical compliance

Security Management

Security Management establishes and maintains protections for data assets and systems within secure research environments. This subdomain focuses on implementing comprehensive technical, administrative, and physical security controls, conducting regular assessments and testing to verify effectiveness, and managing incident response processes that collectively ensure research data remains protected from unauthorised access or breaches while enabling appropriate recovery and improvement from security events.

Security Controls Implementation

Deploys technical, administrative, and physical safeguards to protect data and systems. Involves understanding control concepts, implementing basic and comprehensive security frameworks, evaluating effectiveness, mapping to compliance requirements, developing enterprise strategies, and leading maturity initiatives across the organization.

  • Understands security control concepts and categories
  • Familiar with common security controls and their purpose
  • Can implement basic security controls following guidelines (e.g., password policies, firewall rules)
  • Designs and implements comprehensive security control frameworks
  • Evaluates effectiveness and suitability of security controls
  • Maps controls to specific compliance requirements (e.g., GDPR Article 32, ISO 27001 Annex A)
  • Develops enterprise security control strategies
  • Establishes security control governance and oversight
  • Leads security control maturity initiatives

Security Assessment & Testing

Evaluates the effectiveness of security controls through testing and analysis. Involves understanding assessment methodologies, conducting vulnerability scanning and penetration testing, analyzing results, prioritizing remediation, implementing testing programs, and establishing governance frameworks to mature assessment capabilities.

  • Understands security assessment concepts and methodologies
  • Familiar with vulnerability scanning and penetration testing
  • Can assist with security assessments following established procedures (e.g., running vulnerability scans, documenting findings)
  • Conducts comprehensive security assessments and testing
  • Analyses security assessment results and prioritises remediation
  • Implements security testing programs and schedules
  • Develops enterprise security assessment strategies
  • Establishes security testing governance and methodologies
  • Leads security assessment maturity initiatives

Incident Response Management

Prepares for and manages security incidents effectively to minimise impact. Involves understanding incident response procedures, classifying and reporting incidents, implementing response plans, leading investigations, analyzing for improvement, developing enterprise strategies, and enhancing response capabilities across the organization.

  • Understands incident response concepts and procedures
  • Familiar with incident classification and reporting
  • Can assist with incident response following established protocols
  • Implements incident response plans and procedures
  • Leads incident investigations and coordinates response activities
  • Analyses incidents for lessons learned and improvement opportunities
  • Develops enterprise incident response strategies
  • Establishes incident response governance and oversight
  • Leads incident response capability enhancement initiatives

Ethics & Research Governance

Ethics & Research Governance maintains the ethical integrity of research activities involving sensitive healthcare data. This subdomain encompasses ensuring adherence to ethical principles and requirements, managing data subject consent throughout the research lifecycle, and facilitating thorough ethical review processes that collectively ensure research is conducted responsibly while respecting patient rights, maintaining public trust, and supporting scientific integrity.

Research Ethics Compliance

Ensures research activities adhere to ethical principles and requirements. Involves understanding ethics principles, following approval processes, implementing frameworks, conducting assessments, ensuring compliance, developing enterprise strategies, and establishing governance to enhance ethical research practices across the organization.

  • Understands basic research ethics principles
  • Familiar with research ethics approval processes
  • Can follow established research ethics procedures
  • Implements research ethics frameworks and processes
  • Conducts research ethics assessments and reviews
  • Ensures research activities comply with ethical requirements
  • Develops enterprise research ethics strategies
  • Establishes research ethics governance and oversight
  • Leads research ethics enhancement initiatives

Manages processes for obtaining, recording, and honoring data subject consent. Involves understanding consent requirements, verifying documentation, implementing management systems, ensuring research activities align with consent parameters, developing enterprise strategies, and establishing governance frameworks to enhance consent practices.

  • Understands consent concepts and requirements
  • Familiar with consent documentation and verification
  • Can implement basic consent management procedures (e.g., verifying withdrawal requests)
  • Designs and implements consent management systems
  • Ensures research activities align with consent parameters
  • Conducts consent compliance reviews and assessments
  • Develops enterprise consent management strategies
  • Establishes consent governance frameworks and processes
  • Leads consent management enhancement initiatives

Ethical Review Processes

Facilitates the assessment of research proposals against ethical standards. Involves preparing documentation for review submissions, coordinating complex submissions, implementing tracking systems, ensuring compliance with approvals, developing streamlined frameworks, and leading initiatives to enhance the efficiency and effectiveness of ethical review processes.

  • Understands ethical review requirements and processes
  • Familiar with ethical review documentation
  • Can prepare basic ethical review submissions
  • Coordinates complex ethical review submissions
  • Implements systems for tracking ethical approvals
  • Ensures research activities comply with ethical approvals
  • Develops streamlined ethical review frameworks
  • Establishes ethical review governance and oversight
  • Leads initiatives to enhance ethical review processes

Audit & Compliance Monitoring

Audit & Compliance Monitoring ensures continuous verification of regulatory adherence through systematic tracking and reporting. This subdomain encompasses implementing comprehensive audit trail systems that record system and user activities, conducting regular compliance monitoring with structured reporting processes, and managing certification and accreditation programs that collectively provide assurance that secure data environments maintain required standards while enabling effective oversight and continuous improvement.

Audit Trail Implementation

Creates comprehensive records of system and user activities for security and compliance. Involves implementing logging capabilities, ensuring appropriate content and formats, designing comprehensive strategies, implementing secure collection and storage, developing enterprise architectures, and establishing governance frameworks to enhance audit capabilities.

  • Understands audit logging concepts and requirements
  • Familiar with audit log contents and formats
  • Can implement basic audit logging following guidelines
  • Designs comprehensive audit logging strategies
  • Implements secure audit trail collection and storage
  • Ensures audit coverage across systems and processes
  • Develops enterprise audit strategy and architecture
  • Establishes audit governance frameworks and policies
  • Leads audit capability enhancement initiatives

Compliance Monitoring & Reporting

Continuously assesses and documents adherence to regulatory requirements and standards. Involves producing compliance reports, implementing monitoring programs, analyzing trends and issues, developing enterprise strategies, establishing reporting frameworks, and leading initiatives to enhance monitoring capabilities across the organization.

  • Understands compliance monitoring concepts
  • Familiar with compliance reporting requirements
  • Can produce basic compliance reports using established templates
  • Implements compliance monitoring programs and tools
  • Produces comprehensive compliance reporting and dashboards
  • Analyses compliance data to identify trends and issues
  • Develops enterprise compliance monitoring strategies
  • Establishes compliance reporting frameworks and governance
  • Leads compliance monitoring enhancement initiatives

Certification & Accreditation

Guides systems through formal security validation by external authorities. Involves understanding certification requirements, collecting evidence, managing certification processes, preparing documentation, addressing findings, developing enterprise strategies, and establishing governance to maintain certifications such as ISO27001 across the organization.

  • Understands certification and accreditation concepts
  • Familiar with common certifications (ISO27001, etc.)
  • Can assist with certification evidence collection
  • Manages certification and accreditation processes
  • Prepares systems and documentation for certification
  • Addresses certification findings and remediation
  • Develops enterprise certification strategies
  • Establishes certification governance and oversight
  • Leads certification readiness and maintenance programs