OTS Cloud Risks
Risk Examples using OTS Cloud Platform
R1
Misconfigured access / API exposure.
Unauthorized party gains access to PHI
Privacy breach, fines
Penetration Testing: Undergoes regular third-party penetration testing to validate security controls.
Data Encryption: Encrypts data both at rest and in transit.
Authentication Protocols: Supports secure authentication protocols for secure access.
RBAC: Provides fine-grained role-based access control (RBAC).
R2
Platform outage or network failure
User unable to retrieve or input critical data
Delay in diagnosis or treatment
Extra Horizon has implemented a set of controls to avoid outages and ensure quick recovery when distasters do take place.
High-Availability Architecture: Ensures robust system reliability.
Disaster Recovery Testing: Regular tests for guaranteed business continuity.
24/7 Monitoring and Support: Continuous oversight and on-call engineering support.
ISO 27001 Certification: Adherence to certified security management standards.
Service Level Agreement (SLA): Clear, transparent commitments to meet client needs.
R3
Sync bug or corrupted database
Inconsistent or incorrect patient data
Misdiagnosis, incorrect treatment
In order to ensure data integrity and seamless operations, it is crucial to implement comprehensive disaster recovery strategies. These strategies should encompass several key components:
Platform Logging: Accurate and consistent logging to monitor system performance and identify issues promptly.
Well-defined RTO & RPO Objectives: Clearly established Recovery Time Objectives (RTO) and Recovery Point Objectives (RPO) to guide recovery efforts and minimize downtime.
Disaster Recovery Plans: Detailed plans that outline specific procedures during a disaster to ensure business continuity.
Primary & Secondary Backup Locations: Designation of multiple geographic locations for data backups to safeguard against local failures.
Backup Management Procedures: Systematic processes for managing backups, including regular testing and validation to guarantee data can be restored quickly.
R4
Vendor updates API or backend silently
Dependent system fails or behaves unexpectedly
Unreliable performance, clinical interruption
Extra Horizon has the following controls in place to assure correct change management:
Versioning: Strict semantic version included in the SLA
Development Lifecycle: IEC62304 compliant software development & verification methodology
Source Code Management: Code reviews & branch protection rules
R5
Platform lacks detailed or timestamped logs
Inability to trace user actions
Regulatory non-compliance, inability to investigate
The following controls are in place to ensure auditability and traceability towards user and administrative interactions:
API Interactions: All interactions with the Extra Horizon platform occurs trough our REST API and is logged.
Audit Trails: Audit trails are enabled and coded into the infrastructure to ensure traceability of actions and changes in each dedicated cluster.
R6
Vendor ceases operation or deprecates services
Service unavailable permanently
Permanent data loss or app breakdown
The Contract with the OTS Cloud supplier contains the following controls:
Continuity License: Commercial continuity clause in case of insolvency
EOL clauses and general support: Clear end of support and end of life process with a large window to provide the client to adjust or modify services as required.
Transitioning clauses: Transition services & transition planning
Data Access Tooling: API access for data exports
R8
Platform backend is a black box
Cannot fully verify safety or performance
Unidentified faults in clinical use
Extra Horizon has proper procedures and processes in place to safely operate and manage the provide cluster to it's customers:
Compliant Management System: Extra Horizon is audited by third parties and can prove compliance with it's ISO13485, ISO27001 and IOS27701 certificates.
Software Verification & Validation: Provide compliant documentation and test reports;
R9
Vendor slow to respond to incidents
Long MTTR impacts clinical decisions
Delayed recovery and system unavailability
Extra Horizon has a compliant business continuity management procedure in place to ensure uptime:
Incident Management: Incident management procedure
Business continuity: Frequent disaster recovery planning & testing
24/7 Monitoring and Support: Continuous oversight and on-call engineering support.
Well-defined RTO & RPO Objectives: Clearly established Recovery Time Objectives (RTO) and Recovery Point Objectives (RPO) to guide recovery efforts and minimize downtime.
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