Markets Covered
India · USA · EU
Active Certifications
7 Standards Met
Security Audits
Annual VAPT Renewal
Data Encryption
AES-256 + TLS 1.3

This section explains the measures that Aikenist.com has implemented to secure healthcare data for our customers and partners, and lays out the cybersecurity protections that make our AI products safe for use in clinical environments worldwide.

Aikenist products are designed for use only by appropriately qualified and trained medical personnel — board certified radiologists with a valid license to practice — and are intended solely to support the diagnostic process, not replace clinical judgment.

HIPAA Compliant

United States Health Insurance Portability and Accountability Act
Compliant

Aikenist.com complies with HIPAA by ensuring that any data is de-identified before it leaves a covered entity's premises for cloud processing. On-premise deployments may not de-identify images, provided that data processing occurs entirely within servers that are operated and owned by the covered entity.

  • De-identification before cloud transfer
  • On-premise deployment support within covered entity infrastructure
  • Access controls and audit logging for PHI systems

EU-GDPR Compliant

European General Data Protection Regulation
Compliant

The EU General Data Protection Regulation addresses questions of data security and confidentiality. It introduces measures to limit the amount of data collected, the purposes for which data is used, and the duration for which it is stored.

Aikenist.com is GDPR-compliant with respect to healthcare data as well as other data from users of our websites and portals, including appropriate data minimization, purpose limitation, and retention policies.

  • Data minimization and purpose limitation policies
  • Right to access, correction, and erasure supported
  • Data Processing Agreements (DPA) available for customers

Certified Software Development Processes

International standards governing medical device software
Certified

Aikenist's development processes are governed by internationally recognized standards for medical device software, ensuring quality, safety, and security at every stage of the product lifecycle.

ISO 13485:2016

Certified. Includes protection of confidential data and establishment of requirements for associated medical devices.

ISO 14971

Compliant. Focuses primarily on safety, security, and risk associated with the use of medical devices.

IEC 62304

Compliant. Specifies lifecycle requirements for development of medical software and software within medical devices.

Rigorous Cybersecurity Controls

Real-time vulnerability assessment and threat mitigation
VAPT Passed

Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. As a medical device manufacturer, Aikenist.com is vigilant about identifying risks and hazards associated with our products and proactively mitigating these.

Our cybersecurity team assesses vulnerabilities and threats to Aikenist.com processing servers on a real-time basis and implements the appropriate control measures for both cloud servers and on-premise installations.

  • VAPT (Vulnerability Assessment and Penetration Testing) certified
  • Real-time monitoring of processing servers
  • Controls applied to both cloud and on-premise deployments
  • CERT-In aligned security practices

Protected Data Communication

End-to-end encryption at every layer
AES-256

We protect and encrypt data at every level — both at source and in transit — ensuring clinical imaging data remains secure throughout its journey.

  • DICOM file transfers via our API and demo portal are fully encrypted
  • On-premise server communication is similarly encrypted
  • Gateway servers secured using the latest data protection technology
  • License managers used to authenticate user credentials

Secure Cloud Infrastructure

Enterprise-grade hosting with leading cloud providers
AWS · Azure

Aikenist.com uses cloud servers built by cloud hosting partners with the highest standards for privacy and data security — Amazon Web Services (AWS) and Microsoft Azure Cloud — both of which maintain comprehensive healthcare-grade compliance certifications.

  • Amazon Web Services (AWS) — HIPAA eligible services
  • Microsoft Azure — healthcare data compliance
  • Data residency controls available on request
  • Regular security audits and penetration testing

Transparent User Privacy Policies

Clear policies for all users of our platforms
Transparent

Privacy policies for users of our website, demo portal, and apps are clearly displayed to all visitors who access these applications. We are committed to transparency about how data is collected, used, and stored.

  • Full privacy policy available at aikenist.com/privacy
  • Cookie consent banner on all web properties
  • User data access and deletion requests honoured

Have a Security Question?

For detailed information on Aikenist's information security measures, certifications, or to request a Data Processing Agreement, please get in touch with our team.

Version 1.3.80 | CDSCO MD-5 [MFG/MD/2024/000597] | QuickSuite is intended for use by, or under the supervision of, licensed healthcare professionals only | support@aikenist.com | +91 7560898983