Data Security and Medical Device Regulation



Aikenist.com and Global Medical Device Regulations


Data Security and Privacy at Aikenist.ai


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 are safe for use.


HIPAA compliant

Aikenist.com complies with the United States Health Insurance Portability and Accountability Act 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.


EU-GDPR 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.


Certified Software Development Processes

Aikenist.com is ISO 13485 certified. ISO 13485:2016 includes the protection of confidential data as well as the establishment and review of requirements for associated medical devices.

Aikenist.com is ISO 14971 compliant. ISO 14971 focuses primarily on safety, security, and risk associated with the use of medical devices.

Aikenist.com is IEC 62304 compliant. The IEC 62304 standard also specifies life cycle requirements for the development of medical software and software within medical devices.



Rigorous Cybersecurity Controls

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.


Protected Data Communication

We have protected and encrypt data at every level, both at source and in transit. Communication (typical transfer of DICOM files) via our API and demo portal is encrypted. Communication with Aikenist.com software deployed on-premise servers is similarly encrypted. Gateway servers are secured using the latest data protection technology. License managers are used to authenticate user credentials.


Secure Cloud Servers

Aikenist.com uses cloud servers built by cloud hosting partners with the highest standards for privacy and data security (Amazon Web Services and Azure Cloud).


Transparent User Privacy Policies

Privacy policies for users of our website, demo portal, and apps are displayed to visitors who access these applications.

Please contact contact@aikenist.com for information on Aikenist.ai’s information security measures.