Frequently Asked Questions

What is hema.to?

hema.to is a cloud-based SaaS platform designed to provide diagnostic support for hematological malignancies by analysing raw FCS/LMD files.

How does hema.to differ from traditional softwares?

Unlike traditional manual softwares that require installation and maintenance on individual computers, hema.to is an AI-based software hosted on the cloud, offering easier access, automatic updates, and scalability without the need for hardware investment.

What training resources are available for hema.to?

We currently offer a free demonstration account where you can explore the features and capabilities of hema.to. We also provide a training video where one of our experts demonstrates all details on how you can interact with our interface. Scheduling in-person sessions is also possible. You will have the opportunity to discuss your questions and needs and maybe find more suitable solutions for your laboratory.

What kind of support does hema.to offer?

Besides email support users can schedule a meeting with us to ensure they receive the assistance they need from the most suitable expert.

Can I adjust the results after the automated data analysis?

Yes, you can easily correct the AI's suggestions with just a few clicks. Among other functions, we provide a simply way to relabel cell types.

Do I have to use a specific cytometer / panel / workflow?

You can use your current cytometer / panel / workflow without changing anything. We use AI that is trained under your specific setup. This enables our software to be used by any customer.

How many files per disease do the algorithms need in order to be trained?

We currently have 2 products. Our hema.to BASE product (currently in development) only requires some 10 files per disease and automates single cell classification for your flow cytometry analysis. Our hema.to BNHL product (CE marked under IVDD) additionally provides a diagnostic recommendation and thus requires 1000 files per disease.

How does hema.to protect against data breaches?

hema.to does not expose sensitive internal assets to public networks and is making use of security tooling provided by the google cloud platform. In addition, we use log and event-based intrusion detection systems for detecting unauthorised access or tampering.

How does hema.to handle security vulnerabilities?

We have protocols in place to monitor and address supply chain vulnerabilities (CVEs) frequently and promptly after guidance is published. We create, analyse and address automated security reports before publishing new versions of our software.

How are security incidents reported and resolved in hema.to?

We have a dedicated internal process for incidents and incident reporting; It covers security incidents amongst other incidents. The process consists of immediate incident investigation, reporting, user notification, and resolution steps.

Does hema.to have a disaster recovery plan?

Yes, we have a comprehensive disaster recovery plan that includes regular data backups, continuous monitoring and emergency response procedures.

How is user access managed in hema.to?

User access is managed through a secure login system with support for two-factor authentication. We apply role based permissions that control the scope of access granted to a user.

What measures are in place to ensure the security of mobile or remote access?

hema.to supports the latest security features in supported browsers. Any integration into LIS or other laboratory management systems uses SSL encryption and a VPN where necessary.

How do I know that sensitive data is being encrypted? What kind of encryption does hema.to use to protect data?

All data stored in our cloud computing environment is encrypted at rest using AES 256-bit encryption. All transfer of customer data is encrypted in-transit via SSL encryption.

What is the GDPR and is hema.to compliant with it?

The General Data Protection Regulation (GDPR) is the data protection law in the European Union (EU). The law is designed to give EU citizens more control over how internet services and companies collect and process their personal data. It applies to all organisations who are located in the EU and who process personal data, as well as any organisations who process data of EU citizens. hema.to complies with the GDPR. It does not acquire any patient information nor personal relatable information.

Is hema.to complying with the evolving regulatory requirements?

As of today, hema.to B-NHL is CE-IVD, complying with all relevant regulatory requirements; ranging from the IVDD to product specific standards such as the IEC 62304. hema.to maintains internal processes to ensure ongoing compliance with the latest and most relevant regulatory requirements.

hema.to base is not yet CE-IVD, we are in the progress of getting this product cleared (expected mid '25).

Do you have a Quality Management System in place to ensure compliance with relevant healthcare regulations?

hema.to maintains a robust Quality Management System (QMS) in accordance with the ISO 13485 standard. This system ensures the quality, safety, and efficacy of our medical devices throughout their lifecycle.

Do you provide training and support to users to ensure they understand the regulatory requirements related to your healthcare products?

Yes, hema.to provides comprehensive training and support to users to ensure they understand the regulatory requirements related to our healthcare products. We are committed to empowering our users to use our products safely and effectively while maintaining compliance with applicable regulations.

How do you prepare for and handle audits or inspections by regulatory authorities such as the Notified Bodies?

We maintain meticulous records of our processes and procedures to ensure compliance with regulatory requirements. Additionally, we conduct regular internal audits to identify and address any potential areas of non-compliance proactively.

Have you conducted clinical evaluations or performance studies for your software?

hema.to has conducted a thorough clinical evaluation and performance study to assess the safety and effectiveness of its products. Such studies are crucial in demonstrating compliance with regulatory requirements and ensuring the reliability of our product. We are currently in the process of conducting a follow up study.

Is hema.to compliant with the EU's In Vitro Diagnostic Regulation (IVDR) or the previous In Vitro Diagnostic Directive (IVDD)?

Yes, hema.to is compliant with the EU's In Vitro Diagnostic Directive (IVDD). Additionally, we are in the process of obtaining certification under the new In Vitro Diagnostic Regulation (IVDR).

How do you monitor the performance of your medical devices or diagnostic software after they have been placed on the market?

hema.to maintains a robust post-market surveillance system to monitor the performance of our diagnostic software. This system allows us to promptly identify and address any issues that may arise after our products have been deployed and placed on the market. This includes monitoring for software bugs, security vulnerabilities, and user feedback to continuously improve our product and ensure compliance with regulatory standards.

What types of businesses benefit most from using hema.to?

hema.to can benefit all hematology specialised laboratories that use flow cytometry. Its features are particularly useful for hematologists and pathologists who are struggling with staff shortages and who want to reduce time to diagnosis so that they can help more patients.

Can hema.to scale with my business?

Absolutely. hema.to is designed to grow with your business. It offers scalable features and plans to accommodate your evolving needs.