Legally-Compliant Research
Identity Protection
First name, last name and birth date are automatically pseudonymized according to CNIL recommendations.
Electronic signatures
In accordance with FDA 21-CFR Part 11, you can add timestamped electronic signatures to patient records.
Cropping Tool
Add images easily for any of your patients with our cropping tool. This feature allows you to anonymize uploaded images on the go.
Secured Patient Data
World Class Hosting
Our application is hosted on GDPR & Health compliant, ISO 27001 & SOC2 certified hosting (including HDS** and HIPAA certification).
All data is securely transmitted via HTTPS and TLS 1.3.
Granular Access Control
Easily define access and permission levels for all your collaborators. Plus, if one of your collaborators shares your data with someone else, you will be notified right away.
Strong Password Protocols
To ensure the highest levels of protection on your account and data, we maintain a strict password policy
ISO 9001 Certification
ISO 9001 is an international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements. Quality is paramount at EasyMedStat. Our processes and philosophy reflect this value. This is why our company has received the ISO 9001 certification.
GDPR Compliance
We fully comply with European General Data Protection Regulation. The GDPR is a European Union regulation that establishes a new framework for handling and protecting the personal data of EU-based residents. It came into effect on May 25, 2018. It provides residents of the EU greater control over their personal data and assurances that their information is being securely protected across Europe. EasyMedStat lets you exercise your rights and also gives you the ability to manage patient requests around personal data.
ISO 14155 compliance
You are a medical device company? Your clinical research should comply with the ISO 14155 standard. EasyMedStat provides a robust set of features designed specifically to aid your compliance with ISO 14155.
Comply with Research Regulations
Audit trail / 21-CFR Part 11 Electronic signatures / Queries / Access control with user-level granular permissions / Case report form freezing / Access logs / Software validation package
Built with Security in Mind
Health-certified servers with ISO 27001 and HDS compliance / NIST SP800-63B password policy / Access control with user-level granular permissions / Concurrent login prevention and automated idle logout / Secured communication over TLS 1.3 protocol / Database encryption with multiple 32-bit rotating keys / Salt-hashing of identity data with SHA-256 hash function / Automated backup database every 24 hours with 30-day storage / Automated pseudonymization of identifying data / Anonymization tool for images
Is EasyMedStat GDPR compliant?
EasyMedStat is fully GDPR compliant.
The GDPR is a European Union regulation that establishes a new framework for handling and protecting the personal data of EU-based residents. It came into effect on May 25, 2018. It provides residents of the EU greater control over their personal data and assurances that their information is being securely protected across Europe.
EasyMedStat lets you exercise your rights and also gives you the ability to manage patient requests around personal data.
Where my data is stored?
EasyMedStat is hosted on OVH.
If you are a European company, all your data and your patient data is hosted in Europe and adheres to strict European privacy laws.
If you are an American company, all your data and your patient data is hosted in the US and adheres to HIPAA requirements.
I need to sign a DPA with EasyMedStat
Our DPA (Data Processing Addendum) is part of our service terms.
By accepting our terms, you accept our DPA .You can review it in our terms
here.
Is EasyMedStat health compliant?
EasyMedStat is health compliant
By offering you features such as automatic pseudonymization and automatic birthdate update, we create a health compliant framework that lets you focus only on your research.
Moreover, we comply with French law, one of the most demanding with regards to Health Compliance.
EasyMedStat is hosted on OVH, which has an HDS and HIPAA certification** to ensure the security and the protection of Personal Health Information.
* The CNIL (Commission Nationale de l'Informatique et des Libertés) is an independent French administrative regulatory body whose mission is to ensure that data privacy law is applied to the collection, storage, and use of personal data
** The HDS (Hébergeur de Données de Santé) certification is a French certification that provides a framework to strengthen the security and protection of Personal Health Information. See the full list of HDS certified host here.
