AI · Quality and safety
safety and quality

Clinical security and privacy by design 

ReHub integrates privacy principles into its own architecture: Motion data is processed locally in real time, without storing images or biometrics identifying parameters. We comply with MDR, AI ACT, GDPR, HIPAA and ENS high category to offer maximum protection in digital rehabilitation environments. 

CE CLASS IIA MARK

Medical software device evaluated and certified under Regulation (EU) 2017/745

ISO 13485:2016

Specific quality management system for medical device companies. 

ISO 27001

Information security is systematically managed, ensuring confidentiality, integrity and availability of data. 

ENS High Category

Certification of the national security scheme of Spain, the most demanding standard of cybersecurity for data protection in the health field. 

NIS2 Directive

Alignment with the risk management and cybersecurity requirements of Directive (EU) 2022/2555 for the health and digital sector.

GDPR

Patient data is handled under the EU’s strictest privacy and data protection principles.

HIPAA

Compliance with privacy and security standards for the treatment of protected health information (PHI) in contexts of Business Associates

International Compliance (UKCA)

Adapted to meet the regulatory requirements of medical devices in the UK.

AWS well-architected 

Cloud infrastructure aligned with Amazon Web Services best practices and security. 

Clinical regulation

Regulatory commitment and clinical safety

ReHub AI allows you to see what was previously invisible: how the patient moves, executes each exercise, compensates, progresses, and when they need professional intervention.

The differential principle

More to see

Privacy and security

Privacy and security

ReHub® protects patient data through an architecture that prioritizes privacy, local processing and total control of clinical information. 

Frequently Asked Questions

Do you want to go into detail technical or regulatory?

We have Data Sheets, White Papers and regulatory documentation available to your legal, technical or clinical team. Request them.

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