CEN-ISO / ISO 82304-2 Digital Health Assessment Framework

What Is ISO 82304-2?

ISO 82304-2, developed by the International Organization for Standardization (ISO) and CEN (the European Committee for Standardization), defines the quality and reliability requirements for all types of health and wellness software — from mobile apps and web platforms to connected digital health systems.

It establishes a common international benchmark for assessing health software against core domains of safety, security, usability, reliability, and effectiveness, creating a consistent foundation for national and regional certification schemes.

ORCHA contributed to the development and piloting of ISO 82304-2 through the EU-funded Label Digital Health project, alongside partners from 12+ European countries.

NordDEC acts as both a regional quality mark and a launchpad for global adoption, reflecting Europe’s highest assurance standards.

Why ISO 82304-2 Matters

Digital health has become global — yet until recently, there was no harmonised, cross-border definition of “quality.”

ISO 82304-2 fills that gap by providing a single technical standard recognised across Europe and internationally.

For developers, it offers clarity on design, evidence, and safety expectations.

For health systems, it delivers a trusted quality label that supports safe procurement, reimbursement, and integration of digital tools.

Core purpose:

To enable high-quality, interoperable, and trustworthy digital health software worldwide

What does the ISO 82304-2 cover?

The standard defines 81 quality requirements grouped across four main domains.

ISO 82304-2 applies to any digital health product, whether regulated as a medical device or not - complementing, not replacing, frameworks such as DTAC.

Product Information

Transparency about function, intended use, and developer responsibility.

Health & Safety

Clinical evaluation, risk management, and protection from harm.

Data Protection & Security

GDPR compliance, secure data handling, and information governance.

Usability & Technical Robustness

Accessibility, reliability, and lifecycle maintenance.

ORCHA and ISO 82304-2: From standard to real-world assessment

As a contributing partner to the EU Label Digital Health project, ORCHA helped translate ISO 82304-2 into an operational evaluation framework that can be applied consistently across markets.

Through this work, ORCHA:

Supported the definition of testable quality criteria and scoring guidance.
Helped pilot the standard with digital health suppliers across Europe.
Integrated ISO 82304-2 elements into the ORCHA Global Baseline Review (OBR) and ORCHA Assured schemes.

The result?

A harmonised approach that turns international standards into practical, scalable digital health assurance.

The Label Digital Health Certification

The Label Digital Health (LDH) scheme - built on ISO 82304-2 - enables suppliers to obtain an official quality label recognised by European regulators and health systems.

ORCHA supports innovators through the LDH certification journey by:

Conducting an ISO 82304-2-aligned pre-assessment to identify gaps.
Providing structured feedback and improvement guidance.
Facilitating certification with the authorised LDH body.
Enabling visibility through ORCHA Compare and international directories.

Why work with ORCHA on ISO 82304-2 and LDH

Deep expertise

ORCHA has assessed over 30,000 digital health products globally, embedding ISO 82304-2 principles into every review.

Integrated Frameworks

Our OBR v6 and ORCHA Assured schemes align directly with ISO 82304-2, ensuring consistent, evidence-based outcomes.

European Collaboration

Developed through an EU-funded consortium with 12+ partners, ISO 82304-2 reflects the best of European health and digital policy thinking - and ORCHA’s methodology is part of that DNA.

For Health Systems and Policymakers

ISO 82304-2 and the Label Digital Health framework help national and regional authorities:

Establish consistent quality benchmarks for software procurement and reimbursement.
Recognise trusted, independently assessed digital health products.
Strengthen cross-border trust and regulatory alignment across the EU.
Encourage innovation by offering a clear route to compliance.

The results:

A single European quality language for digital health, enabling innovation with confidence.

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ORCHA Assured: The benchmark of trust

Our frameworks underpin ORCHA Assured, a tiered certification that verifies digital health technologies against essential standards.

Bronze – confirms baseline compliance across privacy, safety, and usability.
Silver – adds deeper evidence and advanced usability checks.

Each ORCHA Assured product carries the ORCHA Guarantee - our commitment to independent, defensible assessment that reduces procurement risk and builds trust.

Learn more about ORCHA Assured

Frequently Asked Questions

What is ISO 82304-2?

It’s the international standard that defines quality and safety requirements for all health software, covering both medical and wellbeing applications.

Who developed it?

The standard was developed jointly by ISO and CEN, with support from an EU-funded consortium - including ORCHA - to ensure its practical application through the Label Digital Health scheme.

What does ISO 82304-2 aim to achieve?

To establish a common, internationally recognised definition of digital health software quality, supporting safe, secure, and effective innovation.

What is the Label Digital Health (LDH) scheme?

An EU certification based on ISO 82304-2 that awards a recognised “Digital Health Label” to products meeting the standard’s requirements. ORCHA supports suppliers through readiness and pre-assessment.

Does ORCHA provide ISO 82304-2 certification?

ORCHA is not a certification body but acts as an assessment and readiness partner, helping suppliers prepare for and align with ISO 82304-2 and LDH certification.

Is ISO 82304-2 recognised outside Europe?

Yes. As an ISO and CEN standard, it is recognised internationally and often used as a reference point for national frameworks and global assurance programmes.

CEN-ISO / ISO 82304-2: Health Software Product Quality Requirements

The international benchmark for safe, reliable, and high-quality digital health software.