ORCHA Baseline Review (OBR)

The global foundation for digital health compliance and assurance

The ORCHA Baseline Review (OBR) is an independent, objective assessment of digital health technologies against over 350 granular criteria, transforming complex standards into clear, comparable compliance.

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Region

global region
Global - adopted and adapted across 10+ countries

Purpose

Foundation assessment for safe, effective digital health

Alignment

Mapped to GDPR, NICE ESF, MDR, ISO standards and more

What is covered in the OBR

The ORCHA Baseline Review provides a consistent, objective, and evidence-based method to evaluate digital health technologies (DHTs) across three critical domains:

Data & Privacy

Protecting personal data through lawful, transparent processing.

Professional Assurance

Governance, regulatory status, and proportionate evidence requirements.

Usability & Accessibility

Inclusive design, accessibility standards, and user-centred development.

Why the Baseline Review exists

Digital health products are evolving faster than traditional health technology assessments can manage. The OBR was designed to solve that, offering a practical, scalable, and internationally relevant framework that makes it possible to assess any digital health solution fairly and efficiently.

It brings together the essential elements of multiple national and international standards - such as GDPR, DCB 0129/0160, ISO 27001, and the NICE Evidence Standards Framework - into one coherent and testable model.

Purpose: To give health systems, regulators, and suppliers a shared global language for quality and compliance in digital health.

A 350+ point assessment that underpins over 70% of the world’s digital health accreditation models

The ORCHA Baseline Review (OBR) is the world’s most widely adopted foundational assessment for digital health technologies. Now in its 6th iteration, it has been refined through 30,000+ assessments to provide consistent, objective, and scalable assurance.

OBR translates complex regulations and best practice standards into more than 350 binary, evidence-based micro-criteria. This ensures a level playing field for suppliers and fair, transparent comparisons for buyers.

ORCHA Assured: The benchmark of trust

The ORCHA Baseline Review underpins ORCHA Assured Bronze certification. Products that successfully meet OBR requirements can achieve ORCHA Assured Bronze status, signalling independent validation across core compliance domains.

Once assessed, products are:

Eligible for ORCHA Assured certification

A globally recognised assurance standard

Listed in ORCHA Verify with increased visibility

Used by the public for instant compliance and assurance status checks

Included in ORCHA Compare with increased visibility

Used by NHS for detailed compliance intelligence

Learn more about ORCHA Assured

Frequently Asked Questions

What is the ORCHA Baseline Review (OBR)?

The OBR is ORCHA’s core digital health assessment framework. It evaluates apps and digital health technologies across key domains including data protection, clinical safety, evidence, and usability. It provides an objective, structured way to determine whether a product meets recognised quality and compliance standards globally.

Who uses the OBR?

The OBR is used by national health systems, regulators, and digital health programmes around the world, including the NHS, the Mental Health Commission of Canada, the American College of Physicians, and the Nordic Council of Ministers. It’s also adopted by developers and suppliers seeking to demonstrate their compliance and readiness for health system deployment.

Is the OBR assessment publicly available?

The domains and principles of the OBR are openly shared, but the detailed question set and scoring logic are proprietary to ORCHA. This protects the integrity of the framework while ensuring transparency in how products are evaluated — all assessments are version-controlled and applied consistently across the ecosystem.

How long does the OBR assessment take?

Timeframes vary by product complexity, but most reviews are completed within a few weeks of receiving all required information.
ORCHA’s assessment team provides clear guidance and support throughout the process.

How can I start an assessment?

You can begin the process by contacting ORCHA’s team or signing up through the [Get Assessed] or [Talk to us] links. An ORCHA representative will guide you through the submission process and help identify the right pathway for your product.