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Digital Health Assessment Frameworks

Building global trust in digital health, through proven, standards-based evaluation.

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Why Assessment Frameworks matter

ORCHA’s assessment frameworks provide a consistent, evidence-based way to measure digital health compliance and quality, helping suppliers gain recognition and enabling healthcare systems to procure with confidence.

With over 38,000 assessments completed across 9,000+ products, ORCHA’s frameworks are the world’s most widely used standards for digital health assurance.

Learn more about ORCHA's assessment frameworks

ORCHA Global Baseline Review

The world’s most trusted foundation for assessing digital health quality and compliance.

Digital Technology Assessment Criteria (DTAC)

The NHS standard for safe, effective, and compliant digital health technologies.

U.S. Digital Health Assessment Framework (DHAF)

The U.S. benchmark for privacy, safety, and clinical quality in digital health.

NordDEC – Nordic Digital Health Evaluation Criteria

A unified Nordic framework ensuring trusted, cross-border digital health adoption.

CEN–ISO / ISO 82304-2

The international quality standard defining safe and reliable health software worldwide.

ORCHA India Data Protection Mark (OIDPM)

The trusted Indian benchmark for data privacy and compliance under the DPDP Act 2023.

The ORCHA Global Baseline Review (OBR)

Our ORCHA Global Baseline Review (OBR) is a 350+ point digital health product assessment that underpins over 70% of the world’s national and regional digital health accreditation models.

It is used to evaluate digital health products across five domains:

  • Data & Privacy – how information is handled, stored, and protected.

  • Clinical Regulation & Safety – compliance with medical device and clinical safety standards.

  • Evidence & Outcomes – proof of effectiveness and impact.

  • Usability & Accessibility – ease of use and inclusivity.

  • Ongoing Compliance – continuous monitoring for updates and changes.

Built for objectivity and repeatability, OBR ensures every product is assessed to the same standard, creating a level playing field across the market.

The ORCHA Global Baseline Review (OBR)

Developed by the NHS, the Digital Technology Assessment Criteria (DTAC) is an assessment framework you can complete yourself, or we can do it for you at ORCHA for independent verification.

Your digital health product, or app, must meet DTAC standards for NHS health systems in the UK to recommend it to the public or commission it.

US Digital Health Assessment Framework (DHAF)

The Digital Health Assessment Framework (DHAF), created by the American College of Physicians (ACP) and American Telemedicine Association (ATA) in collaboration with ORCHA, ensures your digital health product, or app, meets US standards and regulations, including HIPAA.

We can help you pass a DHAF assessment, to encourage healthcare professionals and patients to adopt your digital health product. 

Nordic Digital Health Evaluation Criteria (NordDEC)

The Nordic Digital Health Evaluation Criteria (NordDEC) is the world’s first cross-border digital health accreditation system spanning five countries, accelerating the Nordic region’s aim to be the most sustainable and integrated health region in the world by 2030.

We can help ensure your digital health product is compliant against the standards set out by the NordDEC.

CEN-ISO/TS 82304-2 digital health ISO

The CEN-ISO/TS 82304-2 digital health ISO is a new international technical specification for digital health products to meet, initiated by the European Commission.

ORCHA is part of the consortium working on the EU funded project and can help you to take steps to get ready for CEN-ISO/TS 82304-2 certification today.

Why choose an ORCHA framework

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Proven globally

From the NHS in the UK to the Nordic Council of Ministers, the Mental Health Commission of Canada, and the American College of Physicians, organisations rely on ORCHA’s evidence-based approach to ensure the products they commission or recommend are safe and compliant.

Suppliers get faster market access and health systems have confidence in consistency

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Built for digital health

Traditional medical device or ISO frameworks weren’t designed for digital health products. ORCHA frameworks are. They combine the rigour of established clinical, privacy, and regulatory standards with the agility to reflect app-based, web-based, and AI-driven tools.

Dynamic, evidence-based assurance model that's relevant to the realities of software-as-a-service

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Flexible and scalable

Each ORCHA framework can be adapted to national priorities or sector-specific needs, from mental health and wellbeing to population health or social care. Build upon the ORCHA Global Baseline Review to create local frameworks.

A single, standardised foundation that scales globally but customises locally

600k

healthcare professional network

38,000+

assessments delivered

1m+

Monthly users reached via partner channels

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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.

Trusted by the world’s leading health systems

When the NHS, health boards, and international health systems need a trusted way to assess, procure, and deploy digital health, they turn to ORCHA.

For over a decade, we’ve been the partner of choice for NHS Trusts, ICBs, national regulators, and ministries of health across Europe, North America, and Australasia. These organisations rely on ORCHA to:

Set a standard

Using the ORCHA Global Baseline Review, which underpins NHS DTAC, US DHAF and more

Provide confidence

With over 31,000 independent assessments completed

Access safely

Millions of patients and clinicians already access trusted tools via ORCHA-powered formularies

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Build trust in digital health technology

Talk to us about building your own assessment or explore how ORCHA’s frameworks can support your assurance goals.