Digital Health Assessment Framework (DHAF)

Setting the U.S. standard for safe, effective, and trustworthy digital health.

The U.S. Digital Health Assessment Framework (DHAF) is a national model that defines how digital health technologies (DHTs) should be assessed for privacy, safety, effectiveness, and usability across the U.S. healthcare system.

Region: United States

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What is the U.S. Digital Health Assessment Framework (DHAF)

Developed collaboratively by the American College of Physicians (ACP), American Telemedicine Association (ATA), and ORCHA, the DHAF adapts the proven ORCHA Global Baseline Review (OBR) to U.S. regulatory and clinical requirements.

It offers a single, transparent method to evaluate digital health products consistently, ensuring that both innovators and health systems can trust the technologies they build, buy, and prescribe.

Why DTAC matters

Digital health innovation in the U.S. is growing rapidly, but oversight and assurance have been fragmented.

The DHAF bridges that gap by introducing a common quality benchmark that complements - not replaces - regulatory oversight from the FDA, HIPAA, and other authorities.

Core purpose:

To give providers, payers, and patients confidence that digital tools meet evidence-based, safety-focused standards that align with U.S. healthcare values.

ORCHA and DHAF: Pathway to US digital health assurance

The DHAF was developed by the American College of Physicians (ACP) and the American Telemedicine Association (ATA), in collaboration with ORCHA.

ORCHA acts as the assessment body, applying the DHAF criteria to digital health products via its established review processes.

Through ORCHA, suppliers can:

Undergo independent DHAF-aligned assessments.
Receive structured reports showing compliance with each domain.
Benchmark against global digital health standards.
Demonstrate trust and readiness to U.S. healthcare organisations.

The result?

Evidence-based assurance built on international best practice and localised to U.S. regulation.

Why work with ORCHA for your DHAF assessment:

Proven global methodology

Built on the ORCHA Global Baseline Review, already adopted in 10+ countries and 38,000+ assessments.

Aligned to U.S. regulation

Maps directly to HIPAA, FDA guidance, and ONC interoperability requirements, ensuring U.S.-specific relevance.

Trusted U.S. partnerships

Developed in collaboration with ACP and ATA, two of the most respected clinical and telehealth organisations in America.

For Health Systems and Payers

The DHAF offers U.S. health systems, hospitals, and payers a standardised, third-party-verified approach to evaluating digital health suppliers.

With ORCHA, organisations can:

Verify supplier compliance efficiently.
Build curated formularies of trusted digital tools.
Reduce procurement risk and due-diligence effort.
Support digital prescribing, reimbursement, and telehealth programmes confidently.

The results:

Better governance, safer adoption, and more effective use of digital health technologies across care settings.

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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 the DHAF designed to do?

The DHAF provides a standardised approach to evaluating digital health technologies in the U.S., ensuring they meet accepted standards for privacy, safety, and effectiveness before widespread use.

How does the DHAF relate to FDA or HIPAA requirements?

The DHAF complements, not replaces, existing regulations. It integrates FDA and HIPAA expectations into a comprehensive evaluation framework, offering a broader, more practical picture of digital health readiness.

Is the DHAF mandatory in the U.S.?

No, it’s a voluntary framework. However, many organisations use DHAF results to guide procurement, contracting, or partnership decisions, and some payers and states reference it within their evaluation processes.

How is the DHAF different from the ORCHA Global Baseline Review (OBR)?

The OBR is a global foundation; the DHAF is its U.S. adaptation. It retains OBR’s objectivity and structure while incorporating U.S.-specific standards like HIPAA, FDA, and Section 508.

Can a DHAF assessment count toward ORCHA Assured certification?

Yes. A DHAF review can be used as the basis for ORCHA Assured Silver certification, which extends the evaluation to international benchmarks and adds the ORCHA Guarantee.