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.

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Region

AF Region - US
United States

Purpose

Provides US-specific assurance for digital health technologies, covering privacy, safety, usability, and clinical validity.

Alignment

Maps closely to OBR+ and ISO 82304-2, adding HIPAA-specific controls and FDA SaMD guidance.

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 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.

Domains covered in the DHAF

The DHAF provides a consistent, objective, and evidence-based method to evaluate digital health technologies (DHTs) across five critical domains:

Data Protection & Privacy

How information is handled, stored, and protected, specific to HIPAA & HITECH

Clinical Evidence & Efficacy

Compliance with medical device and clinical safety standards.

Security & Infrastructure

Aligned to NIST and ISO 27001

Usability & Accessibility

Ease of use and inclusivity.

Safety & Risk Management

What's included in the DHAF Assurance Scheme

Achieving DHAF assurance with ORCHA signals trusted, third-party validation of your product’s quality and compliance. It helps you differentiate, build buyer trust, and unlock new distribution and partnership opportunities.

What you get:

DHAF Evaluation Report

Accreditation via ATA/ACP

Visibility on ORCHA Compare

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Why DHAF 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 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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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.