Digital Health Assessment Framework (DHAF)

Become DHAF Certified

Enter the US market with confidence, and ensure your digital health product is safe, by getting a Digital Health Assessment Framework review.

With a population of over 300 million people, and 97% of them owning a smartphone, the DHAF is your gateway to successfully launching your digital health product in the US.

The DHAF was developed by the American College of Physicians (ACP) and American Telemedicine Association (ATA), in partnership with ORCHA. At ORCHA, we can assess your digital health product against the DHAF. Health and care professionals will then have the confidence to recommend your digital health product to their patients.

Crafted to support U.S.-specific guidelines, regulations and best practices, the Framework includes three categories for digital health products to be checked against, including clinical assurance and safety, data and privacy, and usability and accessibility.

The DHAF supplies independent assurance that your product meets best practice and standards, keeping your digital health product where you want it to be, safe in the hands of patients.

BE SEEN AS A TRUSTED DIGITAL HEALTH PRODUCT

Getting your digital health product reviewed using the DHAF will show health and care professionals they can trust what you create. With trust, they can confidently recommend your digital health product to patients and service users.

EXPAND ADOPTION ACROSS THE USA

If your digital health product scores 65% or higher across the quality assurance domains, your product will be listed in an efficient, centrally managed directory that health and care professionals from across the USA can access to find products that are safe to recommend.

AVOID LEGISLATIVE RISKS OF NON-COMPLIANCE

Many companies are not aware of the standards a product needs for safe usage within a healthcare setting. The DHAF is constantly updated to ensure these are checked for, helping to avoid the legislative risks associated with non-compliance. With an ORCHA subscription, a confidential compliance improvement report detailing key actions to take is provided after every assessment.

The DHAF assessment includes more than 400 checks across three main domains:

✔️CLINICAL ASSURANCE AND SAFETY

The DHAF checks if a digital health product is safe and effective by using methodologies informed by global approaches. It identifies if your digital health product is a medical device, as outlined by the US Food and Drug Administration (FDA) and includes methodologies put in place by the UK’s National Institute for Health and Care Excellence.

✔️DATA AND PRIVACY

A close look is taken at the data privacy policy of a digital health product, and how it stores, uses, and transmits data. Part of the review process considers the Health Insurance Portability and Accountability Act (HIPAA), best practice European Union General Data Protection Regulation (EU GDPR) and US data management standards, such as Software Development Life Cycle (SDLC), or any International Data Management Standards such as ISO 27001.

✔️USABILITY AND ACCESSIBILITY

You can get a sense of how easy it is for patients to use your digital health product by looking at usability and accessibility. The DHAF looks at the design of your digital health product and how it was developed. For example, whether your digital health product follows design standards such as WC3, WCAG 2.0 AA, WCAG 2.1 AA, ISO 9241, Apple HIG, or Android App Quality Guidelines.

✔️TECHNICAL SECURITY

An enhanced DHAF review of your digital health product will look at how secure it is. For example, if your digital health product was built using Open Web Application Security Project (OWASP) guidelines.