Digital Health Assessment Framework
Make sure your digital health product meets US standards and regulatory requirements
With more than 86 million Americans already using a health or fitness app, digital health brings new possibilities for the healthcare industry. But, as most health apps fall outside of existing regulations, federal laws, and government guidance, there has been no straightforward way for healthcare providers to decide if a product is safe to use.
To address this assurance gap, the American College of Physicians (ACP), American Telemedicine Association (ATA), and the Organization for the Review of Care and Health Apps (ORCHA) developed the Digital Health Assessment Framework (DHAF), an open framework of 400 criteria, to support the identification and adoption of high-quality digital health technologies.
The Assessment covers three main domains:
- Clinical assurance and safety
- Data and privacy
- Usability and accessibility
You must gain an overall score of 65% in all three main domains to be DHAF compliant.
Crafted to support U.S.-specific guidelines, regulations and best practices, the Framework 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.
The ORCHA assessment platform assesses products accurately and rapidly against the DHAF criteria. Available as part of our ORCHA annual assessment subscription, this includes:
- A confidential report on how well your product meets the DHAF criteria, with a unique insight into your competitive standing.
- If you pass, a certified badge that you can display online to provide independent proof of compliance.
- Products that meet the criteria are listed in a central directory. This is used by payers, providers, and insurers to identify technologies.
- A DHAF reassessment every time you update your digital health product.
For those seeking added technical assurance on the security of their app, the Framework also includes the DHAF Plus (+DHAF), which features a fourth category of checks around technical security and stability standards.
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.
To pass the DHAF and +DHAF, a product needs a score of 65% or above in all categories.
Protect yourself from legislative risks
Meet standards for your digital health product to be used by the US healthcare industry
Expand your reach
Pass the DHAF assessment and get listed in our central US digital health product directory
Increase trust in your product
Show patients and healthcare providers that they can trust you with our DHAF badge
Future-proof your compliance
Get reassessed any time you update your digital health product, and if standards change, for continuous compliance
Get your product DHAF compliant
The DHAF assessment is available as part of the ORCHA level two annual subscription. This includes a range of benefits, including:
- A DHAF reassessment every time you update your digital health product, to ensure your compliance is always up to date.
- Two competitor benchmark reports, giving you unique insight into your competitive standing.
- Start your product assessment within 10 working days of the signed contract.
What is the Digital Health Assessment Framework (DHAF)?
The Digital Health Assessment Framework is a US assessment that checks if your digital health product, or health app, meets the requirements of 400 criteria. These are 400 questions that we answer to score your digital health product against three main domains: clinical assurance and safety, data and privacy, and usability and accessibility.
An enhanced assessment includes a fourth domain: technical security and stability which reflects HIPAA guidelines in the United States and ensures appropriate provisions in place for protected health information.
You need to pass the DHAF so your digital health product will surface on our customer organisation App Libraries, Digital Health Formularies, and Digital Health Toolkits, which we develop for health and care organisations to access digital health products.
How can I assess my digital health product against the DHAF?
We can assess your digital health product, or health app, against the DHAF as part of our annual assessment subscription service.
How much does a DHAF assessment cost?
Please contact us through our free online contact form to see what our current offers are and speak to our team for next steps.
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New Digital Health Assessment Framework Launches in the US
“Although it’s designed specifically for the needs and requirements of the US market, the Framework doesn’t try to reinvent the wheel. It recognizes and points to relevant existing US regulations, and applies several leading international standards and frameworks”
– Tim Andrews, COO at ORCHA
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