Digital health product assessment frameworks are a systematic way to ensure you meet standards and regulations.
Meeting such criteria reassures commissioners and health care professionals about your product’s safety and reliability. They are also helpful for guiding product development, accelerating the adoption of best practice.
But which frameworks are most relevant? How do you establish if you comply with them quickly and efficiently? How do you provide evidence of compliance? And most importantly, how do you continue to meet compliance with every product update?
ORCHA is your partner to find and continuously meet the standards you need for growth.
Take a look at some of the assessments we can offer for your product.
Global ORCHA Baseline Review (OBR)
Our ORCHA 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.
An OBR assessment provides your digital health product, or app, independent verification and certification, which is trusted and accepted by health and care organisations internationally.
UK NHS Digital Technology Assessment Criteria (DTAC)
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 you 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.
Case study
Three digital health suppliers share their experiences of working with ORCHA
“ORCHA provides a great platform and mechanism for people to search out information for themselves, where they can view credible and trustworthy information.
“For companies like us, it’s amazing to be part of an ecosystem that has been validated and that is proven to create value. We’ve been collaborating with ORCHA for several years now, and it’s always been an amazing partnership and collaboration.”
– Felicia Vaz, Project Manager, FibriCheck
