The new 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.
The certification scheme for the ISO will be introduced later in 2023, which will enable a digital health supplier to show compliance with the technical specification. This will help inform health care authorities and providers who review, procure or reimburse digital health. It will also act as an assurance label for patients and the public who use health apps.
Objectives of the CEN-ISO/TS 82304-2
The objectives of the new digital health specification are to:
- Help digital health app manufacturers benefit from enhanced single market conditions across Europe that facilitate economies of scale.
- Enable healthcare systems and authorities across Europe to integrate mHealth solutions more rapidly thanks to a European mHealth label.
- Empower citizens, patients, and health care professionals to make more use of trusted mHealth solutions to promote health and self-manage health care needs.
- Facilitate health systems and citizens with common pan-European principles for validation and certification.
- Enable European mHealth stakeholders to build upon a digital ecosystem around a trusted mHealth label, an EU-wide promotion and uptake of technical specifications for health and wellness apps.
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.
Get ready for your ISO certification
The CEN-ISO/TS 82304-2 is an international specification for digital health and includes criteria covering patient safety, quality of healthcare, effectiveness, interoperability, and productivity.
ORCHA can help digital health suppliers to prepare for certification of this important specification now, ready for when it is introduced later this year, by:
- Conducting the ORCHA Baseline Review (OBR) assessment, which covers criteria present in all international standards, including a proportion of the criteria included within the in-depth CEN-ISO/TS 82304-2, helping you gather the necessary evidence, and give you an indication of how your product will perform, in the relevant areas of the digital health ISO.
- Retain your OBR assessment supporting evidence to use and build upon for your CEN-ISO/TS 82304-2 assessment.
- Keeping you updated of the 82304-2 EU certification scheme as it is introduced.
Start your journey to achieving the digital health ISO certification today and build confidence that your digital health product will comply with the European market’s essential safety regulations.
Accelerate growth and reach new markets
Accelerate growth of your digital health product by meeting a standard recognised across Europe.
Insights to prepare
Receive the results of your 350+ point OBR assessment and your in-depth improvement report, giving you insights as to how you will perform in the ISO.
Your recognised quality mark
Gain an OBR score and badge, internationally seen as a recognised mark of quality.
Future-proof your compliance
Safely keep the quality evidence compiled for the OBR with ORCHA for your ISO application.
Get an OBR assessment of your product
The OBR quality assessment is available as part of our ORCHA level one annual assessment subscription, which will prepare you for the European CEN-ISO/TS 82304-2.
The OBR digital health assessment includes:
- An OBR reassessment every time you update your digital health product.
- A benchmark report, with a unique insight into your competitive standing.
- Product assessment completed with feedback in 20 working days from contract start.
Meet the OBR health app quality standards as part of your preparation for the CEN-ISO/TS 82304-2 digital health ISO.
What is the ORCHA Baseline Review (OBR)?
Our ORCHA Baseline Review (OBR) is an assessment that checks if your digital health product, or health app, meets the requirements of 350 criteria. These are 350 questions that we answer to score your digital health product against three main domains: usability and accessibility, clinical or professional assurance, and data and privacy.
You need a minimum score to pass the OBR to surface on our ORCHA App Library, Digital Health Formulary, 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 OBR?
We can assess your digital health product, or health app, against the OBR as part of our annual assessment subscription service.
How much does an OBR 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.
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
