NORDIC DIGITAL HEALTH
EVALUATION CRITERIA
ONE ASSESSMENT TO MEET THE DIGITAL HEALTH EVALUATION
REQUIREMENTS IN DENMARK, FINLAND, ICELAND, NORWAY, AND SWEDEN.
The Nordic Council of Ministers aims that, by 2030, the Nordics will be the most sustainable and integrated health region in the world, providing the best possible personalised health care for all its citizens. Considering this, the region has established the Nordic Digital Health Evaluation Criteria (NordDEC), a common set of standards for digital health technology to meet.
Taking inspiration from best practice digital health assurance processes worldwide, the NordDEC sets a standard across four important areas. These include data and privacy, technical security and stability, usability and accessibility, and professional and clinical assurance.
Products that have been evaluated against and meet the criteria are listed in a central directory, enabling health and care providers to identify trusted technologies and for patients to live and act in an open, seamless, and crucially safe, cross-border healthcare ecosystem.
The criteria also provide product developers and owners with clear visibility on what good looks like to inform product development, market access strategies and commercial positioning.
The project is run by the Nordic Interoperability Project (N!P), jointly funded by Nordic Innovation and Nordic health tech industry, and operated by the Organisation for the Review of Care and Health Apps (ORCHA).
KEY BENEFITS
 |
BE PART OF A WORLD-LEADING HEALTHCARE SYSTEMPeople from all over the world look to the Nordic countries to see how it addresses social and demographic challenges. The NordDEC supporting the Nordic Health 2030 vision is another example. Undergoing the NordDEC will help you to be part of this world-leading initiative. |
 |
ONE SYSTEM TO ACCESS 27 MILLION PEOPLEIf your digital health product scores 65% or higher in each of the five quality assurance domains, your product will be listed in the Nordic Digital Health & Medication Platform, an efficient, centrally managed directory that health and care professionals from across all five countries can access to find products that are safe to recommend to over 27 million people. |
 |
A SPRINGBOARD FOR INTERNATIONAL GROWTHAs many of the requirements are common, participating in a NordDEC, gives you much of the evidence needed to meet the requirements in other international markets, such as the UK, Netherlands, Canada, The USA, and the forthcoming cross-borders ISO 82304-2. |
FEATURES
DATA AND PRIVACY
This includes checks for criteria such as General Data Protection Regulation (GDPR) regulations and Data Protection Impact Assessment (DPIA), privacy policy, including how data is stored, used, and transferred.
PROFESSIONAL ASSURANCE AND CLINICAL SAFETY
These sections first evaluate if your app is a medical device and if yes does it have correct regulatory approval, whether there is professional backing throughout development, and if there is evidence to support the efficacy of your product. The section also looks to check all clinical safety documentation to ensure the developer has given proper consideration and mitigations to the possible health risks that may come from use of the app.
USABILITY AND ACCESSIBILITY
Within this evaluation section, the criteria look if you considered good app development practices, such as WC3, WCAG 2.0 AA, WCAG 2.1 AA, ISO 9241, Apple HIG, or Android App Quality Guidelines as well as how the well digital health product supports the patient during their user experience, such as whether forums are moderated and what accessibility features are in place.
SECURITY AND TECHNICAL STABILITY
This section looks to see how the digital health product suitably employs appropriate security by design principles across the entire lifecycle. The section takes a holistic approach, looking to capture compliance with regulatory and data privacy obligations, addressing potential risks, and implementing robust security measures throughout the development lifecycle.
INTEROPERABILITY
The interoperability aspect seeks to identify if your product exchanges data with other systems and if so, does it do so in an appropriate and secure fashion. With the power of the NordDEC the exact criteria set within this section can be adapted to best suit the requirements of each individual region.
The number and nature of questions applicable for each product vary depending on its complexity and functionality. This approach to classification is informed by global approaches, including those put in place by the UK’s National Institute for Health and Care Excellence. After the NordDEC has been conducted, the digital health developer is given a 10-day period during which they can review the evaluation and provide any additional information to inform the evaluation.
If a product achieves a score of 65% or above it will be included within a directory of trusted digital health products that have all been assessed against the NordDEC, to be accessed by health and care systems across the Nordics. You will also receive a NordDEC approved badge and certificate.
Once finalised, regardless of the score, every digital health developer is given a confidential improvement report, giving specific guidance as to how their product can meet more of the NordDEC compliance requirements and gain a higher score.
GET YOUR PRODUCT NORDDEC COMPLIANT
The NordDEC assessment is available as part of the ORCHA level two annual subscription. This includes a range of benefits, including a NordDEC assessment following every product update, to ensure your compliance is always up to date and two competitor benchmark reports, giving you unique insight into your competitive standing.
