The Nordic region aims to be the most integrated health region in the world by 2030, according to the Nordic Council of Ministers. A shift towards digital health, and its focus on the self-management of health by Nordic populations, will be an important step on this journey, but it also brings new risks.
Despite the 350,000 digital health technologies on the market, no standardised regulation or risk management system is in place in any of the Nordic countries. This has left medical professionals unable to find and prescribe digital technologies safely.
To resolve this critical issue and lead the world in adopting connected health technologies on a large scale, the Nordic Digital Health and Evaluation Criteria (NordDEC) programme, has been created. The NordDEC is a world-first programme to unify digital health standards across multiple countries, delivering safe digital health across Sweden, Denmark, Norway, Finland and Iceland.
The NordDEC will be launched at HIMMS Europe on 15 June, 2022, by the Nordic Interoperability Project (N!P).
The accreditation framework was developed by UK-based, ORCHA, the Organisation for the Review of Care and Health Apps, and the project is funded jointly by NIP and the Nordic healthtech industry.
The NordDEC will provide a system for healthcare providers in all of the five countries to evaluate and identify trusted digital health technologies within healthcare and preventive care. It will also give guidance to product developers and technology owners, so they have clear parameters when planning new products and new market access strategies.
Drawing from international best practice, the NordDEC establishes a common benchmark of criteria across the entire region, which provides safety and effectiveness assurance in digital health.
However, the framework needs to work seamlessly across five different countries, each of which has an autonomous healthcare system. To cater for this, it allows each country to add on localised accreditation criteria, over and above the region-wide baseline criteria.
The NordDEC will be an extremely robust digital health assurance system, testing products against more than 500 measures across data and technical security, clinical assurance and usability. To strengthen it even more, new criteria have been added, not seen in any other standards, for example, evidence of PEN and vulnerability testing will be required.
NIP’s CEO, Anders Tunold-Hanssen, said: “The Nordics is home to a vibrant and growing health tech industry. This programme provides suppliers with an attractive platform to reach the whole of the Nordics healthcare system, breaking down current barriers to market access. The next stage will be the creation of a digital library for the Nordics, containing thousands of top-quality apps which healthcare professionals can use safely and confidently.”
Founding CEO of ORCHA, Liz Ashall-Payne, said: “This has been a landmark project for ORCHA and all the countries involved and the learning can be rolled out across other geographical regions. It also gives suppliers a good springboard to easily meet the requirements to enter other geographies, such as the UK, Netherlands, Canada and the US.”
Further information about the framework can be found at: norddec.org