Common Nordic digital health evaluation framework launched
Digital Therapeutics (DTx) is a growing trend and is increasingly a recognized market providing an important supplement to the established trillion USD pharmaceutical market (traditional medicine). The DTx trend is evolving fast. In June 2022 the Nordic Digital Health and Evaluation Criteria (NordDEC) program has been created. The NordDEC is a world-first program to unify digital health standards across multiple countries, delivering safe digital health across Sweden, Denmark, Norway, Finland and Iceland.
- The NordDEC digital health evaluation criteria help differentiate and create visibility for high-quality evidence-based Digital Therapeutics (DTx), relative to so-called ‘health apps’, which do not have evidence or live up to high-quality standards.
- Standardized digital health frameworks like NordDEC make it easier for Digital Therapeutics companies like Brain+ to scale across the Nordics and other markets.
- In the Nordic countries, half a million people suffer from dementia disease or mild cognitive impairment, the target disease areas for Brain+.
We welcome the NordDEC initiative, as it will mean that we will be able to scale much more smoothly across not only the Nordics, but also across other geographies because the NordDEC criteria set a high quality bar. I hope and foresee that an initiative like the NordDEC is a first step towards national and regional Nordic reimbursement pathways as well. This is great step for digital therapeutics in the Nordics.
Kim Baden-Kristensen, CEO of Brain+
NordDEC will create trust among medical professionals to prescribe Digital Therapeutics
In several ways, the DTx market has been emerging in Europe since its inception in the US in 2017 (with the founding of the Digital Therapeutics Alliance). In the same period 350,000 unregulated health apps have been launched into what has been termed the ‘wild west’ of health apps, often with unsubstantiated claims, limited credentials and rarely with any clinical evidence. Hence, there is an urgent need for new standards to carve out serious and proven technologies validated by clinical evidence and living up to the highest safety and quality standards.
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 standardized 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. 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 (NordDEC.org).
NordDEC program
On NordDEC from key stakeholders
NIP’s (Nordic Interoperability Project ) 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.” (NordDEC.org)
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.” (NordDEC.org)
Dementia in the Nordics
The number of people with dementia in the Nordic region is expected to increase sharply, now that the large number of people born in the 1940s are reaching old age, and it is estimated that the incidence of dementia will have doubled by 2050. (Nordic Dementia Network)