Recently, DigitalWell Arena and a delegation from the project “Capacity for Quality Assurance of Health Applications” visited Barcelona. The aim was to learn more about the structure launched in Catalonia in 2025. So far, only three services have been audited and certified, but great strides have been made on the journey Sweden has just started.
Over the past decade, Catalonia has been building a coherent system for digital health innovation, of which quality assurance of health apps is a key component. This work is led by the TIC Salut Social Foundation, which operates under the Catalan Ministry of Health, Departament de Salut, Generalitat de Catalunya.
The driving force has been to address the rapidly growing number of digital health solutions on the market and the need to be able to assess their quality, safety and utility in a consistent and transparent way. Previously, there were no uniform guidelines, which created uncertainty for producers, carers and users alike.
A basic inventory showed that around 300 applications were already in use in both primary and specialised care in Catalonia. However, access for patients was uneven and depended on the hospital or health centre to which they belonged. In addition, many of the region’s 70 or so hospitals were found to have developed their own digital solutions, in some cases for the same purpose.
In many ways, the new system brings major improvements by:
What makes the Catalan model unique is that it brings together all digital health solutions, regardless of user, under a government-led framework. In practice, this opens up a single market where certified health apps are made available to the region’s eight million inhabitants.
By launching the new model, Catalonia has taken a major step towards a safer, more efficient and equitable use of digital health services. For the healthcare sector, it means that authorised health apps can be rolled out more quickly, without the need for a full review by each operator. For patients and other users, it provides peace of mind and more equal access to digital tools, regardless of where they live.
Clear and common quality requirements also provide developing companies with a more predictable route to market – strengthening innovation across the ecosystem.
Marie Granander, project manager at DigitalWell Arena, sees the clear commitment of the authorities as a trigger for much of the progress made in Catalonia.
“Without a requirement for a national framework, there is also no clear incentive to adhere to a coherent system. In Sweden, we lack such a decision, and consequently also an organisation with responsibility for building and managing it.”
Marie Granander also sees several parallels between the fragmented picture that motivated the work of change in Catalonia and the challenges that exist in Sweden:
“Today, each region and municipality is independently responsible for assessing the quality of health apps. In practice, this means that a service must be reviewed by 21 regions and 290 municipalities before trust in the service is fully established nationally. This creates unequal access for users – and a difficult market for the companies developing the solutions.”
What makes the Catalan quality assurance model particularly interesting from a Swedish perspective is that it is based on the international technical specification ISO/TS 82304-2. It is also the basis of the Health Apps Quality Assurance Capacity project, led by DigitalWell Arena.
“The technical specification is already available to both buyers and developers to support them in assessing the quality of health apps. In the project, we are disseminating knowledge about the content to both the public sector and businesses. We are also capturing the views of municipalities and regions on the specification and will use it to evaluate a number of relevant applications. This will provide knowledge about how well it meets Swedish needs,” says Marie Granander.
Catalonia’s work provides a valuable insight into how a coherent quality assurance system can be built in practice. Although still new, the model shows how clear mandates and common guidelines can create the conditions for both trust and innovation, which are crucial for increasing the benefits of digital health technologies.
Here you can also register for public sector seminars, which provide a checklist for quality assurance of health apps based on the ISO/TS 82304-2 technical specification.
The prize is awarded by the Swedish Institute for Standards (SIS) to initiatives that demonstrate how standardisation can be used as a lever for innovation, societal benefit and enhanced competitiveness.
– It is incredibly gratifying that our work is being recognised in this way. From DigitalWell Arena’s perspective, it is crucial that Sweden has a uniform framework for quality assurance of health apps in place. Without such a framework, each region and municipality is forced to make an independent assessment, which creates a fragmented market that slows down both innovation and the use of digital health technology,” says Marie Granander, project manager at DigitalWell Arena.
Other nominees for the Standardisation Award are the Renewable 2030 project and the company MannTek. The winner will be selected by a jury and presented on 21 October. In addition to the honour, the winner will have the opportunity to donate SEK 25,000 to a charity of their choice.
– “This year’s finalists show how standardisation can be translated into concrete benefits for people, businesses and society. Whether it is digital health innovation, energy transition or sustainable infrastructure, we see how standards drive development,” says Annika Andreasen, CEO of the Swedish Institute for Standards, SIS.
DigitalWell Arena is now working to evaluate whether the international technical specification ISO/TS 82304-2 can form the basis for a Swedish framework for quality assurance. The work has resulted in, among other things, a seminar series that strengthens knowledge in the public sector. In addition, a number of applications will soon be quality reviewed according to the technical specification – to provide practical experience and contribute to future guidance.
The initiative is run in collaboration with ten partners: Leap for Life, Linnaeus University, DigitalWell Ventures, KTH Royal Institute of Technology, the Swedish Medical Products Agency, Swedish Medtech, Arvika Municipality, Region Värmland and Region Stockholm.
This time it came down to an honourable mention. When the winner of the Standardisation Award was announced on 22 October, it was MannTek, recognised for its pioneering coupling technology for sustainable cryogenic fuels – from the world’s first LNG-powered passenger ferry to new solutions for liquid hydrogen.
Although it didn’t go all the way this time, Marie Granander sees the nomination as a step towards more systematic and trust-building work with digital health in Sweden.“It helps to create attention and legitimacy for our work. Several other countries have come further, but our view is that more and more people in Sweden also recognise the value of a more uniform assessment of the quality of health apps. Ultimately, it’s about increasing the availability and usefulness of technology that can contribute to better health.”
Today, more than 200 000 health apps are available on the Swedish market. However, differing requirements make it difficult for municipalities and regions to determine which solutions are up to scratch. Unlike pharmaceuticals or medical devices, there is no national body that pre-screens health apps. Instead, it is up to each region and municipality to ensure quality – a responsibility that requires both knowledge and structure.
This is where the international technical specification ISO/TS 82304-2:2021 comes in. The specification summarises the relevant quality requirements for health apps and offers a common basis to start from. The seminar series builds directly on this knowledge and translates it into a concrete checklist.
During the seminar series, experts will guide you through four key areas:
Each seminar will combine lectures and dialogue, allowing participants to share experiences and contribute to common interpretations of the requirements.
“The seminar series is aimed at those who are both responsible for and use digital tools. By clarifying and increasing knowledge of the regulatory areas, we create the conditions for using health apps in a safe and effective way in Sweden,” says Mari Banck, development manager in Region Värmland.
The seminar series is organised by DigitalWell Arena, Leap for Life, Region Värmland and Linnaeus University within the framework of the project Capacity for Quality Assurance. In the project, a number of relevant health apps will also be quality reviewed in collaboration with companies, to gain experience in putting the technical specification into practice.
More than 200 000 health apps are available on the Swedish market, but their potential to contribute to better health remains underutilised. To find out why, DigitalWell Arena recently presented a feasibility study highlighting the main challenges. At its core, the lack of a national framework to evaluate the quality of health apps creates barriers for users, manufacturers and the healthcare sector.
The insights from the feasibility study were summarised in a report with a number of recommendations. The most central are that an authority needs to be given overall responsibility for quality assurance of health apps and that a national framework with a clear set of requirements begins to be applied.
In anticipation of structural changes, customers, not least in the public sector, need to prioritise increasing knowledge about quality assurance. The new project run by DigitalWell Arena, Leap For Life and Linnaeus University focuses on just that.
A key aspect is to get public customers to apply existing quality frameworks. In the first instance, these are frameworks that can take a more holistic approach, such as the Nordic quality framework NordDEC and the international technical specification ISO/TS 82304-2:2021.
– Even without a national decision, these frameworks provide guidance for evaluating the safety and efficacy of health apps. By gathering insights from both the public sector and companies, the project creates knowledge that will help show the way forward for Sweden,” says Marie Granander, project manager at DigitalWell Arena.
Four public actors are participating in the project: Region Värmland, Karlstad Municipality, Arvika Municipality and the Academic Primary Care Centre in Region Stockholm. Based on their needs, a number of relevant health apps will be selected for screening according to the existing frameworks.
– The aim is to interpret how companies and the public sector perceive the relevance and scope of the frameworks. It is also about identifying whether there are different interpretations of the regulations, or other obstacles to the use of health apps,” says Marie Granander, project manager at DigitalWell Arena.
Currently, the quality of health apps is assessed by each municipality and region. This slows down the pace of implementation and creates unequal access to new solutions across the country. For the companies, the unclear requirements picture means high development costs, as each customer sets its own requirements.
Anders Åmberg is the IT and digitalisation manager for health and social care in Arvika municipality, which is at the forefront of implementing safety-enhancing technologies in some areas. However, when it comes to implementing health applications, quality issues limit the level of ambition.
– A national framework would make things much easier. Today, a great deal of responsibility is placed on each individual municipality. Arvika is a small municipality with limited resources, and the work involved in quality assurance of a health application means that we have to make a hard prioritisation of what we can take in.
The project will organise several open seminars with the aim of raising awareness in the public sector about the possibilities of using common quality assurance frameworks. The long-term ambition is to lay the foundations of a community, where public actors can exchange experiences that will facilitate the evaluation and implementation of health apps.
The report is the result of a one-year feasibility study in which both authorities and industry organisations, including the Medical Products Agency, the eHealth Agency and Swedish Medtech, participated as an expert group.
– In fact, unlike several other countries, Sweden lacks a designated framework for evaluating all types of health applications. Without a national commitment and quality stamp, it is difficult to build trust and accelerate uptake. Today, there is often a lack of information on whether apps are safe or effective, making it difficult to make informed decisions for both individuals and the health and care sector,” says Marie Granander, project manager at DigitalWell Arena.
The conclusions of the report are summarised in a number of recommendations for further work. The most central ones are:
– Recommendations show that the question is not only about which framework to use, but also how to create a clear and long-term organisation of the work. It would be unthinkable not to have a national process for safe medicines. Similarly, we need a clear common structure for health apps,” says Marie Granander.
For companies, the lack of uniform requirements means that development costs increase, as the quality of apps is currently assessed by each individual customer’s requirements. Ultimately, this means that Sweden risks missing out on good solutions if companies turn to markets with clearer quality requirements and greater opportunities to scale their product.
The report identifies two existing quality frameworks for health apps, the Nordic NordDEC framework and the international technical specification SIS CEN ISO/TS 82304-2, both of which could provide a basis for quality assurance. As part of the feasibility study, three Swedish companies’ health apps have been assessed according to NordDEC. In the report, the companies share their views on the assessment process and the value they think it has added.
The insights from the feasibility study form an important basis for the continued work to get a national framework for quality assurance of health apps in place. DigitalWell Arena, together with several key players, has now been granted continued funding from the Swedish Agency for Economic and Regional Growth to take the work further.
– Even while waiting for a national framework to be identified, customers need to prioritise quality assurance. “For companies, it is a crucial incentive to support the requirements set by the buyer. Therefore, our focus now is to increase the knowledge of both manufacturers and buyers about the common frameworks that exist,” says Marie Granander.
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