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.
From fragmentation to structure
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.
A common model for quality and trust
In many ways, the new system brings major improvements by:
- The authorities have adopted a systematic quality assurance model, sanctioned by the Departament de Salut, Generalitat de Catalunya.
- TIC Salut Social Foundation was commissioned to develop the framework, conduct the reviews and manage the results.
- Approved applications are listed in an open, public library showing the degree to which they fulfil the criteria.
- The common model simplifies both the procurement and deployment of digital solutions. Clear and common quality requirements also provide a more predictable route to market for companies developing health apps.
Opening the market to eight million users
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.
Clear parallels to Swedish challenges
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.”
Providing important insights for Sweden
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.