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.
Makes a number of key recommendations
The conclusions of the report are summarised in a number of recommendations for further work. The most central ones are:
- National requirements for the application of a common quality framework are needed. Common requirements for a health app provide a level playing field for manufacturers and comparability for users, and streamline current business and procurement processes for both manufacturers and buyers. In addition, limit values need to be clarified not only for medical devices, but also for lifestyle and safety-enhancing technologies.
- An authority needs to be given national responsibility for the quality assurance of health apps as a whole. A coherent responsibility provides clarity for health apps that are developed and move between different areas of use.
- Establish libraries of quality-assured health apps. This will clarify what quality-assured solutions are available on the market and simplify access to data as a basis for research and evidence.
– 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.
Test of existing framework tool
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.
Taking the work further
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.