Digital health innovation is an enabler of good and safe care and better health for individuals. However, the lack of a harmonised quality framework for health apps creates challenges in the form of an uncertain market and uneven use of the technology.
There are close to 300 000 health apps relevant to the Swedish market. Both manufacturers and buyers need to be able to quality assure health apps at different stages to ensure that they fulfil all necessary standards and requirements. DigitalWell Arena is therefore working in several ways to help make it easier for companies, the public sector and individuals to interpret the quality of health apps.
The use of digital tools and services in the health sector is regulated with high quality requirements, while social services lack a clear framework for interpretation. Both contribute to a sluggishness in the implementation of new digital solutions.
At the same time, health apps for self-care and well-being are freely available to individuals via, for example, the App Store or Google Play, but it is difficult for individuals to know whether the technology is safe and user-friendly.
Companies developing health apps are faced with 290 municipalities and 21 regions that have different requirements and interpretations of what constitutes quality for a health app. As a result, companies are looking to other countries that have markets with clearer quality requirements and thus Swedish users are missing out on good solutions.
Quality assurance of health apps is crucial to enable synergies and accelerate uptake. Health apps with a medical purpose are CE marked under the EU Medical Device Regulation (MDR). However, health apps that are not medical, or are in a grey area, lack a uniform quality structure to validate against. This makes it difficult to assess their safety and effectiveness.
Ensuring a structured validation of all health apps is a recognised way to indicate that they are safe to use, provide the intended effect and a prerequisite for users to have trust and confidence in the product, e.g. as for over-the-counter and prescription medicines.
Individuals use digital health applications to manage their health regardless of whether they are quality assured or recommended by the healthcare system. DigitalWell Arena is therefore driving the issue of common standards for quality assurance nationally together with other key stakeholders.
Knowledge of testing is a crucial quality factor in the development of new digital health services. Innovative companies rely on early-stage testing to understand what is required to develop the service and to verify both technical and user needs and challenges. As the service becomes more finalised, real-world testing is needed to verify that the service works satisfactorily for clients, users and investors.
The availability of testbeds is crucial.The public sector is a driving force and, by making real-life test environments available, can help to ensure that more innovations are realised and that the health services of the future are used. Another important role for the public sector is to increase knowledge about the possibilities of digital technology in its own organisation.
Public sector management and operations need to be confident that both testing and implementation are carried out safely and that the services used comply with laws and regulations.Interaction with innovative companies and digital technologies often raises complex issues and can require broad knowledge, which can be difficult to gather. It also places demands on resources, which can often be difficult to free up in public organisations.
The methodological support for Real World Testing can be used for training, development and procurement purposes.
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