Pilot study: Quality assurance of health applications
DigitalWell Arena conducted a feasibility study on quality assurance of health apps from autumn 2023 to autumn 2024. The purpose was to develop a basis for establishing a framework and organisation for coherent quality assurance of health apps in Sweden.
The work has included a GAP analysis prior to establishment, testing of the Nordic quality framework NordDEC on three Swedish health apps and benchmarking of how similar work is progressing in the Nordic countries. In parallel with this project, the technical specification ISO/TS 82304-2:2021 has been reviewed.
The feasibility study has resulted in a report. It is aimed at national decision-makers in view of the proposal to establish a framework and organisation for quality assurance of health apps in Sweden. The report is also aimed at regional and local decision-makers who are responsible in various ways for the assessment and implementation of health apps.
The report will be widely disseminated to organisations where digital health and medtech is a strategic issue, incubators, health app developers and healthcare providers.
Recommendations for further work
The report results in a number of joint recommendations. They point out the direction for further work in Sweden, such as
- National requirements for the application of a common quality framework are needed
– Clarifies limit values regardless of use.
– Common requirements for a health app provide a level playing field for manufacturers and comparability for users.
– Streamlines current business and procurement processes for both manufacturers and buyers. - An authority needs to be given national responsibility for quality assurance of health apps as a whole
– The great value lies in how the work is organised and carried out.
– A coherent responsibility provides clarity: the same health app can be further developed and move between different areas of use. - Even while waiting for a national decision, customers need to prioritise quality assurance
– Quality assurance requirements are the most crucial incentive for companies.
– App development is happening fast. Using common quality frameworks helps to identify the way forward for Sweden.
– Purchasing and procurement processes can already be improved in the short term by drawing on existing comprehensive quality frameworks.
– Has an impact on users’ trust in health apps and the quality assurance system. - Establish library of quality-assured health apps
– Clarify what quality-assured solutions are available on the market.
– Enable access to data as a basis for research and evidence. The EHDS also requires us to utilise health data more effectively.
