Academic Journal
The regulatory status of health apps that employ gamification
| Title: | The regulatory status of health apps that employ gamification |
|---|---|
| Authors: | Oscar Freyer, Kamil J. Wrona, Quentin de Snoeck, Moritz Hofmann, Tom Melvin, Ashley Stratton-Powell, Paul Wicks, Acacia C. Parks, Stephen Gilbert |
| Source: | Scientific Reports, Vol 14, Iss 1, Pp 1-18 (2024) |
| Publisher Information: | Nature Portfolio, 2024. |
| Publication Year: | 2024 |
| Collection: | LCC:Medicine LCC:Science |
| Subject Terms: | Medicine, Science |
| More Details: | Abstract Smartphone applications are one of the main delivery modalities in digital health. Many of these mHealth apps use gamification to engage users, improve user experience, and achieve better health outcomes. Yet, it remains unclear whether gamified approaches help to deliver effective, safe, and clinically beneficial products to users. This study examines the compliance of 69 gamified mHealth apps with the EU Medical Device Regulation and assesses the specific risks arising from the gamified nature of these apps. Of the identified apps, 32 (46.4%) were considered non-medical devices; seven (10.1%) were already cleared/approved by the regulatory authorities, and 31 (44.9%) apps were assessed as likely non-compliant or potentially non-compliant with regulatory requirements. These applications and one approved application were assessed as on the market without the required regulatory approvals. According to our analysis, a higher proportion of these apps would be classified as medical devices in the US. The level of risk posed by gamification remains ambiguous. While most apps showed only a weak link between the degree of gamification and potential risks, this link was stronger for those apps with a high degree of gamification or an immersive game experience. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 2045-2322 |
| Relation: | https://doaj.org/toc/2045-2322 |
| DOI: | 10.1038/s41598-024-71808-2 |
| Access URL: | https://doaj.org/article/6e87134c271d45bba890cc237a87ec40 |
| Accession Number: | edsdoj.6e87134c271d45bba890cc237a87ec40 |
| Database: | Directory of Open Access Journals |
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| ISSN: | 20452322 |
|---|---|
| DOI: | 10.1038/s41598-024-71808-2 |
| Published in: | Scientific Reports |
| Language: | English |