Evolving landscape of consumer‐based smartphone apps for skin cancer prevention and early detection

With smartphones now ubiquitous and easily accessible, mobile technologies are emerging as adjuncts to dermatological care. Building on protocols applied in 2017 and 2019, 1, 2 we conducted a cross-sectional study aimed to characterize the evolving landscape of consumer-facing apps for skin cancer prevention and early detection and extend prior work by examining their regulatory status. Between April 2025 and July 2025, Apple and Google Play stores were searched using the terms ‘skin cancer’, ‘mole’ and ‘melanoma’. Eligible apps referenced skin cancer prevention or early detection or mole tracking. Apps developed for clinician users, cosmetics or entertainment, appointment booking or those unavailable in Australia were excluded. Apps were assessed for functionality and indications of regulatory compliance, including European Union's Conformité Européenne (CE) marking, United States (US) Food and Drug Administration (FDA) approval or Australia's Therapeutic Goods Administration (TGA) registration, using information available in the app store and/or affiliated websites. A total of 34 apps were included (Table 1). Less than 21 per cent of apps included in past reviews were still available in 2025 (Table 1). Three apps identified in April 2025 became unavailable by July 2025, and one app (Scanoma) removed its artificial intelligence (AI) analysis feature in 2024, functioning exclusively as a teledermatology service in 2025. These findings highlight the dynamic nature of the skin cancer app market for consumers, where app availability and core functionalities can shift within months, possibly due to the growing emphasis on safety, quality and regulatory compliance. 23/43 apps found in 2017 are still available (47% attrition) 9/39 apps found in 2014 are still available (77% attrition) 14/66 apps found in 2019 are still available (79% attrition) 5/43 apps found in 2017 are still available (88% attrition) 2/39 apps found in 2014 are still available (95% attrition) Education about skin cancer prevention (n = 22, 56%) Monitoring/tracking of skin lesions (n = 24, 56%) Monitoring/tracking of skin lesions (n = 32, 49%) Education about skin cancer prevention (n = 23, 68%) Monitoring/tracking of skin lesions (n = 20, 59%) 28 (72%) free 11 (28%) required payments 23 (54%) free 20 (47%) requiring payments: For 12 months between 13. 82 and 37. 20 (mean 26. 81) 42 (64%) free 24 (36%) requiring payments: Between 13. 82 and 34. 99 for 12-month subscriptions (mean 27. 05) 16 (47%) free 18 (53%) requiring payments: Android Mean rating: 3. 5 (20 apps had reviews) Android Mean rating: 3. 4 (38 apps had reviews) Android Mean rating: 3. 8 (13 apps had reviews) Apple Mean rating: 3. 5 (13 apps had reviews) Apple Mean rating: 4. 0 (26 apps had reviews) Apple Mean rating: 4. 2 (19 apps had reviews) 2 apps had TGA approval 4 apps had CE-mark 0 apps had FDA approval 2 apps had GDPR 2 apps had HIPAA The proportion of apps reporting professional or clinician inputs increased from 10% in 2014 to 59% in 2025 (Table 1). Peer-reviewed evaluation of apps also grew from 8% in 2019 to 26% in 2025. Historically, the lack of expert involvement or validation raised concerns about inaccurate outputs or false reassurances. 3, 4 Encouragingly, apps in this study observed greater collaboration between developers and domain experts, alongside increased peer-reviewed evaluation. In this study, seven apps (24%) reported compliance with at least one regulatory requirement. In terms of compliance with safety and effectiveness, two apps had TGA approval, four had a CE marking, and none had FDA approval. Among AI-based apps available in Australia, only four (24%, n = 17) reported having TGA or CE approval. The expanded use of AI in health apps has prompted stronger regulatory oversight to safeguard user safety. Apps providing diagnostic or therapeutic functions are designated as Software as Medical Device (SaMD) and regulated by the Australian TGA since 2021. 5-7 Regulatory pressures may explain app withdrawals or core functionality shifts, with 18 apps removed following investigations by the British Association of Dermatologists or US Federal Trade Commission. 8, 9 Central distributing platforms, such as Apple and Google Play stores, can act as gatekeepers by ensuring that consumers access health apps that have been assessed for safety and effectiveness. 10 Notably, the overall user ratings had improved from 3. 5 mean star rating in 2017 to 4. 2 mean star rating in 2025, indicating higher user satisfaction. To enable longitudinal assessment of changes over time, this study was limited to smartphone apps available on Apple and Google Play stores using the key words from previous reviews, which may exclude other relevant apps. Reliance on app store descriptions, affiliated websites and targeted searches may also underestimate evaluation efforts. Results indicate that consumer-facing apps appear increasingly well designed with clinician input and validation data. Future research should examine how regulatory compliance is monitored and enforced and explore strategies to address barriers that may limit access to validated health apps. NHMRC Centre of Research Excellence (2006551), NHMRC Synergy Grant (2009923). MJ is supported by NHMRC Fellowship 2034422. The author (s) have no conflict of interest to declare. No ethics approval was required for this study, which uses publicly available data. Not applicable. The data that support the findings of this study are available from the corresponding author upon reasonable request.