Table 1 Five potential approaches to improving the quality of medical apps
From: ‘Trust but verify’ – five approaches to ensure safe medical apps
Approach | Who leads the approach? | Emphasis of approach | Strengths | Weaknesses |
|---|---|---|---|---|
Boost app literacy | The medical technology community | Educate consumers on how to make better decision | Empowering, educational, low-cost, no barrier to innovation | Difficult burden remains on patients, no oversight or enforcement |
App safety consortium | App developers, safety researchers, regulators, patient advocates | Identify harms arising from health apps | Gathers data, raises concerns appropriately | Low yield, no current infrastructure, funding |
Enforced transparency | App Stores and Researchers | Enable external validation by third parties | Continuous quality assessment, enforceable by app stores | Threat to competitiveness, additional work for developers |
Active medical review | App Stores | Medical review of every app before release to the public | Robust, enforceable, drives quality and safety | Barrier to innovation, reduces number and diversity of apps, costly, slow |
Government regulation | Regulators, e.g., Food and Drugs Administration, Medicines and Healthcare products Regulatory Agency | Medical review of every app before release to the public | Existing powers, enforceable, drives quality and safety | Very slow, cost borne by government, barrier to innovation |