A digital health app is a smartphone application that can help a person to manage a disease, monitor their symptoms, or improve their overall wellness. The app is usually prescribed by a physician or psychotherapist. These apps may be available for patients in various countries.
A review of recent studies has found that the current regulatory environment does not adequately protect users of digital health apps. Many apps are inaccurate and lack appropriate standards. These low quality apps can cause adverse outcomes.
Currently, the FDA does not fully regulate digital health apps. It does have some enforcement discretion for a small number of low-risk applications. However, it does not have an easy way to provide frequent post-approval updates.
To address this issue, a set of international standards is being developed to address some of the most pressing challenges facing digital health apps. These standards are designed to provide a framework for evaluating health apps. Specifically, they will identify relevant international and US standards, and will inform efforts to enhance the quality of health apps.
Why You Should Consider Investing in a Digital Health App
These standards are being incorporated into an emerging global digital health app database. A pilot test of this database is now being conducted by the ACP. It will include input from stakeholders and a review of many health apps. The database is a precursor to developing a more robust, evidence-based framework for evaluating digital health apps.
This will allow the ACP to produce a broader library of useable tools and provide guidance on the use of health apps. Moreover, the framework will be built on top of the existing NICE evidence standards framework in the UK. It will also consider input from a wide variety of parties, including patients, consumers, developers, clinicians, regulators, and more.