Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification With Top Health Apps in the United States: Quality Improvement Study.

The FDA's risk-based framework has the potential to improve the efficiency of the regulatory review process for health apps. However, we were unable to identify a standard measure that differentiated apps requiring regulatory review from those that would not. Apps exempt from the review also carried concerns regarding privacy and data security. Before the framework is used to assess the need for a formal review of digital health tools, further research and regulatory guidance are needed to ensure that the Pre-Cert Program operates in the greatest interest of public health.