Why Successful Digital Health Launches Start with Regulated IoT Infrastructure

One of the lasting markers of 2020 will be the speed with which digital transformation occurred within healthcare. Biopharma companies have played a pivotal role with companion apps, digital therapeutics and remote patient monitoring. Both patients and providers are turning to digital health tools to monitor symptoms and vital signs while outside of traditional clinical settings.

Clinical-grade digital health solutions require an infrastructure that can transfer, process and analyze data to support software that has a regulated intended use. This regulated software will require a more robust, regulated Software as a Service platform.

And although some digital health solutions may not require a regulated infrastructure at launch, future goals should be considered from the start to ensure that the technical and regulatory foundation will support more sophisticated versions of the tool without significant rework or limitations of intended use later.

This Biopharma Dive Industry Brief demystifies the regulated and unregulated platforms that serve as a foundation for digital health software, devices or combination products.

Bradley Merrill Thompson, Epstein Becker & Green, P.C., and Prasad Peri, Senior Director Global Regulatory Affairs CMC, Teva Pharmaceuticals and I lend our perspectives on foundational requirements for long-term digital health success. This includes:

Building digital health solutions using an IoT infrastructure that is regulated by the FDA and other regulatory bodies has many advantages. When the foundation is designed to manage regulated device data and protected health information, it is more likely to meet the criteria required as part of FDA’s design input and ultimate validation processes.

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