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Harness the power to transform clinical development

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Institute Report
Digital Health Trends 2021
Innovation, evidence, regulation, and adoption
Jul 22, 2021
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Report Summary

Innovation in digital health tools, including mobile health apps and wearable sensors, bring new approaches to the management of health conditions. Digital therapeutics to treat human disease are being approved by regulatory agencies around the world and routes to reimbursement are being established as developers generate and submit high-quality data on effectiveness to payers and employers.

As these digital tools begin to have a fundamental impact on patient care and influence clinical trial design, it is important to assess the innovation and evidence they contribute as well as the barriers to and facilitators of their adoption.

This study of digital health covers trends in four areas — innovation, evidence, regulation, and adoption — to assess how these new tools are becoming an entirely new therapeutic modality alongside traditional medicines and medical devices.

Key Findings

Advancing regulatory approval and commercialization

Digital therapeutics (DTx) and digital care (DC) products and tools — which incorporate software as a means to treat, prevent or manage specific diseases or conditions — have been proliferating, and more than 250 such products are now identified, including about 150 products that are commercially available.

Growing maturity of clinical evidence

The overall body of clinical evidence on app effectiveness has grown, with more than 2,000 studies published since 2007, including almost 1,500 published in the past five years.

Overcoming barriers to adoption

Multiple commercialization pathways now exist for digital health tools, providing more opportunities to app manufacturers to realize an economic return on investment for those tools supported by robust evidence and user demand.

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