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DOI: 10.1038/s41746-019-0111-3 733.8 KB

The concept of digital health continues to evolve. Clinicians and patients should ask: Which solutions are substantiated and which, despite marketing claims, are not? First introduced in 2000 by Seth Frank, digital health largely encompassed internet-focused applications and media to improve medical content, commerce, and connectivity. The term digital health has expanded to encompass a much broader set of scientific concepts and technologies, including genomics, artificial intelligence, analytics, wearables, mobile applications, and telemedicine. In addition, digital health technologies are being applied much more broadly in medicine to include diagnosis, treatment, clinical decision support, care management, and care delivery. In 2018, the World Health Organization issued a detailed taxonomy of Digital Health, articulating dozens of facets of this expanding space.

Investment in the digital health sector is enormous, with nearly $6B in funding in 2017, increased from $4.4B in 2016. For mobile health applications alone, there exist more than 3,00,000 health apps with more than 200 health apps added daily. This highlights the increasingly voluminous and cluttered landscape all healthcare stakeholders—patients, providers, payers, industry, and regulators—must navigate. Their challenge is finding solutions that provide real value.

Currently, no reliable mechanism exists to identify validated digital health solutions. Payers, too, cannot easily identify quality in this crowded field. Regulatory guidance and oversight are limited, with enforcement restricted to companies that make claims out of proportion to the evidence or where application failures might lead to risks to patient safety.

Oversight frameworks of digital health have been proposed, which mainly focus on patient safety. Healthcare needs a robust and transparent validation process for digital health products. All healthcare stakeholders would benefit from a more standardized, objective, rigorous, and transparent process for validation.

Specifically, the validation domains would be technical validation (e.g., how accurately does the solution measure what it claims?), clinical validation (e.g., does the solution have any support for improving condition-specific outcomes?), and system validation (e.g., does the solution integrate into patients’ lives, provider workflows, and healthcare systems). A proposed pathway is outlined. A forthcoming pilot study (and publication of a detailed corresponding framework) will contain finer details of the proposed pathway.

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