Criteria of demarcation

Back to School Part 3: Clear lines must distinguish what will and won’t be regulated in digital health

PART 1

Rules of the Road

PART 2

Privacy, transparency and consent

PART 3

Criteria of demarcation

PART 4

Rethinking first principles

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Clear lines must distinguish what will and won’t be regulated in digital health. This involves new concepts of product identity and quality, entrenching the idea of continual change.

In digital health, many of the best ideas will come from outside the biopharma industry. That fresh thinking needs to be captured without allowing all app makers to claim the same health benefits, regardless of evidence and without scrutiny.

“What’s the difference in an app that someone can download for well-being versus a digital therapeutic that’s prescribed, with outcomes that are something payers pay for?” said Ameet Nathwani, chief digital officer, CMO and EVP of medical at Sanofi.

Pear Therapeutics Inc. faced these issues when it developed reSET, the first digital therapeutic to gain FDA approval.

Pear CMO Yuri Maricich told BioCentury the company grappled with how the product would fit into the landscape of therapies. “How do we fit into the standard of care? How does

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