BioCentury
ARTICLE | Product Development

Criteria of demarcation

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

August 31, 2019 5:33 AM UTC

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...