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BioCentury

PART 1

Rules of the Road

PART 2

Privacy, transparency and consent

PART 3

Criteria of demarcation

PART 4

Rethinking first principles

ARTICLE | Product Development

Rethinking first principles

Back to School Part 4: Digital health will call for a new set of first principles for clinical development

C. Simone Fishburn, Editor in Chief; Erin McCallister, Senior Editor; and Steve Usdin, Washington Editor
August 31, 2019 5:31 AM UTC

Stakeholders will need to draft a new set of first principles to inform the rules of the road for digital health, because many of the traditional elements of clinical development may not have meaning. Drug developers, regulators and payers will need to continually re-examine the foundations underlying validation, efficacy and outcomes.

Succeeding in digital health will mean being prepared to abandon some deeply embedded concepts, and creatively bridging from analog paradigms that have been the basis of drug development and reimbursement...

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