Product Development

Back to School 2019: Rules of the road for digital health

On the cusp of one of the biggest transformations biopharma has seen, it&rsquo;s time to write the rules of the road for digital health.

Back to School Part 1: It’s time for the biopharma industry to write rules of the road for digital health

Criteria of demarcation

Clear lines must distinguish what will and won&rsquo;t be regulated in digital health. This involves new concepts of product identity and quality, entrenching the idea of continual change.

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

Rethinking first principles

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

Privacy, transparency and consent

Patients need to control the use of their data. This calls for new policies on transparency and consent, and means establishing systems governing the ownership, collection and agency of those data. 

Back to School Part 2: Ensuring patients control their own data is the first tenet of the rules of the digital road

<div class="articleContainer"><div class="articleWrapper"><div class="articleContent"><h1 class="text title">Rethinking first principles</h1><h2 class="title-bottom webtitle">Back to School Part 4: Digital health will call for a new set of first principles for clinical development</h2><div class="byline">C. Simone Fishburn, Editor in Chief; Erin McCallister, Senior Editor; and Steve Usdin, Washington Editor</div><div class="date"></div></div></div></div>

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