Regulatory Roadmap for Digital Health Products

Why a Successful Launch of a Digital Health Product Starts with a Regulated IoT Infrastructure

Challenges with digital health regulation

The transformation healthcare delivery has experienced over the past decade accelerated dramatically in 2020. Telemedicine, once limited to rural communities, is now everywhere. Gene sequencing is helping researchers develop vaccines in record time. And patients and providers are turning to digital health apps and wearables as ways to monitor symptoms and vital signs.

Falling in line with the current “digital health revolution,” companies are taking more decisive steps to incorporate digital solutions into their product lines. But it’s not simple. And regulatory guidance doesn’t provide easy answers.

This Industry Brief from Biopharma Dive demystifies the regulated and unregulated platforms that serve as a foundation for digital health software, devices or combination products.

The Brief features insights from Bradley Merrill Thompson, Epstein Becker & Green, P.C., Prasad Peri, Senior Director Global Regulatory Affairs CMC, Teva Pharmaceuticals and Kal Patel, MD, CEO and Co-Founder, BrightInsight.

Biopharma and R&D 

Regulatory Roadmap

Download Biopharma Dive’s Industry Brief to learn about:

  • The difference between a regulated and unregulated Internet of Things (IoT) infrastructure
  • When (and why) digital health products need a regulated platform
  • How using a regulated platform from the outset can prevent future problems
  • The regulatory landscape for digital health and Software-as-a-Medical Device (SaMD)
  • Teva Pharmaceuticals’ regulatory journey to launch their suite of digital inhalers called Digihalers