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Online Course

Unlocking Regulatory Success for Digital Health Product Developers

A good regulatory strategy is essential to a good business strategy.

I wish this course existed when we were getting started 10 years ago!

Howard Look, CEO of Tidepool

Course Overview

It’s difficult for digital innovators to know how to interact with regulators, which ones, and when. This course will remove the mystery. Learn how to build a fit-for-purpose regulatory strategy that strengthens your business strategy and differentiates your product in today’s digital health market.

Learning Outcomes

Identify whether digital health products in your portfolio are likely to be regulated and through which mechanisms. Build and implement a regulatory strategy that advances the success of your products. Build evidence based, high-quality products without paying for expensive consulting services.

Discover why good regulatory strategy is essential to a good business strategy.

Value of digital health regulations

Topics Include

  • Today’s Regulatory Landscape

What to know about the current and evolving landscape of digital health product regulation by FDA.

  • Elements of a Robust Strategy

Details on the components of a fit-for-purpose regulatory strategy and where to begin when building one.

  • Ensuring Successful Implementation

Obtain the skills necessary to implement your regulatory strategy and interact with regulators.

Meet the Instructors

Learn from DiMe experts and world class guest faculty – including legal, strategy, and security experts from industry, academia, and regulatory bodies – at the cutting edge of the most difficult ethical questions in digital health.

Bradley Merrill Thompson

Bradley Merrill Thompson

Epstein Becker Green

Attorney and Chief Data Scientist

Jennifer Goldsack

Jennifer Goldsack

Digital Medicine Society, Inc


Julia Croxen

Julia Croxen

Rock Health

Digital Health Strategy Consultant

Shrawan Patel M.D.

Shrawan Patel M.D.

Strategy Health

Managing Director

Tahir Rizvi

Tahir Rizvi

Caption Health

Head of Regulatory Affairs and Quality Assurance


    Read what our learners are saying…

    Learning from industry experts throughout this course was very impactful. The course helped me appreciate the challenges and successes of digital innovation using real world cases and provided an understanding of available toolkits to thrive in this volatile and uncertain landscape. I really appreciated the parts of the course that emphasized the need for partnership in development at every stage and the quality improvement tips provided.

    Courisse Knight | Patient Safety and Healthcare Quality Graduate

    The course provided a simple and efficient approach to developing a general understanding of the regulatory frameworks for digital health products–with links and references to dive deeper as needed.

    Omar Manejwala, M.D. | Chief Medical Officer, DarioHealth

    I think the regulatory chart/table for the different device categories is extremely helpful. I also think the outline for developing a fit-for-purpose regulatory strategy provides key guidance to unify the development of trusted digital health products.

    Samantha McClenahan | Program Associate, DiMe

    The emphasis for a fit for purpose reg strat is practical and not just a theoretical concept that I plan to back to work.

    Desmond Dorairajoo | Director, DCT

    Despite being one of the instructors in the course, I definitely learned one or two new things. However, maybe more importantly, the well thought through course structure really lends itself to seeing the bigger picture of digital health product regulation and how to use it to frame product development.

    Shrawan Patel | Managing Director, Strategy Health

    With the knowledge gained from this course I will now be able to confidently guide my digital health clients on every stage of developing and implementing a robust regulatory strategy.

    Richard Bartels | President, DTxCC (Digital Therapeutics Commercialization Consultants)

    Amazing content overall!

    Haresh Keswani | Head of Technology Architecture

    Working daily with med-tech start-ups this course will help us guide them through regulatory challenges, defining a pathway to move forward.

    Tanja Hellier | Digital Transformation Project Lead

    One of my clients has a new clinical research program and is open to innovation. We will develop technologies that reach patients and clinicians, and we will need to work closely with the FDA. I will return to this course to refresh on needed actions and take advantage of the organized, linked external resources and explanations. This course also provides the evidence we need to justify early and often communication with the FDA.

    Paul Martinetti | Principal Consultant, Digital Science Technologies LLC

    Great and comprehensive course about the regulatory strategy one has to consider while developing a digital health solution

    Philippe Lucarelli | Digital Strategy Lead

      What to Expect from DiMe Academy

      What sets us apart is why we’re known as the most trusted name in digital health innovation globally.

      Engaging Courses

      Interactive sessions cater to a variety of learning styles with videos, knowledge checks to test your understanding, and real-world examples.

      Flexible Learning

      You’re busy, and so is your team, so our courses are designed to deliver the material efficiently, but our platform is designed so you can return as many times as you need.

      Relevant Content

      Digital medicine is a fast paced field. We leverage our community to deliver up to date information from actively engaged, diverse experts.


      The views expressed in this course are solely those of the Digital Medicine Society (DiMe) and not the views or opinions of the FDA or anyone else. We hope that this course will help you and your business efficiently and effectively navigate regulatory requirements, but we make no guarantees. All information and materials are provided to you on an “as is” basis without any representation or warranty of any kind. This course is intended solely for general information and education purposes. It is not professional or legal advice or services. This course contains links to third party websites. These links are only for the convenience of the learner. DiMe is not responsible for any information accessed through them.

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