What is a Digital Therapeutic?

What is a Digital Therapeutic?

While definitions vary, digital health products usually refer to information and communications technologies used to send, receive or exchange medical information. Typical examples include telemedicine, mobile apps and predictive analytics.

More recently, however, with the realization that many digital health products are not subjected to clinical testing, a new category has emerged-digital therapeutics.

According to the newly formed Digital Therapeutics Alliance, digital therapeutics represent a new generation of healthcare that uses innovative, clinically-validated disease management and direct treatment applications to enhance, and in some cases replace, current medical practices and treatments.

DTx products demonstrate safety and efficacy in randomized clinical trials, receive regulatory clearance when used as a medical device, integrate into clinical practice, may be prescribed by healthcare providers, and tailor to patients’ clinical needs, goals, and lifestyles.

Yet, many questions remain when it comes to scrutinizing whether something is a "digital therapeutic"

  1. What is the intended use?
  2. How was safety, efficacy and cost-effectiveness demonstrated in clinical trials?
  3. How do the results of the trials compare to outcomes when used in a larger general population.
  4. How was quality defined and measured?
  5. How was cost determined?
  6. How does the value compare to the present standard of care and how and by how much does it reduce overall cost? Over what period of time?
  7. Are there different standards for stand alone digital therapeutics when compared to combined products like smart pills or smart implants?
  8. Should FDA clearance be a prerequisite for inclusion?
  9. What issues arise when AI is a component of the therapeutic e.g. clinical or patient decision support software?
  10. What are the limits of product liability when things, inevitably, go wrong?
  11. How we create a digital therapeutics clinical trials ecosystem that is cheaper, faster and easier to use than the problematic clinical trial ecosystem for drugs and devices?
  12. What will be the impact on digital health investment levels if products have to undergo clinical trials and FDA clearance?

Digital therapeutics is the new word in the digital health lexicon. We will have to wait to see whether it is just parsing words or is something that actually delivers sustainable value compared to all the rest of digital health products.

Arlen Meyers, MD, MBA is the President and CEO of the Society of Physician Entrepreneurs

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  • Sean Ryan

    Thanks for the insights

  • Chloe Bartley

    This will replace medication with behavioral-based treatment

  • Hrishikesh Patil

    The rise of digital therapeutics clearly demonstrates the power of mobile computing

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Arlen Meyers, MD, MBA

Former Contributor

Arlen Meyers, MD, MBA is a professor emeritus of otolaryngology, dentistry, and engineering at the University of Colorado School of Medicine and the Colorado School of Public Health and President and CEO of the Society of Physician Entrepreneurs at www.sopenet.org. He has created several medical device and digital health companies. His primary research centers around biomedical and health innovation and entrepreneurship and life science technology commercialization. He consults for and speaks to companies, governments, colleges and universities around the world who need his expertise and contacts in the areas of bio entrepreneurship, bioscience, healthcare, healthcare IT, medical tourism -- nationally and internationally, new product development, product design, and financing new ventures. He is a former Harvard-Macy fellow and In 2010, he completed a Fulbright at Kings Business, the commercialization office of technology transfer at Kings College in London. He recently published "Building the Case for Biotechnology." "Optical Detection of Cancer", and " The Life Science Innovation Roadmap". He is also an associate editor of the Journal of Commercial Biotechnology and Technology Transfer and Entrepreneurship and Editor-in-Chief of Medscape. In addition, He is a faculty member at the University of Colorado Denver Graduate School where he teaches Biomedical Entrepreneurship and is an iCorps participant, trainer and industry mentor. He is the Chief Medical Officer at www.bridgehealth.com and www.cliexa.com and Chairman of the Board at GlobalMindED at www.globalminded.org, a non-profit at risk student success network. He is honored to be named by Modern Healthcare as one of the 50 Most Influential Physician Executives of 2011 and nominated in 2012 and Best Doctors 2013.

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