Digital health refers to using information and communications technologies to send or receive medical information. Some provide information and education while others have the intended use of diagnosing or treating a patient with symptoms or a disease. In the latter case, they can be considered a medical device , and, as such, what is more commonly being referred to as a digital therapeutic (DTx).
According to the 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.
Since this is an evolving technology in medical care, here are some things you should know:
1. A medical device is defined within the Food Drug & Cosmetic Act as "...an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
2. How the FDA is regulating digital health software and digital health therapeutics is constantly changing and evolving.
3. There are innumerable applications and intended uses for digital health therapeutics
4. Payers are deciding which digital health therapeutics warrant payment or reimbursement
5. There are significant digital therapeutics IP issues.
6. DTx raises myriad pre- and post-launch regulatory, privacy, security and promotional issues.
7. There are significant barriers to DTx clinical translation, dissemination and implementation
8. Medical schools and post-graduate training programs are not providing students and trainees with the knowledge, skills, abilities and competencies to assess and decide whether to prescribe DTx.
9. Patients have low DTx IQs and many are unable to use them due to lack of access to affordable mobile technologies or broadband.
10. There is an inadequate digital health clinical trials ecosystem. Digital health technologies are used to support and make more effective and efficient clinical trials.
11. There is a convergence of medtech, DTx and biopharma complicating the IP, regulatory and reimbursement environment
12. Capital sources are subsegmenting into various DTX applications and technologies
DTx entrepreneurs are pushing the limits of new rules, regulations and commercialization pathways. Regulators and other stakeholders are playing catch up and , as such, are lagging indicators. Like all new therapeutic classes (think immuno-oncology, precision medicine or stem cell treatments) , it will take perhaps a generation or more for DTx applications to become the standard of care. Like other new treatments, most will fail. Consequently,we should subject them to a more rigorous cost-effective analysis so we don't make the same mistakes we've made with me-too drugs and devices that are now collecting dust in medicine cabinets and storage rooms.
Arlen Meyers, MD, MBA is the President and CEO of the Society of Physician Entrepreneurs
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.