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