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The conversations I had at this year’s J.P. Morgan Healthcare Conference were a microcosm of a dominant narrative coming out of one of the industry’s most influential weeks: How do we categorize digital health, an increasingly large, crowded, and diverse field?

“Digital health” is an umbrella term that’s grown to include everything from electronic health records to wellness apps and clinically validated therapeutic interventions that mirror or improve upon existing in-person therapies. It’s an area of intense interest and investment. But it is also a space in which many of the investors who have committed billions are still seeking clarity as to how the puzzle of diffuse digital health offerings fit together.

As the co-founder and CEO of Omada Health, I’ve had the opportunity to play a role over the last eight years defining this growing space into subcategories with true meaning. More than five years ago, Omada catalyzed the use of the term “digital therapeutic” at a time when we sought to differentiate the company from an ever-expanding pool of wellness applications.

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We spawned this category to draw a line in the sand. At the time, our program was specifically focused on the care of individuals with prediabetes. The solution was hyperdesigned for this population. It targeted a particular clinical outcome: weight loss and improvement in hemoglobin A1c, a measure of long-term blood sugar control. We had spent years (and hundreds of thousands of dollars) designing and running clinical trials demonstrating the program’s efficacy.

We sought — and ultimately achieved — approval from the Centers for Disease Control and Prevention (the agency charged with regulating diabetes prevention programs) based on a framework designed to evaluate both in-person and digital interventions using the same key metrics. All previous diabetes prevention programs the CDC had recognized had been conducted in brick-and-mortar settings. Because we had gone through the painstaking work to hit these milestones, we achieved significant commercial traction — and revenue.

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That’s why the term digital therapeutic was born: to categorize evidence-based, clinically validated, and regulatory-adherent digital interventions in a sea of apps and programs claiming the broad mantle of digital health.

In the five years since, I’ve watched two important developments continue to shape the space. First, the number of companies taking up the digital therapeutic banner has grown significantly, with dozens of them now adopting the label. As the number of these companies has grown, the subcategory of digital therapeutics has diversified to include software-only interventions, as well as those that include a significant role for hardware. Many digital therapeutics companies have sought, and are at various stages of achieving, approval from the FDA. Trade associations have emerged to advocate for the category. All of these are positive developments.

A second development, one that is more internal to Omada, caused us to evaluate how our company is best categorized. After establishing commercial traction around a host of new and expanded programs — moving beyond diabetes and into high blood pressure and support for individuals dealing with anxiety and depression — we needed once again to redefine the space.

Omada has morphed from a digital therapeutic to a digital care provider. Digital care shares some similarities with digital therapeutics. But with the expansion beyond a single program and into a constellation of hyper-personalized care pathways, the best analogy for the care we deliver today is a specialty medical clinic or hospital, a “digital Mayo Clinic” if you will. We are now building that kind of delivery focused on conditions best addressed with what Dr. Thomas H. Lee and I described in the New England Journal of Medicine as an “In-Person Health Care as Option B” approach.

As Omada has moved further into the clinical care space — it now employs physicians, licensed clinical social workers, and certified diabetes educators, as well as the largest team of digital health coaches in the country — it has worked with the American Medical Association, American Association of Diabetes Educators, and other leading organizations to develop condition-specific curriculum that can be mixed, customized, and matched for individuals with a variety of comorbidities.

Put simply, our job as a digital care provider is to address the needs of the people who choose to use our program, much as brick-and-mortar clinics or hospitals address the needs of those who come through their doors.

A category without a solid definition becomes little more than a marketing tool. I’ve worked to define both digital therapeutic and digital care provider by focusing on the populations served, outcomes achieved, research conducted, regulatory approval, products delivered, and go-to-market strategies. You can see my current thinking in the table below.

I created this comparison to help other digital health companies better define their places in this ecosystem and add clarity for the dozens of companies or offerings that might fit in either category.

It’s a work in progress. I’d value your feedback, either via the form below or as a comment on the article.

Sean Duffy is co-founder and CEO of Omada Health.

 

 

Digital Therapeutic Digital Care
Basic definition An evidence-based software intervention (a program, application, or the like) that is intended to prevent or treat a disease and carries the attributes below. An approach to improving health outcomes that leverages a personalized combination of devices, content, curriculum, medicines, and licensed personnel with appropriate credentials, with the possibility of other approaches, and carries the attributes below.
Who is the product for? Designed for a hyper-specific patient population and a narrowed clinical indication. Digital therapeutics are by definition point solutions, such as COPD rather than lung disease or depression rather than mental health. Designed for a broad patient population, though still circumscribed by clinical eligibility. Emphasizes and shapes personalized, tailored-care pathways for patients with qualifying conditions.
What does the product aim to achieve? A digital therapeutic targets particular clinical outcomes in line with the defined clinical indication and patient population using the regimented intervention. It is tight in its objectives and the experience varies little from patient to patient. Digital care outcome targets are set according to patients’ individual needs. These programs achieve condition-specific outcomes but take into consideration patients’ full circumstances when evaluating success. Digital care can aggregate similar patients to demonstrate population-level outcomes.
What peer-reviewed evidence is needed? Multiple peer-reviewed publications are needed to demonstrate clinical outcomes around the specific condition for which the therapeutic is designed. A subset of the evidence will likely be in the form of Level 1 evidence, including at least one randomized controlled trial. Published research on the effectiveness of both the digital care approach and its effectiveness against specific conditions are needed. The research questions are likely translational and have wide ranging hypotheses and questions. It’s less likely that digital care organizations have the need for Level 1 evidence, yet some pursue it anyway.
What are the attributes of the product? Digital therapeutics are software only or software mostly. When they do involve people, the primary objective of these people is to provide accountability and support against the defined program of the digital therapeutic. The humans involved do not define the specific path for the patient. Interventions tend to be highly regimented and targeted, with every patient getting a highly similar experience. The objectives of the product involve shaping behavior above and beyond simple medication adherence. Digital care programs have a range of capabilities that can be customized to a patient’s particular clinical need according to a practitioner’s judgment, guidelines, or scope of practice developed by the digital care organization’s medical team. These capabilities can include, but aren’t limited to, devices, content, curriculum, personnel, social support, and medication support tools. Care delivery personnel are able to leverage their credentials in a specific scope of practice for the benefit of the patient.
What regulations oversee the product? Regulatory approval from the FDA is generally sought. As an alternative, it may be possible to fit a digital therapeutic inside an existing regulatory framework in another agency. State and federal provider laws regulate digital care programs and organizations. It’s likely that a digital care company will face complying with telemedicine regulations and staffing needs against state-by-state rules and reciprocity. These organizations must meet and build upon relevant standards of care applied to in-person clinics.
How is the product commercialized? Digital therapeutics nearly always leverage a company’s go-to-market to gain market access (reimbursement) and garner health care professional referrals if a prescription is required. These products likely need to attain a drug code and/or the ability to bill through pharmaceutical claims/spend and drug benefits. Digital care organizations contract with health plans for direct reimbursement while also leveraging existing medical coverage policies for defined services. Digital care providers will generally bill through medical expenditures, file claims, and engage in preference contracting with a health plan’s provider contracting organization. They look to engage and partner with in-person care organizations to optimize the patient experience.


Defining digital therapeutics

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  • Sean – good job opening a conversation about an a additional categorization of healthcare services. I suggest the following as short form definitions of digital therapeutics (DTx) and digital care services (DCs).

    DTx = a personalized digital or combination therapy having a specific biomedical effect that is scientifically linked to a positive clinical outcome.

    DCs = an organized system of digital and non-digital diagnostic and therapeutic components, including whole person considerations, that is intended to deliver measurable health outcomes for a defined population of patients and at risk individuals.

    In pre-digital days we organized care delivery systems for vertically defined populations with an at risk business model. We could only dream (and we did) about the potential of technology to improve outcomes.

    Rob

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