Digital Health has been a hot topic for the past few years, and only getting bigger with new tech acquisitions and expanding technological progress. I would never have contemplated the role of AI/Machine Learning or blockchain in this area when I first started a little under a decade ago making this my passion. Nonetheless, seeing how companies like Amazon, Apple, Google and regulators like the FDA are now getting involved, I feel it's a good time to take a deep dive into one silo of the Digital Health field that is being termed 'Digital Therapeutics (DTx).'

We understand at this point that Digital Health encompasses multiple silos, but no real definition at this time. However, the FDA perhaps is the most relevant organization to follow, since after all, they are the ones who call the shots on what is regulated and not, and most companies need that before they really can get further along to make a profit. The FDA has included technology such as wearables, telemedicine, IT systems, etc. I have taken this framework and modified it a bit.

As you can see from my figure, I have added a few other silos that I think are relevant at this time as well. I will admit, most of these areas cross-over with one another these days, with the era of standalone apps or hardware being outpaced or pushed aside for platforms and systems that encapsulates multiple processes of digital health.

But what is Digital Therapeutics, and why should you care?

Taking that into consideration, Digital Therapeutics has been defined by The Digital Therapeutics Alliance (DTA) recently in a white paper:

Digital therapeutics (DTx) deliver evidence-based therapeutic interventions to patients that are driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes. DTx products incorporate advanced technology best practices relating to design, clinical validation, usability, and data security. They are reviewed and cleared or approved by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use. Digital therapeutics empower patients, healthcare providers, and payers with intelligent and accessible tools for addressing a wide range of conditions through high quality, safe, and effective data-driven interventions.

I feel the key takeaways to create a checklist if a product is a DTx would be essentially:

• Software Based - Is it a digital platform-enabled service?

• Evidence-Based - Any supporting literature published?

• Regulated - Has a relevant agency approved it?

• Integration - Can it utilize other data points and technology?

DTA I feel hit most of the critical points here, and indeed they set the stage for some considerations as the digital health field moves forward. For years, many digital health products have floundered in development and rollout, with many products created having founders raving how their solution would fix most of healthcare ails. A decade later and we are still no closer to any groundbreaking solutions that have redefined the healthcare delivery model or caused a paradigm shift in practice. Yes, there is an uptake of new services, and many items have gone digital that has fixed workflow or data interoperability, but we still practice medicine pretty much the same way day-to-day. Take for instance the following examples of DTx companies:

• Pear Therapeutics - A mobile platform aimed at developing systems to help with disease management. Thus far have received FDA approval for reSET to treat substance use disorders alongside their commercial partner Sandoz/Novartis. They also have in development on their pipeline other therapeutic categories including insomnia/depression, schizophrenia, epilepsy, and Parkinson's Disease.

• Propeller Health and Adherium - Creating smart sensors that attach to inhalers to track adherence and serve as clinical intervention tools for pulmonary diseases.

• Insulia - Created by Voluntis, this is an app platform that helps patients with diabetes and on long-acting insulin analogs to help create ideal doses and lower their A1c.

• Bluestar - Created by WellDoc, this is a type 2 diabetes management platform aimed to help lower blood sugar in patients through the management of their diabetes care plan, including diet/exercise, medication management, and psycho-social well-being.

When I look at this list and contemplate what other platforms and companies are producing, I think we finally arrived at the point where Digital Health can be taken seriously. The ability to have a Digital Health tool that can lead to a clinical outcome, be backed by payors, and prescribed for use I think makes this rather breathtaking in many ways.

Take for instance my background as a pharmacist. Intrinsic to any pharmacy program is a course series of Pharmacotherapeutics that discusses, generally, drug therapy for different organ systems and conditions. Cardiology? Well, let's go over the ACEi/ARB/BB/CCB/etc. and implications for management of HTN, HLD, HF, etc. But now I can actually envision a Digital Therapeutics course as well. Just, instead of pharmacotherapy using drugs, we now have technology that can be introduced as well.

This is why I think DTx is so vital at this point of time, as we are transitioning to a period that is seeing an entirely new therapeutic intervention beyond a medication you take, a surgical intervention, but rather an intervention powered by the internet.

What will it take to expand DTx?

While I am a proponent of the role of DTx in clinical care, there are still several limitations.

• Legislative Backing - It will take time to integrate DTx into practice, but federal support will be critical, and with regulators taking a step in the right direction I think this is on the horizon.

• Cultural Acceptance - Perhaps one of the most challenging areas, and maybe a generational shift in the vision of what healthcare is, since the practice of seeing even your primary care provider for routine checkups is now in dispute, I do not see older patients giving it up so readily.

• Payor Integration - The cornerstone of this issue, who is going to pay for such services and give these companies the 'oomph' they need to get going on a large scale.

• Clinical Integration - Lastly, one of the most significant items I am a proponent of, would be having DTx integrated into clinical guidelines. After all, we see many guidelines recommending initiation of certain medications throughout the disease process, and I expect as DTx creates a more diverse research base we will see the same soon. The first company to do so in their clinical area will probably establish the most significant breakthrough putting them ahead of any competitors.

Why I care about DTx as a Pharmacist

So you may also be wondering at this point, why does a pharmacist care about DTx, it's not a drug. And that's the funny part! One of the things that have stuck out to me thus far is that many DTx are trying to find a way to get into patient hands, and perhaps one of the safest ways to overcome the cultural hurdle is to tie their product to some form of drug treatment at this time. Notice the companies I mentioned either worked with a drug product or took medications into consideration?

With that being the case, it is my firm belief that it could be possible for a pharmacist to prescribe a DTx in the future and help monitor care (especially if pharmacist are allowed to bill for Remote Patient Monitoring). After all, so many of our patients ask if they can get off their drugs and reduce polypharmacy, and I see DTx as an excellent possible substitution with fewer side effects from drug therapy.

In any event, that sums up my introduction to DTx, and I welcome your thoughts!