Home Health Care Creating a common language in digital therapeutics

Creating a common language in digital therapeutics

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The digital therapeutics industry is maturing and that’s leading to a host of growing pains as it looks to define itself as a key pillar of the larger healthcare ecosystem.

At a workshop convening digital therapeutics companies at the DTX West meeting in San Mateo, California, stakeholders debated what was necessary to build successful business models in the industry while navigating a nascent regulatory pathway.

FDA is still in the process of sculpting its “pre-cert” program, which is meant to create a clearance process more in line with the software iteration cycle necessary to develop these kinds of technology.

A general sentiment of the companies in the room, however, was that regulatory barriers were not the larger braking mechanism for the industry. The bigger challenge is instead issues with reimbursement and payment for products still not widely adopted in clinical practice.

At least from the consumer perspective interest in the space is growing. A recent PWC report found that more than half of patients are willing to use digital therapeutics and the 56 percent of physicians have brought up the potential for a digital therapy as an option for patients.

Still in a bit of a testament to the pace of innovation within healthcare, much of the early conversation in the workshop focused on defining the terms that will allow the industry to flourish.

As the heart of the debate was the central question: What exactly is a digital therapeutic?

Digital Therapeutic Alliance, an industry group made of companies from the industry defines the term as follows:

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 validated 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.

But the individual definitions suggested by program participants emphasized different parts of that block of text.

Responses ranged from a software-based product that can be prescribed by a medical professional and reimbursed to a subset of digital health that involves products with a strong clinical evidence base.

One of the core areas of debate was in whether business model or reimbursement terms should be central to the definition of the digital therapeutics as a pathway to larger payment acceptance.

The argument in favor of that idea would be to categorize and group the industry in a way that’s understandable for traditional healthcare payers and fits into the existing coding and payment paradigm.

“I think coding is one of the most limiting factors in our industry if you want to fit into the healthcare system,” said presenter Jeffrey Abraham, Akili Interactive’s vice president of market access and trade.

Photo: exdez, Getty Images

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