Definition to help payers and policymakers navigate emerging industry.     

(Healthcare Brew – Maia Anderson) — Digital therapeutics (DTx) has a new—and very official—definition.

The industry’s trade group, the Digital Therapeutics Alliance (DTA), got together with the International Organization for Standardization (ISO) two years ago to develop the new definition of what exactly constitutes a digital therapeutic. Megan Coder, DTA’s founder and chief policy officer, said the new definition creates a foundation that helps payers and policymakers navigate the emerging industry, which creates software products used to prevent, manage, or treat disease.

The industry has faced some setbacks recently; Pear Therapeutics, a pioneer in digital therapeutics, filed for bankruptcy in early April. The company’s CEO cited a lack of payer reimbursement as a primary cause of Pear’s financial woes.

The new DTx definition: Digital therapeutics is “health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health” (that’s the short version, at least—there’s a much longer version that goes into more detail, but we’ll spare you and won’t publish the entire thing here).

“We know that digital therapeutics can be scalable; we know that they are the future of healthcare,” Coder said at a June 9 press conference in Washington, DC, announcing the change. “But it’s not going to happen until we figure out how to create some harmonization and some standardization and some infrastructure to make this occur.”

The DTA created the initial definition of a digital therapeutic in 2018.

“Digital therapeutics deliver to patients evidence-based therapeutic interventions that are driven by high-quality software programs to treat, manage, or prevent a disease or disorder. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes,” according to the original definition.

But the trade group heard from regulatory agencies that it needed to create something more standardized and internationally recognizable, Coder said. So DTA has worked with the ISO for the past two years to come up with the new definition, involving more than 40 countries in the process.

“As DTx becomes integral to healthcare today, we think it’s really important to clarify and define the role of these types of products for payers, providers, patients, and government agencies, so that everybody’s on the same page,” Jeffrey Abraham, VP of consulting firm Health Advances, which helped DTA in the defining process, said at the press conference.