In an era driven by technology and innovation, the healthcare industry is rapidly evolving and embracing innovative solutions that have the power to transform patient care. One of the fields that’s had a steady incline is digital therapeutics (DTx), a cutting-edge approach to patient care that unites healthcare with digital technology to revolutionize the way we prevent, manage, and treat a number of medical conditions.

This is where the DTx ISO 11147 comes in, this is the new standard set by the International Organization for Standardization (ISO) that specifically addresses digital therapeutics. As a globally recognized benchmark for quality and safety, the digital therapeutics ISO 11147 aims to establish a comprehensive framework for the development, validation, and deployment of these digital interventions. It represents a significant milestone in the healthcare landscape, providing a much-needed foundation to ensure the efficacy, reliability, and security of digital therapeutics.

In this blog post, we will dive into the world of digital therapeutics and explore the impact that the new ISO 11147 is sure to have on this rapidly growing field. We will examine the key principles and requirements outlined in the standard, shed light on its implications for healthcare providers, patients, and regulatory bodies, and discuss the potential benefits and challenges. We also want to take a look at how the definition for digital therapeutics has improved from the previous version.

Changes in the DTx definition with the ISO 11147

As previously stated, Digital Therapeutics (DTx) now boasts an updated, and very official, definition. This redefinition was accomplished through a collaborative effort two years ago by the Digital Therapeutics Alliance (DTA), the leading trade group in the industry, in close partnership with the International Organization for Standardization (ISO). The result is a meticulously crafted and contemporary delineation of what precisely qualifies as a digital therapeutic.This joint effort between the DTA and ISO aimed to establish a clear and comprehensive understanding of what qualifies as a digital therapeutic within the rapidly evolving healthcare landscape.

The original definition was created back in 2018 and stated “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,” Where as the new definition defines it as “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”.

The main objective of the ISO is to provide an all-encompassing comprehension of the dynamic interactions between Digital Therapeutics (DTx) and other elements within the healthcare ecosystem. It explores the relationships between DTx, medical devices, software as a medical device (SaMD), software in a medical device (SiMD), and other digital health technologies (DHT). Additionally, the ISO delves into the relevant health and medical device software standards that exhibit varying degrees of significance and applicability to DTx. By examining these connections, we can establish a cohesive framework that illuminates the position of DTx within the broader landscape of digital healthcare.

As asserted by the Digital Therapeutics Alliance (DTA), the unique characteristics of Digital Therapeutics (DTx) products require the establishment of purpose-fit standards. These standards are essential to accommodate DTx's agile development processes, distinct mechanisms of action, real-time outcome generation, iterative nature, lower risk profiles, and integration into clinical therapy. While incorporating elements from existing pharmaceutical and medical device frameworks, DTx-specific standards should also incorporate customized components to facilitate the appropriate and efficient design, assessment of capabilities, and evaluation of performance specific to DTx products. By tailoring these standards to DTx, we can ensure the integrity and effectiveness of this innovative therapeutic approach.

How do those changes impact the industry

We can see that the change in the wording of the definition is slight but it has a big impact. The main reason the definition needed to be updated was because regulatory agencies manifested that it needed to be more standardized and internationally recognizable. With the growing integration of Digital Therapeutics (DTx) into modern healthcare, it has become increasingly crucial to elucidate and establish a clear definition of the role these products play for payers, providers, patients, and government agencies. By ensuring that all stakeholders are aligned and well-informed, we can foster a collective understanding of the significance and potential of DTx in delivering effective and personalized healthcare solutions.

The DTx ISO 11147 is expected to have a significant impact on the digital therapeutics industry in a number of ways. First, this new standard will help to ensure the quality and safety of digital therapeutic products. By providing clear guidance on the development and use of DTx, the standard will help to protect patients and ensure that DTx products are effective and safe. It sets standards for the development, design, and evaluation of digital therapeutics. This will help ensure that these interventions meet certain quality criteria, including safety, efficacy, and usability.

Second, the digital therapeutics ISO 11147 is expected to facilitate the adoption of DTx by healthcare providers. The standard provides clear guidance on how DTx products can be integrated into clinical workflows, which will make it easier for healthcare providers to adopt these products. Adoption of DTx by healthcare providers is very important because an obstacle in healthcare is getting patients to adhere to their treatment plans. DTx can help to improve adherence by providing patients with personalized feedback, reminders, and support. Abundant evidence supports the effectiveness of digital therapeutics in enhancing patient outcomes across a wide range of conditions, including mental health disorders, chronic diseases, and substance abuse.

Third, the ISO 11147 is expected to promote the growth of the digital therapeutics industry.

Having an internationally recognized ISO for digital therapeutics will hopefully facilitate regulatory processes and promote harmonization among different countries or regions. It can help regulators establish guidelines and frameworks for the assessment, approval, and oversight of digital therapeutics. By providing a clear framework for the development and use of DTx products, the standard will help to attract investment and spur innovation in the industry.

An opinion from our experts at Hattrick

Having an official definition of Digital Therapeutics (DTx) is crucial for several reasons. Firstly, it provides clarity and consistency across different countries and regulatory authorities. By establishing an agreed-upon definition, regulators from all geographies can ensure developing consistent regulatory frameworks. This harmonization also enables more effective international cooperation and the exchange of knowledge and best practices.

Additionally, now that this first standardization is given, we can expect more to come, for example in clinical trial protocols and conditions for specific disease groups. All of these reflect the increasing maturity of the market and it certainly provides reassurance to patients and healthcare providers.

-Maria Eugenia Gonzalez, Innovation Manager

The new DTx ISO 11147 represents a first step towards establishing standards and expectations for software development in the field of Digital Therapeutics. I find it especially useful that this norm compiles an extensive list of existing international standards (ISO/IEC) applicable to the development of medical software and health software, including DTx products. In general, it provides a great overview of the current standardization landscape and introduces some preliminary concepts that can hopefully be leveraged to formulate DTx-specific standards.

-Gaston Kosut, CTO

At Hattrick, we welcomed the release of this new ISO norm with great enthusiasm for several reasons. Firstly, we believe it will significantly aid the industry in addressing some of the major obstacles it currently faces, such as securing regulatory acceptance and fostering adoption by payers for integration into coverage plans. As a relatively new industry pioneering novel patient treatment methods, gaining such recognition can be challenging. However, the introduction of this ISO norm lends credibility to the industry and is a crucial step towards propelling it forward.

Secondly, advancements like this ISO norm serve to equip Hattrick, and indeed companies across the sector, with the tools necessary to better express our mission to key stakeholders – our employees, clients, and community. As the DTx industry is still in its early stages, it often becomes a task to clearly define what we do for industry leaders shaping this space. The new norm, with its clear definitions and useful concepts, provides us with an enhanced framework to communicate our commitment to the industry and our dedication to utilizing software as a means to improve patient health.

-Martin Zuniga, CEO

Overall, the digital therapeutics ISO 11147 is a significant development for the digital therapeutics industry. The standard is expected to help to ensure the quality and safety of DTx products, facilitate their adoption by healthcare providers, and promote the growth of the industry.

From enhancing accessibility and personalization of treatments to redefining the patient-provider relationship, the convergence of medicine and technology holds tremendous promise in revolutionizing healthcare as we know it. Which is why embarking on this exploration of DTx ISO 11147 and its role in catalyzing the transformation of healthcare delivery in the digital age is so important.