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ISO TC 215 Health Informatics Develops Technical Report on Digital Therapeutics Health Software Systems


Q&A with Project Leader Megan Coder

As digital health technologies (DHTs) continue to bloom and revolutionize healthcare treatments, clarification on how they function is essential so that everyone—from doctors to patients to policy makers—can have a clear vision, understanding, and confidence about products in the market. A new technical report (TR) released this month by the International Organization for Standardization (ISO) Technical Committee (TC) 215, Health informatics, provides guidance on digital therapeutics (DTx), a relatively new treatment solution in the healthcare industry.

What are Digital Therapeutics?

Digital therapeutics products, as defined in the TR, are 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. DTx products, which generate and deliver medical interventions that are based on clinical evidence, are designed to be integrated into traditional care pathways, and therefore benefit from the guidance of standards much like traditional therapies.

Some examples of DTx include connected medical devices that provide continuous monitoring and alerts for out-of-range readings; apps with incentives and gamified challenges that drive adherence to diets or medications; and digital exercises that help manage symptoms of anxiety or depression.

ISO/TR 11147:2023, Health informatics – Personalized digital health – Digital therapeutics health software systems, provides an overview of how DTx relates to other ecosystem constructs, including medical devices, software as a medical device (SaMD), software in a medical device (SiMD), and other digital health technologies (DHT). It also addresses relevant health and medical device software standards that have various degrees of applicability to DTx.

ANSI spoke with Megan Coder, PharmD, chief policy officer, founder of Digital Therapeutics Alliance and project leader for ISO/TR 11147:2023, about the significance of the TR; the impact on stakeholders; and how U.S. stakeholders can get involved in the U.S. Technical Advisory Group (TAG) to ISO TC 215, administered by ANSI.

ANSI: What is the main goal of this technical report and why is guidance necessary for DTx?

Coder: Digital therapeutics are expected to consistently deliver high quality, evidence-based therapy to patients. It is critical for policy and healthcare decision makers to align in a harmonized way to identify, assess, and implement digital therapeutics across real-world settings, particularly considering the global trend to increasingly regulate and provide patient access to digital therapeutics. Standardization improves the understanding and trustworthiness of this new therapy class.

ANSI: Who are the stakeholders across the health pipeline that will benefit from this report?

Coder: The report will support manufacturers so that they can develop products based on a consistent set of expectations of what “good” and “sufficient” quality, design, and lifecycle support are. It is also relevant to policymakers and payors so that they can access and develop consistent requirements across healthcare settings and jurisdictions. Additionally, it will help patients and clinicians so that they can clearly understand what types of products are available to them and how these products are designed to protect their safety and security, while providing high quality healthcare.

ANSI: Did the COVID pandemic factor into the development of TR 11147? 

Coder: While the pandemic didn’t directly impact the TR development process, it did demonstrate the need for digital therapeutics in patient care. DTx supports the delivery of personalized care directly to patients in their home environments for a wide variety of mental health and chronic conditions. DTx also serves to expand the reach of clinicians and support healthcare teams in settings with varying degrees of healthcare infrastructure.

ANSI: As security and confidentiality remain a challenge as healthcare tech expands, does guidance exist to support DTx security to protect patient information?

Coder: DTx products are often subject to various privacy standards and requirements at the national and regional levels, such as General Data Protection Regulation in Europe and HIPAA in the United States. There are also multiple cybersecurity certifications that DTx products may utilize to demonstrate excellence, such as the Health Information Trust Alliance (HITRUST) and Systems and Organization Controls 2 (SOC-2), a voluntary compliance standard for service organizations. The ad hoc group will identify the most appropriate ISO standards for DTx product privacy and security.

ANSI: What’s next in standardization work for ISO/TC 215 and how can stakeholders get involved?

Coder: The next phase of the ISO process is to propose a Technical Specification (TS), which aims to provide specific standards for DTx products. An AHG is developing the proposal to go out to the TC 215 members for vote. This process is being led as a joint effort between ISO TC 215 and the International Electrotechnical Commission (IEC) TC 62, Subcommittee 62A, Common aspects of medical equipment, software, and systems.

We invite all interested entities to join us by contacting ISO/TC 215 committee manager Rachel Hawthorne: [email protected] for this next phase.

About Megan Coder

Megan Coder, MBA, founded DTA in 2017 and remains instrumental in developing the foundations for this quickly evolving industry. She leads DTA’s efforts related to thought leadership, global policy, international standard development, and the Alliance’s DTx Value Assessment & Integration Guide.

Trained as a pharmacist, Megan graduated from the University of Wisconsin—Madison and completed an Executive Residency in Association Management and Leadership with the American Pharmacists Association Foundation. Prior to DTA, Megan worked with Voluntis, Iodine, the Pharmaceutical Care Management Association, and the Pharmacy Technician Certification Board.

About the U.S. TAG to ISO/TC 215, Health Informatics

The U.S. TAG to ISO TC 215, Health Informatics, represents national interests on health information technology (HIT) and health informatics standards at ISO. ANSI administers the U.S. TAG to ISO TC 215 to coordinate national standards activities for existing and emerging health sectors. The U.S. TAG is guided by the ANSI cardinal principles of consensus, due process, and openness.

The scope of ISO TC 215, and consequently of the U.S. TAG, is standardization in the field of health informatics, to facilitate capture, interchange, and use of health-related data, information, and knowledge to support and enable all aspects of the health system.


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