Value of DTx  /  Policymakers

Developing Legislation and Regulations

Policymakers at the local, national, and regional levels are facing a number of important questions related to the regulatory recognition of DTx products and legislative actions necessary to enable public payor coverage and patient access.

DTA promotes industry core principles and best practices to ensure that patients and clinicians are assured they are accessing trustworthy therapies that consistently demonstrate meaningful outcomes. Building on the ease of product scalability and access through patient-owned devices, DTx products can more easily reach high-risk, rural, and underserved communities that often lack access to healthcare services even during the best of times.

"As a regulator, it is important for us to identify and properly categorize new technologies, including digital therapeutics."

Terry R.

DTx in the Era of Covid-19

Digital therapeutic products offer solutions to leaders focused on healthcare as they search for new ways to address increasing mental health challenges caused or exacerbated by Covid-19, enable patients with chronic diseases to control their conditions outside of traditional office settings, and reduce unnecessary burdens placed on over-taxed clinicians and healthcare organizations.

According to the U.S. Food and Drug Administration:

“In the context of the Covid-19 public health emergency, the use of digital health technologies, including software as a medical device or other digital therapeutics solutions, may improve mental health and well-being of patients with psychiatric conditions during periods of shelter-in-place, isolation, and quarantine. In addition, the use of such technologies has the potential to facilitate “social distancing” by reducing patient contact with, and proximity to, health care providers, and can ease the burden on hospitals, other health care facilities, and health care professionals that are experiencing increased demand due to the Covid-19 public health emergency.”

Frequent Questions

Digital therapeutics are regulated as medical devices. They are most frequently categorized by regulatory jurisdictions as a subset of Software as a Medical Device (SaMD), a framework developed by the International Medical Device Regulators Forum (IMDRF). It is important to note that not all DTx products qualify as SaMD, and not all SaMD products qualify as a digital therapeutic.

Created in February 2011, IMDRF is a forum of voluntary medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and to accelerate international medical device regulatory harmonization and convergence.

The SaMD Working Group develops guidance that supports innovation and timely access to safe and effective SaMD globally. Their work is intended to identify commonalities, establish a common vocabulary, and develop approaches for appropriate regulatory controls that promote prospective convergence in areas of advanced and innovative technologies.

To date, IMDRF’s SaMD Work Group has published the following documents:

(Source: IMDRF Work Items)

United States: Food and Drug Administration (FDA)

The Digital Health Center of Excellence (DHCoE) is part of the planned evolution of the Digital Health Program in the Center for Devices and Radiological Health (CDRH) and will align and coordinate digital health work across the FDA. It marks the beginning of a comprehensive approach to digital health technology, setting the stage for advancing and realizing the potential of digital health.

The DHCoE provides regulatory advice and support to the FDA’s regulatory review of digital health technology and is not responsible for making marketing authorization decisions. Key documents include:

United Kingdom: National Institute for Health and Care Excellence (NICE)

NICE provides national guidance and advice to improve health and social care. As digital health technologies develop at an increasing pace, they worked with partners to develop standards that ensure new technologies are clinically effective and offer economic value.

The aim of NICE’s Evidence for Effectiveness standards is to make it easier for innovators and commissioners to understand what good levels of evidence for digital healthcare technologies look like. Digital healthcare technologies must also meet the needs of the health and care system, patients, and users.


Germany: Federal Institute for Drugs and Medical Devices

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the German Federal Ministry of Health.

BfArM’s Assessment Procedure is designed as a fast-track process: Within a three-month period at the most, starting with the filing of the complete application, BfArM will the DiGA, a subset of which include DTx products. The essence of this assessment is the examination of the manufacturer’s statements about the product qualities – from data protection to interoperability and user friendliness – and the examination of the evidence of the positive healthcare effect of the DiGA provided by the manufacturer. These are effects through which the state of a patient’s health or his/her possibilities for dealing with his/her disease are improved by the use of the DiGA. (Source)

Additional resources include:

Digital therapeutics are categorized based on the level of risk associated with each product’s claim. Best practices all digital therapeutics should adhere to include:

  • Be compliant with oversight provided by each national regulatory agency or notified body, including review of safety and efficacy medical claims
  • Register with the applicable regulatory agency or notified body in each jurisdiction the product is being used
  • Be compliant with regional manufacturing requirements
  • Ensure that product claims are appropriate to clinical validation, regulatory status, and marketing authorization
  • Adhere to labeling and advertising regulations under appropriate authorities, including all labels and other written, printed, or graphic matter accompanying or associated with the product

"We strongly believe that Dario's offering fills a major unmet need by helping practices achieve meaningful improvements in medical outcomes while potentially increasing efficiency and reducing healthcare costs."

Hugh Hamer
Williams Medical

"I was an aggravated mess, short tempered for no reason, and always on edge. That edge was very sharp and when people got close I would ‘cut’ them with my behavior. The breathing causes me to stop and slow down. It’s like my edge is dull now instead of sharp and people can get close to me. My children really noticed that there has been a change. I am so glad my doctor suggested I do this."

United States

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