Digital Therapeutics Regulatory Process, Updates and Trends

Digital Therapeutics Regulatory Process, Updates and Trends

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The market for digital therapeutics (DTx) is expanding tremendously, aided by the increased popularity of decentralized medicine that the pandemic brought about. The global market for DTx was predicted to be worth $3.35 billion in 2021 and would grow to $12.1 billion by 2026.

CATEGORY: Digital Health GEOGRAPHY: Global

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There is a huge amount of uncertainty as a result of this rapid rise I n its Action Plan for Digital Health Innovation.  The main thing that needs to be determined for early regulatory planning is whether a gadget even fits into this regulatory category. Sponsors need to be certain of how regulators will recognize their products in order to avoid starting a regulatory process that may take a lot of time and money. 


Digital Therapeutics - Overview

Digital Health

  • Definition: Technologies, platforms, and systems that engage users for lifestyle, wellness, and health-related reasons, collect, store, or transmit health data, and/or support life science and clinical operations are all considered to be part of the field of digital health
  • Clinical Evidence: Typically do not require clinical evidence
  • Regulatory Oversight: These products do not meet the regulatory definition of a medical device and do not require regulatory oversight]

Digital Medicine

  • Definition: Evidence-based hardware and/or software products that monitor, treat, or otherwise contribute to human health are included in digital medicine
  • Clinical Evidence: Clinical evidence is required for all digital medicine products
  • Regulatory Oversight: Regulatory requirements may vary. Digital medicine products that are classified as medical device require clearance or approval

Digital Therapeutics (DTx)

  • Definition: Digital therapeutics (DTx) products deliver evidence-based therapeutics interventions to prevent, manage or treat a medical disorder or disease
  • Clinical Evidence: Clinical evidence and real world outcomes are required for all DTx products
  • Regulatory Oversight: DTx products needs to be certified by regulatory bodies so as to support product claims of risk, efficacy and intended use


Digital Therapeutics - Definition by FDA (US)

Digital therapeutics are generally regulated as software by the FDA under the agency’s software-as-a-medical-device (SaMD) category and are subject to regulatory obligations much like conventional medical devices

  • Development of a Software Precertification Program (Pre-Cert) aimed to replace the need for a premarket submission for certain products and allow for reduced submission content and/or faster review of the marketing submission
  • The FDA’s vision for the future is that companies taking advantage of the Pre-Cert program will also be able to utilize the National Evaluation System for health Technology (NEST) system
  • This aims to generate better evidence for medical device evaluation and regulatory decision making across the device lifecycle by collecting post-market, real-world data in order to affirm the regulatory status of the product and support new applications of the technology
  • Section 3060 of the Cures Act excludes from the definition of “device” software functions intended for activities such as healthcare facility administrative support, healthy lifestyle maintenance, or serving as electronic patient records, so long as the function is not intended to interpret or analyze them for the purpose of condition diagnosis, cure, mitigation or treatment

US FDA Medical Device Classifications for DTx



Digital Therapeutics Regulatory Process in Germany

  • Germany passed the Digital Care Act (‘Digitale Versorgung Gesetz’ or ‘DVG’) in 2019, it created a pathway for doctors to prescribe digital therapeutics to publicly-insured patients and receive reimbursement in much the same way as a traditional treatment
  • Germany’s Federal Institute for Drugs and Medical Devices ('BfArM') has issued guidelines relating to the evaluation process digital health apps (DiGAs) must go through to be eligible for reimbursement

Regulatory Process

  1. For any app to be eligible it must of the risk class I or IIa under the EU's Medical Device Directive (MDD) or, more importantly, the incoming Medical Device Regulation (MDR)
  2. Most apps that self-classify as class I under MDD will be "up-classed" to class IIa under MDR, which means they'll have to adhere to stricter requirements in order to acquire a CE mark
  3. BfArM's guidelines define further requirements for issues such as safety and efficacy, and the timeframe DiGA developers must meet for their DTx to be approved
  4. Process has been dubbed the ‘Fast-Track’, as it allows DiGAs to be granted preliminary approval following an evaluation, after which developers have 12 months to generate sufficient evidence for full approval

Insights10 will provide you with the reports within 10 key parameters which are:

  1. Market Overview
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Last updated on: 28 February 2023

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