Global 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

FDA medical device classification

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

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)
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
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
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

1. Executive Summary
1.1 Digital Health Overview
1.2 Global Scenario
1.3 Country Overview
1.4 Healthcare Scenario in Country
1.5 Digital Health Policy in Country
1.6 Recent Developments in the Country

2. Market Size and Forecasting
2.1 Market Size (With Excel and Methodology)
2.2 Market Segmentation (Check all Segments in Segmentation Section)

3. Market Dynamics
3.1 Market Drivers
3.2 Market Restraints

4. Competitive Landscape
4.1 Major Market Share

4.2 Key Company Profile (Check all Companies in the Summary Section)

4.2.1 Company
4.2.1.1 Overview
4.2.1.2 Product Applications and Services
4.2.1.3 Recent Developments
4.2.1.4 Partnerships Ecosystem
4.2.1.5 Financials (Based on Availability)

5. Reimbursement Scenario
5.1 Reimbursement Regulation
5.2 Reimbursement Process for Diagnosis
5.3 Reimbursement Process for Treatment

6. Methodology and Scope

Methodology for Database Creation

Our database offers a comprehensive list of healthcare centers, meticulously curated to provide detailed information on a wide range of specialties and services. It includes top-tier hospitals, clinics, and diagnostic facilities across 30 countries and 24 specialties, ensuring users can find the healthcare services they need.

Additionally, we provide a comprehensive list of Key Opinion Leaders (KOLs) based on your requirements. Our curated list captures various crucial aspects of the KOLs, offering more than just general information. Whether you're looking to boost brand awareness, drive engagement, or launch a new product, our extensive list of KOLs ensures you have the right experts by your side. Covering 30 countries and 36 specialties, our database guarantees access to the best KOLs in the healthcare industry, supporting strategic decisions and enhancing your initiatives.

How Do We Get It?

Our database is created and maintained through a combination of secondary and primary research methodologies.

1. Secondary Research

With many years of experience in the healthcare field, we have our own rich proprietary data from various past projects. This historical data serves as the foundation for our database. Our continuous process of gathering data involves:

Analyzing historical proprietary data collected from multiple projects.
Regularly updating our existing data sets with new findings and trends.
Ensuring data consistency and accuracy through rigorous validation processes.

With extensive experience in the field, we have developed a proprietary GenAI-based technology that is uniquely tailored to our organization. This advanced technology enables us to scan a wide array of relevant information sources across the internet. Our data-gathering process includes:

Searching through academic conferences, published research, citations, and social media platforms
Collecting and compiling diverse data to build a comprehensive and detailed database
Continuously updating our database with new information to ensure its relevance and accuracy

2. Primary Research

To complement and validate our secondary data, we engage in primary research through local tie-ups and partnerships. This process involves:

Collaborating with local healthcare providers, hospitals, and clinics to gather real-time data.
Conducting surveys, interviews, and field studies to collect fresh data directly from the source.
Continuously refreshing our database to ensure that the information remains current and reliable.
Validating secondary data through cross-referencing with primary data to ensure accuracy and relevance.

Combining Secondary and Primary Research

By integrating both secondary and primary research methodologies, we ensure that our database is comprehensive, accurate, and up-to-date. The combined process involves:

Merging historical data from secondary research with real-time data from primary research.
Conducting thorough data validation and cleansing to remove inconsistencies and errors.
Organizing data into a structured format that is easily accessible and usable for various applications.
Continuously monitoring and updating the database to reflect the latest developments and trends in the healthcare field.

Through this meticulous process, we create a final database tailored to each region and domain within the healthcare industry. This approach ensures that our clients receive reliable and relevant data, empowering them to make informed decisions and drive innovation in their respective fields.