Digital Therapeutics Regulatory Process, Update and Trends

1. A market research report on Digital Therapeutics Regulatory Process, Updates & Trends

2. Digital Therapeutics - Overview DIGITAL HEALTH DIGITAL MEDICINE DIGITAL THERAPEUTICS (DTx) 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 Evidence-based hardware and/or software products that monitor, treat, or otherwise contribute to human health are included in digital medicine Digital therapeutics (DTx) products deliver evidence-based therapeutics interventions to prevent, manage or treat a medical disorder or disease Definition Clinical evidence and real world outcomes are required for all DTx products Clinical Evidence Clinical evidence is required for all digital medicine products Typically do not require clinical evidence Regulatory requirements may vary. Digital medicine products that are classified as medical device require clearance or approval DTx products needs to be certified by regulatory bodies so as to support product claims of risk, efficacy and intended use These products do not meet the regulatory definition of a medical device and do not require regulatory oversight Regulatory Oversight 2

3. 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 Summary • 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 3

4. US FDA Medical Device Classifications for DTx FDA Medical Device Classification Class I - Low Risk (Bandages, bedpans etc) Class II – Medium Risk (40%) (Wheelchair, pregnancy kits etc) Class III – High Risk (10%) (Pacemakers, breast implatns) Premarket Notification (510(k)) Breakthrough Devices Program (BDP) Humanitarian Device Exemption (HDE) Investigational Device Exemption (IDE) Company Registration Premarket Approval (PMA) De Novo Program New or similar Class III medical devices that support or sustain life New or similar device for clinical studies to support PMA New or similar device for conditions that affect less than 8,000 US per year New combinations of devices & softwares Novel device of low to moderate risk that don’t have a valid predicate device. May be marketed & used as a predicates for future 510(k) submissions Demonstrate that device to be marketed is at least as safe and effective – equivalent to a legally marketed device that is no subject to PMA; 95% of Class I devices do not require FDA approval before marketing the device in US Priority review from FDA. A breakthrough technology with no approved alternative or offers clinically meaningful advantages Almost all Class III devices are required to complete an IDE application before PMA unless exempt Meant to speed /incentive devices targeting rare diseases Software only DTx(subsequent products) Software only DTx (first products) 4

5. US FDA Digital Therapeutics Initiatives Pilot Project by FDA FDA Digital Health Innovation Future Action Plan Digital Health FDA Pre-certification • FDA launched the Software Precertification (Pre-Cert) Pilot Program ("the pilot") in 2017 to foster innovative technologies and advance FDA's mission to protect and promote public health FDA Pre-certification Level Based on SaMD Risk + Pre-Cert Level • Pilot explored innovative approaches to regulatory oversight of medical device software developed by organizations that have demonstrated a robust culture of quality and organizational excellence and who are committed to monitoring real-world performance of their products once they reach the U.S. market SaMD Types Landscape/Sc ope Streamlined Premarket Review • In September 2022, the Software Precertification (Pre-Cert) Pilot Program was completed with the issuance of the Report: The Software Precertification (Pre-Cert) Pilot Program Commercial Distribution & Real World Use Real-World Data Collection 5

6. Digital Therapeutics Regulatory Process in Germany 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) 1 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 2 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 3 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 4 6

7. Digital Therapeutics Regulatory Process – Other Countries Purchase the report for in-depth information 7

8. Who should buy this report? HealthTech MedTech Other Lifesciences Pharmaceutical Digital Health Companies Players Companies Players Entities

9. Topics of Upcoming Reports Will the Expiry of Humira Market Exclusivity and Entry of its Biosimilars Move the Needle in BioPharma Market? From the Fringes to the Forefront: mRNA is here to Transform Global Health Cost of this report: Melting the Iron Triangle: 10 Healthcare Players aiming Beyond Health Equality to Conquer Health Equity $2,500 Robotics: Embarking a New Era in Surgical Innovations Annual Subscription: Metaverse: Paving the way for Health 4.0 Healthcare Future Outlook 2023 $125,000 $60,000 Patient Engagement- a New Standpoint on Care that is Patient-Centered (Includes a total of 50 reports) E-Rx, the Digital Version of Prescription Improvising the Chances of Better Patient Outcomes www.insights10.com Integration of Healthcare Systems with Big Data and Data Silos

10. Methodology & Scope

11. Research Methodology Insights 10’s research methodology delves deeper into the market, covering the macro and micro aspects of the industry. We identify the key growth drivers, opportunities, and restraints that might promote or hinder the future industry growth along with an expansive overview of the competitive landscape to help our clients make informed strategic decisions ▪ ▪ We implement a mix of primary and secondary research for our market estimate and forecast. The secondary research forms the initial phase of our study where we conduct extensive data mining, referring to verified data sources such as independent studies, government and regulatory published material, technical journals, trade magazines, and paid data sources ▪ For forecasting, the following parameters are considered: ❑ Market drivers and restraints along with their current and expected impacts ❑ Technological scenario and expected developments ❑ End use industry trends and dynamics ❑ Trends in the consumer behavior ❑ Regulatory scenario and expected developments ❑ Current capacity and expected capacity additions up to 2030 ▪ We assign weights to these parameters and quantify their market impacts using the weighted average analysis to derive the expected market growth rate ▪ We appoint data triangulation strategies to explore different areas of the market. Our qualitative and quantitative assessments are time-sensitive, reflecting the most recent value and volume of the market across regions ▪ ▪ All our estimates and forecasts are verified through exhaustive primary research with the Key Industry Participants (KIPs) Currency used in the report is the US dollar (USD), with the market size indicated in USD million/billion (Mn/Bn) 11

12. Analysis Methodology Our Analysis Methodology involves three critical stages: Market Data Analysis & Statistical Model Interpretation & Presentation Data Collection Analysis & 01 01 Market Trends Interpretation Secondary 01 Research Market Sizing & Insights 02 02 Analysis Primary 02 Research Presentation & Data Triangulation & 03 03 Reporting Validation 12

13. Data Triangulation & Data Validation Top Down Approach Final Market Size Final Market size break up to rest of segmentation Bottom Up Approach Top Down Approach Validation from Primary Interview Arriving at market size of each segment Summarization of revenue generated from companies to arrive at total market size Validation from Primary Interview Revenue generated by products & services offered by companies Final Summary Bottom Up Approach 13

14. Key Benefits for Stakeholders from this Report Study provides an in-depth analysis of the market with current trends and future estimations to elucidate the imminent investment pockets Our tools provides stakeholders with a cohesive understanding of the industry outlook, considering the qualitative and quantitative industry variables Comprehensive analysis of factors that drive and restrict the market growth is provided Comprehensive quantitative analysis of the industry from 2021 to 2030F is provided to enable the stakeholders to capitalize on the prevailing market opportunities Extensive analysis of the key segments of the industry helps understand the applications and technologies used globally Our rigorous data collection, thorough statistical analysis and specialist assessments ensure that our clientele has a greater understanding of the industry space, supply chain, price fluctuations, competitive landscape, and other vital factors 14

15. Time Frame Report Attribute Details Quantitative Units Revenue in USD Million/Billion (Mn/Bn) Base Year for 2021 Market Overview, Revenue Forecast, Market Segmentation, Growth Factors and Trends, Company Profiles, Competitive Landscape, Regulatory Landscape, Future Opportunities Estimation Report Coverage Report Customization (5 working days) with purchase. We will provide you with data that is currently not a part of our scope as a part of customization Customized Report Forecast 2022- 2030 Period Pricing and purchase Avail customized purchase options to meet your exact research needs options

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25. Project Leadership Team Dr. Purav Gandhi Founder & CEO Mukesh Nayak Head - Marketing Ritu Baliya Engagement Manager Dhruv Joshi Consultant Purav is a physician and an Mukesh is an engineering graduate Ritu has over 6 years of experience in Dhruv Joshi is an engineer and has done entrepreneur with 12+ years of with an MBA in Marketing. He is a strategy building, market assessments, Masters in Hospital Administration with experience in Healthcare & Life seasoned healthcare market market sizing, and RWE for global MNC over 4 years of experience in the Sciences industry spanning across research & marketing professional healthcare & biopharma clients across healthcare and life science industry. He strategy, market access, health with a progressive experience of over diff. markets (America, Europe, Africa, has gained proficiency in market informatics and RWE, Digital 20 years in Life Sciences, Pharma APAC and Middle East). Her areas of research, market assessment, and Healthcare, analytics and data science. and Medical Device sectors . With an expertise include: Indentifying emerging developing insights from it. He has Purav studied medicine from Gujarat in-depth understanding of primary trends in life sciences industry, worked on various consulting projects University and also completed his MBA research, he has conducted Competitor landscape assessment, across different geographies including from IIM-Kozhikode. Purav started his hundreds of interviews of various Disease opportunity assessments etc. Asia, Europe, US, MENA. He has been career with Deloitte working on strategy stakeholders in pharma & healthcare She is a pro in secondary and primary aligned in working for sector reports of consulting engagements and also & completed several research research with a deep domain expertise various geographies along with market co-founded ConvergeHealth by projects across life sciences industry. in healthcare sector. sizing and forecasting. Deloitte.

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