Digital technologies are now integral to daily life, and the world’s population has never been more interconnected. Innovation, particularly in the digital sphere, is happening at unprecedented scale. Even so, its application to improve the health of populations remains largely untapped, and there is immense scope for use of digital health solutions. WHO is harnessing the power of digital technologies and health innovation to accelerate global attainment of health and the well-being. The purpose for a Global Strategy on Digital Health is to promote healthy lives and wellbeing for everyone, everywhere, at all ages. To deliver its potential, national or regional Digital Health initiatives must be guided by a robust Strategy that integrates financial, organizational, human and technological resources.

1. A SEMINAR AS A PART OF CURRICULUM OF
M.PHARM
EXPLORING THE WORLD OF DIGITAL MEDICINES
&
DIGITAL THERAPEUTICS
Presented by
Tejaswini Kakade
Roll No : 7
Quality Assurance
Under the guidance of
Ms. Nima Suthar
Assistant Professor
Anand Pharmacy College
1

2. 2

3. OUTLINE OF THE PRESENTATION:
1) Introduction to Digital Health
2) FDA’s focus on Digital Health
3) Application of digital health
4) Relationship between Digital Health, Digital
medicines, and Digital therapeutics
5) Digital medicine
6) Scope
7) Digital therapeutics
8) Working
9) Benefits and Advantages
10)Commercialization
11)Limitations
12)Conclusion
3

4. INTRODUCTION
4

5. WHAT IS DIGITAL HEALTH?
Digital health is the
convergence of digital
technologies with
health, healthcare,
living and society to
enhance the efficiency
of healthcare delivery
and make medicines
more personalized and
precise[1,2]
.
5

6. DIGITAL HEALTH
• Digital health refers to the use of information and communications
technologies in medicine and other health professions to manage
illnesses and health risks and to promote wellness.
• Digital health has a broad scope and includes the use of wearable
devices, mobile health, telehealth, health information technology,
and telemedicine[1,2].
6

7. PATIENT
AGE
CHRONIC
DISEASES
DIGITAL
TECHNOLOGIES
7

8. • Improve access to healthcare
• Reduce any inefficiencies in the healthcare system
• Improve the quality of care
• Lower the cost of healthcare
• Provide more personalized health care for patients
 Patients and consumers can use digital health technologies to better
manage and track their health and wellness-related activities.
 The use of technologies, such as smart phones, social networks, and
internet applications, is not only changing the way we communicate, but
also providing innovative ways for us to monitor our health and well-being
and giving us greater access to information[3].
Digital Health has been gaining momentum because it is
envisioned to:
8

9. FDA’s focus in digital health
Many medical devices now have the ability to connect to and
communicate with other devices or systems. Devices that are already
FDA approved, authorized, or cleared are being updated to add
digital features[4].
New types of devices that already have these capabilities are being
explored.
The FDA's Center for Devices and Radiological Health (CDRH) is
excited about these advances and the convergence of medical
devices with connectivity and consumer technology.
9

10. The following are topics in the digital health field on which the FDA has
been working to provide clarity using practical approaches that balance
benefits and risks:
 Software as a Medical Device
(SaMD)
Artificial Intelligence and
Machine Learning (AI/ML)
 Cybersecurity
 Health IT
 Medical Device Data Systems
 MedicalDevice Interoperability
 Telemedicine
 Wireless Medical Devices
10

11. THE TWO MAIN PEERS OF DIGITAL HEALTH :
DIGITAL
MEDICINES
DIGITAL
THERAPEUTICS
Digital medicine refers to the application of advanced digital technologies,
such as artificial intelligence, machine learning, and big data analytics, to
improve patient outcomes and healthcare delivery.
Digital therapeutics, a subset of digital health, are evidence-based
therapeutic interventions driven by high quality software programs to
prevent, manage, or treat a medical disorder or disease.
11

12. RELATIONSHIP BETWEEN DIGITAL HEALTH, DIGITAL MEDICINE AND
DIGITAL THERAPEUTICS
12

13. 13

14. UNDERSTANDING DIGITAL MEDICINES
 Digital medicine is a field
derived from the merger of
pharmaceutical and medical
devices technologies.
 In recent years, two major
healthcare sectors
pharmaceuticals and medical
devices have become
increasingly connected through
advancements made in digital medicine.
 Digital medicine is the application of technology in healthcare, not just
to better understand and track physiological systems, but also to process
the vast amounts of data generated by medical devices that can collect
patient data, such as patient monitoring devices.
14

15. SCOPE
PATIENT
ENGAGEMENT
&
EDUCATION CLINICAL RESEARCH
&
TRIALS
PREVENTION
AND
WELLNESS
PERSONALIZED
MEDICINES
REMOTE
HEALTHCARE
&
TELEMEDICINE
DISEASE
MANAGEMENT
15

16. OBJECTIVES FOR ADVANCEMENTS IN DIGITAL MEDICINE
 Enhancing patient care and outcomes
 Increasing accesibility and reach
 Empowering patients
 Enabling personalized and precision medicines
 Improving efficiency and reducing healthcare costs
 Driving innovation and research
 Enhancing care coordination and communication
 Promoting preventive and proactive healthcare
16

17. APPLICATIONS
DIGITAL THERAPEUTICS
REMOTE PATIENT MONITORING SYSTEMS
MEDICATION ADHERENCE APPS
TELEMEDICINE PLATFORMS
HEALTHTRACKING APPS & WEARABLE DEVICES
ELECTRONIC HEALTH RECORDS
PERSONALIZED MEDICINES
ARTIFICIAL INTELLIGENCE BASED DIAGNOSTIC TOOLS
HEALTH AND WELLNESS APPS
TELEMEDICINES
17

18. 18

19. EXPLORING DIGITAL THERAPEUTICS
Digital therapeutics, a subset of digital health, are
evidence-based therapeutic interventions driven by
high quality software programs to prevent, manage,
or treat a medical disorder or disease
19

20. HISTORY
“One to many model” of care
for overcoming physical
distance for healthcare
deliveries
In 1995, Dr. Joseph Kvedar from Boston
led a program to learn the development
and application of technology for
delivering care outside the traditional
setup of a hospital or a doctor's office
This attempt by Dr. Kvedar could be attributed to being among the firsts made by
researchers in the digital health/DTx domain.
20

21. EVIDENCE BASED APPROACH
DATA COLLECTION & MONITORING
PERSONALIZATION & TAILORING
USER INTERFACE & EXPERIENCE
SOFTWARE BASED PLATFORM
21

22. BEHAVIOURAL CHANGE
TECHNIQUES
INTEGRATION WITH
HEALTHCARE
OUTCOME MEASUREMENT &
REPORTING
COACHING AND SUPPORT
EDUCATION AND INFORMATION
22

23. How does digital therapeutics work?
 DTx industry often refers to DTX applications as “clinically
validated,” “rigorous,” “focused,” and “FDA-approved,”
depending on the situation.
 Therapeutics mimicking the product development path of
pharmaceutical drugs are often referred to as “software as
medicine” or “behavioral medicine in a digital format,” which
indicates online or mobile delivery of skills-based psychotherapy
techniques.
Diagnostic and therapeutic use of DTx can be categorized under
one class while many companies are trying to transform several
behavioral interventions in digital formats.
 DTx relies exclusively on algorithms for its mechanism of action
as well as the algorithmic information management, both of which
make it easier to generate, collate, and analyze the health data.
 DTx industry often refers to DTX applications as “clinically
validated,” “rigorous,” “focused,” and “FDA-approved,” depending
on the situation.
 Therapeutics mimicking the product development path of
pharmaceutical drugs are often referred to as “software as
medicine” or “behavioral medicine in a digital format,” which
indicates online or mobile delivery of skills-based psychotherapy
techniques.
Diagnostic and therapeutic use of DTx can be categorized under
one class while many companies are trying to transform several
behavioral interventions in digital formats.
 DTx relies exclusively on algorithms for its mechanism of action as
well as the algorithmic information management, both of which
make it easier to generate, collate, and analyze the health data[5,6,7].
23

24. 1] Assess relevant data and diagnosis
gather user information to set diagnostic premise
2] Tailored treatment plan
generate personalized treatment plans using interventions such as
educational content, behavior change techniques, cognitive
exercises, or guided therapeutic activities.
3] Interactive Engagement:
engage users in their treatment utilize multimedia elements like
videos, animations, quizzes, and interactive exercises to deliver the
therapeutic content
4] Data tracking and monitoring
includes data on treatment progress, health outcomes, medication
adherence, symptom severity, and other relevant metrics. analyzed
to assess the effectiveness of the treatment and make necessary
adjustments.
5] Feedback and support
6] Continuous iteration and improvement
1] Assess relevant data and diagnosis[6,7]
gather user information to set diagnostic premise
2] Tailored treatment plan
generate personalized treatment plans using interventions such as
educational content, behavior change techniques, cognitive exercises, or
guided therapeutic activities.
3] Interactive Engagement:
engage users in their treatment utilize multimedia elements like videos,
animations, quizzes, and interactive exercises to deliver the therapeutic content
4] Data tracking and monitoring
includes data on treatment progress, health outcomes, medication
adherence, symptom severity, and other relevant metrics. analyzed to assess
the effectiveness of the treatment and make necessary adjustments.
5] Feedback and support
6] Continuous iteration and improvement
24

25. remote access
real time monitoring
personalization
cost effectiveness
consultation & support
Significant enhanced
accessibility and
convenience
Real time patient monitoring
Timely interventions
Personalized feedback
Behaviouraltracking,
data analysis
Continuous monitoring and
feedback
adaptive
treatment plans
data-driven
insights
targeted
interventions
behavioural
modifications
Capability to
provide
personalized
and tailored
interventions
25

26. REGULATORY FRAMEWORK
 While a broad range of unregulated health apps have historically been
available in the App Store (iOS/iPadOS) or Google Play since their launch,
many of these have been found to produce inconsistent, misleading, or
dangerous results[8].
 In response, regulators in the United States such as the Food and Drug
Administration have developed regulatory frameworks such as software
as a medical device which require manufacturers to prove that their apps
are safe, effective, and that rigorous quality management
system processes are in place to ensure that remains the case as software
updates occur.
 In the European Union, regulation (EU) 2017/745, commonly known as
"EU MDR" classifies potential digital therapeutics in terms of their
intended use, application, and potential to cause harm..
26

27. While many manufacturers seek FDA clearance or approval, this is only the
first step on the path to being reimbursed for the use of a DTX.
Accordingly, digital therapeutics companies pursue a range of business
models[8,9]:
BUSSINESS TO
BUSSINESS
INDUSTRY
PARTNERSHIPS
BUSSINESS TO
BUSSINESS
PAYER
REIMBURSEMENTS
27

28. ADHD
AUTISM
HYPERTENSION
DYSLIPIDEMIA
GERD
BOWEL SYNDROME
SUBSTANCE ABUSE
CVS DISORDERS
GIT DISORDERS
28

29. VIVID IQ PORTABLE CVS ULTRASOUND SEGMENT 3D PRINTING DEVICE
ARTIFICIAL INTELLIGENCE/ MACHINE LEARNING DEVICES
29

30. AUGMENTED & VIRTUAL REALITY
Operations conducted using virtual reality
30

31. BIOHACKING
OURA RING
Sleep Activity tracking device
NARBIS GLASSES
Neurofeedback device
31

32. Wireless Wearable Devices
SMART PROSTHETICS REMOTE POWERED BP SENSOR
32

33. Counseling + community+ chatbot
33

34. Dtx Apps
Behavior tracking app
34

35. Challenges facing digital therapeutics
Regulatory Challenges
Data security & privacy
Technological Expertise
Physical Adoption
Lack of strategic alliance
in Dtx
35

36. CONCLUSION:
In conclusion, digital health, medicines, and therapeutic
presentations have tremendous potential to transform
healthcare by improving access, patient engagement,
personalized medicine, and overall efficiency.
As technology continues to advance, it is crucial to address
challenges and establish robust regulations to maximize the
benefits of these innovations while safeguarding patient
privacy and ensuring equitable access for all.
However, it's important to acknowledge some challenges
associated with digital health.
Privacy and security concerns surrounding patient data,
interoperability issues between different health systems, and
ensuring equitable access to digital health solutions are areas
that need ongoing attention and development.
36

37. REFERENCES
1] Boston technologies, Digital Therapeutics: Improving Patient
Outcomes
Through Evidence-Based Technologies
https://www.boston-technology.com/blog/digital-therapeutics
2] Dimple Arora, Pawan rane and Amit Dang ,’ Role of digital
therapeutics
and the changing future of healthcare, May 2020
3. Rastegayeva I. The rise of digital therapeutics
https://blogs 3dscom/northamerica/the-rise-of-digital-therapeutics/
Updated 2019 Sept 10; Cited 2020 Jan 09.
4. Martin M. The dawn of digital therapeutics
http://blogcastacorg/2019/04/the-dawn-of-digital-therapeutics/
Updated 2019 Apr 16; Cited 2020 Jan 09.
5. DTA. Digital therapeutics alliance 2017.
https://wwwdtxallianceorg/ Cited 2020 Jan 09.
37

38. REFERENCES
6. Akbar S, Coiera E, Margrabi F. Safety concerns with consumer-
facing mobile health applications and their consequences: a scoping
review. J Am Med Inform Assoc. 2019;27(2):33040.
https://doi.org/10.1093/jamia/ocz175.
7. DTx by Country—Digital Therapeutics Alliance. Digital Therapeutics
Alliance. 2021.
https://dtxalliance.org/understanding-dtx/dtx-by-country.
8. Weir K. The ascent of digital therapies
https://www.apa.org/monitor/2018/11/cover-digital-therapies.
9. Artificial intelligence in medicine regulation—European Medicines
Agency. European Medicines
Agency. https://www.ema.europa.eu/en/news/artificial-intelligence-
medicine-regulation.
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