Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Contents
1 Digital Therapeutics within the Digital Health Landscape: Foundational
Aspects
1
2 Sector Perspective: Digital Therapeutics in Behavioral Health
17
3 Navigating the Code to Commercial Lifecycle of Digital Health Apps:
Defining and Defending Your Strategy for Success
33
4 Designing and Delivering a DTx Clinical Research Program: No Need to
Re-invent the Wheel
59
5 Statistical Designs for Developing Personalized Mobile Treatment
Interventions
6 Statistical Approaches in the Development of Digital Therapeutics
7 Health Economics Aspects of Digital Therapeutics
161
99
121
8 Healthcare Data Ownership and Privacy: A Perspective for Digital
Therapeutics
177
9 Building the Story of Scientific Evidence for Digital Therapeutics: Trials,
Meta-Analysis, and Real-World Data
195
10 US Regulatory Pathways for Digital Therapeutics
219
v
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
We Don’t reply in this website, you need to contact by email for all chapters
Instant download. Just send email and get all chapters download.
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
You can also order by WhatsApp
https://api.whatsapp.com/send/?phone=%2B447507735190&text&type=ph
one_number&app_absent=0
Send email or WhatsApp with complete Book title, Edition Number and
Author Name.
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
vi
Contents
11 Building Digital Health and Therapeutic Solutions for the Future:
What’s Required for Success?
245
12 Digital Therapeutics for Sleep and Mental Health
261
13 DTx for the NEXT three billion!
281
14 Akili: A Novel Approach to Clinical Intervention with Digital
Therapeutics
293
15 SilverCloud Health: Online Mental Health and Wellbeing Platform
307
16 Digitally Augmenting Therapies: A DTx Opportunity for Pharma
Portfolio Development
331
17 The Convergence of Digital Health Technologies: The Role
of Digital Therapeutics in the Future Healthcare System
18 Decentralized Clinical Trials: A New Paradigm for New Medical
Product Development and Digital Therapeutics
373
351
19 The Past, Present, and Future of Digital Therapeutics
405
Index
431
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
List of Abbreviations
ACCC: American Association of Community Cancer Centers
ACP: Algorithm Change Protocol
ADHD: Attention Deficit Hyperactivity Disorder
AI: Artificial Intelligence
AMCP: Academy of Managed Care Pharmacy
BfArM: Bundesinstitut für Arzneimittel und Medizin-produkte
BIA: Budget Impact Analysis
BLA: Biologics License Application
BMI: Body Mass Index
BSM: Behavioral Sleep Medicine
BYOD: Bring Your Own Device
CAGR: Compound Annual Growth Rate
CBA: Cost Benefit Analysis
CBT: Cognitive-Behavioral Therapy
CCPA: California Consumer Privacy Act
CDC: Center for Disease Control and Prevention
CDRH: Center for Devices and Radiological Health
CEA: Cost-Effectiveness Analysis
CED: Coverage with Evidence Development
CEEs: Causal Excursion Effects
CER: Comparative Effectiveness Research
CFIUS: Committee on Foreign Investment in the United States
CFR: Code of Federal Regulations
CGM: Continuous Glucose Monitoring
CM: Contingency Management
CMA: Cost Minimization Analysis
xi
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com List of Abbreviations
xii
CNS: Central Nervous System
COI: Cost of Illness
CONSORT: Consolidated Standards of Reporting Trials
CPRA: California Privacy Right Act
CPT: Current Procedural Terminology
CRA: Community Reinforcement Approach
CTTI: Clinical Trials Transformation Initiative
CUA: Cost-Utility Analysis
D2C: Direct-to-Consumer
DALYs: Disability-Adjusted Life Years
dCBT: Digital Cognitive Behavioral Therapy
DCT: Decentralized Clinical Trial
DHAs: Digital Health Apps
DHCE: Digital Health Center of Excellence
DiMe: Digital Medicine Society
DPP: Diabetes Prevention Program
DSME: Diabetes Self-Management Education
DTx: Digital Therapeutics
DVG: Digitale Versorgung Gesetz (Digital Healthcare Act)
EAP: Expedited Access Pathway
eCOAs: Electronic Clinical Outcome Assessments
EDC: Electronic Data Capture
EHR: Electronic Health Record
eIC: Electronic Informed Consent
ELR: Electronic Life Record
EMA: European Medicines Agency
EMR: Electronic Medical Record
ESF: Evidence Standards Framework
EudraCT: European Union Drug Regulating Authorities Clinical Trials Database
FCC: Federal Communications Commission
FDA: Food and Drug Administration
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
List of Abbreviations
xiii
FDASIA: Food and Drug Administration Safety and Innovation Act
FDAMA: Food and Drug Administration Modernization Act
FMEA: Failure Mode and Effects Analysis
FTC: Federal Trade Commission
GAD: Generalized Anxiety Disorder
GCP: Good Clinical Practice
GDPR: General Data Protection Regulation
GEE: Generalized Estimating Equations
GMLP: Good Machine Learning Practice
GRADE: Grading of Recommendations, Assessment, Development, and Evaluation
HCDM: Healthcare Decision Maker
HCP: Healthcare Professional
HDI: Human Development Index
HIPAA: Health Insurance Portability and Accountability Act
HITECH: Health Information Technology for Economic and Clinical Health Act
HRU: Health Resource Utilization
HSE: Health Service Executive
HTA: Health Technology Assessment
HTN: Hypertension
IADL: Instrumental Activities of Daily Living
IAPT: Improving Access to Psychological Therapies
ICH: International Conference on Harmonization
IDEs: Investigational Device Exemptions
IMDRF: International Medical Device Regulators Forum
ICER: Incremental Cost-Effectiveness Ratio
ICH: International Council on Harmonisation
IDNs: Integrated Delivery Networks
IF: Impact Factor
IMP: Investigational Medical Product
IoT: Internet of Things
IP: Intellectual Property
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com List of Abbreviations
xiv
IPO: Initial Public Offering
IPD-MA: Individual Participant Data Meta-Analysis
IRB: Institutional Review Board
IRT: Imagery Relief Therapy
IS: Implementation Science
ISL: Integrated Scientific Learning
ISRCTN: International Standardised Randomised Controlled Trial Number
LMICs: Low and Middle-Income Countries
LoC: Level of Concern
MADRS: Montgomery-Åsberg Depression Rating Scale
MDCG: Medical Device Coordination Group
MDD: Major Depressive Disorder
MDDS: Medical Device Data System
MDR: Medical Devices Regulation
MDUFMA: Medical Device User Fee and Modernization Act
MEE: Marginal Excursion Effect
MHRA: Medicines and Healthcare Products Regulatory Agency
ML: Machine Learning
MRC: Medical Research Council
MRT: Micro-Randomized Trial
MS: Multiple Sclerosis
MVF: Mirror Visual Feedback
NAI: National Advertising Initiative
NDA: New Drug Application
NHRIC: National Health-Related Item Code
NHS: National Health Service
NICE: National Institute of Health and Care Excellence
NIDA: National Institute on Drug Abuse
NIH: National Institutes of Health
NIMH: National Institute of Mental Health
NSE: Not Substantially Equivalent
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
We Don’t reply in this website, you need to contact by email for all chapters
Instant download. Just send email and get all chapters download.
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
You can also order by WhatsApp
https://api.whatsapp.com/send/?phone=%2B447507735190&text&type=ph
one_number&app_absent=0
Send email or WhatsApp with complete Book title, Edition Number and
Author Name.
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
List of Abbreviations
xv
OOP: Out-of-Pocket
OTC: Over-the-Counter
PBM: Pharmacy Benefit Managers
PD: Pharmacodynamics
PDT: Prescription Digital Therapeutics
PHI: Protected Health Information
PICOT: Population, Intervention, Comparison, Outcome, Time
PK: Pharmacokinetics
PMA: Premarket Approval
PMPM: Per Member Per Month
PMx: Pharmacometrics
PRISMA: Preferred Reporting Items for Systematic Reviews and Meta Analyses
P&T: Pharmacy & Therapeutics
PTSD: Post-Traumatic Stress Disorder
QALYs: Quality-Adjusted Life Years
QMS: Quality Management System
QSP: Quantitative Systems Pharmacology
RCT: Randomized Controlled Trial
R&D: Research & Development
RDT: Randomized Discontinuation Trial
ROI: Return-on-Investment
RWD: Real-World Data
RWE: Real-World Evidence
SaMD: Software as a Medical Device
SARA: Substance Abuse Research Assistant
SCED: Single-Case Experimental Design
SCRIBE: Single-Case Reporting Guidelines in Behavioural Interventions
SDK: Software Development Kit
SE: Substantially Equivalent
SI: Substantive Interaction
SDLC: Software Development Life Cycle
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com List of Abbreviations
xvi
SPIRIT: Standard Protocol Items: Recommendations for Intervention Trials
SPS: Software as a Medical Device Pre-Specifications
SSRI: Selective Serotonin Reuptake Inhibitor
STROBE: Strengthening the Reporting of Observational Studies in Epidemiology
T2DM: Type 2 Diabetes Mellitus
TAU: Treatment-as-Usual
TES: Therapeutic Education System
TGA: Therapeutic Goods Administration
TOVA: Tests of Variables of Attention
TPLC: Total Product Lifecycle
UCD: User-Centered Design
V&V: Verification and Validation
VFM: Value for Money
VR: Virtual Reality
WHO: World Health Organization
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
1
Digital Therapeutics within the Digital Health
Landscape: Foundational Aspects
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
1.9
1.10
1.1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
What Are Digital Therapeutics? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Digital Therapeutics in the Digital Health Technology Product Spectrum . . .
Matching Digital Technologies to Needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.1
Appropriate Product Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.2
Appropriate Environment of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4.3
Appropriate Phase of Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ensuring Product Safety and Efficacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
How Do Digital Therapeutics Provide Value? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
How Can Digital Therapeutics Be Used in Clinical Practice? . . . . . . . . . . . . . . . .
1.7.1
Assessing Appropriate Utilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.7.2
Providing Product Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.7.3
Utilizing Actionable Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.7.4
Ensuring Practice Integration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gaps in Care to Be Addressed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.1
Existing Clinical Care Needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8.2
Healthcare Disparities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
COVID-19 Era Lessons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Looking to the Future . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
About the Author . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
2
3
5
6
6
6
7
8
9
9
10
11
11
12
12
13
14
15
16
Introduction
While the philosophy of medical care has remained relatively consistent for centuries,
treatment options have continued to evolve with successive scientific discoveries and technological improvements. New medicine and treatment modalities directly influence medical
practices, expand clinicians’ ability to deliver enhanced patient care, and provide patients
with access to entirely new treatment options. Enhanced therapeutic modalities also broaden
the types of medical conditions that may be addressed by clinicians, employers, and payors as they proactively provide patient populations with care options that were previously
unavailable—both in terms of clinical and geographic reach.
This chapter expounds on digital therapeutics (DTx)—software-based treatment modalities that deliver therapeutic interventions directly to patients. Section 1.2 defines digital
therapeutics and describes foundational principles that any DTx product should satisfy.
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
2
DTx within the Digital Health Landscape: Foundational Aspects
Section 1.3 describes digital therapeutics within a broader class of digital health products.
Section 1.4 presents some important considerations on the use of digital health technologies
in general and digital therapeutics in particular. Section 1.5 outlines existing best practices
on the standards of evidence for digital therapeutics. Section 1.6 describes the potential
merits of digital therapeutics, and Section 1.7 presents some considerations on how DTx
products can be used in practice. Section 1.8 describes existing gaps in clinical care that may
be filled by digital therapeutics, and Section 1.9 corroborates these ideas in the COVID-19
pandemic crisis. Finally, Section 1.10 concludes with some insights into the future of digital
therapeutics.
1.2
What Are Digital Therapeutics?
Industry leaders provide the following definition:1
Digital therapeutics (DTx) represent a subcategory of digital health technologies
that deliver therapeutic interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a disease or disorder. They
are used independently or in concert with medications, devices, or other therapies
to optimize patient care and health outcomes.
DTx products incorporate advanced technology best practices relating to design,
clinical evaluation, usability, and data security. They are reviewed and cleared or
certified by regulatory bodies as required to support product claims regarding risk,
efficacy, and intended use.
Digital therapeutics empower patients, clinicians, and payers with intelligent and
accessible tools for addressing a wide range of conditions through high quality, safe,
and effective data-driven interventions.
Software content and algorithms in digital therapeutics directly impact the targeted
aspects of medical diseases and disorders, like how active pharmaceutical ingredients are responsible for the drug’s mechanism of action and in-person therapies deliver transformative
clinical changes.
As digital therapeutics are increasingly incorporated into medical practice and become
available to patients and caregivers, end-users need to understand the nature of these products and the associated medical claims. Any product claiming to be a digital therapeutic
must have properties that adhere to the following foundational principles:1
• Prevent, manage, or treat a medical disorder or disease.
• Produce a medical intervention that is driven by software.
• Incorporate design, manufacture, and quality best practices.
• Engage end-users in product development and usability processes.
• Incorporate patient privacy and security protections.
• Apply product deployment, management, and maintenance best practices.
• Publish trial results inclusive of clinically meaningful outcomes in peer-reviewed
journals.
1 Digital Therapeutics Alliance. “Digital Therapeutics Definition and Core Principles”
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
DTx in the Digital Healthetutorsource@gmail.com
Technology Product Spectrum
3
FIGURE 1.1
Current DTx clinical targets. This list will continue to evolve as the industry grows.
• Be reviewed and cleared or certified by regulatory bodies as required to support product
claims of risk, efficacy, and intended use.
• Make claims appropriate to clinical evaluation and regulatory status.
• Collect, analyze, and apply real-world evidence and/or product performance data.
Digital therapeutics can provide personalized, remote treatment options for conditions
that have previously been untreated or not adequately addressed through traditional therapies (Figure 1.1). They may also enhance the impacts of—or optimize the use of—traditional
medications, in addition to addressing specific comorbidities, side effects, or affiliated conditions to offer a more complete and well-rounded therapy. While some DTx products may
provide a standalone treatment, others directly enhance, support, or optimize current medical therapies.
DTx product quality extends from the components and processes used to manufacture
digital therapeutics to the systems relied on to ensure patient safety, all the way through
to the outcomes achieved by these therapies. Patients, clinicians, and decision-makers can
use these principles as a guide to understand and evaluate the quality of digital therapeutic products while also protecting against the risk of counterfeit, unproven, or potentially
harmful products.
1.3
Digital Therapeutics in the Digital Health Technology Product
Spectrum
Digital health technologies (DHTs) have been available to patients for over a decade.
These technologies continue to evolve and increase their collective ability to address
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
We Don’t reply in this website, you need to contact by email for all chapters
Instant download. Just send email and get all chapters download.
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
You can also order by WhatsApp
https://api.whatsapp.com/send/?phone=%2B447507735190&text&type=ph
one_number&app_absent=0
Send email or WhatsApp with complete Book title, Edition Number and
Author Name.
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
4
DTx within the Digital Health Landscape: Foundational Aspects
fundamental problems within the healthcare industry. The World Health Organization’s
2019 Recommendations on Digital Health Interventions for Health System Strengthening
state:2
. . . digital technologies provide concrete opportunities to tackle health system challenges, and thereby offer the potential to enhance the coverage and quality of health
practices and services.
There are numerous ways to categorize and classify DHTs. Figure 1.2 provides one
representation of this growing industry.3 Notably, this chart does not assign a hierarchy
to the digital health technology categories. Each category is governed by different sets
of evidence and regulatory requirements, but no category is more or less valuable to the
advancement of health and healthcare. Additionally, although digital therapeutics deliver
patient-facing interventions, they can provide clinical decision-makers with a wide range of
insights related to therapy outcomes and next steps.
FIGURE 1.2
Digital health technology categories (Source: Digital Therapeutics Alliance. “Digital Therapeutics: Reducing Rural Health Inequalities”).
2 World Health Organization. “WHO Guideline: recommendations on digital interventions for health
system strengthening”
3 Digital Therapeutics Alliance. “Digital Therapeutics: Reducing Rural Health Inequalities”
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Matching Digital Technologies
to Needs
5
Over the past decade, DHTs have become significantly diversified in product claims,
purposes, safety, and levels of clinical evidence. For instance, digital technology has long
been used to record patient-reported outcomes related to symptoms or triggers related to
sleep problems (e.g., wellness apps). A subsequent generation of DHTs introduced the ability for patients to utilize clinical-grade wearables to track digitally captured sleep measures
to better monitor and diagnose sleep disorders (e.g., remote patient monitoring, diagnostic
products). The next generation of DHTs—digital therapeutics—can provide clinically validated cognitive-behavioral therapy (CBT) to treat chronic sleep problems and insomnia
directly. This set of examples demonstrates that each DHT product type serves a different
purpose and must be used accordingly.
In an environment where some products present more significant levels of risk (and
opportunity) than others, patients and clinicians should begin to understand what each
product is designed to do, whether it is safe and effective, and the degree of privacy protection it provides. For example, popular patient-facing wellness and lifestyle products often
do not require clinical evidence or regulatory oversight to be on the market. In comparison,
diagnostic, monitoring, and therapeutic interventions require varying degrees of evidence
and oversight to demonstrate product safety and efficacy. These factors are increasingly important for end-users to understand as they face the difficult decision of determining which
products best meet their needs (Figure 1.3).
Patients
Clinicians
Payers
Regulators
should understand:
should understand:
should understand:
should understand:
• What am I using?
• Why am I using it?
• How will it help?
• Has someone
verified it is safe
and effective?
• What should I
expect?
• Does this provide
actionable data or
insights?
• Is it necessary for
me to prescribe
this?
• How does it relate
to other
treatments?
• What type of
product are we
covering?
• How will it benefit
patients?
• How do we
measure
engagement?
• What type of value
and clinical
outcomes should
we expect?
• What level of risk
does each product
pose to patients?
• What is the
appropriate level of
regulatory
oversight?
FIGURE 1.3
Considerations on digital health technologies and digital therapeutics for patients, clinicians,
payers, and regulators.
1.4
Matching Digital Technologies to Needs
Patients, clinicians, and enterprises can experience the full spectrum of intended benefits
derived from DHTs when products are used for the appropriate purpose, in the appropriate environment, and during the appropriate phase of care. If a mismatch occurs between
technology and its clinical or system-level intended use, it will provide reduced value and
introduce unexpected or undesired outcomes. In what follows, we describe some essential
considerations on the use of DHTs in general and digital therapeutics in particular.
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
6
DTx within the Digital Health Landscape: Foundational Aspects
1.4.1
Appropriate Product Purpose
Not all medications are the same, nor are all digital health technologies. A product intended to remind patients to take their medication every morning is different from a product
designed to calculate a personalized insulin dose. Once the intended use of a DHT is understood, decision-makers can identify the end-user target population, provide appropriate
access, and derive the full benefit of the product.
To ensure that DHTs are used appropriately to support clinicians and provide targeted
care to patients, one should match exact clinical needs to each technology’s capability. For
example, remote patient monitoring or diagnostic tools may be most helpful if a clinician
needs to better assess a patient’s condition outside of a clinic setting. Suppose the clinician
connects with patients who cannot travel to their office for an in-person visit. In that
case, utilizing a telehealth platform becomes a vital technology resource. Finally, suppose a
clinician needs to deliver active care to patients between or beyond an in-person or virtual
visit. In that case, a digital therapeutic may be the best way to advance therapy further.
1.4.2
Appropriate Environment of Use
Digital health technologies also enable the expansion of medical care outside of a traditional clinic environment. During the COVID-19 era, clinicians quickly adopted telemedicine
to meet with their patients remotely when in-person visits were not a viable option. In
line with the industry-wide expansion of telehealth, clinicians expanded their use of remote monitoring tools and digital therapeutics to provide active monitoring and clinical
care for patients with chronic diseases and behavioral health conditions in between and in
preparation for traditional or virtual care visits. Products such as remote monitoring and
digital therapeutics enable the monitoring and delivery of high-quality care in previously
non-traditional settings, foremost of which is the patient’s home environment.
To identify the appropriate environment of use, one should primarily determine whether
a product is intended to support a patient, clinician, or health system. In addition, some
setting-specific considerations should apply. For example, patient-facing wellness and support products are most frequently intended for personal use and do not produce clinicalgrade data. In this circumstance, it is rare for clinicians to utilize this data in clinical practice
and decision-making. However, if the DHT generates and provides clinical-grade data, then
a clinician must understand whether that data is provided as baseline background information or whether it is actionable data for clinical decision support and therapy optimization.
In parallel, patients must understand whether data generated by the digital product
they are using provides “helpful to know” insights versus data that should be acted upon
to maintain therapeutic outcomes. Patients and caregivers must also be informed of what
types of data generated by their DHTs are being shared with clinicians and other healthcare
decision-makers.
Across all DHT product types, patients, clinicians, and decision-makers need to understand which environments the DHT is intended to be used, data generated by the product,
and which outcomes are shared between patient use environments and clinical settings.
1.4.3
Appropriate Phase of Care
It is not only important to match the product’s intended use and environment of care to
the end user’s clinical need but also the product’s functionality during the various phases
of clinical care.
Digital health technologies can support, supplement, or optimize the following phases of
healthcare:
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
Ensuring Product Safety etutorsource@gmail.com
and Efficacy
7
• Direct, supervised care—the period of time when patients receive active, personalized
care from a clinician (e.g., in-person or virtual care encounters).
• Maintenance period —the period of time when patients self-manage their condition
and/or carry out recommendations provided by a clinician (e.g., taking medications,
completing exercises).
• Self-directed, autonomous care—the period of time when patients are not under
the direct supervision of a clinician and/or are not being actively treated by a clinician
or healthcare professional.
Depending on their purpose, digital health technologies will provide differing levels of
value during the different phases of healthcare. For instance, during the “direct, supervised
care” phase, clinicians may rely on clinical decision support tools or digital diagnostics
to obtain reliable information that can be applied to clinical care, thereby enabling the
ability to triage patients, assess health status, and improve the delivery of care. During
the “maintenance period,” patients can rely on digital therapeutics to receive personalized
remotely-delivered therapies to continue disease treatment or self-manage their conditions.
During the “self-directed, autonomous care” phase, patients may use activity and fitness
trackers, wellness apps, preventative behavior change tools, wearables, or sensors to track
their health status or monitor for potential condition flares or disease state changes, or
digital therapeutics. These options enable patients and clinicians to appropriately determine
if or when an escalation of care is necessary.
Once end-users understand the purpose of the product, its appropriate environment of
use, and its role during the multiple phases of healthcare, it is possible to optimize both
the product’s value and the related healthcare outcomes.
1.5
Ensuring Product Safety and Efficacy
Digital therapeutics should be held to similar standards of evidence as other medical
products. Essential considerations in the evaluation of DTx products include selecting the
proper trial design, utilization of standardized endpoints, alignment with Good Clinical
Practices (GCP), and appropriate reporting of outcomes. Some additional evidence-related
best practices for digital therapeutics are:4
• Adherence to rigorous clinical evidence generation, analysis, and application standards
throughout the DTx product lifecycle.
• Conducting one or more adequately-powered, well-controlled, fit-for-purpose clinical trials in the target population.
• Publication of trial results in peer-reviewed journals.
• Monitoring and analyzing real-world outcomes and product performance data to ensure
ongoing product safety, efficacy, quality, and improvement.
• Implementing a proactive approach to surveillance, assessment of user needs, and continuous learning.
4 Digital Therapeutics Alliance. “DTx Product Best Practices”
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
8
DTx within the Digital Health Landscape: Foundational Aspects
From a regulatory perspective, DTx products are subject to various frameworks depending on the region they are manufactured and utilized in. These regulatory frameworks are
rapidly evolving to accommodate digital therapeutics’ review and appropriate approval.
While numerous regulatory jurisdictions regulate digital therapeutics as a medical device, categorizing them as Software as a Medical Device (SaMD),5 others recognize DTx
products as standalone medical devices or as companion products. Additionally, some jurisdictions exert enforcement discretion over certain DTx product types. These regulatory
categorizations and frameworks are based on the level of risk associated with each product’s
claim and intended use.
Regulatory-related best practices for digital therapeutics include:4
• Compliance with oversight provided by each national regulatory agency or notified body,
including review of medical claims of safety and efficacy.
• Registration with the applicable regulatory agency or notified body in each jurisdiction
the product is being used and compliance with all manufacturing requirements.
• Undergoing a risk-based assessment by bodies responsible for market authorization when
appropriate to evaluate product safety, claims, and efficacy.
• Ensuring that product claims are appropriate to clinical validation, regulatory status,
and marketing authorization.
• Adherence to labeling and advertising regulations under appropriate authorities, including all labels and other written, printed, or graphic matter accompanying or associated
with the product.
National and international frameworks that represent digital therapeutics must become
more harmonized. Without this, healthcare decision-makers and policymakers do not have
consistent ways to define, assess, and realize the value of digital therapeutics and other
digital health technologies. The impacts of this are wide-reaching. If specific technologies
are left out of frameworks or miscategorized, this may result in technologies not being
introduced into various geographic or economic regions, but health systems will also not
achieve their optimal value if products are presented without consideration of the broader
digital health ecosystem.
1.6
How Do Digital Therapeutics Provide Value?
Across the DTx industry, individual products can address patient, caregiver, clinician,
and payor needs.6
• Addressing patients’ needs and goals. DTx products can offer personalized therapeutic interventions, considering patients’ needs and abilities, work or education schedules, language, cultural aspects, and other characteristics. They can often be accessed
securely through patient-owned devices such as smartphones and tablets. These products
can provide meaningful insights on patients’ goals, engagement, quality of life measures,
and disease state outcomes. In addition, some DTx products can optimize treatment,
reduce reliance on certain medications, and lower the stigma associated with the delivery
of specific traditional therapies.
5 IMDRF (International Medical Device Regulators Forum). “Software as a Medical Device (SaMD)”
6 Offerings provided by individual digital therapeutics may differ based upon product indication.
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
We Don’t reply in this website, you need to contact by email for all chapters
Instant download. Just send email and get all chapters download.
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
You can also order by WhatsApp
https://api.whatsapp.com/send/?phone=%2B447507735190&text&type=ph
one_number&app_absent=0
Send email or WhatsApp with complete Book title, Edition Number and
Author Name.
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
How Can Digital Therapeutics
Be Used in Clinical Practice?
9
• Expanding therapeutic options. Digital therapeutics can address a broad range
of behavioral, mental, and physical diseases and disorders. Some DTx products may
complement other therapeutic interventions, including medications, clinician-delivered
therapies, and services. Ultimately, digital therapeutics may bring expanded access to
evidence-based medical treatments locally, nationally, and globally.
• Improving patient and population health outcomes. Digital therapeutics can enhance patients’ understanding, management, and ways of engagement in their healthcare. Real-world studies of digital therapeutics aim at demonstrating product effectiveness in various target populations. Such studies generate important data on product use,
patient-reported outcomes, and clinical outcomes. With modern information technology
and advanced data analytics, it is possible to facilitate frequent and secure updates on
DTx product utility in real-world settings, providing patients, caregivers, and clinicians
the means to make intelligent healthcare decisions.
• Extending active delivery of care. Digital health technologies and digital therapeutics can be implemented in the context of traditional or novel clinician-delivered care
models. They can expand the ability to provide clinical-grade, personalized therapies
to patients in their home environment. Further, they can improve access to therapy
options for previously untreated or undertreated conditions, thus filling critical patient
care gaps.
• Achieving economic benefits. There is increasing evidence that digital therapeutics
can make effective, patient-centered treatments accessible and scalable at a relatively
low cost. The financial burden of certain medical conditions may be decreased by reducing overall costs, emergency room visits, and other in-person healthcare encounters. Prevention of disease exacerbations may reduce unnecessary expenses and chronic
disease-related hospitalizations.
• Supporting user-resourced settings. Digital therapeutics offer an opportunity to
increase population exposure to effective and engaging treatments without requiring an
equivalent workforce expansion. Digital health technologies bring novel and efficient ways
to support healthcare teams in settings with varying degrees of healthcare infrastructure.
1.7
How Can Digital Therapeutics Be Used in Clinical Practice?
Due to the broad range of medical needs that can be addressed by digital therapeutics
and the diverse set of delivery mechanisms, it is impossible to state the only way DTx
products should be used in practice. While some critical considerations (e.g., those related
to appropriate utilization, product access, and data generation) apply to all digital therapeutics, other considerations may apply only to the DTx products used in the context of
clinical practice (where a clinician’s engagement is essential).
1.7.1
Assessing Appropriate Utilization
Digital therapeutics create new treatment and self-management options for behavioral
health and chronic disease populations. Of primary concern to clinicians is the clear understanding of which disease or condition the DTx product is indicated to treat, manage,
or prevent. It is also essential to determine if the therapy is intended to be used independently, in tandem with in-person or remote clinician-delivered treatment, and/or paired
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
10
DTx within the Digital Health Landscape: Foundational Aspects
Is this DTx product being used for the:
Right indication?
Which disease or medical disorder does the product have an indication to treat, manage, or
prevent?
Right patient?
For which patient populations does this product offer targeted, evidence-based, clinically
evaluated therapies?
Right therapy?
Should the product be used independently, or with medications, devices, or other therapies?
Does it align with the patient’s current care?
Right timing and
frequency?
What is the appropriate timing, duration, and frequency of therapy use?
For a time-limited therapy, when does it need to be reassessed, escalated, or stopped?
Right language?
Is product content available to the patient in a familiar language and with appropriate
cultural references?
Right outcome
documentation?
What clinical outcomes are collected by the product and shared pending patient-granted
permissions with end users, caregivers, and clinicians?
Right response to
therapy?
How are real-world data leveraged to detect clinical outcomes and success of therapy?
How is data used to demonstrate product utilization and engagement?
Right evaluation?
How are actionable insights able to be leveraged by clinicians to assess and optimize overall
therapy?
FIGURE 1.4
“DTx Rights” to ensure that DTx products are used appropriately.
with medications, devices (e.g., sensors, glucometers), or other therapies to optimize patient
outcomes. Given numerous factors that need to be considered before patient use, particularly for products requiring clinician authorization, clinicians may wish to consider the
following “DTx Rights” to ensure that DTx products are used appropriately and that the
right care is delivered at the right time (Figure 1.4).
1.7.2
Providing Product Access
Digital therapeutics are designed to meet specific patient needs at specific times. Patient
access to DTx products may be granted through 1) prescription from a qualified healthcare
provider; 2) authorization or referral by a clinician or payor; 3) eligibility determination via
a validated screening tool or clinical guideline; 4) delivery of an activation code via a payor
or employer; etc.
Many DTx products do not require authorization or direct engagement from a clinician.
However, the products used in clinical settings generally align with clinical guidelines, are
integrated into health systems and are used in the context of patients’ current care plans.
In any case, before patients and caregivers can utilize DTx products, it is critical to ensure
that access is provided to end-users at the appropriate time.
The Digital Therapeutics Alliance (DTA)—an international non-profit trade association—collaborates with members and industry stakeholders to develop more detailed frameworks on product access and scalability. For DTx products that seek third-party coverage,
the following considerations may be helpful for healthcare decision-makers:
• What type of third-party payor does the patient receive access through? (e.g., public
payor, private payor, employer, pharmacy benefit manager)
• What form of screening and/or assessment process does the patient need to assess the
appropriateness of therapy and relevant access to the product? (e.g., clinician authorization, third-party review, validated screening tool)
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
How Can Digital Therapeutics
Be Used in Clinical Practice?
11
• If clinician authorization is necessary, what level of authorization is needed for appropriate patient access? (e.g., prescription, referral, recommendation)
• How does the patient access the product shell? (e.g., download from an app store,
emailed link generated through electronic health record (EHR))
• How does the patient formally access the product? (e.g., product activation code delivered by a third party, dispensed through a pharmacy, provided by the product manufacturer or vendor)
• What type of device does the patient use to access the therapy? (e.g., patient smartphone, tablet, computer, VR headset)
• Are additional components may be necessary to optimize the product’s value? If so,
how do patients access these components? (e.g., wearables, sensors, hardware, affiliated
medical devices)
Additional patient access considerations include the product’s ability to integrate with
other technology platforms, scalability, clinical appropriateness, patient engagement and
sustainability, and privacy and security requirements.
1.7.3
Utilizing Actionable Data
Digital therapeutics can automatically capture real-world data and generate patientspecific metrics such as clinical outcome measures, product functionality, patient and clinician product utilization, etc. (Figure 1.5). This data may be applied back to patient care in
various ways. Patients and caregivers may use this data to understand their progress better
and directly correlate reported outcomes with the visible progress being made. In the case
of outcomes stagnation, patients can share datasets with their clinicians to better determine how to modify therapy. Clinicians may use actionable clinical reports to gauge the
degree of patient progress and appropriately adjust treatment plans. Where appropriate,
data may also be used to optimize affiliated medication-delivered or in-person therapies,
prevent disease state exacerbations, or reduce otherwise unnecessary hospitalizations. Payors and employers may use real-world data to assess the value being provided to patients,
caregivers, and clinicians regarding improved health outcomes, reduced overall healthcare
utilization costs, and individual and population health benefits.
From a population health perspective, data generated by DTx products may be aggregated to track progress or compare aggregate outcomes within target subpopulations (e.g.,
based upon patient disease state, level of disease severity, geographic location, age, gender).
This information may be used to directly improve the product’s functionality, provide more
targeted assistance to key populations, or influence social determinants of health factors
that may cause impediments to therapy.
1.7.4
Ensuring Practice Integration
Not all digital therapeutics require or benefit from integration into clinical practice.
However, those that do are increasingly represented in clinical guidelines and are integrated
into clinical workflows and EHRs. Such integration enables products to function alongside
other therapeutic interventions in complex treatment protocols and be recommended, authorized, or prescribed as independent therapies, in concert with medications and devices,
or used with other interventions.
For those products that require direct clinician engagement, potential roles that clinicians may undertake are:
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
12
DTx within the Digital Health Landscape: Foundational Aspects
Clinical measures
•
•
•
•
•
•
•
•
•
Patient and clinician utilization
Clinical outcomes (e.g., respiratory control, mobility,
mental health status)
Digital endpoints (e.g., measures not previously
available or assessed)
Digital biomarkers (e.g., walking gait, joint mobility)
Standardized patient assessments (e.g., GAD-7, PHQ-9)
Patient-reported outcomes (PROs) (e.g., validated
outcome measures, disease state triggers, pain
perception)
Physiologic data via associated sensors and hardware
(e.g., pulse, breathing rates, blood pressure)
Insight on related therapies (e.g., medication use and
dosages, adherence patterns)
Degree of disease state severity and change (e.g.,
condition improvement, deterioration)
Other: _____________________
•
•
•
•
•
•
•
•
•
Patient engagement (e.g., time, frequency, duration of product
utilization)
Patient onboarding (e.g., consent documentation,
patient/caregiver training, patient preferences)
Patient utilization (e.g., registration, downloads, screen time
usage, long-term retention)
Patient adherence (e.g., completed vs. recommended modules,
exercises, or lessons)
Patient open-ended comments (e.g., patient preferences,
satisfaction, surveys)
Clinician inputs (e.g., prescribing parameters, authorization and
discontinuation orders)
Clinician engagement (e.g., registrations, initial and ongoing
activity)
Patient-clinician communications (e.g., scheduling, messaging)
Other: _____________________________________
Product functionality
•
•
•
•
•
Product performance (e.g., product up/down time, internet connectivity)
Analytics (e.g., system or product performance, efficiency)
Quality measures (e.g., HEDIS, CAHPS measures)
End user satisfaction measures (e.g., product acceptability, perceived helpfulness)
Other: _________________________________________
FIGURE 1.5
Various types of data that can be generated by digital therapeutics.
• Initial assessment of the product’s intended use, safety, and efficacy.
• Product authorization for patients access (e.g., prescription, referral).
• Dispensing or distributing the product.
• Patient education related to product purpose and anticipated outcomes.
• Product onboarding (e.g., logistical product use considerations).
• Review and assessment of patient-specific data and outcomes.
• Optimizing therapy following an evaluation of clinical outcomes.
Depending on the DTx product, specific actions listed above may be provided by the
DTx manufacturer or other affiliated companies. For tasks completed by a clinician or
qualified support personnel, it is important to appropriately recognize these individuals for
the time spent working with patients to enable optimal therapeutic value.
1.8
Gaps in Care to Be Addressed
1.8.1
Existing Clinical Care Needs
Even during the best of times, healthcare systems face significant gaps in care related to
mental health, behavioral, and chronic conditions. Cognitive and behavioral health needs
are increasingly being recognized, but access to mental healthcare providers and services
often remains a challenge for patients.
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Gaps in Care to Be Addressed
13
In the context of chronic diseases and a pandemic era such as COVID-19, gaps in care
include vulnerable populations’ lack of access from the safety of their homes to clinicallyvalidated therapies that align with clinical guidelines and current standards of care. The
usual burdens faced by patients with chronic conditions are compounded during pandemic
periods by food chain disruptions, limitations on physical activity, and redistribution of
healthcare resources toward more acute or infectious issues. Consequently, patients have
a greater risk of worsening, relapsing, or requiring in-person care when they do not have
access to ongoing active clinical care.
Before the emergence of digital health technologies, traditional infrastructure has revealed: 1) lack of therapy options that are provided to patients in their own environment
and according to their schedule availability; and 2) scarcity of platforms that enable clinicians to better engage with patients, obtain objective and subjective measurements, and
provide optimal therapy.
1.8.2
Healthcare Disparities
Digital therapeutics have the potential of addressing critical problems related to access
and personalized therapies. Examples of these healthcare disparities include:
• Economic disparities, such as the inability to pay for or access in-person clinical
services.
• Cultural and language differences, resulting in patients not receiving care from
clinicians due to not incongruences in the content and methods of communication.
• Geographic settings, in which urban and rural populations face different but significant disadvantages in accessing timely and reliable healthcare.
• Age or mobility hindrances, such that the ability to physically travel from a home
environment to in-person medical visits are greatly limited.
• Disease state disparities, by which not all conditions have a sufficient depth and
breadth of treatments available to address the multiple aspects of comorbidities associated with each physical, mental, or behavioral disorder.
• Work-life circumstances, where patients with multiple jobs or family responsibilities
may have difficulty scheduling and attending appointments, in addition to completing
prescribed therapeutic regimens.
Additional disparities are related to patients’ potential inability to have full access or
continue in-person care once it is initiated. Patients face the ongoing cost of care, lack of
consistent access to primary care providers or specialists, and inability to undertake all
prescribed therapies. Other disparities may emerge depending on which type of payor is (or
not) covering patient access to medical care. Since employers, private payors, and public
payors have vastly different approaches in developing insurance coverage policies, patients
with varying forms of coverage are likely to have different degrees of access to clinicians,
medications, and digital technologies.
Disparities related to access to direct clinical care include the type of disease a patient
has and its likelihood of progressing or escalating before the patient has the opportunity to
visit their clinician. This particular disparity is more nuanced than the others but equally
important since the pace of clinical care must be at least as (or more) dynamic as the disease
state being addressed. If a patient first presents to a clinician with an advanced medical
condition, they will require more frequent visits and “touchpoints” with their clinical team,
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
14
DTx within the Digital Health Landscape: Foundational Aspects
potentially more than what is typically possible in an in-person format. Rarely do disease
state fluctuations or escalations occur in direct alignment with patient visits scheduled every
six, twelve, or more months.
In response to these disparities, clinicians should have access to technologies that enable
them to provide care to patients during critical times when therapies need to be escalated,
de-escalated, or changed altogether. In-person visits alone do not sufficiently address these
issues. If stagnation occurs amid a highly dynamic clinical situation, patient outcomes
and quality of life will likely worsen. Traditionally underserved populations do not always
have the same access to clinical care as is often required to titrate disease states therapies
appropriately. Such individuals should be granted access to technologies that can identify
critical points in disease state shifts, provide therapeutic interventions between clinician
visits, and guide them through changing disease state factors. Software-based products can
offer scalability and reachability that traditional healthcare service models haven’t provided
thus far.
1.9
COVID-19 Era Lessons
During the COVID-19 crisis—a time marked by extended periods of quarantine and
physical distancing, plus overwhelmed hospitals and shuttered outpatient clinics—many
patient populations have often been unable to receive in-person care for non-COVID medical
needs. People with chronic medical conditions such as diabetes, lung disease, and heart
disease, in addition to those facing existing disparities and inequities in healthcare access,
were at an increased risk of being hospitalized with COVID-19.
In parallel, patients with anxiety, depression, cognitive impairments, and other mental
health conditions faced new challenges amid the COVID-19 pandemic. With an increased
focus on social distancing, people entered into long quarantine periods, social isolation,
and uncertainty. Children and adults with behavioral conditions are often significantly impacted by stress. During the pandemic, they did not receive the stimulation they usually
would for long periods, thus enabling a more rapid exacerbation of symptoms and conditions.
Due to the burden placed on healthcare systems, clinicians could not provide evidence-based
therapies to all individuals dealing with mental health conditions and disorders, thus revealing a high degree of unmet medical need.
When vulnerable populations do not have access from the safety of their preferred environments to clinically-validated therapies that align with clinical guidelines and current
care, they are at greater risk of worsening, relapsing, or requiring in-person care.
Digital therapeutics have played a critical role in rapidly meeting this need by providing
safe and effective care that is deliverable remotely. As part of temporary guidance released
during COVID-19 in April 2020, the United States Food and Drug Administration stated:7
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.
7 US FDA. “Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During
the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” April 2020
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
Get all Chapters For Ebook Instant Download by email at
Looking to the Future etutorsource@gmail.com
15
Building on the ease of product scalability and access through patient-owned devices,
the lessons learned during COVID-19 demonstrated that DTx products could more easily
reach high-risk, rural, and underserved communities that often lack access to healthcare
services even during the best of times.
1.10
Looking to the Future
As with any new category of medicine, the risks and rewards must be intensely studied to
guide regulators, clinicians, and patients through the development and adoption phases to
ensure quality outcomes. Stakeholders across the digital therapeutics spectrum have made
significant steps in terms of product design, evaluation, and meaningfulness in the context
of patient care. There is still much to be done yet across the broader healthcare industry
to ensure that these products are appropriately represented in clinical guidelines, covered
alongside other medical treatments, and delivered at scale to patients worldwide.
Harmonized regulatory frameworks need to continue developing to categorize and recognize digital health technologies properly. Advances made within other digital health technology landscape sectors, such as telehealth, need to be expanded to include DTx products.
Interoperable platforms need to be developed to enable patient and clinician access to integrated dashboards with actionable data from multiple product sources, fluidity between
the monitoring, diagnostic, and therapeutic tools, and an increased ability to reach target
populations.
Digital therapeutics may bring tremendous personal and public health benefits to patients, caregivers, clinicians, and health systems. It will require continued teamwork among
the broad spectrum of stakeholders to ensure they provide their full value and be recognized
as a permanent part of the medical care ecosystem.
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
We Don’t reply in this website, you need to contact by email for all chapters
Instant download. Just send email and get all chapters download.
Get all Chapters For Ebook Instant Download by email at
etutorsource@gmail.com
You can also order by WhatsApp
https://api.whatsapp.com/send/?phone=%2B447507735190&text&type=ph
one_number&app_absent=0
Send email or WhatsApp with complete Book title, Edition Number and
Author Name.