Digital Therapeutics: Increasing Patient Outcomes Through Evidence-Based Technologies

Sushmitha Das

Funding for digital therapeutics (DTx) reached 14.7 billion in 2021, surpassing the annual investment in 2020 and doubling that in 2019.

Subsequently, the adoption of DTx around the world continues to grow and isn’t projected to slow down anytime, as shown in the Statista infographic below:

Image source: Statista 2022

Digital therapeutics are products that deliver evidence-based therapeutic interventions directly to patients using high-quality, clinically evaluated software.

The aim of digital therapeutics is for medical practitioners to achieve clinical endpoints and improve patient outcomes through a scalable, personalized, and customized digital solution.

How do they work?

Digital therapeutics provide adequate and evidence-based treatments to manage chronic and physical mental health conditions.

DTx services fall under the FDA’s Software as a Medical Service (SaaMS) and are administered by software applications through consumer devices such as smartphones and tablets.

Digital therapeutics work by offering patients:

  • Health-related tips
  • Behavior recommendations
  • Exercise plans
  • Medicine intake time alerts

Adaptive algorithms make the function of digital therapeutics possible. These algorithms learn and improve gradually with exposure to data and scenarios. They can offer

1. Preventative Care

Digital therapeutics help patients with lifestyle management and nutrition. These software applications help patients track their weight, portions, and exercise, resulting in more commitment and better health outcomes.

DTx solutions also come in handy for detecting early signs of disease or injury. Software solutions, for example, can help clinicians of patients predisposed to heart conditions identify the early signs of cardiac arrest, congestive heart failure, and heart attack.

2. Source of health information

Digital therapeutics helps practitioners keep track of their outpatient patients through a consistent stream of feedback.

By leveraging wearable devices such as the Apple Watch, a custom-made digital therapeutics software can provide daily report submissions, track patients’ blood pressure, and give reports on other wellness metrics and markers.

3. Independent or complementary treatments

Clinicians can offer DTx solutions as stand-alone treatments for disorders such as depression. They can be used to offer therapies, the most common examples being exposure therapy and aversion therapy.

Alternatively, medical practitioners can have digital therapeutics developed to complement other treatments such as hemodialysis for chronic kidney disease.

Why is digital therapeutics important?

Digital therapeutics provide patients with disease management, care, support, and information with next-level convenience and consistency.

DTx solutions allow medical practitioners to address gaps in treatment and delivery that might not be addressed by more conventional means.

By doing so, they come with several benefits for both the patients, healthcare providers, and payers.

These include:

1. Benefits to patients

Patients who use DTx solutions receive more personalized care and treatment programs tailored to their individual needs.

Digital therapeutics solutions, given that they’re delivered through mobile devices, make health care more accessible since patients don’t have to commute to receive care.

2. Benefits to healthcare providers

Digital therapeutics help s healthcare providers extend their limited services and stretch finite resources to a broader scope of patients.

Healthcare providers who use and understand DTx solutions meet patient needs without traveling or having to address patients one at a time due to the ease of scalability,

These digital solutions also enhance the efficiency of healthcare delivery by bridging geographical barriers to health care access and natural disasters such as Tornadoes and Hurricanes.

3. Benefits to payers

Digital therapeutics reduces the cost of patient care for reimbursement schemes regardless of whether the payer is the government, insurance companies, or individuals.

Some aspects of digital therapeutics, such as behavior control and monitoring, help patients cut trips to the medical office together with the various consultation fees and medication that come with them.

Challenges facing digital therapeutics

The rapid development of DTx hasn’t been without challenges; these include:

1. Regulatory challenges

Coming up with a robust regulatory framework for DTx industries to work with, flourish and grow has been a challenge for the government.

This, in turn, has affected innovation, R&D, and the overall growth of Digital Therapeutics as an industry.

2. Data security and privacy

Conveying regulated data such as Personal Health Information(PHI) remotely and over the cloud through DTx raises several cloud and data security concerns.

Without a competent custom DTx developer, it becomes more challenging for healthcare providers to develop DTx solutions that don’t break HIPAA and SOC compliance rules for healthcare or aren’t susceptible to hackers.

3. Technological expertise

Given that DTx is a relatively young field, most healthcare providers and software vendors will struggle with finding the technical and development talent to help them build their custom DTx software.

However, this isn’t a problem once a provider embraces a competent developer who has access to complex DTx talent pools and employment sources.

4. Physician adoption

Many practitioners are yet to consider adopting custom DTx software in their medical practices. This is primarily due to apathy, doubt, or a lack of knowledge about recent developments in digital therapeutics.

That said, one of the ways to make your software enticing to physicians is choosing a tried and tested developer that has already made inroads in the physician community.

5. The lack of strategic alliances in DTx

For a custom DTx software solution to be effective, it has to work within a framework of the network, payment, and marketing alliances. It also has to be compatible with other software and services.

Hence, healthcare organizations must ensure that their software developer already has access to strategic alliances for the software they develop.

DTx still has several challenges before its mass adoption. However, most of these challenges can be mitigated by embracing a competent, reputable, and experienced development company like the Boston Technology Corporation (BTC)

BTC has made advancements in:

  • Creating a framework to ensure that its software work within a regulatory scope
  • Access to the best software developer talent pools
  • Strategic alliances within the healthcare and software industries in general
strategic-alliances
Providing daily wellness metrics and markers

Digital health vs. Digital therapeutics: the difference

Unlike most digital apps, digital therapies are medical treatments that can make medical claims receive regulatory authorization and reimbursement.

The features of DTx that separate them from wellness and fitness apps are:

1. Used to treat medical disorders

Digital therapeutics are created to address specific medical disorders, mitigate particular problems and push toward a medical goal or outcome.

On the other hand, digital health solutions are generic healthcare solutions that address a broad spectrum of healthcare conditions (sometimes none specifically) and aim to achieve a mixture of healthcare outcomes.

2. DTx treatments are clinically validated

For your custom-built digital therapeutics solution to be allowed on the market, it must be clinically validated through randomized clinical trials.

This condition means that it has to be peer-reviewed, unlike other healthcare apps, and display efficacy in clinical trials and real-world trials.

3. DTx treatments are prescribable and reimbursable

A medical practitioner can prescribe digital therapeutics solutions to a patient as a stand-alone or a complementary prescription.

These digital medical devices are also reimbursable by public or private insurance and can be paid for by subsidized healthcare programs by the government.

4. DTx treatments are regulated

Like conventional medicine and therapeutic drugs, digital therapeutics need to be reviewed by regulatory bodies for their efficacy, safety, and risk.

The government doesn’t only regulate DTx treatments but has also put measures in place for its growth.

One such regulatory pathway is the Software Precertification Program in the recent 2016 CURES Act. This program commits to a law that aims to succeed the requirement of a premarket submission for DTx to be approved by the CDC or FDA.

5. The DTx alliance

In 2017, DTx companies merged to form a Digital Therapeutics Alliance. This collaboration of key industry leaders seeks to prove the efficacy of DTx solutions, build an understanding of DTx and work to improve the legitimacy and approval of DTx solutions.

What disorders do digital therapeutics usually aim for?

Digital therapeutics treat disorders rarely treated or entirely ignored by conventional non-digital medicines.

These disorders fall into categories such as

1. Mental health

DTx software programs find use cases in treating mental health conditions. Such disorders include Schizophrenia, bipolar disorder, Attention Deficit Hyperactivity Disorder (ADHD), depression, Autism Spectrum Disorder (ASD), and the broad spectrum of anxiety disorders.

For these software solutions such as mobile apps and hardware such as virtual reality and HD screens can be leveraged to offer behavioral therapy, aversion therapy, and exposure therapy;

2. Cardiovascular disorders

Digital therapies are also used widely to help health practitioners address heart-related disorders in their patients. These conditions include acute coronary syndrome, hypertension, and dyslipidemia.

Healthcare providers can have custom DTx products developed to address two cardiovascular use cases.

The first is for at-home and real-time patient monitoring for cardiovascular markers. The other is to advance positive lifestyle changes through exercise, sleep, and calorie intake tracking.

3. Gastrointestinal disorders

A branch of digital therapeutics leverages an ingestible sensor and custom-developed DTx software to help treat and control gastrointestinal disorders and diseases.

DTx software, together with the necessary hardware, helps treat conditions such as gastroesophageal reflux disease (GERD) and irritable bowel syndrome.

4. Substance use disorders

High-quality software programs have shown efficacy in treating and managing substance use complications such as opioid use disorder.

Software systems come in handy in helping substance use and abuse patients to build better habits, embrace better thoughts and keep track of their progress.

DTx products use cases

Custom-developed DXT software is already in use or product development stages to help medical practitioners meet patient demand gaps in the market.

These use cases include:

1. Behavioral intervention

A 2002 study revealed that continual behavioral intervention targeting diet and exercise could help significantly reduce the incidence of Type 2 diabetes in patients.

Custom-developed DTx solutions, with the continuous care and delivery they give, make an excellent option for offering behavioral intervention.

Digital therapeutic software can help patients stick to diet and exercise commitments hence reducing the progress or development of Type 2 diabetes.

2. Virtual reality

Virtual reality is another use case of digital therapeutics. These custom-developed software programs use state-of-the-art VR artificial intelligence, VR headsets, and motion controllers to help practitioners offer exposure and aversion therapy to people suffering from mental health disorders.

3. Asthma treatment

Medical practitioners could develop custom software that helps their patients track their asthma. A sensor placed on an asthma patient’s inhaler and connected to a mobile phone software can help track the use of the inhaler.

This adaptive AI will help develop patterns and eventually predict asthma attacks(or the conditions that enable it) long-term. From this data, the software can give the patient reminders and updates about when to take the treatment and places or weather to be wary of.

4. Drug administration

A sensor placed on a medical prescription bottle or case can help medical practitioners track the adherence to a prescription.

Subsequently, the custom-developed application program connected to such a sensor can help remind patients through alerts and notifications whenever it’s time to take their drugs.

For easily overdosed or abused drugs, software connected to the case can help administer precisely the needed dose.

Common FAQs

Some of the frequently asked questions about digital therapeutics include:

1. What is DTx digital therapeutics?

Digital therapeutics, abbreviated as DTx, are evidence-based health interventions that leverage software to prevent and manage a specific disorder or disease.

2. What are prescription digital therapeutics?

Prescription digital therapeutics are FDA-approved software solutions physicians prescribe as treatments for disorders and health complications.

3. What are digital therapeutics examples?

Some digital therapeutics examples include:

  • Basal insulin dose calculator for patients with Type 2 diabetes
  • Neurological music therapy to treat cognitive dysfunction
  • Digital sleep software that leverages Cognitive Behavioural Therapy (CBT)

5. How are digital therapeutics regulated?

National and regional agencies regulate digital therapeutics. On a national scale, they are regulated through the Food and Drug Administration (FDA) like any other conventional treatment and cure.

6. To what standards are digital therapeutics held?

Digital therapeutics are held to a similar standard with other prescription medicines and treatments. Their efficacy must be clinically validated through rigorous clinical trials like other conventional treatments.

They are also:

  • Documented in peer reviews
  • Held to Good Clinical Practices (GCP) standards
  • Tested using proper trial design

Key takeaways

Digital therapeutics are digital solutions to help improve patient health outcomes by targeting specific diseases.

It does this while at the same time making service provision essential and convenient for both health practitioners and payers.

Despite the many challenges DTx faces as an industry, it continues to grow thanks to technological disruption and the custom software developers helping practitioners navigate the evolving DTx landscape.

Powering the DTx ecosystem

Behind the curtain of this growing DTx ecosystem that continues to improve patient outcomes while making medical practice easier is custom software development leveraging advanced technologies.

This leads to digital therapeutics solutions that are catered to the needs of a physician’s practice and patients on a granular level.

Boston Technology Corporation is one such custom software development solution that spent the past decades perfecting the art of developing custom web and mobile healthcare applications.

We partnered with the FDA  and Google to develop MyStudies platform for collecting real-world evidence. ‘Heroes Health’ app was built on the FDA MyStudies platform to capture data about frontline workers and support their mental health during the pandemic. 

Similarly, BTC helped Glucose Advisors, a leading diabetes management company, to build a real-time decision support app (iOS and Android) for Type 1 diabetes patients using nutrition level and physical activity. 

Our technical expertise and experience over the years show our impeccable product engineering. 

That said, we now offer:

  • Managed Services for applications and infrastructure
  • Cloud migration for a healthcare organization
  • Digital native approach and agile product development
  • Adherence to stringent data security and privacy such as HIPAA standards
  • Testing and quality assurance services
  • Support and maintenance

For more information, contact BTC, and our teams will be more than willing to help.

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