Clinical laboratories with strong digital and information technology capabilities may find opportunities in this growing field of healthcare

Digital therapeutics (DTx), a growing trend in life sciences technology, is emerging as a popular form of connected healthcare physicians can use to transform patient behavior and improve clinical outcomes. This development may create opportunities for IT-savvy clinical laboratories.

The software applications (apps) and hardware monitoring devices involved in digital therapeutics enable physicians and patients to target and alter specific behaviors that affect certain medical conditions, such as substance abuse or depression. Combined with or without drugs, digital therapeutics are achieving positive results, according to the United Kingdoms PwC (PricewaterhouseCoopers) Health Research Institute (PwC HRI).

Clinical laboratory leaders engaged in precision medicine and pharmacogenomic initiatives will be intrigued by potential opportunities to support digital therapeutics. The FDAs Digital Software Precertification Program has already begun awarding approvals for digital therapeutics that address diabetes and central nervous system disorders, in addition to substance abuse and birth control.

And more FDA approvals for digital therapeutics are expectedin 2020, PwC HRI predicted.

Pharmaceutical and Tech Companies Collaborate on DigitalTherapeutics

A PwC report, titled, Top Health Industry Issues of 2019: The New Health Economy Comes of Age, describes digital therapeutics is an emerging health discipline that uses technology to augment or even replace active drugs in disease treatment.

The report goes on to state that digital therapeutics isreshaping the landscape for new medicines, product reimbursement and regulatoryoversight [and that] new data sharing processes and payment models will beestablished to integrate these products into the broader treatment arsenal andregulatory structure for drug and device approvals.

Connected health services, the report continues, enabled by devices that transmit data or connect to the Internet, give additional visibility into care delivery and new ways to improve patient outcomes.

Digital therapeutics combine apps and monitoring devices forthe management and treatment of medical conditions. While similar to customerwellness apps, digital therapeutics focus on specific clinical outcomes.

The non-profit Digital Therapeutics Alliance says that, unlike common wellness apps, digital therapeutics possess the unique ability to incorporate additional functionalities into a comprehensive portfolio of synchronous products and services. This includes potential integration with mobile health platforms; the provision of complementary diagnostic or adherence interventions; the ability to pair with devices, sensors, or wearables; the delivery of interventions remotely; and integration into electronic prescribing, dispensing, and medical record platforms.

Digital therapeutics are the next frontier, Sai Jasti, Chief Data and Analytics Officer, GlaxoSmithKline (NYSE:GSK), told PwC HRI. I think we will see a lot more collaboration between pharmaceutical and technology companies to drive this forward, ultimately to the benefit of patients.

Digital Therapeutics That Already Have FDA Approval

Digital therapeutics and their connected devices are subjectto the approval process of the federal Food and Drug Administration (FDA), andsome have already received that coveted clearance:

Digital technologies and data science have incredible potential to unlock the next chapter of medical innovation and to help individuals finally take control of their own health in a meaningful way, said Richard Francis, Division Head and CEO, Sandoz, in a press release. New digital therapeutics such as reSET-O also have the potential to fundamentally change how patients interact with their therapies and thus improve patient outcomes.

Both reSET and reSET-O are software mobile apps that use cognitive behavioral therapy (CBT) to help individuals struggling with addictions.

Nearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the U.S. in 2017, said Corey McCann, MD, PhD, President and CEO of Pear Therapeutics, in the press release following receiving FDA approval. There is an urgent need for new and innovative therapeutics to address this public health epidemic. This groundbreaking decision by the FDA ushers in a new standard for treating patients with Opioid Use Disorder and it signals a new path for therapeutic software to be used in conjunction with pharmacotherapy to improve efficacy.

We know that women are more likely to use contraceptive methods when they have a variety of methods available to them, and the reality is that not every method is going to work for every woman, Rebecca Simmons, PhD, Research Assistant Professor, Department of Obstetrics and Gynecology, University of Utah, told Health. This is really exciting, in the sense that the more methods we have, the more likely it is that people can find something that works for themand then can avoid unwanted pregnancy.

The role that technology plays in allowing patients to capture meaningful data about whats happening with their heartat the moment when its happening, like the functionality of an on-demand ECGcould be significant in new clinical care models and shared decision-making between people and their healthcare providers, said Nancy Brown, CEO of the American Heart Association, in a press release.

Patients, Providers, and Big Pharma All Like DigitalTherapeutics

There is some evidence that patients and healthcareproviders are intrigued and willing to try digital therapeutics. In a PwC HRI survey,more than 50% of respondents said they would be somewhat or very likely to tryan FDA-approved app or online tool for treatment of a medical condition.

Pharmaceutical companies also are interested in digital therapeutics. A 2018 PwC HRI survey found that 80% of pharmaceutical executives had plans to invest in digital therapeutics in the near future.

A 2019 PwC article, titled, Digital Health Products Need Evidence and Buy-In to Succeed, states that drug companies see the following opportunities for DTx to improve the patient experience:

With precision medicine and pharmacogenetics, clinical laboratoriescould play an essential role in supporting digital therapeutics in the future. Butto truly be competitive in this space and take advantage of the opportunity, medicallaboratories will need to increase their information technology and digitalcapabilities.

JP Schlingman

Related Information:

Digital Therapeutics and Connected Care Reshape the Life Sciences Industry

The Emerging World of Digital Therapeutics

Top Health Industry Issues of 2019: The New Health Economy Comes of Age

Digital Therapeutics: Combining Technology and Evidence-based Medicine to Transform Personalized Patient Care

Everything You Need to Know About the Controversial New Birth Control App

Digital Health Software Precertification (Pre-Cert) Program

Sandoz Inc. and Pear Therapeutics Obtain FDA Clearance for Reset-O to Treat Opioid Use Disorder

Everything You Need to Know About the Controversial New Birth Control App

More than Half of Patients Willing to Use Digital Therapeutic, Study Says

ECG App and Irregular Heart Rhythm Notification Available Today on Apple Watch

Digital Health Products Need Evidence and Buy-in to Succeed

Life Sciences May See Accelerated Digital Health Pathway as Soon as 2020

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