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FDA Approves Digital Therapeutics Technologies to Treat Patient Behavioral Conditions That Interfere with Positive Healthcare Outcomes

Jan 27, 2020 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology

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 Kingdom’s 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 FDA’s 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 expected in 2020, PwC HRI predicted.

Pharmaceutical and Tech Companies Collaborate on Digital Therapeutics

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 “is reshaping the landscape for new medicines, product reimbursement and regulatory oversight … [and that] new data sharing processes and payment models will be established to integrate these products into the broader treatment arsenal and regulatory 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 for the management and treatment of medical conditions. While similar to customer wellness 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 subject to the approval process of the federal Food and Drug Administration (FDA), and some 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.”

  • Natural Cycles is a birth control app created by a Sweden-based company of the same name. It was approved by the FDA in 2018. This mobile app helps women track their fertility to prevent unwanted pregnancies via the rhythm method. The app analyzes data from past menstrual cycles and body temperature readings to determine when the user is most fertile. On the days the user is most likely to be ovulating, the app displays “Use Protection” on the mobile device’s screen. 

“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 them—and then can avoid unwanted pregnancy.”

  • Apple, headquartered in Cupertino, Calif., received FDA clearance in 2018 for an electrocardiogram (ECG) app for its Apple Watch Series 4 that allows users to take an ECG from their wrist to detect irregular heart rhythms and atrial fibrillation (AFIB).

“The role that technology plays in allowing patients to capture meaningful data about what’s happening with their heart—at the moment when it’s happening, like the functionality of an on-demand ECG—could 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 Digital Therapeutics

There is some evidence that patients and healthcare providers 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 try an FDA-approved app or online tool for treatment of a medical condition.”

The graphic above is taken from the PwC HRI 2019 annual report on digital therapeutics and connected care. It shows that “a majority of consumers surveyed are interested in FDA approved digital apps or online tools to treat their medical conditions.” (Graphic copyright: PwC HRI.)

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: 

  • Digital product support and educational tools,
  • Patient adherence and compliance programs,
  • Remote patient monitoring,
  • Data sharing with healthcare providers, and
  • Caregiver tools and support.

With precision medicine and pharmacogenetics, clinical laboratories could play an essential role in supporting digital therapeutics in the future. But to truly be competitive in this space and take advantage of the opportunity, medical laboratories will need to increase their information technology and digital capabilities.

—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

Flu Season Brings Shut Down of Elective Surgeries and Procedures in United Kingdom’s National Health Service Hospitals

Mar 14, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

Mounting financial and patient-care problems in UK show NHS may not provide a quality blueprint for fixing US healthcare system flaws

Patients scheduled for elective surgeries—such as hip replacements or penciled in for routine outpatient appointments—have been turned away this winter from National Health Service (NHS) hospitals as the United Kingdom’s (UK’s) public healthcare system suffers another care emergency.

This latest crisis in the UK should provide further evidence to anatomic pathologists and medical laboratory leaders that the United States healthcare system is not alone in facing mounting financial and patient care questions. While an NHS-like single-payer healthcare system in the US is the goal of many reformers, the UK’s current crisis indicates such a system has serious flaws.

UK News Organizations Disagree with Government Leaders as to Cause of Crisis

NHS officials estimate as many as 55,000 elective operations and outpatient procedures were cancelled as hospitals attempted to free up capacity for the sickest patients. The Telegraph reported that the bed shortfall is blamed on a spike in winter flu, with budget cuts to social services for home healthcare, staff shortages, and an aging population further pressuring the healthcare system.

In late January, the NHS’ National Emergency Pressure Panel (NEPP) announced that planned operations, such as elective surgeries, that had been “suspended because of pressure on the NHS in January,” would be able to resume in February, Sky News reported.

Meanwhile, in response to the original decision in January to have hospitals stop performing elective surgeries and similar procedures, an editorial in The Guardian challenged Prime Minister Theresa May’s suggestion that the current crisis was primarily due to the flu epidemic.

“This is not the flu: it is a system-wide crisis brought about by seven years of mounting austerity,” The Guardian’s editors wrote. “Oh, and that is getting worse, too. The official defense is that this is not a crisis because there is a plan … But planning can’t magic up highly trained doctors and nurses. Plans do not make hospital beds. And while vaccination helps, you can’t entirely plan your way out of the impact of flu.”

Doctors Report ‘Intolerable Conditions’ at 68 Hospitals

The crisis reached new heights when specialists in emergency medicine from 68 hospitals sent a letter to the prime minister stating the “current level of safety compromise is at times intolerable, despite the best efforts of staff.” The letter, published in The Guardian, also pointed out media coverage reporting anecdotal accounts of “appalling” situations in many emergency departments “are not outliers.” According the doctors, conditions include:

  • Over 120 patients a day managed in corridors, some dying prematurely;
  • An average of 10-12 hours from decision to admit a patient until they are transferred to a bed;
  • Over 50 patients at a time awaiting beds in the emergency department; and,
  • Patients sleeping in clinics as makeshift wards.

One doctor, Richard Fawcett, MD, drew media attention when he used Twitter to apologized for “third world conditions” caused by overcrowding in the hospital where he works, The Telegraph reported.

Richard Fawcett, MD

Richard Fawcett, MD (above), a consultant in emergency medicine for University Hospitals of North Midlands NHS Trust, drew widespread media attention in England when he apologized to patients on Twitter for the “third world conditions” this winter at the hospital where he works. A Lieutenant Colonel in the British Royal Army, Fawcett has done three deployments to Afghanistan. (Photo copyright: Midlands Air Ambulance Charity.)

NHS officials acknowledged staff criticism but attempted to paint the crisis as temporary. University of North Midlands NHS Trust (UHNM) told BBC News that area hospitals had been under “severe and sustained pressure over the Christmas period,” which had “continued into the new year.”

“Our staff want the very best for our patients and at times they find the situation frustrating, which can be reflected on social media. However, we are a leading trauma, stroke, and cardiac center and have been regularly praised by external independent commentators for the quality of compassionate care provided at our hospitals despite all our pressures,” Dr. John Oxtoby, Consultant Radiologist and Deputy Medical Director, UHNM, told BBC News.

“We have to keep going and turn up in a fit state to do the best job that we can. But it’s been really tough, particularly on more junior staff,” one hospital staff member told The Guardian. “And when they ask me, ‘Will it always be like this and will it get better?’ I cannot say it will improve as the truth is it won’t unless the NHS gets the resources and investment it needs.”

Basic Elements of Care Neglected

This is not the first time the NHS has come under fire for substandard patient care.

Between 400 and 1,200 patients are estimated to have died as result of poor care between January 2005 and March 2008 at Stafford Hospital, reported The Guardian. A 2010 report into care at the hospital, now named County Hospital and run by UHNM, found a litany of problems.

“For many patients, the most basic elements of care were neglected,” inquiry Chairman Sir Robert Francis, QC, told The Guardian. “Some patients needing pain relief either got it late or not at all. Others were left unwashed for up to a month … The standards of hygiene were at times awful, with families forced to remove used bandages and dressings from public areas and clean toilets themselves for fear of catching infections.”

Reports of substandard patient care within the United Kingdom’s National Health Service are not new. British barrister Sir Robert Francis, QC (above), led investigations into the Stafford Hospital scandal, which uncovered that an estimated 400 to 1200 patients died between 2005 and 2008 at the facility due to appalling conditions and lax procedures. (Photo copyright: The Telegraph.)

Why not this crisis in US? Because, even if our system of healthcare has flaws, it is responsive to consumer/patient demand. Whereas, in the UK, the NHS is always budget short and so is always struggling to invest in expanding hospital/physician capacity to meet the steady increase in patient demand.

Dark Daily’s goal in reporting on this story is to help anatomic pathologists and clinical laboratory leaders in the United States understand that every country’s health system—like ours—has its share of unique problems and is not perfect.

—Andrea Downing Peck

Related Information:

NHS Patients Dying in Hospital Corridors, A/E Doctors Tell Theresa May

The Guardian View on the Crisis: It’s Not Just the Flu

Mid Staffs Hospital Scandal: The Essential Guide

NHS Crisis: ‘I Live in Fear I’ll Miss a Seriously Ill Patient and They Will Die’

Hospitals to Delay Non-Urgent Operations

NHS to Lift Suspension of Elective Surgery as Hospital Pressures ‘Ease’

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