March 13, 2021 – The Digital Therapeutics Alliance (DTA) submitted comments related to Health and Human Services’ ‘Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements’ (86 FR 4088), published on January 15, 2021.
Although DTA does not support HHS 86 FR 4088 as currently written, we propose the following steps for HHS and FDA:
DTA’s full comments are provided here.
Thursday, January 28 – Arlington, VA – The Digital Therapeutics Alliance (DTA) is pleased to welcome member company leaders to the DTA Board of Directors and Work Group leadership. In our effort to transform global healthcare by advancing digital therapeutics, we are grateful to work with each of the following individuals.
Board of Directors
The DTA Board of Directors provides critical guidance related to the strategy and direction of the organization. The newest member of DTA’s Board is Scott Kollins, Ph.D, Professor within the Department of Psychiatry and Behavioral Science at the Duke University School of Medicine, and Co-Lead Digital Health Solutions with Duke Clinical Research Institute.
DTA’s 2021 Executive Committee includes: Debra Reisenthel (Chair), Eddie Martucci (Vice-Chair), Pierre Leurent (Secretary), and Scott Kollins (Treasurer).
Board Chair, Debra Reisenthel shares: “I am honored to assume the role of Board Chair of DTA during this exciting time for the Alliance. We accomplished much on behalf of our members in 2020 and we look forward to continuing this momentum in 2021. Our focus this year will be on the following global initiatives: expanding payor reimbursement opportunities, educating healthcare providers on the efficacy and value of digital therapeutics, and building confidence in the application of digital therapeutics within the healthcare ecosystem.”
DTA Member Work Groups
In line with DTA’s growing global work, this year we are proud to launch three regionally-based work groups led by industry experts:
As DTA leads the digital therapeutic industry in 2021, our collective efforts will be instrumental in providing patients and caregivers, clinicians, policy and healthcare decision makers with reliable resources to meaningfully integrate DTx products into practice and transform global healthcare.
About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding and adoption of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors in order to improve clinical and health economic outcomes. To learn more please visit: www.dtxalliance.org.
Expands DarioHealth’s multi-condition platform into the $213 billion musculoskeletal market and creates one of the most comprehensive digital health platforms. Financing supported by leading health care focused institutional investors, including Nantahala Capital Management, LLC, Perceptive Advisors, Driehaus Capital Management, Farallon Capital Management, Pura Vida Investments, and others priced at market pursuant to Nasdaq rules. Increases membership to more than 150,000 and combined proforma 2020 full-year revenue to more than $20 million.
Digital Therapeutics Edition (ep 03): In the previous episode, Brian Dolan and I discussed the definition of digital therapeutics. The term ‘digital therapeutics’ has been used since about 2012, and in 2017 the Digital Therapeutics Alliance, aka DTA, came on the scene.
In this two-part deep dive we go inside the DTA and in this episode, we start with Megan Coder, the Executive Director.
I remember meeting the energetic, polished, and absolutely no BS, Megan, at the 2017 Frontiers Health in Berlin – yes, when face-to-face conferences were still a thing. At that conference, the DTA was officially launched. I strongly believe this was a historic moment for the overall industry.
MedCityNews (Eddie Martucci) — This burgeoning industry has been propelled to the forefront of medicine with the onset of the Covid-19 pandemic, which shined a light on the need for innovative treatment options that can be used at home from your phone or tablet.
In medicine, we’re getting real-time experience with what many believed was an inevitable but potentially distant future – fully digital treatments.
In what may have sounded like a futuristic scenario mere months ago, doctors today can prescribe a video game treatment for their patients. Children with ADHD are now “playing” their medicine thanks to an emerging category of medicine – digital therapeutics (DTx).
Wednesday, October 28 – Arlington, VA – Individuals living in rural and underserved settings encounter challenges that others may not regularly experience. Barriers to healthcare include factors such as mismatched clinician supply and demand, long distances between patient homes and sites of care, and isolation measures during Covid-19 that prevent ongoing in-person visits.
Traditional therapies in the United States may not be able to sufficiently address the increase in unmet medical needs that are emerging during this pandemic. DTA’s report “Digital Therapeutics: Reducing Rural Health Inequalities,” calls for Medicare and Medicaid to leverage evidence-based digital therapeutics (DTx) to address critical gaps in care for underserved populations, regardless of whether disparities are based on patient age, language, culture, income, disease state, or geography.
Value of DTx Products in Providing Care to Underserved Populations
Building on the ease of DTx product scalability and access through patient-owned devices, digital therapeutics create new treatment and self-management options for a broad range of chronic and mental health conditions. DTx products can easily reach high-risk, rural, and underserved populations who often lack access to healthcare services even during the best of times. This include digital therapeutics’ ability to:
Unbalanced DTx Access Across Underserved Populations
While numerous patients who receive their insurance coverage through private payors and employers in the U.S. have access to DTx products, low income and aging populations covered by Medicare, Medicaid, and other publicly funded programs generally do not have access to these important therapies. Until Medicare and Medicaid begin providing patients with access to remotely delivered therapies and enable the formal reimbursement of DTx products, there will continue to be an unbalanced ecosystem.
Policy Solutions for Underserved Populations
Comprehensive, multi-faceted solutions are necessary to achieve healthcare parity for rural residents. It is crucially important that a key component of these plans include the expansion of digital therapeutic coverage and patient access. We encourage legislators to direct CMS to expand access to DTx products as follows:
Digital therapeutics offer a new ability to provide interventions to patients in rural and underserved settings. These opportunities — among others — can only be capitalized on if Medicare and other publicly funded programs create an adequate clinical payment mechanism and patient access pathway for high quality, clinically-validated DTx products.
About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding and adoption of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors in order to improve clinical and health economic outcomes. To learn more please visit: www.dtxalliance.org.
A post written by Jessica Shull (Digital Therapeutics Alliance), Dr. Keith Grimes (Babylon Health), and Alexandra Yembele (Withings)
The evolution of health systems is speeding up
Physicians in Europe have been devoting 100% of their time and effort to caring for patients for decades; their grueling schedules leave them with little bandwidth for anything other than direct patient care activities. With this as the backdrop, Covid-19 introduced a whole new category of patient concerns and access problems.
Health systems are increasingly overburdened, and the majority of national healthcare budgets cannot be expanded. This is not ideal as countries aim to maintain current standards of care for their aging populations while needing to develop novel ways to treat patients with acute and mental health conditions in the midst of a continuously shifting pandemic.
However, healthcare processes and treatments continue to evolve — as they always have — from penicillin and the X-ray to gene therapy and digital health technologies (DHT). This evolution of healthcare has sped up in the last 20 years. In particular, innovations in digital health now provide invaluable assistance to clinicians and nursing staff, easing their ability to triage patients, rely on actionable insights, and extend care beyond the office setting. These advances offer integrated care for whole populations in countries across the globe, providing the tools so that potentially, no one is left behind.
New solutions for new challenges
Recognizing the immense need, healthcare systems are adopting innovative pathways for DHTs. Three examples include:
This did not replace or reduce the value of the physicians. Instead, it was quite the opposite. These examples highlight countries’ need to find new ways to interact with patients and provide care within existing healthcare systems.
The best-case scenario is when these three resources — digital therapeutics, remote patient monitoring, and telemedicine platforms — work together. This trio of digital health technologies can be used to assist a wide variety of patients.
A concrete potential
In the example of patient Maria, who was diagnosed with Chronic Obstructive Pulmonary Disease (COPD) in 2015, she consistently visits Dr. Becker every 6 months for a routine check-up. The European Respiratory Society estimates 15–20% of adults over 40 in Europe suffer from this disease. In 2019, Maria learned that she could begin accessing digital care products to manage her disease. She now has a Withings ScanWatch to monitor her oxygen saturation and daily walking distance. The backend integration of Withings’ open API allows Babylon, a telemedicine platform, to automatically and safely receive data that Maria has authorized to be sent. Now, Dr. Becker has on-demand access to the data she needs and can adjust Maria’s medication accordingly, while also monitoring the long-term effectiveness of Maria’s treatment.
Additionally, Maria uses a companion digital therapeutics (DTx) for COPD, which works with her medications, tracks her triggers, and helps her adjust key behaviors to optimize her overall condition. Due to the insights provided via the DTx, she now avoids taking walks on days with high levels of air pollution, has lowered her use of rescue inhalers, understands how to best exercise, and appreciates reduced dyspnoea episodes.
Through this suite of technologies, Maria and Dr. Becker have co-created a care plan that helps identify goals and well-defined actions to help improve her health and change key behaviors. While Maria still checks in every 6 months with Dr. Becker, she hasn’t been admitted to the hospital and each of her health indicators is better. During the COVID-19 quarantine months, in-person visits have been performed virtually on the Babylon digital platform. If Maria’s condition changed, Dr. Becker could enable a series of alerts that would initiate a clinician review. Through these configurations, defined by triggers based on Maria’s condition and history, Dr. Becker only sees the information that is needed, not daily dumps of data.
This scenario is real and these collaborations could provide additional access to people who need care when systems are stressed.
More about the digital health spectrum contributors:
Babylon Health
Babylon Health is a globally leading technology company with the ambitious mission to put an accessible and affordable health service in the hands of every person on Earth. We combine technology and medical expertise to bring doctors and people closer together, with digital health tools designed to empower people with knowledge about their health. Through a range of digital health services — such as an AI-backed app and video doctor appointments — we provide around-the-clock access to affordable, holistic healthcare services and information. We work with governments, health providers and insurers across the globe, and healthcare facilities from small local practices to large hospitals. With a $2Bn valuation, Babylon covers 20 million people across the globe, and has delivered more than 8m virtual consultations and AI interactions. We have teamed up with 170 impactful worldwide partners — including Mount Sinai Health Partners, the NHS, Telus Health, the Bill & Melinda Gates Foundation and the Government of Rwanda — to fulfil our vision of accessible and affordable healthcare, for all. For more information, visit https://www.babylonhealth.com.
Digital Therapeutics Alliance
Founded in 2017, the Digital Therapeutics Alliance (DTA) is a non-profit trade association of industry leaders and stakeholders engaged in the evidence-driven advancement of digital therapeutics. DTA maintains an international industry focus and is headquartered in the United States. DTA exists to broaden the understanding, adoption, and integration of clinically evaluated digital therapeutics into healthcare through education, advocacy, and research. In Europe, digital therapeutics offer regulated, CE marked digital therapies to patients with a diagnosed condition or disease. Most DTx products in Europe require third-party authorization or a prescription from a qualified clinician. Digital therapeutics undergo clinical trials, collect real world outcomes, and are based on patient-centered core principles and product development best practices, including product design, usability, data security, and privacy standards.
Withings
Withings produces medical grade devices for at-home monitoring so that patients can understand with precision their symptoms and trends in indicators. Withings’ mission is to continuously and effortlessly provide healthcare professionals with medical-grade data generated by patients from an ecosystem of connected devices. For more than a decade, Withings has built a range of award-winning products including activity trackers, connected scales, a wireless blood pressure monitor, a smart temporal thermometer, and an advanced sleep system. From remote patient monitoring to clinical research to chronic disease management, Withings has dedicated solutions that provide the richest array of accurate real-world data thanks to a complete ecosystem of connected devices, data connectivity options, and a remote patient monitoring platform. Visit our website here.
Arlington, VA: In June, the Digital Therapeutics Alliance (DTA) submitted formal comments in response to the United States Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander’s call for recommendations on pandemic preparedness. These recommendations are part of DTA’s ongoing global 2020 initiative to break down obstacles to patient access to digital therapeutics (DTx).
As part of our comments, the Digital Therapeutics Alliance highlighted how in the United States private insurers and employers are increasingly embracing digital therapeutic technologies to improve patient outcomes. Unfortunately, traditional Medicare and most Medicaid programs do not currently recognize and reimburse for these clinically validated therapies. Due to their flexible delivery platforms and ability to treat underserved populations, DTx products offer critical solutions for the three following lessons that we’ve learned during the Covid-19 pandemic:
The Digital Therapeutics Alliance recommends that policymakers take this opportunity to curate a cohesive, efficient healthcare system that includes the necessary spectrum of available digital technologies, including telehealth platforms, remote patient monitoring, and digital therapeutics. In particular, DTx products can begin helping the nation break down some of the health disparities that are experienced by minority populations, rural residents, and patients with chronic and mental health conditions, while additionally addressing other significant policy issues.
Digital therapeutics have clinically demonstrated reliable patient outcomes for numerous health conditions. DTx products for chronic diseases have demonstrated a 63% increase in asthma control, increased symptom free days for COPD patients by 35%, and decreased A1c levels in patients with diabetes by 1.7 to 2.0 points. DTx products have also demonstrated that 60% of patients with a depression-only diagnosis can achieve recovery criteria, 50% of PTSD patients can achieve remission, and the abstinence rate of substance abusers can double. This represents a fraction of the clinical outcomes that are being demonstrated by DTx products for physical, mental, and behavioral health conditions.
“We will have an unbalanced ecosystem in the United States until Medicare and Medicaid begin providing patients with access to remotely delivered digital therapies and enable the formal reimbursement of DTx products,” shared Megan Coder, DTA Executive Director. “While many patients who receive insurance coverage through private payors and employers have access to DTx products, low income and aging populations covered by Medicare, Medicaid, and other publicly funded programs are generally prevented from accessing these important therapies. Given that DTx products may be accessible via patient-owned devices, they can become important treatment options for many underserved and rural populations who require care but may not always have access to it.”
Digital therapeutics deliver therapeutic interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of behavioral, mental, and physical diseases and disorders. These products differ from health and wellness apps, telehealth platforms, or tools solely designed for monitoring, diagnostic, and adherence purposes. DTx products comply with rigorous patient-centered core principles and best practices to ensure product integrity, user-centered designs, patient privacy through HIPAA (in the US), and validated clinical outcomes via randomized controlled trials (RCT) and real world evidence (RWE).
About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding and adoption of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors in order to improve clinical and health economic outcomes. To learn more please visit: www.dtxalliance.org.