As the leading global authority on the evolution of digital health technology, Digital Therapeutics Alliance (DTA) is a 501(c)(6) non-profit trade association of industry leaders and stakeholders dedicated to the understanding, adoption, and integration of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors to improve clinical and health economic outcomes. As the leading international organization on digital therapeutic thought leadership and education, DTA provides the digital health ecosystem with the necessary tools to define, evaluate, and utilize DTx products. For more information, please visit: www.dtxalliance.org.
External link for Digital Therapeutics Alliance
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Exciting news for DTA member, Dario! 👏 🎉
Dario continues to gain momentum with employers looking for a better experience for their employees and better results for their organization. We are excited to show these new clients how Dario drives best-in-class engagement to deliver meaningful clinical outcomes in 2025. https://lnkd.in/e7DjrSTY #digitalhealth #dario
Will we see you at DTA's Reimbursement Intensive in January? Register now to secure one of the last tickets! 🎟 https://lnkd.in/giNv4UP6 ⬇ What to Expect ⬇ This workshop will provide a comprehensive understanding and strategy framework for the key payor landscapes for digital therapeutics, including government, commercial, employer, and direct-to-consumer models. You’ll explore the latest trends and challenges in securing reimbursement from Medicare, Medicaid, VA, and commercial payors, and gain insight into the pathways for inpatient, outpatient, and durable medical equipment services. The presentations and workshops will cover compliance, regulatory issues, and strategies for navigating complex systems, with a focus on aligning business models to optimize reimbursement opportunities. For those targeting direct-to-consumer markets, you’ll also learn effective multi-channel marketing approaches and how to address unique regulatory challenges. Secure your seat: https://lnkd.in/giNv4UP6 #DTA #DTx #DigitalTherapeutics #DTAEvents #DigitalTherapeuticsAlliance #MedTech #HealthTech
What is PDURS? PDURS (“Prescription Drug Use Related Software”) is software designed to complement prescription drugs, managing treatment in real-time. It can offer tools for tracking medication adherence, optimizing doses, and reducing side effects. With FDA guidance expected by 2025, the regulatory framework for these drug-software combinations will further support their development and use in clinical settings. This evolution comes as healthcare moves toward personalized treatment, where software isn’t just a companion but an integral part of the therapeutic approach. Join us to discuss: - An overview of PDURS - How PDURS influences patient safety and health outcomes - How PDURS can aid in solving current challenges in the healthcare system - What the Digital Therapeutics Alliance is doing for PDURS Register for free: https://lnkd.in/giQEF9Jk Andy Molnar Marty Culjat Steven L. #DTA #DigitalTherapeuticsAlliance #DTx #DigitalTherapeutics #DTAEvents #PDURS
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Deadline for comments this Friday, November 22! The Digital Therapeutics Alliance and DirectTrust® have partnered to provide accreditation for efficacy and data privacy and security for digital therapeutic products. As part of this collaboration, DirectTrust has released the proposed criteria for the Digital Therapeutics program. The criteria is open for public review and comment until this Friday, November 22, 2024. This program, which builds on DirectTrust's Health App accreditation, is designed to assess the efficacy, privacy, and security of DTx platforms. We encourage you to participate in this comment period to help shape the standards that will impact the future of DTx accreditation! Learn more and comment: https://lnkd.in/dGDvWQ2j
Tomorrow, DTA's Andy Molnar will be attending the FDA's first Digital Health Advisory Committee Meeting where they will be discussing generative AI-enabled devices. You can watch the meeting webcast on YouTube. Learn more about the DHAC meeting here: https://lnkd.in/dkJ9HRpZ #DTx #digitalhealth #digitaltherapeutics #FDA #medtech #AI
175+ healthcare providers have completed DTA's CME module! After completing this activity, participants are able to: 🔹 Describe and define the International Organization for Standardization (ISO) of DTx 🔹 Identify the difference between healthcare professional and patient-facing digital health technologies 🔹List the criteria for differentiation of categories for digital health therapeutics based on 4 key areas 🔹Describe which patient populations might be impacted by the ability to access DTx. Access the CME module for free: https://lnkd.in/dEiN6d8e
Earlier this month, Centers for Medicare and Medicaid Services (CMS) finalized the 2025 Medicare Physician Fee Schedule (https://lnkd.in/emTP-kNS; see pages 583-601), which includes the groundbreaking decision to cover “Digital Mental Health Treatment” (DMHT) devices. This milestone means that Medicare will now reimburse for certain DTx products , making these life-changing technologies more accessible to millions of patients. CMS has created 3 new HCPCS codes for DMHT devices: 1️⃣ G0552: For supply of digital mental health treatment device and initial education and onboarding, per course of treatment that augments a behavioral therapy plan for furnishing a DMHT device. 2️⃣ G0553: First 20 minutes of monthly treatment management services directly related to the patient’s therapeutic use of the digital mental health treatment (DMHT) device that augments a behavioral therapy plan, physician/other qualified health care professional time reviewing data generated from the DMHT device from patient observations and patient specific inputs in a calendar month and requiring at least one interactive communication with the patient/caregiver during the calendar month. 3️⃣ G0554: Each additional 20 minutes of monthly treatment management services directly related to the patient’s therapeutic use of the digital mental health treatment (DMHT) device that augments a behavioral therapy plan, physician/other qualified health care professional time reviewing data generated from the DMHT device from patient observations and patient specific inputs in a calendar month and requiring at least one interactive communication with the patient/caregiver during the calendar month. This is a huge win for digital therapeutics and for providers focused on mental health, ensuring Medicare beneficiaries will benefit from the latest advancements in care. Today we hosted a DTA members-only webinar where we discussed the newly finalized DMHT codes and how they will impact digital therapeutics companies. To learn more, join us at the DTA Reimbursement Intensive in January, where there will be time carved out to talk specifically about implementing this reimbursement opportunity. 📆 Register now: https://lnkd.in/giNv4UP6 Thank you to DTA members for supporting the critical advocacy work to reach this milestone. Special thank you to DTA's US Policy Task Group for their consistent input into crafting DTA’s positions and outreach. Interested in joining DTA's advocacy work? Reach out to Hazel Nugent (hazel@dtxalliance.org) to learn more about membership! Carrie Nixon Nixon Law Group Andy Molnar
Join us tomorrow for a Value Guide Meetup on best practices for health information privacy & Security! Register for free: https://lnkd.in/grShcYya
New Event 📣 Value Guide Meetup: Best Practices for Health Information Privacy & Security Digital therapeutics must comply with a variety of international and national security standards. Join us to learn how to adhere to appropriate regulations and laws which will generally reduce the risk of security breaches, clinician and patient mistrust, and compromised electronic health data. In the rapidly evolving field of digital therapeutics (DTx), ensuring patient privacy, governance, and consent is essential for building trust and maintaining the safety of these products. Compliance with regional and local regulations governing electronic Protected Health Information (PHI) and sensitive data is crucial for DTx manufacturers. This webinar will explore the critical privacy and security considerations that underpin the successful development and implementation of DTx products. Register for free: https://lnkd.in/grShcYya Download a copy of the DTx Value Guide: https://lnkd.in/g7-itFXR #DTA #DTAEvents #DTx #DigitalTherapeutics Lani Reilly, OTR/L Ronald S. Moser Carrie Nixon
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Digital Therapeutics Alliance is hosting HelloBetter's Journey Through Germany and France Reimbursement Pathways. Register for free to attend this Thursday!
📣 Upcoming Webinar: Navigating DTx Evaluation: HelloBetter's Journey Through Germany and France Reimbursement Pathways 📅 Date: Thursday, November 14 ⏰ Time: 9:00AM ET Join us for a landscape analysis on the current regulatory, assessment, and reimbursement pathways in France and Germany and HelloBetter's experience navigating these two pathways. Objectives: - Learn the current pathway in Germany (DiGA fast track) - Learn the current pathway in France (PECAN) - HelloBetter's experience navigating the two systems Speakers: - Daphne Petrich, Country Manager France, HelloBetter - Dr. Victor Stephani, Lead Policy & Regulatory Affairs Manager, HelloBetter - Stephane Tholander, Vice-President, Digital Health, France Biotech Moderator: - Emilie Lopes-Fernandes, Head of European Policy, Digital Therapeutics Alliance Register for free: https://lnkd.in/gCw26GY4
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To advance the effort to publish an International Standard for DTx Product Requirements, DTA's COO, Jessica Hauflaire, met with an international coalition of ISO - International Organization for Standardization participants last week. The ISO project group and the DTA Task Group have worked at a fast pace to develop the first draft of the standard. Next steps are to circulate a working draft amongst the broader ISO Working group and other relevant parties. This next step will validate the draft leading to a stronger and more clear draft for an international review in the spring. If you're a DTA member interested in joining 2025 task group meetings, contact Jessica (jhauflaire@dtxalliance.org). Contact Hazel (hazel@dtxallinace.org) to learn more about DTA membership and benefits.