ArticleInternational journal of technology assessment in health care2023
Dynamic HTA for digital health solutions: opportunities and challenges for patient-centered evaluation.
Article in International journal of technology assessment in health care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices andFrontiers in medical technology · 2026Pooled it
- Artificial intelligence needs better health systems to reduce inequalities.NPJ digital medicine · 2026Review
- Real-world data on uptake and use of digital mental health interventions among waitlisted patients with various mental disorders.Internet interventions · 2026Article
- Multi-stakeholder use of patient experience data (PED): current state and future opportunities for the application of PED to inform decision-making.Journal of patient-reported outcomes · 2026Review
- Advancing the use of artificial intelligence in health technology assessment activities: insights and next steps from the 2025 HTAi Global Policy Forum.International journal of technology assessment in health care · 2026Article
- Digital health to strengthen pediatric surgical referral and follow-up in Low-resource settings: progress, gaps, and future directions.Frontiers in surgery · 2026Review
- Comprehensive policies for scaling systemic and equitable integration of digital health technologies.NPJ digital medicine · 2025Article
- Unpacking Performance Factors of Innovation Systems and Studying Germany's Attempt to Foster the Role of the Patient Through a Market Access Pathway for Digital Health Applications (DiGAs): Exploratory Mixed Methods Study.Journal of medical Internet research · 2025Article
- Health technology assessment of surgical robots: a mini-review of a rapidly evolving field.Frontiers in public health · 2025Review
- Co-Creation in the Development of Digital Therapeutics: A Narrative Review.International journal of environmental research and public health · 2024Review
- "Towards harmonizing assessment and reimbursement of digital medical devices in the EU through mutual learning".NPJ digital medicine · 2024Review
- Digital Health Applications (DiGAs) on a Fast Track: Insights From a Data-Driven Analysis of Prescribable Digital Therapeutics in Germany From 2020 to Mid-2024.Journal of medical Internet research · 2024Article
- How can regulation and reimbursement better accommodate flexible suites of digital health technologies?NPJ digital medicine · 2024Article
- Digital health technologies need regulation and reimbursement that enable flexible interactions and groupings.NPJ digital medicine · 2024Article
- The three-year evolution of Germany's Digital Therapeutics reimbursement program and its path forward.NPJ digital medicine · 2024Review
- Lifecycle HTA: promising applications and a framework for implementation. An HTAi Global Policy Forum Task Force report.International journal of technology assessment in health care · 2024Review
- Under the Tech Umbrella: Assessing the Landscape of Telemedicine Innovations (Telemechron Study).Healthcare (Basel, Switzerland) · 2024Review
- Review
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesGermany's 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the healthcare delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital health applications (digitale Gesundheitsanwendungen, or DiGA). Worldwide, this is the first structured pathway for "prescribable" health applications at scale. As of October 10, 2023, 49 DiGA were listed in the official directory maintained by Germany's Federal Institute for Drugs and Medical Devices (BfArM); these are prescribable by physicians and psychotherapists and reimbursed by the German statutory health insurance system for all its 73 million beneficiaries. Looking ahead, a major challenge facing DiGA manufacturers will be the generation of the evidence required for ongoing price negotiations and reimbursement. Current health technology assessment (HTA) methods will need to be adapted for DiGA.
methodsWe describe the core issues that distinguish HTA in this setting: (i) explicit allowance for more flexible research designs, (ii) the nature of initial evidence generation, which can be delivered (in its final form) up to one year after becoming reimbursable, and (iii) the dynamic nature of both product development and product evaluation. We present the digital health applications in the German DiGA scheme as a case study and highlight the role of RWE in the successful evaluation of DiGA on an ongoing basis.
resultsWhen a DiGA is likely to be updated and assessed regularly, full-scale RCTs are infeasible; we therefore make the case for using real-world data and real-world evidence (RWE) for
conclusionsContinous evaluation using RWD is a regulatory innovation that can help improve the quality of DiGAs on the market.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.