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Reimbursement is a key challenge for many new digital health solutions, whose importance and value have been highlighted and expanded by the current COVID-19 pandemic. Germany’s new Digital Healthcare Act (Digitale–Versorgung–Gesetz or DVG) entitles all individuals covered by statutory health insurance to reimbursement for certain digital health applications (i.e., insurers will pay for their use). Since Germany, like the United States (US), is a multi-payer health care system, the new Act provides a particularly interesting case study for US policymakers. We first provide an overview of the new German DVG and outline the landscape for reimbursement of digital health solutions in the US, including recent changes to policies governing telehealth during the COVID-19 pandemic. We then discuss challenges and unanswered questions raised by the DVG, ranging from the limited scope of the Act to privacy issues. Lastly, we highlight early lessons and opportunities for other countries.

Digital Health Technologies (DHTs) such as connected sensors offer particular promise for improving data collection and patient empowerment in neurology research and care. This study analyzed the recent evolution of the use of DHTs in trials registered on ClinicalTrials.gov for four chronic neurological disorders: epilepsy, multiple sclerosis, Alzheimer’s, and Parkinson’s disease. We document growth in the collection of both more established digital measures (e.g., motor function) and more novel digital measures (e.g., speech) over recent years, highlighting contexts of use and key trends.

Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a useful structure, but the evolution of digital devices requires concomitant innovation in regulatory approaches to maximize the potential benefits of these emerging technologies. A number of specific adaptations could strengthen current regulatory oversight while promoting ongoing innovation.

An abundant and growing supply of digital health applications (apps) exists in the commercial tech-sector, which can be bewildering for clinicians, patients, and payers. A growing challenge for the health care system is therefore to facilitate the identification of safe and effective apps for health care practitioners and patients to generate the most health benefit as well as guide payer coverage decisions. Nearly all developed countries are attempting to define policy frameworks to improve decision-making, patient care, and health outcomes in this context. This study compares the national policy approaches currently in development/use for health apps in nine countries. We used secondary data, combined with a detailed review of policy and regulatory documents, and interviews with key individuals and experts in the field of digital health policy to collect data about implemented and planned policies and initiatives. We found that most approaches aim for centralized pipelines for health app approvals, although some countries are adding decentralized elements. While the countries studied are taking diverse paths, there is nevertheless broad, international convergence in terms of requirements in the areas of transparency, health content, interoperability, and privacy and security. The sheer number of apps on the market in most countries represents a challenge for clinicians and patients. Our analyses of the relevant policies identified challenges in areas such as reimbursement, safety, and privacy and suggest that more regulatory work is needed in the areas of operationalization, implementation and international transferability of approvals. Cross-national efforts are needed around regulation and for countries to realize the benefits of these technologies.

Over recent years, the adoption of connected technologies has grown dramatically, with potential for improving health care delivery, research, and patient experience. Yet, little has been documented about the prevalence and use of connected digital products (e.g., products that capture physiological and behavioral metrics) in formal clinical research. Using 18 years of data from ClinicalTrials.gov , we document substantial growth in the use of connected digital products in clinical trials (~34% CAGR) and show that these products have been used across all phases of research and by a diverse group of trial sponsors. We identify four distinct use cases for how such connected products have been integrated within clinical trial design and suggest implications for various stakeholders engaging in clinical research.

Growing enthusiasm for remote patient monitoring has been motivated by the hope that it can improve care for patients with poorly controlled chronic illness. In a national commercially insured population in the US, we found that billing for remote patient monitoring increased more than fourfold during the first year of the COVID-19 pandemic. Most of this growth was driven by a small number of primary care providers. Among the patients of these providers with a high volume of remote patient monitoring, we did not observe substantial targeting of remote patient monitoring to people with greater disease burden or worse disease control. Further research is needed to identify which patients benefit from remote patient monitoring, to inform evidence-based use and coverage decisions. In the meantime, payers and policy makers should closely monitor remote patient monitoring use and spending.

FDA approval is widely regarded as a benchmark of quality for medical devices. However, concerns persist regarding its regulatory framework for digital mental health devices. This perspective article examined FDA-authorized Software as a Medical Device (SaMD) in mental health, tracing the devices’ regulatory lineage through the De Novo and 510(k)-clearance pathways while assessing the quality of evidence that led to their authorization. Many 510(k)-cleared devices lacked direct evidence of effectiveness, relying solely on equivalence to predicate devices. Furthermore, we identified four FDA-authorized SaMD whose pivotal randomized controlled trials tested prototypes delivered on different digital platforms than those of the final marketed products. Strengthening regulatory standards requires randomized controlled trials evaluating the final marketed product on its intended platform and the use of context-appropriate control conditions. Sham placebo controls may be considered feasible; however, evidence supporting fully inert and fully blinding sham controls for digital interventions remains limited at present. This should occur alongside consistent application of the FDA’s discretionary authority to require new 510(k) submissions when substantial product changes occur.

Systemic integration and equitable adoption of Digital Health Technologies (DHTs) require timely, comprehensive, harmonised policies. This paper presents five complementary key enablers: defining DHTs in the scope of fit-for-purpose policy interventions, implementing AI-ready regulatory approaches, adopting dynamic assessment criteria, establishing dedicated reimbursement models, and promoting evidence generation, clinical guidelines, interoperability, and education. Cross-border and multistakeholder collaboration are also crucial to reducing fragmentation, addressing inequities, and driving scalable, systemic value.

As the use of remote patient monitoring services grows — driven by health care limitations imposed by the Covid-19 pandemic — clinicians, payers, and patients face important questions regarding the volume, value, and appropriate use of this care model.

Consumer-grade wearables offer promising opportunities for remote patient monitoring (RPM) in neurological disorders, yet their clinical application remains uncertain. In this exploratory analysis, we draw on prospective observational trials using smartwatches in patients with multiple sclerosis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and migraine, who were monitored for 6 to 24 months. Through detailed clinical case narratives, we illustrate both the potential and the limitations of RPM in neurology. Wearable-generated data successfully captured early, clinically meaningful changes, such as the onset of a myasthenic exacerbation, and supported patient engagement in identifying individual triggers, including for migraine. However, external influences such as holidays, infections, or mobility aid use confounded activity signals, underscoring the importance of contextual interpretation. While wearables can enhance neurological care, their integration into clinical workflows is challenged by limited validation and interpretability. Realising their potential requires robust validation in clinical settings and the development of interoperable RPM platforms supported by close collaboration between clinicians, engineers, and patients. Smartwatches and fitness trackers are increasingly used to monitor health, but how helpful are they for people with neurological conditions? In this study, we followed patients with multiple sclerosis, myasthenia gravis, chronic inflammatory polyneuropathy, and migraine for up to two years using everyday wearables. By looking at real-life cases, we found that these devices can detect important changes in health, such as early signs of worsening symptoms. They also helped some patients better understand their condition and identify possible triggers, like for migraines. However, the data from wearables can be misleading—for example, during vacations, infections, or when using mobility aids—so it’s important to interpret the results carefully. To truly benefit patients, these tools need to be better tested in clinical settings and integrated into easy-to-use systems that support doctors and patients working together.