Jürgen Wasem

Background: Digital health applications (digitale gesundheitsanwendungen; DiGA) were integrated into the German statutory health care system in 2020 and can be prescribed by physicians and psychotherapists. Nevertheless, their use within routine care, particularly in the treatment of mental disorders, remains limited. Previous research suggests that a lack of information and knowledge among health care providers and patients may contribute to these difficulties. Objective: This study aimed to explore the perspectives of stakeholders on the information-related aspects of DiGA implementation in outpatient mental health care in Germany. This included investigating the perceived information status, information needs, suitable information providers, and potential approaches to improve information provision. Methods: We conducted semistructured interviews with experts representing stakeholder groups relevant to DiGA in outpatient mental health care in Germany. Participants were recruited using purposive stakeholder sampling. Potential participants were identified through existing professional contacts and web-based searches and were subsequently approached by email. The web-based interviews were conducted via Microsoft Teams between September and November 2023. The transcripts were analyzed using qualitative content analysis based on the method described by Kuckartz, combining deductive and inductive category development. Results: A total of 13 interviews with 14 participants were conducted, comprising 5 health care provider representatives, 4 statutory health insurance representatives, 4 DiGA developer representatives, and 1 patient representative. The findings were grouped into 3 main themes: perceived information status, improvement of the information status, and information suppliers. Representatives of health care providers described a general awareness of DiGA but said they lacked more detailed knowledge required to assess and compare individual applications. They also perceived information gaps among patients. Participants distinguished between general information on aspects such as regulatory requirements and organizational processes and more detailed product-specific information. Different potential information suppliers were associated with different opportunities and problems, particularly regarding expertise, objectivity, available resources, and the ability to provide product-specific information. Conclusions: The findings indicate that information-related challenges in the implementation of DiGA extend beyond general awareness. Health care providers may require accessible information with different levels of detail, while the source of information also appears relevant. Addressing these different information needs may support the integration of DiGA into outpatient mental health care. International Registered Report Identifier (IRRID): RR2-10.2196/56205

Background: Digital health interventions, including mobile health apps, increasingly complement outpatient mental health care. In Germany, certified digital health applications (DiGA [Digitale Gesundheitsanwendungen]) can be prescribed and reimbursed in the statutory health care system. However, real-world evidence on patient-reported use of DiGA for mental disorders remains limited. Objective: This study aimed to analyze usage patterns and experiences among DiGA users and expectations among nonusers. Among users, we examined duration of active use, self-reported completion, and experienced reasons for discontinuation; among nonusers, whether DiGA use would be an option and the perceived relevance of hypothetical reasons for discontinuation. Methods: We conducted an anonymous cross-sectional mixed-mode survey among adults insured by Techniker Krankenkasse, Germany’s largest statutory insurer. Random samples of 2000 individuals per group were invited in April 2024, and data collection ended in September 2024. Users received an activation code for a DiGA authorized for mental disorders. Nonusers had a documented diagnosis for which a DiGA was available but had no prior use. Analyses were descriptive, using available cases, frequencies, and medians with IQRs for ordinal Likert-type items. Actual and intended use were treated as distinct. Exploratory subgroup analyses were conducted. Results: Overall, 1413 participants were included in the analysis (769 of 2000 invited users; 644 of 2000 invited nonusers), with response rates of 38.5% (95% CI 36.3%-40.6%) and 32.2% (95% CI 30.2%-34.3%), respectively. A total of 840 of 1249 (67.3%; 95% CI 64.6%-69.8%) participants were female. Nonusers were older and more often lived in rural areas. Among users, 487 of 687 (70.9%; 95% CI 67.4%-74.2%) reported active use for at least 5 weeks; 409 of 700 (58.4%; 95% CI 54.7%-62.0%) reported completion of their DiGA program. The proportion of reported completions increased from 111 of 250 (44.4%; 95% CI 38.4%-50.6%) among those aged 18-40 years to 85 of 112 (75.9%; 95% CI 67.2%-82.9%) among those aged 61 years and older. The most frequently endorsed reasons for discontinuation among users reporting noncompletion were lack of motivation (151/272, 55.5%; 95% CI 49.6%-61.3%) and insufficient personalization (114/255, 44.7%; 95% CI 38.7%-50.8%). Among nonusers, the most frequently endorsed hypothetical reasons for discontinuation were mismatch with their condition (431/540, 79.8%; 95% CI 76.2%-83.0%) and technical difficulties (432/545, 79.3%; 95% CI 75.7%-82.5%). Conclusions: This study provides patient-reported real-world evidence on certified and reimbursable digital mental health interventions. Many users reported weeks of active use, but noncompletion remained common and was more frequent among younger users. Lack of motivation as a frequently reported reason for discontinuation suggests that supporting continued engagement may be important during DiGA use. Beyond Germany, these findings may support implementation of digital mental health interventions in other health care systems. International Registered Report Identifier (IRRID): RR2-10.2196/56205

Cardiovascular, renal, and metabolic (CVRM) conditions—including hypertension (HTN), chronic kidney disease (CKD), type 2 diabetes (T2D), heart failure (HF), obesity (OBS), and dyslipidemia (DLD)—s...

Objectives. Regulation (EU) 2021/2282 introduces the Joint Clinical Assessment (JCA), a common descriptive clinical evaluation that Member States must take into account in national appraisal. Because national health technology assessment (HTA) systems have developed distinct methodologies, their alignment with the JCA is uncertain. We characterised it across six European jurisdictions and interpreted how the pattern arose. Methods. Qualitative comparative study combining structured expert-consensus rating with documentary process tracing. Two EU-HTA methodologists derived 35 methodological dimensions in five domains from the Regulation, its Implementing Regulation and HTA Coordination Group guidance, fixing and source-tracing the JCA reference position for each before any national rating. Expert pairs in six jurisdictions (France, Germany, Italy, Spain, the Netherlands and England) rated their system against every reference position by consensus, on an anchored three-point qualitative alignment scale. Reporting follows the SRQR. Results. Germany was aligned on 33 of 35 dimensions, with no substantial divergence. England was most distant (23 substantially divergent), followed by France (18); Italy and the Netherlands were intermediate (14 each). Spain recorded no aligned dimension but the fewest substantial divergences of any non-German system (7), diverging in degree rather than in kind. Divergence concentrated in the domains the JCA excludes and in appraisal posture, yet German proximity persisted once these were removed (27 of 29; 19 of 20). Documentary evidence on the legislative compromise, EUnetHTA21 methodological production and subgroup leadership suggests the JCA has emerged as a German-compatible default rather than a neutral synthesis of national traditions. Conclusions. National methodologies align with the JCA to markedly different degrees, the closest fit being the most codified national model. The alignment finding is empirical, the influence account interpretive; neither ranks any national model as superior. Because divergence concentrates where national appraisal remains sovereign, the framework may displace methodological heterogeneity downstream rather than resolve it.

Health technology assessment is a discipline that has developed, over five decades, an elaborate scientific and institutional identity centered on the evaluation of clinical evidence, comparative effectiveness, and economic value

The Joint Clinical Assessment (JCA), introduced by Regulation (EU) 2021/2282, is often presented as a procedurally neutral input that leaves national health technology (HTA) appraisal and decision-making untouched. This paper argues that this neutrality is only apparent. Because national appraisal systems differ profoundly in how they process evidence on relative effect and certainty, an identical JCA conclusion will not carry identical consequences across Member States. Germany’s IQWiG/G-BA system, tightly structured around confidence intervals, endpoint categories and certainty grading, shares the JCA’s own vocabulary and therefore has comparatively little room to reinterpret a JCA conclusion once issued. Systems built around broader clinical deliberative frameworks — as in France, Italy, and countries with formal cost-effectiveness components — retain greater latitude to contextualise, weigh or offset the same conclusion. This asymmetry is practical and epistemic rather than legal: the JCA remains formally non-binding, yet its methodological architecture may be more readily absorbed by some national traditions than others. The paper argues that this risk — uniform in form, divergent in the interpretive latitude it leaves Member States — deserves explicit attention while JCA practice and methodological guidance are still being established, and proposes measures to make the JCA’s methodological choices more transparent to rule-based and deliberative systems alike.

Background: The EU Health Technology Assessment Regulation (EU-HTA R), effective January 2025, mandates Joint Clinical Assessments (JCAs) to harmonize HTA across Member States. However, its implementation raises fundamental questions about methodological coherence, institutional capacity, and epistemological alignment. Objectives: This manuscript (1) systematically assesses whether the stated strategic and operational objectives of the EU-HTA R are achievable under current implementation conditions; (2) examines the implications for EU institutional legitimacy if these objectives are not met; and (3) proposes an epistemological framework as a prerequisite for developing a coherent joint HTA methodology. Methods: We conducted a critical policy analysis of the EU-HTA R, its implementing guidance documents, and published templates, supplemented by a comparative review of Member State HTA methodologies and their underlying philosophical foundations. Results: The analysis reveals that the EU-HTA R is unlikely to achieve its strategic goals under current conditions. Key findings include: guidance documents of substandard methodological quality; a restricted assessment scope that excludes scientific judgement and contextualization; insufficient resources and additional workload for national HTA bodies without reducing existing obligations; unresolved epistemological divergences among Member States spanning Bayesian vs. frequentist approaches, Fisher vs. Neyman–Pearson frameworks, and utilitarian vs. deontological ethical foundations; and procedural shortcomings in stakeholder consultation and expert involvement. These shortcomings risk undermining the epistemic authority and legitimacy of EU institutions. Conclusions: Prior epistemological and normative alignment across Member States is a prerequisite for any robust shared HTA methodology. Revisions to the EU-HTA R and comprehensive updates of guidance documents are necessary, with concrete safeguards—including independent peer review, identified authorship, and adequate resourcing—to ensure substantive rather than merely nominal implementation. A phased roadmap is proposed: establishing clear objectives, aligning epistemological foundations, developing institutional structures, and creating operationally consistent guidance.

Background: Mental disorders affect nearly one-third of adults in Germany, with a 12-month prevalence of approximately 28%. Following Germany’s 2019 Digital Care Act, digital health applications (Digitale Gesundheitsanwendungen [DiGA]) became reimbursable interventions by the statutory health insurance for mental health conditions. However, adoption remains uneven. General practitioners (GPs) issue most mental health DiGA prescriptions, while psychotherapists or psychiatrists prescribe far fewer, even though most DiGA target mental health. Existing studies imply profession-specific barriers but lack quantitative evidence on preference drivers or remain descriptive. Whether and how these preferences differ across professional groups has not been systematically quantified. Objective: This study aimed to quantify and compare GPs’ and psychotherapists’ or psychiatrists’ preferences for factors associated with DiGA prescription decisions using best-worst scaling (BWS). Methods: A cross-sectional BWS study was conducted among outpatient GPs and psychotherapists or psychiatrists. Eleven DiGA objects were evaluated using a balanced incomplete block design. Preferences were analyzed using conditional logit regression. Likelihood ratio tests assessed differences between professional groups, with stratified models estimating group-specific odds ratios (OR) and 95% CIs. Results: Of 484 respondents (244 GPs and 240 psychotherapists or psychiatrists), 408 completed the BWS experiment. Group-specific ORs ranged from 0.47 to 1.72 (likelihood ratio test: χ210=328.76; P<.001), suggesting that GPs and psychotherapists or psychiatrists operate within a broadly shared evaluative space but assign different relative emphasis to specific factors influencing DiGA prescription decisions. Relative to the reference object (intuitive usability for patients), GPs most strongly preferred scientific recommendations (OR 1.72, 95% CI 1.42-2.09) and patients’ interest in DiGA (OR 1.70, 95% CI 1.40-2.06) while significantly showing lower preferences for cross-device availability (OR 0.57, 95% CI 0.47-0.69) and access to patient-entered data (OR 0.47, 95% CI 0.39-0.57). Psychotherapists or psychiatrists showed different preference patterns, most strongly preferring device availability (OR 1.47, 95% CI 1.22-1.76) and contact points for technical support (OR 1.36, 95% CI 1.13-1.64) while showing significantly lower preference for alignment with scientific recommendations (OR 0.75, 95% CI 0.62-0.90). Conclusions: Professional role is a source of preference heterogeneity for factors associated with DiGA prescription decisions. GPs assigned comparatively greater weight to evidence-based recommendations and patient interest, while psychotherapists or psychiatrists emphasized technical integration feasibility and peer experience. These structured differences in priority gradients indicate that uniform implementation approaches may not adequately reflect the evaluative frameworks of both professional groups.

On 14 May 2026, the Member State Coordination Group on Health Technology Assessment (HTA Coordination Group) adopted Guiding Principles on Data Transparency under Article 3(7), points (c) and (h), of Regulation (EU) 2021/2282. The document opens with a disclaimer of legal force; its operational architecture, a self-authored definition of ‘commercially confidential information’, a categorical declaration that broad classes of clinical data are in general non-confidential, and a recourse procedure run by the same family of actors that produced the rule, has consequences that the disclaimer cannot dissolve. We argue that the Guiding Principles sit uneasily with EU lex specialis on commercial confidentiality and with case-by-case jurisprudence on disclosure; that, in producing them, the HTA Coordination Group has concentrated rulemaking, executive and quasi-judicial functions in a manner that engages the principle of conferred powers, the Meroni doctrine, and Articles 41 and 47 of the Charter; and that the corrective is institutional rather than substantive: the problem lies in how the rules were made and by whom, not only in their content.

The Joint Clinical Assessment (JCA) report on tovorafenib (Ojemda), the first assessment of an orphan oncology medicinal product completed under Regulation (EU) 2021/2282 [1], conformed closely to predictions made across our earlier work. This Perspective argues that the outcome was foreseeable from the framework’s design rather than from any feature of the product. We characterise the JCA as an audit that confronts developer-submitted evidence against a corpus of EUnetHTA methodological guidance whose scientific validity and development process have been widely contested. Four structural features explain the result: the referential cannot function as a settled gold standard; the assessment omits the interpretive, context-dependent judgment that gives evidence meaning, on the assumption — specific to one national tradition — that assessment can be separated from appraisal and conducted free of judgment; products supported only by single-arm trials are predictably assessed negatively, as Ojemda illustrates; and the framework departs from the tripod of evidence-based medicine by marginalising clinicians and patients. By multiplying PICOs, subgroups and outcomes and then criticising the resulting analyses as post hoc, the JCA generates its own limitations and ultimately cannot state a degree of certainty of relative effectiveness. We conclude that single-arm-supported products should fall outside the JCA’s remit and that the framework requires a transparent route from documented uncertainty to a stated certainty.