UNASSIGNED: The Covid-19 pandemic has accelerated the adoption of digital technologies to address social needs, leading to increased investments in digital healthcare applications. Germany implemented a special law called the \"Digitales Versorgungsgesetz\" (DVG-Digital Supply Act) in 2019, which enables the reimbursement of digital health applications, including digital therapeutics (DTx), through a fast-track process. The Federal Institute for Drugs and Medical Devices (BfArM), the German federal authority responsible for overseeing digital health applications, has implemented legislative adjustments since the law\'s introduction, which have increased requirements for these applications and potentially led to the removal of some from the directory as well as a slowdown in the addition of new ones. To counteract this trend, this work aimed to identify key success factors for digital health applications (DiGAs).
UNASSIGNED: This research identifies critical success factors through a structured literature review for developing sustainable digital health applications within the European healthcare systems, specifically DiGAs. The study aims to support the ongoing digital transformation in healthcare.
UNASSIGNED: The identified success factors that significantly impact the sustainability of DiGAs include patient-centered design, application effectiveness, user-friendliness, and adherence to data protection and information security regulations using standardized approaches. These factors are crucial in preventing the failure of DiGA manufacturers in European countries.
UNASSIGNED: By considering and implementing these critical success factors, DiGA manufacturers can enhance their chances of long-term success and contribute to the digital transformation of the healthcare system in Europe.

BACKGROUND: The use of technology in health care, often referred to as digital health, has expanded rapidly because of the need to provide remote care during the COVID-19 pandemic. In light of this rapid boom, it is clear that health care professionals need to be trained in these technologies in order to provide high-level care. Despite the growing number of technologies used across health care, digital health is not a commonly taught topic in health care curricula. Several pharmacy organizations have called attention to the need to teach digital health to student pharmacists; however, there is currently no consensus on best methods to do so.
OBJECTIVE: The objective of this study was to determine if there was a significant change in student pharmacist scores on the Digital Health Familiarity, Attitudes, Comfort, and Knowledge Scale (DH-FACKS) after exposure to digital health topics in a yearlong discussion-based case conference series.
METHODS: Student pharmacists\' initial comfort, attitudes, and knowledge were gathered by a baseline DH-FACKS score at the beginning of the fall semester. Digital health concepts were integrated into a number of cases in the case conference course series throughout the academic year. The DH-FACKS was administered again to students after completion of the spring semester. Results were matched, scored, and analyzed to assess any difference in DH-FACKS scores.
RESULTS: A total of 91 of 373 students completed both the pre- and postsurvey (response rate of 24%). Using a scale from 1 to 10, the mean student-reported knowledge of digital health increased from 4.5 (SD 2.5) before intervention to 6.6 (SD 1.6) after intervention (P<.001) and the mean self-reported comfort increased from 4.7 (SD 2.5) before intervention to 6.7 (SD 1.8) after intervention (P<.001). There was a significant increase in scores for all 4 elements of the DH-FACKS. The mean familiarity scores increased from 11.6 (SD 3.7) to 15.8 (SD 2.2), out of a maximum of 20 (P<.001). The mean attitudes scores increased from 15.6 (SD 2.1) to 16.5 (SD 1.9), out of a maximum of 20 (P=.001). The mean comfort scores increased from 10.1 (SD 3.9) to 14.8 (SD 3.1), out of a maximum of 20 (P<.001). The mean knowledge scores increased from 9.9 (SD 3.4) to 12.8 (SD 3.9), out of a maximum of 20 (P<.001).
CONCLUSIONS: Including digital health topics in a case conference series is an effective and approachable way of providing education on important digital health concepts to students. Students experienced an increase in familiarity, attitudes, comfort, and knowledge after the yearlong intervention. As case-based discussions are an important component of most pharmacy and other medical curricula, this method can be easily applied by other programs that wish to give their students practice applying their knowledge of digital health to complex case-based scenarios.

UNASSIGNED: We describe two case studies that use embodiment in virtual reality as a treatment for chronic low back pain. The purpose of this case series was to determine the feasibility of a novel virtual reality-based digital therapeutic for the treatment of chronic pain.
UNASSIGNED: Two patients with chronic low back pain received seven sessions, two sessions per week, of a novel digital therapeutic that combines virtual embodiment with graded motor imagery to deliver functional rehabilitation exercises using an off-the-shelf virtual reality system. Pain intensity was measured using a visual analog scale before and after each session to get an indication whether individual sessions of virtual embodiment training decrease pain intensity. Pain catastrophizing scale was assessed before the first session and after the seventh session to determine the extent to which virtual embodiment training can improve psychological symptoms of chronic low back pain.
UNASSIGNED: In both patients, pain intensity was improved after individual sessions of virtual embodiment training as measured by a paired t-test: (Patient A: t = 2.890, P < 0.05) and (Patient B: t = 5.346, P < 0.005). This indicates that individual sessions of virtual embodiment training decrease pain intensity. In both patients, improvements were observed in three subscales of the pain catastrophizing scale (rumination, magnification, and helplessness). This indicates that virtual embodiment training may have benefits for chronic pain symptoms such as pain intensity, pain-related mobility impairment, and disability.
UNASSIGNED: This case series provides evidence that embodiment in virtual reality improves symptoms of persistent chronic low back pain. We propose a mechanism by which virtual embodiment may improve chronic pain symptoms by recontextualizing sensory feedback from the body as patients engage in functional rehabilitation exercises while in virtual reality.

BACKGROUND: Smartphones and wearable devices can be used to obtain diverse daily log data related to circadian rhythms. For patients with mood disorders, giving feedback via a smartphone app with appropriate behavioral correction guides could play an important therapeutic role in the real world.
OBJECTIVE: We aimed to evaluate the effectiveness of a smartphone app named Circadian Rhythm for Mood (CRM), which was developed to prevent mood episodes based on a machine learning algorithm that uses passive digital phenotype data of circadian rhythm behaviors obtained with a wearable activity tracker. The feedback intervention for the CRM app consisted of a trend report of mood prediction, H-score feedback with behavioral guidance, and an alert system triggered when trending toward a high-risk state.
METHODS: In total, 73 patients with a major mood disorder were recruited and allocated in a nonrandomized fashion into 2 groups: the CRM group (14 patients) and the non-CRM group (59 patients). After the data qualification process, 10 subjects in the CRM group and 33 subjects in the non-CRM group were evaluated over 12 months. Both groups were treated in a similar manner. Patients took their usual medications, wore a wrist-worn activity tracker, and checked their eMoodChart daily. Patients in the CRM group were provided with daily feedback on their mood prediction and health scores based on the algorithm. For the CRM group, warning alerts were given when irregular life patterns were observed. However, these alerts were not given to patients in the non-CRM group. Every 3 months, mood episodes that had occurred in the previous 3 months were assessed based on the completed daily eMoodChart for both groups. The clinical course and prognosis, including mood episodes, were evaluated via face-to-face interviews based on the completed daily eMoodChart. For a 1-year prospective period, the number and duration of mood episodes were compared between the CRM and non-CRM groups using a generalized linear model.
RESULTS: The CRM group had 96.7% fewer total depressive episodes (n/year; exp β=0.033, P=.03), 99.5% shorter depressive episodes (total; exp β=0.005, P<.001), 96.1% shorter manic or hypomanic episodes (exp β=0.039, P<.001), 97.4% fewer total mood episodes (exp β=0.026, P=.008), and 98.9% shorter mood episodes (total; exp β=0.011, P<.001) than the non-CRM group. Positive changes in health behaviors due to the alerts and in wearable device adherence rates were observed in the CRM group.
CONCLUSIONS: The CRM app with a wearable activity tracker was found to be effective in preventing and reducing the recurrence of mood disorders, improving prognosis, and promoting better health behaviors. Patients appeared to develop a regular habit of using the CRM app.
BACKGROUND: ClinicalTrials.gov NCT03088657; https://clinicaltrials.gov/ct2/show/NCT03088657.