Digital health applications in psycho-oncology. Claims and reality

Background: Digital health applications (DiGA) have been available as prescriptions in Germany since 2020. Research question: What use do DiGA have for psycho-oncology? Methods: The applications listed in the DiGA directory were examined and their use and effectiveness as well as the perspectives of various stakeholders (companies, health insurance, community, patients, service providers) were determined in a literature review (including gray literature). In addition, qualitative interviews were conducted with physicians, medical assistants, and psychotherapists regarding their experiences with DiGA. Results: The DiGA market is dynamic. There are currently 26 DiGAs approved for mental illnesses and three for breast cancer. Six DiGA were initially approved and then removed from the list. By September 2023, 451,056 DiGA codes had been approved, 11% of which were approved directly by the health insurer, i.e., without the involvement of physicians or psychotherapists. Independent reviews have conclude that the evidence for positive care effects is currently insufficient and that there is a high risk of bias (main problems: no active control group, single-center studies, direct involvement of manufacturers, no blinding, high dropout, lack of recording of adverse effects). The stakeholders' perspectives on DiGA vary. A total of 13 interviews were conducted with service providers. They expect rapid support, especially until a psychotherapy can start (to bridge the waiting time), psychoeducation and empowerment. A lack of proof of efficacy and weak approval criteria compared to medication were criticized. Concerns are directed at the dehumanization of human contact, which is important for psychotherapeutic processes, as well as data protection and data security, which are assumed to be inadequate. Conclusion: The experiences with DiGA to date are mixed. There is not enough good evidence for the improvement of patient-relevant endpoints. Physicians and psychotherapists should gather information about the respective DiGA before prescribing it. Information on the efficacy and data safety of DiGA must be compiled by independent institutions, critically reviewed and easily accessible.