TY - JOUR
T1 - Nachweis positiver Versorgungseffekte von digitalen Gesundheitsanwendungen – methodische Herausforderungen und Lösungsansätze
AU - Arbeitsgruppe Digitale Gesundheitsanwendungen (DiGA) und künstliche Intelligenz (KI) in Leitlinien der Kommission Digitale Transformation der Deutschen Gesellschaft für Innere Medizin (DGIM)
AU - König, Inke R
AU - Mittermaier, Mirja
AU - Sina, Christian
AU - Raspe, Matthias
AU - Stais, Patrick
AU - Gamstätter, Thomas
AU - Stachwitz, Philipp
AU - Wolfrum, Sebastian
AU - Richter, Jutta G
AU - Möckel, Martin
N1 - © 2022. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.
PY - 2022
Y1 - 2022
N2 - Since 2020, digital health applications (DiGA) can be prescribed at the expense of the German statutory health insurance (SHI) system after undergoing an approval procedure by the Federal Institute for Drugs and Medical Devices (BfArM). DiGA can be approved provisionally for 1 year (with the option of extension) or permanently. The latter is dependent on scientific evidence of a positive effect on care, which can be a medical benefit or a patient-relevant structural and procedural improvement in care. However, it is apparent that the investigation of DiGA in scientific studies is challenging, as they are often complex interventions whose success also includes user and prescriber factors. In addition, health services research data underpinning the benefits of DiGA are lacking to date. In the current article, methodological considerations for DiGA research are presented, and a selection of internal medicine DiGAs is used to critically discuss current research practice.
AB - Since 2020, digital health applications (DiGA) can be prescribed at the expense of the German statutory health insurance (SHI) system after undergoing an approval procedure by the Federal Institute for Drugs and Medical Devices (BfArM). DiGA can be approved provisionally for 1 year (with the option of extension) or permanently. The latter is dependent on scientific evidence of a positive effect on care, which can be a medical benefit or a patient-relevant structural and procedural improvement in care. However, it is apparent that the investigation of DiGA in scientific studies is challenging, as they are often complex interventions whose success also includes user and prescriber factors. In addition, health services research data underpinning the benefits of DiGA are lacking to date. In the current article, methodological considerations for DiGA research are presented, and a selection of internal medicine DiGAs is used to critically discuss current research practice.
U2 - 10.1007/s00108-022-01429-2
DO - 10.1007/s00108-022-01429-2
M3 - Übersichtsarbeiten
C2 - 36279007
SN - 2731-7080
VL - 63
SP - 1298
EP - 1306
JO - Innere Medizin (Heidelberg, Germany)
JF - Innere Medizin (Heidelberg, Germany)
IS - 12
ER -