Advancing digital health applications: priorities for innovation in real-world evidence generation
Summary: In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a “Fast-Track” regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can present evidence for new di...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2022-03-01
|
| Series: | The Lancet: Digital Health |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589750021002922 |
| _version_ | 1818329755122925568 |
|---|---|
| author | Ariel D Stern, PhD Jan Brönneke, LLM Jörg F Debatin, MD Julia Hagen, MPA Henrik Matthies, PhD Smit Patel, PharmD Ieuan Clay, PhD Bjoern Eskofier, ProfPhD Annika Herr, ProfPhD Kurt Hoeller, PhD Ashley Jaksa, MPH Daniel B Kramer, MD Mattias Kyhlstedt Katherine T Lofgren, PhD Nirosha Mahendraratnam, PhD Holger Muehlan, PhD Simon Reif, PhD Lars Riedemann, MD Jennifer C Goldsack, MA |
| author_facet | Ariel D Stern, PhD Jan Brönneke, LLM Jörg F Debatin, MD Julia Hagen, MPA Henrik Matthies, PhD Smit Patel, PharmD Ieuan Clay, PhD Bjoern Eskofier, ProfPhD Annika Herr, ProfPhD Kurt Hoeller, PhD Ashley Jaksa, MPH Daniel B Kramer, MD Mattias Kyhlstedt Katherine T Lofgren, PhD Nirosha Mahendraratnam, PhD Holger Muehlan, PhD Simon Reif, PhD Lars Riedemann, MD Jennifer C Goldsack, MA |
| author_sort | Ariel D Stern, PhD |
| collection | DOAJ |
| description | Summary: In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a “Fast-Track” regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can present evidence for new digital products, including the use of real-world data and real-world evidence. Against this backdrop, the Digital Medicine Society and the Health Innovation Hub of the German Federal Ministry of Health convened a set of roundtable discussions to bring together international experts in evidence generation for digital medicine products. This Viewpoint highlights findings from these discussions with the aims of (1) accelerating and stimulating innovative approaches to digital medical product evaluation, and (2) promoting international harmonisation of best evidentiary practices. Advancing these topics and fostering international agreement on evaluation approaches will be vital to the safe, effective, and evidence-based deployment and acceptance of digital health applications globally. |
| first_indexed | 2024-12-13T12:53:06Z |
| format | Article |
| id | doaj.art-946b756032bc47a5b92f1ed2d9bfbfbd |
| institution | Directory Open Access Journal |
| issn | 2589-7500 |
| language | English |
| last_indexed | 2024-12-13T12:53:06Z |
| publishDate | 2022-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | The Lancet: Digital Health |
| spelling | doaj.art-946b756032bc47a5b92f1ed2d9bfbfbd2022-12-21T23:45:16ZengElsevierThe Lancet: Digital Health2589-75002022-03-0143e200e206Advancing digital health applications: priorities for innovation in real-world evidence generationAriel D Stern, PhD0Jan Brönneke, LLM1Jörg F Debatin, MD2Julia Hagen, MPA3Henrik Matthies, PhD4Smit Patel, PharmD5Ieuan Clay, PhD6Bjoern Eskofier, ProfPhD7Annika Herr, ProfPhD8Kurt Hoeller, PhD9Ashley Jaksa, MPH10Daniel B Kramer, MD11Mattias Kyhlstedt12Katherine T Lofgren, PhD13Nirosha Mahendraratnam, PhD14Holger Muehlan, PhD15Simon Reif, PhD16Lars Riedemann, MD17Jennifer C Goldsack, MA18Technology and Operations Management Unit, Harvard Business School, Boston, MA, USA; Health Innovation Hub, Berlin Germany; Digital Health Center, Hasso-Plattner Institute, Potsdam, Germany; Correspondence to: Dr Ariel D Stern, Technology and Operations Management Unit, Harvard Business School, Boston, MA 02163, USAHealth Innovation Hub, Berlin GermanyHealth Innovation Hub, Berlin GermanyHealth Innovation Hub, Berlin GermanyHealth Innovation Hub, Berlin GermanyDigital Medicine Society (DiMe), Boston, MA, USADigital Medicine Society (DiMe), Boston, MA, USA; Evidation Health, San Mateo, CA, USADepartment Artificial Intelligence in Biomedical Engineering, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, GermanyInstitute of Health Economics, Department of Economics, Leibniz University Hannover, Hannover, GermanyEIT Health, Erlangen, GermanyAetion, Boston, MA, USARichard A and Susan F Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Boston, MA, USASynergus RWE, Stockholm, SwedenFoundation Medicine, Cambridge, MA, USAAetion, New York, NY, USAPsychological Institute, Department Health & Prevention, University of Greifswald, Greifswald, GermanyHealth Care Markets and Policy Group, ZEW – Leibniz Centre for European Economic Research, Mannheim, GermanyDepartment of Neurology, Heidelberg University Hospital, Heidelberg, GermanyDigital Medicine Society (DiMe), Boston, MA, USASummary: In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a “Fast-Track” regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can present evidence for new digital products, including the use of real-world data and real-world evidence. Against this backdrop, the Digital Medicine Society and the Health Innovation Hub of the German Federal Ministry of Health convened a set of roundtable discussions to bring together international experts in evidence generation for digital medicine products. This Viewpoint highlights findings from these discussions with the aims of (1) accelerating and stimulating innovative approaches to digital medical product evaluation, and (2) promoting international harmonisation of best evidentiary practices. Advancing these topics and fostering international agreement on evaluation approaches will be vital to the safe, effective, and evidence-based deployment and acceptance of digital health applications globally.http://www.sciencedirect.com/science/article/pii/S2589750021002922 |
| spellingShingle | Ariel D Stern, PhD Jan Brönneke, LLM Jörg F Debatin, MD Julia Hagen, MPA Henrik Matthies, PhD Smit Patel, PharmD Ieuan Clay, PhD Bjoern Eskofier, ProfPhD Annika Herr, ProfPhD Kurt Hoeller, PhD Ashley Jaksa, MPH Daniel B Kramer, MD Mattias Kyhlstedt Katherine T Lofgren, PhD Nirosha Mahendraratnam, PhD Holger Muehlan, PhD Simon Reif, PhD Lars Riedemann, MD Jennifer C Goldsack, MA Advancing digital health applications: priorities for innovation in real-world evidence generation The Lancet: Digital Health |
| title | Advancing digital health applications: priorities for innovation in real-world evidence generation |
| title_full | Advancing digital health applications: priorities for innovation in real-world evidence generation |
| title_fullStr | Advancing digital health applications: priorities for innovation in real-world evidence generation |
| title_full_unstemmed | Advancing digital health applications: priorities for innovation in real-world evidence generation |
| title_short | Advancing digital health applications: priorities for innovation in real-world evidence generation |
| title_sort | advancing digital health applications priorities for innovation in real world evidence generation |
| url | http://www.sciencedirect.com/science/article/pii/S2589750021002922 |
| work_keys_str_mv | AT arieldsternphd advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT janbronnekellm advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT jorgfdebatinmd advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT juliahagenmpa advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT henrikmatthiesphd advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT smitpatelpharmd advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT ieuanclayphd advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT bjoerneskofierprofphd advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT annikaherrprofphd advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT kurthoellerphd advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT ashleyjaksamph advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT danielbkramermd advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT mattiaskyhlstedt advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT katherinetlofgrenphd advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT niroshamahendraratnamphd advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT holgermuehlanphd advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT simonreifphd advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT larsriedemannmd advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration AT jennifercgoldsackma advancingdigitalhealthapplicationsprioritiesforinnovationinrealworldevidencegeneration |