1、 2023 HealthwareGroup and Digital Therapeutics Alliance All rights reserved.Confidentialand proprietaryDTx policy pathways:the evolving scenario in Europe Landscape Analysis&Converging TrendsEnhancing equitable access to digital healthcareDIGITAL THERAPEUTICS POLICY REPORTJune 2023 2023 HealthwareGr

2、oup and Digital Therapeutics Alliance All rights reserved.Confidentialand proprietaryThis Digital Therapeutics(DTx)Policy Report stems from the partnership between the Digital Therapeutics Alliance(DTA)and Healthware to support the development of ecosystems that enable equitable patient,caregiver,an

3、d clinician access to safe and effective DTx products globally.This DTx Policy Report specifically aims to provide clarity on and inform the development of adequate and enabling policies for Digital Medical Devices and,specifically,DTx to drive equitable access to digital health care for all.Authors

4、:Alberta Spreafico,Managing Director Digital Health&Innovation,Healthware GroupMegan Coder,Chief Policy Officer&Founder,Digital Therapeutics AllianceValeria Boccardo,Digital Health,Value&Access Analyst,Healthware GroupEmilie Lopes-Fernandes,Program Lead,Digital Therapeutics AllianceKristin Milburn,C

5、hief Marketing Officer&Managing Director Publications&Digital Health Ecosystem,Healthware GroupAcknowledgements:We thank all policy makers and leaders who have contributed to this report and to our broader DTx Policy Coalition from*:Belgium,Catalonia(Spain),Denmark,England(UK),Estonia,Finland,France

6、,Germany,Italy,Lithuania,Netherlands,Portugal,Sweden and from European-level Institutions and initiatives;as well as from the broader global community as Australia,China,Japan,South Korea,cross-APAC initiatives,Canada and the United States.Cite this document as follows:A.Spreafico,M.Coder et.al.“DTx