Table 2.

Enablers and barriers for scaling up digital health innovations on the macro level identified in the workshop and aligned with prior work.

Categorya	Enabler	Barrier
Regulatory issues	A method for approval of market entry (guidelines and rules along which new digital innovations can be developed and introduced, eg, Digital Health Applications process from the German Federal Institute for Drugs and Medical Devices) [40] Legislative change (recent changes improving the development, implementation, and reimbursement of digital health innovations, eg, Digital Healthcare Act [Digitale-Versorgung-Gesetzes] passed on December 19, 2019, the “app on prescription” for patients was introduced into health care [sections §§ 33a and 139e of the Fifth Book of the German Social Code Book V])	Legal regulations (legislation that regulates development and market entry for digital health innovations) Liability issues (unclear who is responsible for the safety and possible claims that could arise in the future) High regulatory barriers (overhead to develop and distribute digital innovations is high) Health system is not innovation-friendly
Funding	—b	Missing funding (funding necessary for the development and accreditation of digital health innovations is often missing)
Reimbursement	—	Reimbursement is not guaranteed (unclear whether health care providers will get paid for using/prescribing the digital health innovation)
Planning	—	The aim of the research is not a successful implementation

^aAll categories were adopted from Kowatsch et al [3].

^bNot available.