Table 1.

Overview of medical app regulation for selected countries.

	Germany	Italy	Australia	Canada
Actors developing national policy regulation	Health Innovation Hub, an external, interdisciplinary expert think tank to the Federal Ministry of Health and the Federal Institute for Drugs and Medical Devices	Ministry of Health overseeing conformity following the European Medical Device Regulation and classification of SaMDa	TGAb	Health Canada (federal government agency)
Intended use of the framework	It helps in determining the eligibility of an app for reimbursement through the public insurance scheme either permanently or on a preliminary basis.	—c	It provides national guidance and a helpful reference tool for app developers working on mobile health apps for release in Australia. It provides a solid basis for further research and analysis.	It helps in determining whether the app meets the legal definition of a SaMD.
Key regulations underpinning the policy framework	DiGAsd under the Digital Care Act	—	The Privacy Act 1988, overseen by the Office of the Australian Information Commissioner; the Competition and Consumer Act 2010 administered by the Australian Competition and Consumer Commission	Risk classification as an SaMD
Risk classification framework for medical apps	European Medical Device Regulation (Risk classes I, IIa, IIb and, III)	European Medical Device Regulation (risk classes I, IIa, IIb, and III)	TGA (Medical Devices) Regulation 2002 (risk classes I, IIa, IIb, and III)	Health Canada Medical Device Classification (risk classes I, II, III, and IV)
Reimbursement approval policy regulation developed?	Applications get approved through the DiGA fast-track procedure. Approved DiGAs are reimbursed through health insurance	—	—	—
End-user interface to clinical practice and patients, which lists approved medical apps	DiGA directory	—	—	None. However, Health Canada does engage with the Canadian Agency for Drugs and Technologies to provide evidence and publicly available health technology assessments.
Are RCTs explicitly mentioned in the regulation?	Mentioned as an example of a methodology designed to demonstrate a positive care effect	—	—	—

^aSaMD: software as a medical device.

^bTGA: Therapeutic Goods Administration.

^cNot applicable.

^dDiGAs: digital health applications.