Table 6.

Examples of regulatory and ethical considerations related to the use of digital health technologies in different countries or regions.

Country/Region	Regulatory considerations	Ethical considerations	Reference
United States	FDA regulations apply to digital health technologies intended for medical use	Protect patient safety, privacy concerns on patient data, sharing regulatory duties with developers to balance between regulation and space for innovation	(99)
European Union	The CE marking is required for certain digital health technologies, and the General Data Protection Regulation (GDPR) applies to data privacy	Balance the protection of individual privacy and the promotion of growing European data economy	(100, 101)
Canada	Health Canada regulates digital health technologies that meet the definition of medical devices	Ensure patient safety in the use of digital health technologies, to reduce barriers to market entry, stimulate innovation, and encourage adherence	(102)
Australia	The Therapeutic Goods Administration (TGA) regulates digital health technologies that meet the definition of medical devices	Protect data privacy, and protect patient safety	(103)
China	The National Medical Products Administration (NMPA) regulates digital health technologies that meet the definition of medical devices	Foster patient safety and device reliability	(104)