Table 3.
Some of the key international regulations and guidelines for digital health.
| Regulation/Guideline | Brief Description | Reference |
|---|---|---|
| EU Medical Device Regulation (MDR) | Establishes regulations for medical devices, including software and apps, sold within the European Union (European Commission, 2017). | European Commission (96) |
| FDA Digital Health | Provides regulatory oversight for mobile health apps and other digital health technologies in the United States (U.S. Food and Drug Administration, 2023). | U.S. Food and Drug Administration (97) |
| General Data Protection Regulation (GDPR) | Regulates the processing and protection of personal data for individuals within the European Union (European Commission, 2016). | European Commission (98) |
| Health Insurance Portability and Accountability Act (HIPAA) | Sets standards for the protection of individuals’ health information and ensures privacy and security in the United States (U.S. Department of Health & Human Services, 2003). | U.S. Department of Health & Human Services (99) |
| International Medical Device Regulators Forum (IMDRF) | Provides guidance on the regulation of medical devices, including software, to harmonise global regulatory practices (IMDRF, 2023). | IMDRF (100) |
| ISO 27001:2013 | Information technology—Security techniques—Information security management systems—Requirements | International Organisation for Standardization (101) |
| ISO 13485:2016 | Medical devices—Quality management systems—Requirements for regulatory purposes | International Organisation for Standardization (102) |
| ISO 82304-1: Part 1: 2016 and Part 2: 2021 | Health software—Part 1: General requirements for product safety Health software—Part 2: Health and wellness apps—Quality and reliability | International Organisation for Standardization (103) |
| International Organisation for Standardization (104) | ||
| National Institute for Health and Care Excellence (NICE) Guidelines | Provides evidence-based guidance on the use of digital health technologies, such as mobile apps and telehealth, in the United Kingdom (NICE, 2023). | NICE (105) |
| World Health Organisation (WHO) Digital Health Guidelines | Offers guidelines on various aspects of digital health, including telehealth, mobile health, and health information systems (WHO, 2023). | World Health Organization (106) |