Digital Health

Artificial Intelligence in Healthcare

Cybersecurity Regulations

Data Privacy

Mobile Health (mHealth) and Digital Therapeutics (DTx)

Telehealth

International Frameworks

Group	Guidelines
World Health Organisation	WHO Regulatory considerations on artificial intelligence for health 2023 WHO Regulatory considerations on artificial intelligence for health 2023
Joint European and North American Multisociety	Ethics of AI in Radiology
U.S. FDA, Health Canada and UK’s MHRA	Good machine learning practice for medical device development: Guiding principles 2021 Transparency for machine learning enabled medical devices guiding principles 2024
IMDRF	IMDRF Good machine learning practice for medical device development: Guiding principles 2025
FUTURE-AI	FUTURE-AI International consensus guideline for trustworthy and deployable artificial intelligence in healthcare 2025
Australian Alliance for Artificial Intelligence in Healthcare	AAAiH A National Policy Roadmap for Artificial Intelligence in Healthcare

Australia

Policies	Guidelines	Other readings
Therapeutic Goods (Medical Devices) Regulations 2002	TGA Guidance on Regulation of Software-Based Medical Devices AHPRA Professional obligations when using AI in healthcare TGA Understanding regulation of software based medical devices	TGA Software based medical devices FAQs AI Implementation in hospitals: Legislation, policy, guidelines and principles, and evidence about quality and safety

Europe

Policies	Guidelines	Other readings
EU AI Act EU Regulation 2017/745 - Medical Device Regulation	-	-

Hong Kong

Policy	Guideline	Other readings
-	Digital Policy Office Ethical Artificial Intelligence Framework 2023 Department of Health Medical Device Administrative Control System Artificial Intelligence Medical Devices TR-008 2024	-

Singapore

Policies	Guidelines	Other readings
-	MOH Artificial Intelligence in Healthcare Guidelines (AIHGle) 2021 HSA Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software 2022 HSA Change Management Requirements for SaMD 2023 HSA Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach 2024	MOH AIHGle Infographic HSA Guidance Documents for Medical Devices Model Artificial Intelligence Governance Framework 2020 Model AI Governance Framework for Generative AI 2024

United Kingdom

Policies	Guidelines	Other readings
-	UK National AI Strategy 2021 MHRA Impact of AI on the Regulation of Medical Products 2024	MHRA Software and AI as a Medical Device Change Programme - Roadmap AI Airlock: The regulatory sandbox for AIaMD

United States

Policy	Guideline	Other readings
-	Artificial Intelligence and Machine Learning Software as a Medical Device Action Plan 2021 Good Machine Learning Practice for Medical Device Development: Guiding Principles 2021 Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles 2024 Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions 2024	-

China

Policies	Guidelines	Other readings
The Cybersecurity Law 2016 (translation)	-	-

Europe

Policies	Guidelines	Other readings
The EU Cybersecurity Act 2019/881	Network and Information System Directive 2022/2555 (NIS2)	FAQs on the NIS2 Directive

Hong Kong

Policies	Guidelines	Other readings
Protection of Critical Infrastructure (Computer Systems) Bill (accepted 2025)	-	Key provisions of the Critical Infrastructures (Computer Systems) Bill 2025

Malaysia

Policies	Guidelines	Other readings
Cyber Security Act 2024	-	-

Singapore

Policies	Guidelines	Other readings
Cybersecurity Act 2018 Cybersecurity (Amendment) Act 2024 Computer Misuse Act 1993	Cyber and Data Security Guidelines for Healthcare Providers 2023 Cybersecurity Labelling Scheme for Medical Devices 2024	-

United Kingdom

Policies	Guidelines	Other readings
The Network and Information Systems Regulations 2018	Cyber Security and Resilience Policy Statement 2025 AI Cyber Security Code of Practice	-

United States

Policies	Guidelines	Other readings
The Health Information Technology for Economic and Clinical Health (HITECH) Act 2009 Federal Information Security Modernization Act 2014 California Consumer Privacy Act 2018 New York State Department of Health Hospital Cybersecurity Requirement 2024	-	What is the HITECH Act? FAQs on NYSDOH Hospital Cybersecurity Requirements

China

Policies	Guidelines	Other readings
Personal Information Protection Law 2021 (translation) The Data Security Law 2021 (translation)	-	-

Europe

Policies	Guidelines	Other readings
European Health Data Space Regulation 2025 General Data Protection Regulation 2018	-	Overview of the European Health Data Space Regulation FAQ about GDPR

Hong Kong

Policies	Guidelines	Other readings
Electronic Health Record Sharing System Ordinance Personal Data (Privacy) Ordinance	-	Overview of the Personal Data (Privacy) Ordinance

United Kingdom

Policies	Guidelines	Other readings
Data Protection Act 2018	NHS guidelines on Protection of Patient Data 2023	-

United States

Policies	Guidelines	Other readings
Health Insurance Portability and Accountability Act 1996 Federal Trade Commission Act Health Breach Notification Rule	FTC Business Guidance on Collecting, Using or Sharing Consumer Health Information	Health and Human Services Summary of the HIPAA Privacy Rule 2003 DLA PIPER State Privacy Laws

Australia

Policies	Guidelines	Other readings
-	Australian Digital Health Agency Assessment Framework for mHealth Apps 2022	-

Europe

Policies	Guidelines	Other readings
EU Regulation 2017/745 - Medical Device Regulation	Health and wellness apps - quality and reliability ISO/TS 82304-2:2021	Status of Code of Conduct on privacy for mHealth apps. Report of the working group on mHealth Assessment Guidelines 2016-2017 Code of Conduct on privacy for mHealth apps - draft 2016

France

Policies	Guidelines	Other readings
-	France Good Practice Guidelines on Health apps and Smart Devices 2016 France Assessment of apps in the mobile health sector 2021	-

Germany

Policies	Guidelines	Other readings
Digital Health Care Act, DVG 2019	The fast-track process for Digital Health Applications (DiGA) according to Section 139e SGB V (BfArM) The directory for digital health applications (DiGA) (BfArM)	-

Singapore

Policies	Guidelines	Other readings
-	HSA Regulatory guideline for telehealth products 2019 HSA Guidelines on risk classification of standalone medical mobile applications and qualification of clinical decision support software 2021	HSA FAQ Telehealth Product

United Kingdom

Policies	Guidelines	Other readings
-	MHRA Guidance on Digital Mental Health Technology - regulation and evaluation for safe and effective products 2025 NICE Guideline on Behaviour change: digital and mobile health interventions 2020 Guidance on Criteria for health app assessment	-

United States

Policies	Guidelines	Other readings
-	Policy guidance for device software functions and mobile medical applications 2022	Mobile Health App Developers: FTC Best Practices FTC Interactive Tool to find out which federal laws and regulations apply in developing a mobile health app

International Frameworks

Group	Guidelines
World Health Organisation	Framework for the Implementation of a Telemedicine Service 2017 WHO-ITU Global standard for accessibility of telehealth services 2022 Consolidated Telemedicine Implementation Guide 2022

Australia

Policies	Guidelines	Other readings
-	AHPRA Guidelines: Telehealth consultations with patients 2023.. AHPRA Information for practitioners who provide virtual care	Culturally safe eHealth interventions with aboriginal and Torres Strait Islander People: Protocol for a best practice framework

China

Policies	Guidelines	Other readings
-	-	Evidence of telemedicine's popularity in China Digital health apps and telemedicine in China Laws and Regulations on Telemedicine in China

Germany

Policies	Guidelines	Other readings
Federal Ministry of Health Germany Digital Law - DigiG 2025	Federal Ministry of Health Digital Together Germany's Digitalisation Strategy for Health and Care	-

Japan

Policies	Guidelines	Other readings
-	MHLW issued the Guideline concerning Proper Implementation of Telemedicine 2022	Culturally safe eHealth interventions with aboriginal and Torres Strait Islander People: Protocol for a best practice framework

Singapore

Policies	Guidelines	Other readings
Overview of the Health Care Services Act MOH-HSA-SMC Circular on Regulations and Professional Standards for Telemedicine Services and Advertisements	MOH National telemedicine guidelines 2015 HSA Regulatory guideline for telehealth products 2019 HSA Guidance for HCSA Licensees and Telemedicine Service Providers on Advertisement Controls of Health Products 2024	MOH National Telemedicine Guidelines Summary Card

United Kingdom

Policies	Guidelines	Other readings
-	Care Quality Commission How CQC monitors, inspects and regulated providers of online primary care 2021	-

United States

Policies	Guidelines	Other readings
State by state legal requirements for using telehealth services	HIPAA guidanace on using remote communication technologies for audio only telehealth	National telehealth policy resource center

Think Tank
Health Regulation Projects
Asia Pacific (APAC) Network of Healthcare Regulators
Digital Health

Digital Health

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