Digital Health

Think Tank
Health Regulation Projects
Asia Pacific (APAC) Network of Healthcare Regulators
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 - Ethics and governance of artificial intelligence for health: Guidance on large multi-modal models 2025
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
Organisation for Economic Co-operation and Development (OECD)	OECD Report on AI in Health: Huge Potential, Huge Risks 2024
CIOMS	CIOMS Report: Artificial Intelligence in Pharmacovigilance 2025
International Telecommunication Union-World Health Organisation (ITU-WHO)	Shaping ethics, regulation and standardization in AI for health - ITU-WHO Focus Group on AI for Health

Australia

Policies	Guidelines	Other readings
Therapeutic Goods (Medical Devices) Regulations 2002	TGA Guidance on Regulation of Software-Based Medical Devices AHPRA Guideline: Meeting your professional obligations when using Artificial Intelligence in healthcare 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

Policies

Guidelines

Other readings

Therapeutic Goods (Medical Devices) Regulations 2002

TGA Guidance on Regulation of Software-Based Medical Devices

AHPRA Guideline: Meeting your professional obligations when using Artificial Intelligence in healthcare

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	AIB 2025-1 MDCG: Interplay between MDR/IVDR and AI Act	-

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	-

Malaysia

Policies	Guidelines	Other readings
Medical Device Act 2012 (Act 737) Medical Device Regulations 2012 Medical Device (Exemption) Order 2024	MMC Guideline on the Ethical Use of Artificial Intelligence (AI) in Medical Practice 2025	Guidance Documents under Medical Device Act 2012 (Act 737)

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 AI Growth Lab - Cross Economy Sandbox for AI-enabled Products

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

AI Growth Lab - Cross Economy Sandbox for AI-enabled Products

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) TC260 Artificial Intelligence Security Governance Framework Version 2.0 2025	-	-

Policies

Guidelines

Other readings

The Cybersecurity Law 2016 (translation)

TC260 Artificial Intelligence Security Governance Framework Version 2.0 2025

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 CSA Guidelines on Securing AI Systems 2024	Public Consultation Paper on Proposed Health Information Bill 2024 Public Consultation Paper on Proposed Health Information Bill (Annexes) 2024 FAQs on Proposed Health Information Bill Companion Guide on Securing AI Systems 2024

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

CSA Guidelines on Securing AI Systems 2024

Public Consultation Paper on Proposed Health Information Bill 2024

Public Consultation Paper on Proposed Health Information Bill (Annexes) 2024

FAQs on Proposed Health Information Bill

Companion Guide on Securing AI Systems 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

Singapore

Policies	Guidelines	Other readings
Personal Data Protection Act (PDPA) 2012	-	PDPC - PDPA Overview

Japan

Policies	Guidelines	Other readings
Act on the Protection of Personal Information (APPI) 2003	-	-

International

Group	Guidelines
World Health Organisation	Policy Brief on Digital Health Data 2023
Organisation for Economic Co-operation and Development (OECD)	Report on Health Data Governance for the Digital Age: Implementing the OECD Recommendation on Health Data Governance 2022 OECD Paper on Facilitating the secondary use of health data for public interest purposes across borders 2025 OECD Paper on personal health data systems in OECD countries 2025

Group

Guidelines

World Health Organisation

Policy Brief on Digital Health Data 2023

Organisation for Economic Co-operation and Development (OECD)

Report on Health Data Governance for the Digital Age: Implementing the OECD Recommendation on Health Data Governance 2022

OECD Paper on Facilitating the secondary use of health data for public interest purposes across borders 2025

OECD Paper on personal health data systems in OECD countries 2025

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)	-

Malaysia

Policies	Guidelines	Other readings
Medical Device Act 2012 (Act 737) Medical Device Regulations 2012 Medical Device (Exemption) Order 2024	-	Guidance Documents under Medical Device Act 2012 (Act 737)

Singapore

Policies	Guidelines	Other readings
Health Products Act 2007	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 Guidelines on Risk Classification of SaMD and Qualification of Clinical Decision Support Software (CDSS) 2025	HSA FAQ Telehealth Product

Policies

Guidelines

Other readings

Health Products Act 2007

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 Guidelines on Risk Classification of SaMD and Qualification of Clinical Decision Support Software (CDSS) 2025

HSA FAQ Telehealth Product

United States

Policies	Guidelines	Other readings
New York Artificial Intelligence Companion Models Law (General Business Law Article 47) 2025 California Law SB243 Companion Chatbots 2025	FDA Guidance: De Novo Classification Process (Evaluation of Automatic Class III Designation) 2021 US FDA Premarket Notification 510(k) 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 FTC Infographic on Consumer Privacy When Using a Health App US FDA Report on Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings 2022

Policies

Guidelines

Other readings

New York Artificial Intelligence Companion Models Law (General Business Law Article 47) 2025

California Law SB243 Companion Chatbots 2025

FDA Guidance: De Novo Classification Process (Evaluation of Automatic Class III Designation) 2021

US FDA Premarket Notification 510(k)

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

FTC Infographic on Consumer Privacy When Using a Health App

US FDA Report on Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings 2022

United Kingdom

Policies	Guidelines	Other readings
UK Medical Devices Regulations (MDR) 2002	NICE Evidence Standards Framework for Digital Health Technologies 2018 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	-

Policies

Guidelines

Other readings

UK Medical Devices Regulations (MDR) 2002

NICE Evidence Standards Framework for Digital Health Technologies 2018

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

Japan

Policies	Guidelines	Other readings
Pharmaceuticals and Medical Devices Act 2015	PMDA Medical Products Review 2024	-

Policies

Guidelines

Other readings

Pharmaceuticals and Medical Devices Act 2015

PMDA Medical Products Review 2024

China

Policies	Guidelines	Other readings
Provisions for Medical Device Adverse Event Monitoring and Re-evaluation 2019 Provisions for Supervision and Administration of Medical Device Manufacturing 2022 Interim Measures for the Administration of Generative Artificial Intelligence Services 2023	Guidelines for Medical Device Software Registration Review (Revised 2022)	Zhu et al. (2025) China’s emerging regulation toward an open future for AI

Policies

Guidelines

Other readings

Provisions for Medical Device Adverse Event Monitoring and Re-evaluation 2019

Provisions for Supervision and Administration of Medical Device Manufacturing 2022

Interim Measures for the Administration of Generative Artificial Intelligence Services 2023

Guidelines for Medical Device Software Registration Review (Revised 2022)

Zhu et al. (2025) China’s emerging regulation toward an open future for AI

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
Health Practitioner Regulation National Law Act 2009	AHPRA and National Boards Guidelines for Advertising a Regulated Health Service 2020 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 AHPRA Joint statement on professional responsibilities for prescribing and dispensing medicines 2024

Policies

Guidelines

Other readings

Health Practitioner Regulation National Law Act 2009

AHPRA and National Boards Guidelines for Advertising a Regulated Health Service 2020

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

AHPRA Joint statement on professional responsibilities for prescribing and dispensing medicines 2024

China

Policies	Guidelines	Other readings
-	NMPA Notice on Guidelines for On-Site Inspection of the Quality Management Specifications for Online Sales of Medical Devices 2025	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
-	-	Culturally safe eHealth interventions with aboriginal and Torres Strait Islander People: Protocol for a best practice framework Japan Telemedicine Survey 2022

Singapore

Policies	Guidelines	Other readings
Overview of the Health Care Services Act MOH Health Care Services Act Summary of Requirements MOH-HSA-SMC Circular on Regulations and Professional Standards for Telemedicine Services and Advertisements Healthcare Services (Advertisement) Regulations 2021	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 2015 MOH HCSA 2020 FAQs MOH Inquiries and Complaints Guide Healthcare Services (Advertisement) Regulations FAQs 2024 MOH Inappropriate Telemedicine Practices Parliament Questions and Answers 2025

Policies

Guidelines

Other readings

Overview of the Health Care Services Act

MOH Health Care Services Act Summary of Requirements

MOH-HSA-SMC Circular on Regulations and Professional Standards for Telemedicine Services and Advertisements

Healthcare Services (Advertisement) Regulations 2021

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 2015

MOH HCSA 2020 FAQs

MOH Inquiries and Complaints Guide

Healthcare Services (Advertisement) Regulations FAQs 2024

MOH Inappropriate Telemedicine Practices Parliament Questions and Answers 2025

United Kingdom

Policies	Guidelines	Other readings
NHS England Review of digital clinical safety standards: DCB0129 and DCB0160	Care Quality Commission How CQC monitors, inspects and regulated providers of online primary care 2021 Guidance: A guide to good practice for digital and data-driven health technologies 2021 DiCE Online Best Practice Guidelines (BPGs) - Various	MHRA Report on Impact of AI on the Regulation of Medical Products: Implementing the AI White Paper Principles

Policies

Guidelines

Other readings

NHS England Review of digital clinical safety standards: DCB0129 and DCB0160

Care Quality Commission How CQC monitors, inspects and regulated providers of online primary care 2021

Guidance: A guide to good practice for digital and data-driven health technologies 2021

DiCE Online Best Practice Guidelines (BPGs) - Various

MHRA Report on Impact of AI on the Regulation of Medical Products: Implementing the AI White Paper Principles

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

Malaysia

Policies	Guidelines	Other readings
Medical Regulations 2017 Medical Regulations (Amendment) 2025 Notification on the Issuance of Medical Sick Certificate by Registered Medical Practitioners through Teleconsultation 2025	Malaysian Medical Council Guideline on Telemedicine 2024	MMC Complaint or Form Information Against Registered Medical Practitioner

Policies

Guidelines

Other readings

Medical Regulations 2017

Medical Regulations (Amendment) 2025

Notification on the Issuance of Medical Sick Certificate by Registered Medical Practitioners through Teleconsultation 2025

Malaysian Medical Council Guideline on Telemedicine 2024

MMC Complaint or Form Information Against Registered Medical Practitioner