AI/ML in Digital Health Technologies (DHTs)
Project Scope  | 
The use cases of artificial intelligence and machine learning (AI/ML) in digital health technologies to improve healthcare through software. Understand the challenges, and identify the gaps. Connect different stakeholders, share knowledge, and advance in developing AI/ML in DHTs.  | 
| Project Statement | 
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DHTs are revolutionising the healthcare industry, with AI/ML playing a key role in the development of new solutions. With more applications of AI/ML in practice, from optimising workflows to improving diagnostic capabilities, the collaborations to learn from the use cases and the partnership to overcome challenges are urgently needed.  | 
| Project Impact | 
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The integrated effort to study real-world applications will ensure the emerging technologies are used effectively and in compliance with relevant guidelines and regulations.  | 
| Project Leads | |
|---|---|
Ying Su, Pfizer  | |
Radha Railkar, Merck  | radha_railkar@merck.com | 
| Nicola Newton, PHUSE Project Assistant | 
CURRENT STATUS Q2 2025  | 
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Objectives & Deliverables | Timelines | 
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| Identify the industry knowledge-sharing community of practice, prioritise future project topics | Q2/3 2023 | 
| PHUSE/FDA CSS presentation/poster | Q3 2023 | 
| Start gathering use cases | Q4 2023 | 
Quarterly Community Forums Invited expert talks   | Q1 2024 | 
| Q2 2025 | 
Sub-Team  | Forum Topic  | Lead  | 
GA  | Generative AI in healthcare  | Jeffrey Lavenberg  | 
AP  | Application of AI/ML in precision medicine (includes RWE)  | Shraddha Thakkar  | 
RL  | Regulatory landscape of AI/ML in DHTs (current landscape, knowledge gaps, best practices for regulatory submissions, challenges of regulating AI)  | Richard Baumgartner  | 
MD  | AI/ML models (logistic regression, support vector machines, decision tree, convolutional neural networks, etc.)  | Hanming Tu  | 
UC  | Challenges of use of AI/ML in DHTs (ethical concerns, privacy issues/cybersecurity, misuse of data, complexity of data management including data interoperability, etc.)  | Jessica Hu  | 
SD  | Software-driven medical devices  | Anders Vidstrup  |