The BHSC Strategic Planning Session (SPS) unveiled on 28 March 2024, drawing a vibrant assembly of over 120 experts from the biomedical and healthcare domains, including industry mavens, governmental figures, and trailblazing R&D institutions.

The sitting Chair of BHSC, Dr Yong Chern Chet, opened the event by introducing the Singapore Standardisation Programme, elucidating the standardisation ecosystem, national standards’ definitions, applications, and development process.

Prof Patrick Tan, Executive Director of Precision Health Research Singapore (PRECISE), then took the spotlight. His presentation, “Precision Medicine End-to-End: Real-World Patients to Real-World Data,” transported audience into the realm of the Singapore National Precision Medicine (NPM) Programme, showcasing its global positioning alongside GA4GH standards.

Dr Cheng Chee Leong, Director of SGH Computational and Digital Pathology Unit, shared insights on “AI in Pathology,” tracing their journey from building digital foundation and integrating AI potentials in anatomical pathology.

Ms Fiona Loke, Assistant Director of SingHealth Medical Technology Office (MTO), discussed “Gaps, Practices, and Opportunities for Early Feasibility Studies (EFS),” delineating standardisation gaps to apply ICH harmonised guidelines and ISO standards, and suggested potential solutions.

Dr Du Hao, CTO of NUS spin-off startup company, FathomX Pte Ltd, recounted their AI technology translation into medical imaging applications, advocating collaboration among AI scientists, clinicians, engineers, and regulators.

Following each presentation, engaging Q&A discussions ensued, succeeded by breakout sessions exploring new standardisation directions.

Under the dynamic guidance of Dr Adrian Yeo and Dr Cheong Jit Kong, Topic 1 participants immersed themselves into biotechnology, precision medicine, next-generation sequencing, and clinical laboratory testing. The focus group recommended standardisation directions encompassing various aspects, including:

1. Guidance for laboratory-developed tests (LDT)
2. Guidance for genomic sequencing of infectious pathogens
3. Guidance for multiplex nucleic acid diagnostic testing
4. Guidance for the application of AI in diagnostic pathology
5. Guidance for pre-examination processes for nucleic acid testing
6. Guidance for sample preparation and evaluation of massively parallel sequencing
7. Guidance for production and quality control of synthesised oligonucleotides
8. Guidance for data and metadata for genomic sequence information in electronic health records
9. Guidance for next-generation sequencing (NGS) data sharing

In Topic 2, led by Dr Adam Chee and Mr Lee Suen Ming, the focus shifted to health informatics, emphasising data interoperability, bioinformatics, data management, cybersecurity, AI integration, and software engineering in healthcare. Key outcomes include exploration of new health informatics standards in:

1. Interoperability and integration reference architecture
2. Framework for healthcare and related data reporting
3. Electronic health record communication
4. Medical waveform format
5. Framework of event data and reporting definitions for health software safety
6. Guidance on HL7 clinical document architecture
7. Principles and concept of health software and health IT systems safety, effectiveness, and security
8. Healthcare system product life cycle management
9. Implementation, disclosure, and communication of security needs, risks, and controls
10. Information security management for remote maintenance of medical devices and information systems
11. Secure access and safe management for healthcare cloud data
12. Guidance for AI in healthcare

Moving on to Topic 3, led by Ms Heidi Goh and Ms Chan Yang Sun, discussions revolved around biological and clinical evaluation of medical devices, quality management, medical equipment, related software, and best EFS practices. New standardisation recommendations include:

1. Framework for biological evaluation of medical devices
2. Guidelines on medical device software – application, validation and reference model
3. Medical device software life cycle processes
4. General requirements for product safety of health software
5. Good practice for clinical performance studies using IVD medical devices
6. Good practice for investigational device exemptions (IDEs) for early feasibility studies (EFS)

Lastly, Topic 4, led by Dr Clement Ng and Ms Poon Wai Mun, delved into safety in acupuncture practices, TCM clinic protocols, health supplement quality, and regulatory considerations for cosmetics. The consensus calls for new standards regarding:

1. Good distribution practice for health supplements
2. Guidance for preparation for health claims substantiation
3. Standard for testing of active ingredients for health supplements
4. Cosmetics Microbiology Guidelines for the risk assessment and identification of microbiologically low-risk products
5. Quality and safety of TCM raw materials and finished products
6. Procedures for standard acupuncture treatment

The convention has sparked the creation of over 30 new standardisation topics, perfectly aligned with national strategies for advancing digitalisation, sustainability, and resilience in the biomedical and healthcare sectors. CoRE-SDO will form technical working groups dedicated to developing these cutting-edge standards. Through seamless collaboration with the vibrant BHSC partner community, we aim to enhance efficiency and safety in biomedical processes and healthcare products, propelling innovation and excellence in our field.

Attendees can access event materials through the password-protected SPS webpage.