“Regulatorism” is the way to go for Singapore’s digital health space, says Jack Wong

The healthcare sector is rapidly changing, driven by swift technological advances. Balancing innovation with patient safety remains a significant concern. These developments will continue to shape the future of healthcare.

Jack Wong plays a central role in managing this balance. As the founder of the Asia Regulatory Professionals Association and chief executive officer of RNAscence Biotechnology, he helps digital health companies navigate complex regulatory requirements, ensuring that innovation aligns with safety standards and prioritises patient well-being.

Wong highlights Singapore’s leadership in regulating emerging technologies. “The Health Sciences Authority has played a key role in offering clear, practical guidelines,” Wong says. 

“These help innovators understand exactly what’s expected in terms of clinical validation, real-world performance, and compliance, all while fostering innovation. The clarity of these guidelines provides a clear path for companies, helping them bring innovations to market without compromising on safety.”

Given the pace of technological change, Wong stresses the need for adaptable regulations. “In many countries, regulatory frameworks take time to catch up with new technologies, but Singapore has managed to stay ahead,” he notes.

Recent updates to Singapore’s risk classification guidelines for software medical devices provide greater clarity, reducing delays and improving market access for developers.

The Ministry of Health has also introduced flexible regulatory models, such as the regulatory sandbox for medical devices. “This sandbox allows public healthcare institutions to deploy tools in-house, without the usual regulatory hurdles, which helps accelerate development and deployment,” Wong adds.

“It’s a model that allows for controlled testing while still ensuring patient safety through ongoing clinical oversight. The ability to test within real-world settings without full regulatory approval means innovations can be introduced much faster, under the guidance of regulatory experts.”

Keeping regulations flexible is the way forward

Despite these advancements, Wong acknowledges significant challenges remain, particularly around data governance and interoperability. “Effective healthcare tools require high-quality data, but ensuring privacy and security in an increasingly interconnected world is complex,” Wong says.

“We need to ensure that data sharing is equitable and secure across institutions and borders. The technology is there, but data privacy laws are still catching up.”

Wong’s work at RNAscence Biotechnology — an innovative spin-off from the National Skin Centre and Nanyang Technological University — illustrates how regulation shapes product development. The company’s BioRNA Antiscar patch, designed to reduce scarring, has faced regulatory hurdles as it expands into markets across Asia and Europe.

“We work closely with regulatory experts to explore different pathways to ensure we stay compliant and move the business forward,” Wong explains. “There’s no one-size-fits-all approach, so we focus on finding the best strategy for each product and market.”

Admittedly, “this process can be daunting for startups, especially when dealing with multiple regulations in different regions. But we’ve seen that once you have the right regulatory framework in place, it drives faster product launch and greater confidence in your product”. And that’s invaluable for market adoption, Wong adds.

This mindset is central to Wong’s approach within the digital health space. “Regulatory affairs shouldn’t be seen as a hurdle to overcome, but as a strategic approach for faster product launch and market differentiation,” he says.

“We call this mindset ‘Regulatorism’. It’s about embedding regulatory understanding into every part of a company’s operations, and being a springboard that accelerates development by offering clarity and consistency.” In other words, regulatory affairs should enable companies to create safe and effective products, not hinder progress.

It’s why regulatorism is not just about compliance. Instead, it’s about creating a culture where regulation drives innovation. And as healthcare technologies continue to develop, Wong stresses that regulations must evolve alongside them, adding that flexible regulations can help build trust in new technologies, facilitating their adoption across the healthcare sector. “It’s not enough to just catch up with the technology; regulations must be a step ahead to ensure safety and efficacy,” he says.