Adding meat to the OHS regulatory framework

Estimated reading time: 5 minutes

The Ministry of Health (MOH) in collaboration with Futurise Sdn Bhd, have launched the OHS regulatory lab and are inviting the online health services (OHS) provider community to register to participate in it.

The OHS regulatory lab could be seen as a platform for multiple stakeholders to better understand new innovative online health services (OHS) by allowing selected OHS platform providers to operate in a live and controlled environment within specified parameters and time frame under close monitoring by multiple stakeholders.

Datuk Dr. Hishamshah bin Mohd Ibrahim, MOH’s Deputy Health Director for research and technical support, described during his welcome address  how the rapid deployment of innovation and deployment of technology will continue to transform the healthcare industry and create a major impact in the formation of patient behaviour and demands.

He was referring to delivery of medical services to patients, which once was deemed possible only where there is a doctor and patient meeting face-to-face in the clinics or wards. Especially during the COVID-19 pandemic era, medical services and consultation can now be delivered virtually and over a distance.

“The Ministry of Health (MOH) has always supported and looked forward to new innovations that can accelerate transformation of healthcare delivery for Malaysia without compromising the five principles of healthcare services; safety, quality, accountability, privacy, and confidentiality, as well as traceability,” he said.

Application to the OHS regulatory lab

Senior Deputy Director of the Planning Division, Dr. Fazilah Shaik Allaudin, also briefed the over 100 participants on how to register for the regulatory lab.

She explained why MOH is doing this by saying,“This effort began 3 to 4 years ago when many business entities approached MOH with requirement to be regulated for various purposes – investment, reimbursement, financing and so on.

“We realised that business entities providing OHS is not regulated by MOH, and hence it was difficult to ensure OHS adherence to the five guiding principles. “

In summary, there were no OHS standards or clear guidelines, which is what the regulatory lab hopes to address.

An OHS platform provider is one who provides patients’ access to Healthcare Professionals, and facilitates arrangements, bookings and delivery of Online Healthcare Services through its specialised and secure technology platform, mobile application, web portal and/or website.

Sandbox

Now, MOH in collaboration with Futurise will leverage upon the National Regulatory Sandbox, or NRS initiative, to conduct the OHS Regulatory Lab.

With this regulatory lab, providers will also have opportunity to evaluate the guidelines and provide appropriate feedback to ensure they can run and operate within a well-defined framework.

Dr. Hishamshah said, “It’s very important that we get feedback from the ground. I think a lot of OHS are giving services that were non-existent previously.

“It is good for the country, for the nation that we use innovative technology for us to get healthcare services to the next level. But we need to make sure these services provided to our people are safe, high-quality, and of obvious efficacy, with privacy, confidentiality and traceability still maintained.”

A framework can help ensure these components are maintained. There must also be feedback from industry and stakeholders while looking at existing processes, guidelines, SOPs and Acts, to formulate the regulatory framework.

Dr. Fazilah wanted to add, not everything requires regulation. So, the lab is also to find the best regulatory instrument. It could require improvement of guidelines, or improvement of policies, or just updating of Acts, to include necessary clauses.

None of the current OHS players will be in the market if existing guidelines as of today were enforced, Dr. Fazilah candidly remarked highlighting how important it is for as many OHS players to register to participate in the regulatory lab.

“A lot of things can be done,” she pointed out.

This guideline is available to an OHS provider that is registered in the Regulatory Lab

Conclusion

Dr. Fazilah explained that the first version  of the guideline is ‘practice as of today’. This is the base, and hopefully by the end of the lab, there will be a new version of the guideline, she expressed.

None of the current OHS players will be in the market if existing guidelines as of today were enforced, Dr. Fazilah candidly remarked highlighting how important it is for as many OHS players to register to participate in the regulatory lab.

Refining the OHS Regulatory Lab guideline version 1, 2021 and healthcare delivery standards is MOH’s short term goal for 2022 to 2023.

After briefing on how to register for the Regulatory Lab, Dr. Fazilah also moderated an open dialogue between the various OHS players and associations, working groups, and regulatory bodies within the local healthcare industry.