February 28, 2024

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First healthcare regulatory sandbox launched in Singapore for telemedicine services

First healthcare regulatory sandbox launched in Singapore for telemedicine services

The Ministry of Health (MOH) in Singapore has launched
a new Licensing Experimentation and Adaptation Programme (LEAP), beginning with telemedicine services.

LEAP was first announced
by Senior Minister of State for Health, Dr Lam Pin Min, at the 2018 Committee
of Supply debate. It will provide regulatory sandboxes that enable new and
innovative healthcare models and services to be developed and refined in a safe
and controlled environment. Participating providers and MOH will achieve this through
clear boundary conditions, data governance measures and risk mitigation
strategies.

Telemedicine will be the first service to be explored under
LEAP. Telemedicine enables greater convenience and improved accessibility to
medical support and medication through new digital self-help options. It has
the potential to enhance productivity and cost-effectiveness, and become an
impactful enabler in Singapore’s healthcare landscape.

MOH will take a risk-based approach by focusing on
tele-consultation services, which provide direct clinical care (e.g. diagnosis
and intervention) between a doctor and patient, and work with the participating
providers to bring about a safe and vibrant telemedicine environment.

The plan is to eventually regulate telemedicine as a
licensed healthcare service after the successful completion of the regulatory
sandbox.

Earlier this year, MOH invited
public feedback on a proposed Bill for regulation of healthcare services, which
will replace the Private Hospitals and Medical Clinics Act (PHMCA). The Bill will
shift the regulatory basis from ‘premises-based’ licensing to ‘services-based’
licensing and include telemedicine which was not regulated under the PHMCA.

The first two providers participating in the programme are WhiteCoat and RingMD.  More providers may come on board
later, as more telemedicine providers recognise the benefits of LEAP and work
to meet the requirements.

MOH sandbox providers will bear a Regulatory Sandbox logo for
identification purposes:

Credit: Ministry of Health, Singapore

LEAP is expected to bring about a wide range of potential
benefits for patients and caregivers, as well healthcare providers, and also MOH.

Patients and caregivers utilising services under LEAP will
benefit from early access to new healthcare models with the assurance that
essential safety and risk mitigation measures are in place.  Being able to
develop an appropriate and clear regulatory regime with LEAP will enable the
growth of these services that can bring benefits to more patients and
caregivers, while safeguarding their interest.

Providers participating in the regulatory sandbox will be
able to introduce new healthcare models or evolve their current models in a
safe manner, with early visibility over the eventual regulatory environment.
This would position them to transit more seamlessly into the eventual
regulatory framework and meet patient safety and welfare requirements. 

Furthermore, LEAP will enable MOH to keep in step with the
fast-evolving healthcare landscape.  By working alongside providers
participating in the sandbox, MOH can develop more timely, fit-for-purpose and
effective regulations that support new services that benefit patients while
safeguarding their interests. Services under the sandbox can eventually
transition to licensed services. 

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CTC Global Singapore, a premier end-to-end IT solutions provider, is a fully owned subsidiary of ITOCHU Techno-Solutions Corporation (CTC) and ITOCHU Corporation.

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SIRIM is a premier industrial research and technology organisation in Malaysia, wholly-owned by the Minister​ of Finance Incorporated. With over forty years of experience and expertise, SIRIM is mandated as the machinery for research and technology development, and the national champion of quality. SIRIM has always played a major role in the development of the country’s private sector. By tapping into our expertise and knowledge base, we focus on developing new technologies and improvements in the manufacturing, technology and services sectors. We nurture Small Medium Enterprises (SME) growth with solutions for technology penetration and upgrading, making it an ideal technology partner for SMEs.

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