The Singapore Government has consistently placed strong emphasis on the Healthcare and Information and Communications Technology (“ICT”) sectors, and has invested significant resources in developing Singapore’s capabilities to meet the evolving demands in these sectors.
With Singapore’s aging population, the need to adapt its healthcare services towards this growing segment of society has become a matter of priority. Coupled with the relative shortage of healthcare professionals and caregivers, it is no surprise that Telemedicine is a key feature in the Infocomm Media 2025 Masterplan’s Smart Health-Assist pilot programme, which aims to boost the quality of healthcare through innovation and by leveraging on the country’s robust ICT infrastructure.
Telemedicine has actually been practiced across various medical disciplines in Singapore for close to a decade. For example, in home teleconsultations conducted by doctors specialising in geriatric medicine, remote examination of stroke patients, as well as in the fields of radiology and ophthalmology.
The age of digital disruption has brought about waves of transformative innovations in virtually every aspect of our daily lives. What happens when these innovative technologies overlap with the highly regulated medical and healthcare sector? It is hence timely that steps are being taken to evaluate and address the legal and regulatory implications that may arise with the proliferation of Telemedicine in Singapore.
B. National Telemedicine Guidelines
The National Telemedicine Guidelines (“NTG”) were therefore first issued by the Ministry of Health in 2015, and the scope of Telemedicine was then broadly categorised as:
- Tele-collaboration, which refers to the interaction between both onsite and remote Healthcare Professionals (“HCP”) for clinical purposes;
- Tele-treatment, which refers to the interaction between a patient (or caregiver) and HCP for the purposes of direct clinical care, where such interaction creates or presupposes the existence of a professional-patient relationship;
- Tele-monitoring, which refers to biomedical or other forms of data collection obtained remotely from patients, and which are used for clinical purposes (such as vital signs monitoring or home nursing). These interactions do not create professional-patient relationships, even though the healthcare organisation as a whole may owe a duty of care to the patient; and
- Tele-support, which refers to the use of online services for non-clinical purposes (such as health education and care administration) to support patients and their caregivers.
The NTG sets out the broad framework and provides guidance on best practices to ensure patient and provider safety in the delivery of Telemedicine services. Some of these guidelines include:
(i) The overall standard of care provided by any Telemedicine service must not be any less compared to that of non-Telemedicine methods of delivery, and HCP should follow existing Clinical Practice Guidelines, where appropriate.
(ii) Patients must be given the freedom to make informed decisions about receiving Telemedicine services, and HCP should provide patients with the relevant information relating to the Telehealth service before obtaining informed consent.
(iii) Licensable HCP delivering Telemedicine services from or within Singapore must be registered and licensed with the respective regulatory and licensing body.
(iv) HCP providing Telemedicine services to patients outside Singapore should adhere to the respective licensing requirements imposed by the country where the patient is residing.
(v) Healthcare organisations must ensure that patient information and records are well protected by having a confidentiality policy in place.
The first edition of the NTG was intended to establish the initial direction for Telemedicine services, and healthcare organisations are encouraged to tailor these guidelines to meet their own specific requirements. To ensure relevancy, the NTG would also be reviewed and revised regularly.
C. Proposed Guidelines on Telehealth Devices
Following the issuance of the NTG and in keeping pace with advances in technology, the Health Sciences Authority ("HSA") has further introduced a set of proposed guidelines relating to Telehealth Devices in September 2016. These draft guidelines were intended to provide further clarity on the classification of Telehealth devices as medical devices, as well as the regulatory approach and requirements for these types of medical devices. These proposed guidelines are expected to be finalised in 2017.
As a general rule, a Telehealth device intended for medical purposes will be classified as a medical device, and thus subject to HSA’s regulatory control. Such “medical purposes” include the diagnosis of disease or medical conditions, the cure, mitigation, treatment or prevention of diseases, or if intended to affect the structure or any function of the human body.
The proposed regulatory controls to be imposed by HSA include product registration, dealer’s license requirements and post-market obligations to ensure accountability and continued safe use of the device. The level of scrutiny and regulatory requirements imposed by HSA will also be commensurate with its risk classification, which is in turn dependent the nature of the particular medical device and its intended functions.
Telehealth devices intended for general well-being or lifestyle purposes will however not be regulated as medical devices. These devices have become very popular of late. Examples include heart-rate monitors in smartphones and other wearables, mobile applications that provide educational medical information (i.e. Tele-support) or calculate Body Mass Index but do not perform any medical diagnostic or therapeutic functions. However, manufacturers will be required to label such Telehealth devices with a clarification statement, cautioning users not to misconstrue any health-related information accessed through these devices as medical advice. Companies such as Fitbit, and products and services such as Apple Health, would therefore need to take note of these guidelines and respond accordingly.
The purpose of HSA’s proposed guidelines is to enable and enhance access to new and innovative Telehealth devices, and also to facilitate the provision of Telemedicine services, but all the while still safeguarding public health and interest. Whilst Telemedicine may not yet be universally adopted, it is increasingly recognised as an efficient and cost-effective alternative as it bridges the constraints of distance and maximises our limited healthcare resources. We can therefore anticipate further developments in Singapore’s healthcare regulatory landscape in future, as technological advances bring about new possibilities and as we move towards the vision of becoming a Smart Nation.