From Uber to Oculus; Spotify to Siri; Airbnb to Alexa – transformative innovation (disruptive or otherwise) pervades our daily lives. Telehealth 1 is the upcoming transformative innovation that will revolutionise how healthcare is provided.
Telehealth is the use of information technology to provide health-related services at a distance. The information technology, also termed Telehealth Devices, encompasses instruments, apparatus, machines, and communication software, to name a few. Examples of such devices include a remote surgical system that allows a doctor to operate on a patient located elsewhere, a device that controls a pacemaker from a distance, and even a mobile app that provides educational medical information.
As with any transformative innovation, Telehealth presents interesting and evolving legal and regulatory issues. The Singapore government has taken steps to regulate Telehealth. In 2015, the Ministry of Health ("MOH") issued guidelines governing the delivery of Telehealth services. Notably, the guidelines state that:
Recently, the Singapore government took yet another step to regulate Telehealth. The Health Sciences Authority ("HSA") issued draft guidelines on the classification of Telehealth Devices as medical devices. The draft guidelines are particularly important to Telehealth Device manufacturers. This article summarises this recent development and highlights other emerging issues that merit further consideration.
HSA's draft Guidelines on Telehealth Devices
In the draft Guidelines on Telehealth Devices published in September 2016, HSA has proposed a regulatory regime which classifies Telehealth Devices into medical devices and devices for general well-being, depending on their purpose. The following table summarises the key points set out in the draft guidelines regarding these two categories:
Draft guidelines |
Devices for medical purposes |
Devices for general well-being |
Description |
Devices intended for medical purposes:
|
Devices not intended for medical purposes. For example, devices to encourage users to maintain and track a healthy lifestyle. |
HSA requirements |
Registration as a medical device. |
No registration as a medical device. However, device must accompany a clarification statement describing the device is not for medical purposes and information assessed through the device should not be treated as medical advice. |
Examples*
|
|
|
The classification of a Telehealth Device as a “medical device” carries significant implications, because medical devices are heavily regulated by HSA under a stringent regulatory regime. This includes:
As the classification principle appears to rest upon the purpose of the device, it is not entirely clear how HSA will categorise a device with both "medical" and "general well-being" purposes/functions. It may well be classified as a medical device by virtue of its medical purpose notwithstanding its other collateral purposes. HSA is considering feedback from a recent public consultation concluded on November 30th and is expected to finalise the new guidelines in 2017.
Other legal issues to watch for
Looking ahead, regulators should consider the broader legal ramifications involved. The following are but a few examples:
Conclusion
With the ever-increasing demand for accessible health-related services, the Telehealth market is poised to grow in leaps and bounds. The proliferation of Telehealth technology will give rise to a perplexing legal and ethical thicket that stakeholders such as regulators, health providers, Telehealth Device manufacturers and insurance companies will have to navigate. The Singapore government has taken steps to address some of these concerns but there remains broader complex legal issues that deserve further consideration.
In the brave new world of Telehealth, it is imperative that regulators keep pace with innovative technology and respond in a timely fashion, particularly on issues relating to an individual's health.
[1]The terms ‘Telehealth’ and ‘Telemedicine’ are used interchangeably in some quarters. However, there is a difference. 'Telemedicine' refers specifically to remote clinical services, whereas 'Telehealth' refers to the broader scope of health services including non-clinical services, such as health education. For this article, I have used the broader term ‘Telehealth’.
This article is produced by our Singapore office, Bird & Bird ATMD LLP, and does not constitute legal advice. It is intended to provide general information only. Please contact our lawyers if you have any specific queries.