Health Sciences Authority of Singapore Proposes Telehealth Devices Guidelines

08 February 2017

Alban Kang, Gene Kwek, Yuet Ping Tai

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:

  • Healthcare providers when delivering Telehealth services must provide a standard of care not any less than that delivered by conventional means.
  • Healthcare providers providing Telehealth services to a patient in another country should meet the licensing requirements set by the country where the patient is located.
  • Patients must have the freedom to make informed decisions about receiving Telehealth services. Healthcare providers should share relevant information unique to Telehealth before obtaining informed consent.
  • Healthcare organisations must have confidentiality policy to ensure patient's privacy and confidentiality.
  • Healthcare organisations should have policies and procedures to ensure all staff involved in delivering the Telehealth services is competent to do so safely. 

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:

  • the diagnosis of disease or medical conditions;
  • the cure, mitigation, treatment;
  • prevention of disease;
  • affecting the structure or any function of the human body.

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*

 

 

 

  • Remote surgical system
  • Device that controls pacemaker from a distance
  • Software that predicts hypoglycaemia episodes based on past glucose measurements
  • Mobile app that displays ECG or other vital signs in remote location
  • Wearable pedometer
  • Heart-rate monitor in a smart phone
  • Mobile app that provides educational medical information
  • Mobile app that calculates BMI based on input but do not perform diagnosis
  • Device that is solely for communication purposes to perform remote consultations
 
 
 
 
 
 
 
 

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:

  • Device registration process, which depending on the class of device and evaluation route may require extensive documentations such as risk analysis, design verification and validation, etc.
  • Where applicable, manufacturing, import or wholesale licences need to be obtained.
  • Compliance obligations such as specific manufacturing safety requirements, advertising and post-marketing obligations.

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:

  • Where a doctor treats a patient across borders via a remote surgical system, which country's medical liability laws should apply? Is it the jurisdiction where the patient is situated or where the health provider is based?
  • In light of the large volume of sensitive personal data that will be processed via Telehealth devices, should the Personal Data Protection Act be amended to accord Telehealth users greater protection?
  • Where a doctor provides the wrong diagnosis based on an X-ray image that was distorted by the Telehealth Device due to a software bug, should the doctor or the Telehealth Device manufacturer be liable? What happens in the event the treatment is interrupted due to internet connectivity issues? How should malpractice and product liability insurances be tailored for Telehealth?

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’.

Authors

Kang-Alban

Alban Kang

Partner

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Gene Kwek

Managing Counsel

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Tai Yuet Ping

Yuet Ping Tai

Associate

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