Singapore in process of establishing Telehealth guidelines

 in Singapore  tagged Medical Device / Regulations / Singapore / Telehealth by

Telehealth is the use of information technology to provide health-related services at a distance. 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 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.

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.