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Digital Health

UNDERSTANDING DIGITAL HEALTH PRODUCTS AND THE REGULATIONS

What is Digital Health

Digital health includes diverse categories of products comprising telehealth and telemedicine, mobile health, wearable devices, health information technologies and personalised medicine.

It refers to the usage of connected devices, wearables, software including mobile applications (apps) and artificial intelligence (AI) to address various health needs via information and communications technologies.

Digital health has opened up the medical device space to an array of providers such as software or mobile app developers and IT solution providers.

Supporting Digital Health Product Innovation

1. Regulatory Guidelines for Telehealth Products

This guideline was developed in 2017 to help manufacturers, developers or importers of a digital health device or tool i) to determine if their device, software or app are regulated medical devices under HSA and ii) understand the relevant regulatory requirements.

2. Immediate Registration Pathway for Standalone Software and Mobile Applications

This pathway was implemented in 2018 by leveraging the regulatory review and approval from our reference regulatory agencies in Australia, Canada, the European Union, Japan and the United States. This pathway allows immediate market access upon successful submission of a product registration application, while we perform a backend review to verify the qualification criteria are met and that these devices are safe and effective for use on our patients. More information on the various product registration pathways can be accessed in our Guidance on medical device product registration.

3. Device Development Consultation Scheme

Under this scheme, we provide consultation to researchers, developers and manufacturers of digital health devices, software, apps and AI solutions. To date, digital health products constitute over 40% of these consultations.

4. Regulatory Guidelines for Software Medical Devices

This guideline was published in April 2020 to mitigate digital threats such as cybersecurity, data integrity, and data security. This serves as a one stop reference on the regulatory requirements for management of software in medical devices throughout its entire life cycle.

Identifying Digital Health Products that are Medical Devices

As a general rule, a digital health device intended for medical purposes such as investigation, detection, diagnosis, monitoring, treatment or management of any medical condition, disease, anatomy or physiological process; will be classified as a medical device subject to HSA’s regulatory controls.

Examples of medical devices which incorporate digital health technology are as follows:

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Overview of Regulatory Controls

If your digital health device is a regulated medical device, below is the summary of the relevant regulatory controls which you need to meet. You can refer to regulatory overview of medical devices to find out more.

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HSA will continue to ensure that our regulatory framework remains relevant and fit for purpose to support the ever evolving and dynamic digital health landscape. HSA will conduct our post-market surveillance and monitoring efforts (e.g. real-world performance) to ensure timely identification and effective management of new and evolving risks (e.g. cybersecurity threats) arising from these digital health products.

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