2. Definitions
Feedback & supportIn this Order —“AI standalone mobile application” means a medical device that is an artificial intelligence software, and a standalone mobile application as defined in regulation 26(5) of the Regulations;“cluster HQ” means any of the following:
National Healthcare Group Pte Ltd;
National University Health System Pte. Ltd.;
Singapore Health Services Pte Ltd;“HCSA” means the Healthcare Services Act 2020;“healthcare service” has the meaning given by section 3 of HCSA;“HPB” means the Health Promotion Board established under section 3 of the Health Promotion Board Act 2001;“medical device” means a health product that is a medical device as defined in item 1 of the First Schedule to the Act;“public healthcare entity” means any of the following:
a public healthcare institution;
a cluster HQ;
Synapxe Pte. Ltd.;
MOH Office for Healthcare Transformation Pte. Ltd.;“public healthcare institution” means any of the following that holds a licence under HCSA:
a subsidiary of a cluster HQ;
a business registered by a cluster HQ under the Business Names Registration Act 2014;
an entity managed and controlled by a cluster HQ;“Regulations” means the Health Products (Medical Devices) Regulations 2010 (G.N. No. S 436/2010).
“AI standalone mobile application” means a medical device that is an artificial intelligence software, and a standalone mobile application as defined in regulation 26(5) of the Regulations;
“cluster HQ” means any of the following:
National Healthcare Group Pte Ltd;
National University Health System Pte. Ltd.;
Singapore Health Services Pte Ltd;
“HCSA” means the Healthcare Services Act 2020;
“healthcare service” has the meaning given by section 3 of HCSA;
“HPB” means the Health Promotion Board established under section 3 of the Health Promotion Board Act 2001;
“medical device” means a health product that is a medical device as defined in item 1 of the First Schedule to the Act;
“public healthcare entity” means any of the following:
a public healthcare institution;
a cluster HQ;
Synapxe Pte. Ltd.;
MOH Office for Healthcare Transformation Pte. Ltd.;
“public healthcare institution” means any of the following that holds a licence under HCSA:
a subsidiary of a cluster HQ;
a business registered by a cluster HQ under the Business Names Registration Act 2014;
an entity managed and controlled by a cluster HQ;
“Regulations” means the Health Products (Medical Devices) Regulations 2010 (G.N. No. S 436/2010).