Remote Patient Monitoring

 

Standards and specifications

General requirements

Cyber security

The software must demonstrate adherence to the ‘Essential 8’ cyber security principles.

Core requirements

Standards for identification

The software must:

• support the use of Healthcare Identifiers in accordance with the Healthcare Identifiers Act 2010
• support data capture and storage of unique device identification of medical devices as defined within AS ISO/IEC 15459.4:2023 Information technology — Automatic identification and data capture techniques — Unique identification, Part 4: Individual products and product packages
• support adherence to Patient Identification best practices as outlined by the Australian Commission on Safety and Quality in Health Care
• utilise Individual Healthcare Identifiers (IHIs) to integrate and link records to the local patient record.

Australian Core Data for Interoperability (AUCDI)

The software should support the use of AUCDI Release 1.

Note: The focus of the AUCDI Release 1 is the representation of the clinical content necessary for each of the data groups identified within the Release 1 scope.

Development is continuing to enhance AUCDI.

Standards for data sharing

The software should be capable of using:

• HL7 FHIR-compliant API when sending clinical information
• HL7 FHIR-compliant API when receiving clinical information.

Standards for terminology, code sets and classifications

If relevant, the system should:

• support Systematised Nomenclature of Medicine-Clinical Terms AU (SNOMED CT-AU)
• support the use of Australian Medicines Terminology (AMT) for the storage of patients’ current medicines.
• support Data Set Specifications including but not limited to National Minimum Data Sets (NMDS), as defined within Australian Institute of Health and Welfare Metadata Online Registry (METEOR)
• be capable of using METEOR for recording clinical information with data specifications
• be capable of using Nutrition Care Process Terminology (NCPT)
• support the inclusion of medicines listed on the Australian Register of Therapeutic Goods (ARTG)
• support Standardised Pathology Informatics in Australia (SPIA)
• support demographic AU core data set
• support person identification in healthcare National Best Practice Data Set
• support the National Clinical Terminology Service (NCTS).

National Safety and Quality Health Service (NSQHS) Standards

Implementation of NSQHS is mandated in all hospitals, day procedure services and public dental services across Australia.

The system must support adherence to:

• best practices related to Informed Consent
• all relevant National Safety and Quality Health Service Standards in accordance with the intended scope of the system being procured. These may include, but not limited to the following standards:
  • Partnering with Consumers Standard
  • Communicating for Safety Standard
  • Comprehensive Care Standard
  • Blood Management Standard
  • Medication Safety Standard
  • Clinical Governance Standard.
• all relevant Clinical Care Standards.

Other Standards

International

The system should:

• refer to the IHE Patient Care Coordination Technical Framework, which describes the already existing set of standards and interfaces defined by the Personal Connected Health Alliance (PCHA) for the delivery of remote patient data to the care provider as a reference.

National

The system should:

• refer to the Australian Health Practitioner Regulation Agency and the National Boards’ Information for practitioners who provide virtual care as a guide.

The system must comply with:

• AS2828.2: Digitised health records where digitisation of paper records is required
• AS ISO 18308:2022 Health informatics — Requirements for an electronic health record architecture 
• ATS ISO 14265-2013 Health informatics – Classification of purposes for processing personal health information
• AS ISO 27269:2022 Health informatics – International patient summary.

Connections to National Systems 

As relevant, requirements for connections to:

Specific pharmacy related systems

If the system includes electronic prescribing functionality, the software must connect to the:

• National Real Time Prescription Monitoring (RTPM) system
• National Prescription Delivery Service (PDS).

Conformance

Electronic Prescribing

The software should:

• have the ability to send and receive ADHA conformant Electronic Prescriptions.

State and territory requirements

The following state and territory requirements must be upheld based on location.