Standards development
Digital health standards are formal documents, developed by accredited standards development organisations, which have attained the consensus of experts. A standard may specify the use of required processes, criteria or methodology to improve consumer confidence that a digital health solution is safe and reliable.
Digital health specifications describe an explicit set of requirements or design criteria that must be satisfied. Specifications do not require the endorsement of an accredited standards development organisation but may be adopted into a standard by a standards development organisation. Specifications can also support conformance testing.
Multiple Australian and international standards development organisations exist to develop, maintain and publish standards needed by industry. Development of standards is a complex, open and transparent process requiring the input and consensus of multiple expert stakeholder groups.
Typically, the use of standards in Australia is voluntary. Standards may be specified in legislation or recommended for conformance. The Agency provides recommendations and guidance for industry seeking to connect to national infrastructure through the publication of developer guides, specifications, and conformance profiles.
Types of standards
Interoperability standards can be categorised by type:
- Transport & Messaging - message formatting for data exchange between systems
- Terminology & Vocabulary - structured classification systems for unanimous understanding of health concepts
- Security - protection of control over personal or organisational information
- Privacy - protection of data integrity and confidentiality
- Identifiers - unique identification of an individual provider, patient, organisation or device
- Content - organisation and structure of message content (data)
Industry networks
The Australian Digital Health Agency provides support for industry and governments to reach consensus on the selection and development of technical standards and to ensure standards are suitable for Australian industry requirements. We work with standards development organisations, state and territory governments, health care providers and consumers, academia, industry associations and software vendors to support stakeholder engagement and identify future needs for the benefit of all Australians who rely on safe, quality and equitable healthcare outcomes.
We are growing a community-of-practice for professionals with an interest in technical standards. The Agency is responding to several barriers to standards adoption identified by industry. The availability of multiple international, national and regional standards can present complex challenges in identifying appropriate resources for Australian use. Collective industry participation in standards selection, development and maintenance will strengthen expertise and help identify emerging sector needs.
Industry training and support
The Agency endorses the use of HL7 Fast Healthcare Interoperability Resources (HL7 FHIR). FHIR is an open, global standard available for rapid deployment of interoperable solutions. We provide training on FHIR implementation through our partnership with HL7 Australia.
Agency-funded places were offered in 2023. Further Agency-funded places will be offered in 2024 to continue to support the needs of software developers, solution architects, project managers, executives and government officials considering the use of HL7 FHIR.
- FHIR Fundamentals for Australian Developers
- Introduction to FHIR for Project Managers
- Opportunities for Australia with SMART on FHIR Apps
- What does it take to make the switch from HL7 V2 to FHIR?
- Should my organisation implement FHIR?
For further information and to register your interest visit https://hl7.com.au/training
Digital Health Standards Catalogue
The Australian Digital Health Agency is developing a Digital Health Standards Catalogue. The catalogue will contain a library of published standards and specifications accessible via a single front-door.
The Digital Health Standards Catalogue will be a dynamic resource that is continually improved through co-design. The resource library will provide streamlined and up-to-date information on standards, specifications and supporting materials. Discussion forums will be launched alongside the catalogue to allow industry professionals to share experiences and insights on the use of standards, growing connections and collaboration across the sector.
Guiding principles
Purpose
The guiding principles are evidence-based statements developed in consultation with our partners in standards and interoperability.
The principles aim to:
- Support the digital health community in fostering positive participation in standards development,
- Guide the Australian healthcare technology sector in its adoption and implementation of digital health standards,
- Set the foundation for working relationships between the Agency and standards development organisations in relation to standards development, prioritisation, selection, and maintenance.
Background
Drawing on international evidence, the principles were developed with a community spirit at the heart of the project. The Agency consulted broadly throughout 2022 and distilled the key messages into the seven principles.
Guiding principles align and integrate with associated principles of standards development, monitoring and conformance which are already being used or being developed. The principles are a guide for the operation of the process and not for the selection of digital health standards themselves.
Digital health standards should be published and developed transparently. They should be readily available, be reviewed regularly and have an acceptable level of use.
A health system that provides accessible, reliable, useful and up-to-date information to all interested stakeholders so they can acquire meaningful understanding of the quality, patient experience, finance, governance, and individual health data associated with the health system, and make judgement on its fairness.
Digital health standards support evolving models of care across multiple settings and will be adopted and implemented by a broad range of providers, promoting a re-use first approach. Standards need to support interoperability and information access in a secure setting.
Rather than create new standards, we need to work together (as a community) to reach agreement on a common set of standards.
Digital health standards will enable software developers in the health technology sector to compete on a level playing field. Conformant processes and technology for interoperability in Australia be adopted.
It is essential that future investments consider methods for capturing, sharing, and managing clinical information. Procurement documentation and strategies should include consistent interoperability requirements that support an efficient and innovative health technology sector and provide the solutions required to deliver an interoperable digital health system.
Digital health standards are selected and developed based on systematic reviews of both local and international standards. Where possible recognised international standards both in health and other sectors should be used building on core national healthcare digital infrastructure and supporting Australian health priorities.
Digital health standards guide the assessment, sourcing, development, adoption and conformance across the Australian health care system.
Update, improve, and refine our standards, implementation guides, and testing strategies to attain interoperability across systems for all Australians Healthcare data to be shared.
Digital health standards support safe, seamless and secure patient centred care prioritising privacy requirements and enhanced user experience for consumers, carers and service providers.
Safe secure and seamless centred care is paramount in achieving positive patient outcomes.
Digital health standards require a supportive ecosystem comprised of 5 elements:
- Complementary clinical standards
- Guidelines for digital health care
- National privacy regulatory framework
- Well trained and available digital health workforce
- Vibrant software research and development sector