Participant Information

Low Risk Review Panel Number:   2023_041_LR

Introduction 

CSIRO has been funded by the Department of Health and Aged Care to deliver national FHIR standards over the next two years to improve the accessibility of real-time health information, a vital component for a connected healthcare system.   

CSIRO’s Australian eHealth Research Centre, in collaboration with the Department of Health and Aged Care, the Australian Digital Health Agency, and HL7 Australia, will lead the development, management, and support of these standards.      

The program will launch Sparked to support the development and adoption of standards for sharing healthcare data.  Sparked specifications will move Australia towards a digital healthcare system, improve the interaction between private and public health services across all states and territories, and support a modern Australian Health system.   

What is the aim of this program?

The program will be conducted in collaboration with the stakeholder community using the Australian FHIR Community Process (AFCP).  The program will develop:    

  • Australian Core Data Set for Interoperability (AUCDI) 
  • HL7 AU eRequesting Data Set for Interoperability (eRDI) 
  • HL7 AU Core FHIR Implementation Guide   
  • HL7 AU eRequesting FHIR Implementation Guide   
  • Pathology and Radiology Referral Set ( SNOMEDCT ValueSets) 

How will the program be carried out?

This program will be run through an open, transparent, co-design, co-development approach with participants forming design groups. 

The Sparked Clinical Data Design Group, AU Core Technical Design Group and the AU eRequesting Technical Design Group (the Design Groups) bring together key stakeholders with expertise and experience in clinical practice, software development, FHIR implementation and those who have health industry and practice knowledge to work in partnership. 

The Design Groups will: 

  •  Validate and define the data elements of the common data set against the agreed use cases
  •  Validate the value sets which will form the value sets required for the data dictionary and FHIR Implementation Guides,
  • Consider recommendations for implementation, including but not limited to,
    • Search capability
    • The use of terminology maps and the impacts on data quality
  • Identify, design and validate FHIR structures, and RESTful operations to support the information exchange needs of digital health and administrative information associated with a patient
  • Monitor international FHIR standards and terminology standards and attempt harmonisation of information content and representation of such standards with the Australian content 

The Design Groups are open for any interested FHIR developer or implementer, software vendor, clinician, or domain expert to participate in the design, development and validation of the national Data Sets and FHIR Standards. 

The program will be delivered as a series of face-to-face and online discussion groups, meetings, conferences, networking events and workshops.   

What are the benefits of participating in the program?

Members may not benefit directly from participation in this program but will be providing a valuable contribution to the advancement of standards-based interoperability within the healthcare sector. 

Are there any risks involved?

CSIRO do not anticipate any risk related to your participation in the program. 

All human research undertaken by the CSIRO must comply with the values, principles, governance and review process specified in the NH&MRC National Statement on Ethical Conduct in Human Research (2007). A copy of the National Statement can be found at www.nhmrc.gov.au/guidelines/ethics/human_research/index.htm 

How will my privacy be protected?

CSIRO is governed under the Privacy Act 1988 (Cth).  CSIRO is collecting your personal information for the purposes of conducting the program and related scientific research.  CSIRO will only use and disclose your personal information in accordance with the Privacy Act 1988 and the NH&MRC National Statement on Ethical Conduct in Human Research (2007) as amended from time to time, and as otherwise required by law. 

In relation to studies conducted by CSIRO, it is customary for all personal information to be identified by a code and stored at CSIRO under lock and key for a period of at least 15 years. Except where otherwise required by law or a government body, at the end of this period your records will be destroyed or permanently de-identified.  

Where third parties are assisting CSIRO in relation to the conduct of this study (such as university staff, students and other health professionals), we may disclose your personal information to those third parties for this purpose on a confidential basis. Your personal information may be disclosed to partners and collaborators including:

  • the Department of Health and Aged Care;
  • the Australian Digital Health Agency, HL7 Australia; and
  • specialist medical colleges listed by the Australian Medical Council;

CSIRO will require such third parties to keep this information confidential and to only use your personal information for the purposes of the study and otherwise in accordance with the Privacy Act 1988.

We will not use or disclose your information for direct marketing purposes. 

The personal information you provide while participating in the program, including your name, email address, affiliations and any opinions, input, or content you provide, is collected for the purpose of conducting this program and related research.  

The personal information you provide while participating in the program may be posted on the publicly accessible program confluence page. This is key to an open and transparent process to co-design and co-develop the resulting standards.  The publicly accessible confluence site allows read-only access to anyone in the world, while write-access requires user registration. Any comments or attachments posted on the confluence page will include attribution to the user as part of the process.  

We note that your contributions in the program or via Confluence may include sensitive information, such as political and philosophical beliefs. You are not required to provide any such information in your response. However, if you do provide such information, it will be taken as your consent to provide that information to us.

CSIRO has obligations under APP 8 when disclosing data overseas. Where an individual consents to an overseas disclosure CSIRO no longer has those obligations. By participating in the project and signing the consent form below, you are consenting to your personal information being published on the CSIRO Confluence site, which is accessible by anyone in the world and may be stored on Confluence servers which may be located overseas. Further, you acknowledge and consent to your personal information being collected and held on Microsoft or servers, which may be located overseas, and acknowledge that CSIRO is not required to comply with APP 8 in relation to that information.

If you choose to participate in Mentimeter polling during the program, you also consent to information you provide via Mentimeter being held on Mentimeter’s servers in locations including Ireland and the United States. Mentimeter’s data handling procedures are explained in the Mentimeter security policy.  By participating in this project and signing this consent form, you will consent to the potential disclosure of your personal information to overseas recipients through Mentimeter, Confluence and/or Microsoft.  Where personal information is disclosed to an overseas recipient with your consent as provided in this consent form, APP 8 will not apply in relation to the handling of that personal information.  If the overseas recipient handles your personal information in breach of the APPs, the entity will not be accountable under the Privacy Act and you will not be able to seek redress under the Privacy Act.

The reports and standards developed during the course of the project will not contain information directly attributable to participants but will rather reflect the decisions that results from the collaborative process of the working groups.

 The CSIRO Privacy Policy available at https://www.csiro.au/en/About/Access-to-information/Privacy outlines:

  • How your personal information will be handled;
  • How you can seek access to or correction of the personal information we hold about you; and
  • How you can complain about a breach of the APPs and how CSIRO will deal with the complaint.

If you require further information on how your personal information will be handled, please contact privacy@csiro.au. 

What if I wish to withdraw?

Members are free to withdraw at any time during the program. To withdraw from the program and/or any of the design groups, please email fhir@csiro.au

Please note any data collected prior to your withdrawal from the program will be maintained. Data up until withdrawal are an important part of the data. Personal information will be kept with those of continuing participants. 

Your obligations as a participant

Design group member responsibilities include:

  • Respectful participation in meetings
  • Identify any issues relevant to their areas of expertise
  • Take action on allocated tasks within agreed timeframes
  • Review content and provide input outside of meetings
  • Share and discuss content with their colleagues
  • Send apologies when needed to secretariat via email or phone prior to the session
  • Not to provide any identifying information about someone else without their authorisation during meetings, workshops or other events or via Confluence

If you have further questions

Please contact the Sparked Team via email: fhir@csiro.au

This study has been approved by the CSIRO Low Risk Review Panel. If you would like to speak with someone with respect to ethical matters or wish to register a formal complaint about the conduct of this research, please contact the Secretary of the Committee via email at chmhrec@csiro.au.