Med.data.edu.au Online Interactive Use Guide
Download as PPTX, PDF1 like312 views
This document discusses navigating privacy and security considerations for medical researchers dealing with health data. It summarizes that the national medical data facility stores petabyte-scale research data across four nodes from various health organizations. It manages data using several platforms and protects human-derived data at a higher level. Researchers must consider relevant privacy legislation, ethics approval, informed consent requirements, and identifiability of data. Controls are needed to protect health information in research, including following national standards and guidelines regarding legislative frameworks, best practices, IT security, and roles and responsibilities of data custodians and users. An online use guide and wizard is proposed to simply navigate researchers through these complex issues.
Med.data.edu.au Online Interactive Use Guide
- 1. Navigating data-driven medical researchers through the IT privacy/security landscape Jeff Christiansen, Jared Winton and Kathy Dallest
- 2. med.data.edu.au NCRIS-funded project A national facility for petabyte scale research data storage and high-speed networked computational services to Australian Health and Medical Research organisations
- 3. med.data.edu.au 4 RDS nodes: Intersect, VicNode, eRSA, QCIF Health/medical research data: 4 states 7 Universities 12 Medical Research Institutes 2.2PB (91 data collections) Human genomic data ~85% Human 3D imaging ~10% Other health datasets <5%
- 6. med.data.edu.au FIND DATA Dataset descriptions listed Tools and processes to publish dataset descriptions Leverages institutional and national infrastructure (ANDS)
- 8. med.data.edu.au USE DATA Generally, users requiring large data storage and associated HPC or cloud (Nectar) compute, or Collaborative research across Institutions BYO software
- 10. med.data.edu.au STORE DATA Data is managed using various platforms (Mediaflux, Aspera, MyTardis) Human-derived data is subject to a higher level of protection than other data
- 11. Health and Medical information
- 12. Health and Medical information Collected for healthcare provision Held by health service providers Derived from or relating to human individuals It is personal* info: i.e. about an identified or reasonably identifiable individual It is sensitive* info: i.e. about an individual’s Health; or Genetic or Biometric info. * As defined by The Privacy Act 1988 (Cth)
- 13. Health and Medical information Collected for healthcare provision Held by health service providers Derived from or relating to human individuals It is personal* info: i.e. about an identified or reasonably identifiable individual It is sensitive* info: i.e. about an individual’s Health; or Genetic or Biometric info. Must be protected (Privacy Act (Cth) and various state health privacy legislation)
- 14. Health and Medical information in research
- 15. Health and Medical information in research Collected for healthcare provision OR specifically collected for use in research studies Held by researchers Derived from or relating to human individuals (i.e. is personal and sensitive)
- 16. Health and Medical information in research Collected for healthcare provision OR specifically collected for use in research studies Held by researchers Derived from or relating to human individuals (i.e. is personal and sensitive) Must be protected from misuse, interference and loss, and from unauthorised access, modification or disclosure.
- 17. Health and Medical information in research POINTS FOR CONSIDERATION
- 19. Privacy Protection Legislation Protecting an individual’s privacy (and health privacy) is enshrined in Commonwealth and State Legislation: Commonwealth • Privacy Act (1988) NSW • Privacy and Personal information Protection Act 1998 • Health Records and Information Privacy Act 2002 (HRIPA) VIC • Information Privacy Act 2000 (Vic) • Privacy and Data Protection Act 2014 • Health Records Act 2001 (Vic) • Charter of Human Rights and Responsibilities Act 2006 (Vic) QLD • Information Privacy Act 2009 (Qld) • Health Services Act 1991 (Qld) • Information Standards 42 (general) & 42A (health) • Public Health Act 2005 Chapter 6, Part 4, Division 2, s281 SA • Department of the Premier and Cabinet IPPs WA • Information Privacy Bill 2007 TAS • No health specific privacy legislation. • Personal Information and Protection Act 2004 ACT • Information Privacy Act 2014 (ACT) (ACT Public Sector Agencies) • Health Records (Privacy and Access) Act 1997 NT • No health specific privacy legislation.
- 20. Ethics
- 21. Ethics When health data is collected for research purposes, Human Research Ethics Committee (HREC) approval is required first. HREC approval is also required for its use (usually only approved for use in a specific research study). Must not be shared in an identifiable form with those outside the HREC- approved research project(s).
- 22. Consent
- 23. Consent The guiding principle for researchers is that a person’s decision to participate in research is to be voluntary, and based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it. “Informed consent” As defined in the National Statement on Ethical Conduct in Human Research (NHMRC, ARC, Universities Australia)
- 24. Consent When consent has not been given to use personal health data in research, the use of health data use may still be permitted for research purposes: Cth Privacy Act Section 95 – allows Commonwealth managed health data to be used for research in an identifiable form if the proposed research has been approved by a HREC. Cth Privacy Act Section 95A – allows private sector data to be used for research where gaining consent is not practical, and the research has been approved by a HREC. Note – neither are applicable for data from State Health Departments - however some states e.g. NSW have comparable legislation (e.g. NSW – HRIPA)
- 26. Identifiability of data Individually identifiable data – where the identity of a specific individual can reasonably be ascertained (e.g. a name, image, date of birth or address). Re-identifiable data - where identifiers have been removed and replaced by a code, but it remains possible to re-identify a specific individual by, for example, using the code or linking different data sets. Non-identifiable data - has never been labelled with individual identifiers or from which identifiers have been permanently removed, and by means of which no specific individual can be identified. As defined in the National Statement on Ethical Conduct in Human Research (NHMRC, ARC, Universities Australia)
- 27. Identifiability of data Individually identifiable data – where the identity of a specific individual can reasonably be ascertained (e.g. a name, image, date of birth or address). Re-identifiable data - where identifiers have been removed and replaced by a code, but it remains possible to re-identify a specific individual by, for example, using the code or linking different data sets. Non-identifiable data - has never been labelled with individual identifiers or from which identifiers have been permanently removed, and by means of which no specific individual can be identified. As defined in the National Statement on Ethical Conduct in Human Research (NHMRC, ARC, Universities Australia)
- 28. Identifiability of data Individually identifiable data – where the identity of a specific individual can reasonably be ascertained (e.g. a name, image, date of birth or address). Re-identifiable data - where identifiers have been removed and replaced by a code, but it remains possible to re-identify a specific individual by, for example, using the code or linking different data sets. Non-identifiable data - has never been labelled with individual identifiers or from which identifiers have been permanently removed, and by means of which no specific individual can be identified. As defined in the National Statement on Ethical Conduct in Human Research (NHMRC, ARC, Universities Australia)
- 29. Identifiability of data Making data non-identifiable, decreases risks associated with inadvertent release Removal of overt identifying information or identifiers - e.g. name, image, date of birth, address, medicare/patient numbers. Statistical methods - applied by an expert and the methods must be documented As defined in the Guidelines for the disclosure of Secondary Use Health Information for Statistical Reporting, Research and Analysis 2015 (National Health Information Standards and Statistics Committee)
- 30. Legislation affecting trans-border dataflow
- 31. Legislation affecting trans-border dataflow Commonwealth – Privacy Act (1988) Australian Privacy Principle (APP)-8 cross-jurisdictional transfer of personal information out of Australia. NSW – NSW Health Records and Information Privacy Act 2002 Health Privacy Principle (HPP)-14 Trans-border data flows and data flow to Commonwealth agencies. VIC – Health Records Act 2001 (Vic) Health Privacy Principle (HPP)-9 Transborder Data Flows WA – Information Privacy Bill 2007 (WA) Information Privacy Principle 8: Transborder data flows TAS – Personal Information Protection Act 2004 NT – Information Act: Information Privacy Principle (IPP)-9 Transborder data flows
- 32. So… what controls are needed to protect HM data in research?
- 33. So… what controls are needed to protect HM data in research? National eHealth Transition Authority (now Australian Digital Health Agency) Health Informatics Society of Australia Australian Standards Australian Signals Directorate
- 34. There IS no definitive checklist - it’s about risk management So… what controls are needed to protect HM data in research?
- 35. Discussion paper Legislative framework (Commonwealth, State and International) Best Practice (Ethics, Research etc) IT Security requirements for Health (Human-derived) data Roles and Responsibilities (Data Custodians, Users, Nodes)
- 36. 41 pages and heavy going Need something simpler Discussion paper
- 37. Use Guide On-line wizard Navigates the user through relevant info
- 38. Use Guide On-line wizard Navigates the user through relevant info
- 40. Info when requested Authoritative references Use Guide
- 41. Option to be contacted for Node Specific Information End Use Guide
- 42. Node Specific Security Info How do each Node’s Storage, HPC and Cloud compute stack up against… • National Standards for Protected or Sensitive Info (ASD ISM)? • Common other standards (e.g. NIH Best Practices for storage of Human Genomic Sequence)? Required for an informed conversation about risk with each Data Custodian • Node set-up, Roles and Responsibilities of Data Custodians, Data Users and Node Operators).