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OFFICE OF THE PRIVACY COMMISSIONER

1. The Office of the Privacy Commissioner (the Office) is an independent statutory body whose purpose is to promote and protect privacy in Australia. The Office, established under the Privacy Act 1988 (Cth) (the Privacy Act), has responsibilities for the protection of individuals' personal information that is handled by Australian and ACT Government agencies, and personal information held by all large private sector organisations, all private sector health service providers and some small businesses.

2. The Office appreciates the opportunity to comment on Discussion Paper Five, Developing an Information and Communications Technology (ICT) Strategic Plan for Clinical Trials (Discussion Paper). [1] Our comments below assume that at least some of the entities involved in the clinical trials are private sector organisations that are bound by the National Privacy Principles (NPPs). [2]

Sensitivity of health information

3. Individuals view their health information as particularly sensitive, and expect that it will be handled carefully. The Office's own community attitude research [3] , found that many individuals feel that their personal health information is particularly sensitive and should be handled with an increased level of care. Sensitivity around secondary uses of health information is also illustrated by qualitative research conducted by AC Nielsen which indicates a strong preference for health information to be only used for the direct clinical care of the individual, with any other uses being premised on obtaining the individual’s informed consent. [4]

Remote monitoring of clinical trials

4. The Discussion Paper notes that recent efforts by industry to access patient records remotely have met difficulties because of the design of some databases. In particular, our Office understands that some databases do not enable clinicians to isolate the records of patients who have consented to participate in a clinical trial from those of other patients. Further, the Discussion Paper suggests that ‘ This issue could be potentially resolved with advice from the relevant privacy authorities, outlining the safeguards required that would enable trial monitors to comply with the privacy regulations .’ [5]

5. In the Office’s view, health providers taking part in clinical trials may risk breaching current privacy obligations, particularly obligations relating to the use and disclosure of personal information, if they were to provide access to the records of patients who have not given their consent to participate in the trial.

6. The privacy obligations that regulate the purposes for which personal information can be used and disclosed are set out in NPP 2. This principle regulates the purposes for which personal information can be used and disclosed and imposes higher levels of privacy protection for the handling of ‘health information’. [6] In addition, specific limitations apply to the use and disclosure of personal information for research purposes.

7. In terms of the issues considered in the Discussion Paper, the relevant sections of NPP 2 are summarised below:

• NPP 2.1 provides that a health service provider must not use or disclose health information about an individual for a purpose other than the primary purpose unless the individual consents or another exception applies.
• Under NPP 2.1(a) a health service provider may use or disclose health information if the secondary purpose is directly related to the primary purpose of collection and the individual would reasonably expect the organisation to use or disclose the information for the secondary purpose. In the Office’s view, the disclosure of health information for the purpose of monitoring clinical trials would appear to be unlikely to satisfy the requirements of NPP 2.1(a).
• NPP 2.1(d) allows for the use and disclosure of health information for research purposes in accordance with guidelines issued under section 95A of the Privacy Act where it is impracticable for the organisation to seek the individual’s consent. However, the Office suggests that it would be unlikely that a Human Research Ethics Committee applying the s95A guidelines would allow research that applies to the records of patients who are not part of the clinical trial.
• The Office believes that it is unlikely that another exception in this principle would apply in these circumstances.

The monitoring of clinical trials using the national e-health system

8. The Office notes that the development of an ICT strategy for clinical trials is linked to the proposed national e-health system and, in particular, seeks to determine how research undertaken via clinical trials can benefit from the electronic recording and monitoring of patients’ health information.

9. The first stage of implementing the proposed national e-health system is the creation of individual health identifiers. On 10 February 2010, the Healthcare Identifiers Bill 2010 (the Bill) [7] was tabled in Parliament. The Bill’s primary purpose is to set out the functions of the HI Service Operator and the authorised purposes for which an individual health identifier (IHI) can be used by the HI Service Operator, healthcare providers and other authorised entities. The Office supports the introduction of a unique health identifier provided that appropriate privacy protections underpin the introduction of such identifiers to ensure that they are only used for limited and prescribed purposes.

10. This is consistent with the intent of the Council of Australian Governments (COAG) and the Australian Health Ministers Conference statements that the use and disclosure of individual electronic health records will be underpinned by prescribed limited purposes, regulatory oversight and strong penalties for unauthorised use. [8]

11. The Bill is also a fundamental building block in the implementation of the national e-health system. As the implementation of the e-health system develops, the Office considers it is important that individuals have control about the degree to which they participate in the e-health system and how the information stored with the identifiers is used and disclosed. In particular, individuals should be asked to consent to their health information being used for any secondary purposes that are unrelated to their immediate care. The Office believes that these principles should also apply to the development of ICT strategies for clinical trials.

12. In the Office’s view, it would not appear to be consistent with the policy intent for the proposed national e-health system if health providers taking part in clinical trials were to provide access to the records of patients who have not given their consent to participate in the trial.

13. As previously noted, in the Office’s view, health providers taking part in clinical trials may also risk breaching privacy obligations if they were to provide access to the records of patients who have not given their consent to participate in the trial.

Longer term monitoring of patients

14. Privacy issues may also arise in relation to the proposal in the discussion paper to extend electronic access to participant files to allow ongoing access to the participants’ medical files following trial completion. In particular, where a Human Research Ethics Committee (HREC) approves a research proposal under section 95A of the Privacy Act, approval is generally given for a defined period. Consequently the Privacy Act may not permit use or disclosure of information of the participants’ medical files following completion of the trial, regardless of whether the information is accessed electronically or from paper based records.

Privacy Impact Assessments

15. A privacy impact assessment (PIA) is an assessment tool that describes in detail the personal information flows in a project and analyses the possible privacy impacts of the project. The Office would encourage the Clinical Trial Action Group to undertake a PIA as part of developing the new approach to clinical trials.

16. For example, electronic access to health information gathered for assessment and monitoring during a clinical trial could raise different data security issues than those that exist for accessing such information via paper records. Also, the ongoing access to personal information could increase the risk that the information gathered for the trial could be seen as being useful for other related purposes, which may not be covered by the consent given by individuals participating in the trial or within their reasonable expectations.

17. The overarching benefit of a PIA is that the identification and analysis of privacy impacts during a project’s design phase can assist in determining the appropriate management of any potentially negative impacts. Thus, PIAs are an aid to building community trust in new proposals.

18. Ideally, a PIA should be conducted by an independent expert in privacy and conducting PIAs. Further information on PIAs can be found in the Office’s Privacy Impact Assessment Guide. [9] The Office would welcome the opportunity to provide further advice and comment as part of the consultation process for a PIA.