As the clinical implications of the genetic components of disease come to be better understood, there is likely to be a significant increase in the volume of genetic information held within clinical records. As patient health care records, in turn, come on-line as part of broader health information networks, there is likely to be considerable pressure in favour of special laws protecting genetic privacy. This paper reviews some of the privacy challenges posed by electronic health records, some government initiatives in this area, and notes the impact that developments in genetic testing will have upon the ‘genetic content’ of e-health records. Despite the sensitivity of genetic information, the paper argues against a policy of ‘genetic exceptionalism’, and its implications for genetic privacy laws.
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The development of HealthConnect is being coordinated by the National Health Information Management Advisory Council (NHIMAC), established in July 1998 by Australian Health Ministers, and bringing together consumers and representatives of Australian governments and the private health sector. Following on from its November 1999 report, Health Online, the National Electronic Health Records Taskforce was established by Health Ministers through the Council. The Taskforce's July 2000 report, A Health Information Network for Australia, proposed key features of a network of electronic health records, although the architecture currently remains fluid (Commonwealth of Australia2000).
50.
The National Electronic Health Records Taskforce quotes studies to the effect that three consumers per 1000 admitted to hospital will die and one will suffer long-term disability due to adverse drug events, and that up to 70% of such events may be prevented by improved information systems (Commonwealth of Australia2000, p.57; Report to the Electronic Health Records Taskforce, The Benefits and Difficulties of Introducing a National Approach to Electronic Health Records in Australia April 2000, p.22).
51.
Recently, Production of the Medicare number became a prerequisite to the receipt of pharmaceutical benefits (in addition to Medicare benefits): See National Health Amendment (Improved Monitoring of Entitlements to Pharmaceutical Benefits) Act2000 (Cth).
52.
Specifically, digital certificates will ensure authentication (the identity of the message sender), data integrity (non-alteration of data between sending and receiving), non-repudiation (assurance that the sender cannot dispute creating and sending the message) and confidentiality, in respect of data transfers between subscribers to the relevant certificate policies. There are two types of digital certificates: Healthcare Location Certificates, and Healthcare Individual Certificates (Health Insurance Commission, undated).
53.
These include the secure transmission of referrals from doctors to specialists and to hospitals, secure discharge summaries from hospitals to doctors, secure transmission of pathology results to doctors, secure on-line claiming for doctors and pharmacists, and secure access to the Australian Organ Donor Register and Australian Childhood Immunisation Register (Health Insurance Commission, undated).
54.
The record would include the ‘consumer's details, their needs as identified or assessed, what services are planned and when they are required, relevant data collected (for example, test results) and summary reports from each contact with the consumer. The record should also have the capability to notify providers and consumers when actions, such as service reviews, scheduled appointments or proposed remedial action, are required and to notify consumers when scheduled self-management activity should occur’ (Department of Human Services (Victoria) 2001b, pp.30–31).
55.
PoCCS would record admission history, vital signs and clinical measurements, and could be used to generate clinical pathways and care plans, to order tests, and to generate discharge referrals and clinical reports (Ayres, Horvath and Kidd2001, pp.14–15).
56.
In Australia, as in other developed countries, there is strong pressure towards cost savings and efficiency gains in the health sector. Spending on health care is slowly increasing, and the budget impact is expected to be magnified in future by the health needs of a growing, aged population (Commonwealth of Australia2000, p.11). Through the 1990s, total spending on health services (government and non-government) grew at an average annual rate of 4%, reaching $53.7 billion in 1999/2000 (Australian Institute of Health and Welfare2001).
57.
Mount, Kelman and Smith argue that the health information system:.
58.
(a) should serve the health needs of both the individual and the nation.
59.
(b) should enable the monitoring of trends, and facilitate health administration and management.
60.
(c) should improve the efficiency of health service delivery, both personal care and public health services.
61.
(d) should build from a primary care and population health base.
62.
(e) should meet privacy and confidentiality requirements.
63.
(f) should be developed intentionally rather than accidentally, in a coordinated rather than fragmented manner (MountKelmanSmith2000).
64.
The WHO defines health as ‘a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity’, viewed 28 March, 2002, < http://www.who.int/aboutwho/en/definition.html>.
65.
See Privacy Act1988 (Cth), Schedule 3, National Privacy Principle 2.1(a); Office of the Federal Privacy Commissioner2001, pp.14–15.
66.
See Privacy Act1988 (Cth), Schedule 3, National Privacy Principle 2.1; Health Records Act 2001 (Vic), Schedule 1, Health Privacy Principle 2.2; Privacy and Personal Information Protection Act 1988 (NSW) ss 17–19; Health Records (Privacy and Access) Act 1997 (ACT) s 5 Privacy Principles 9–10.
67.
In New South Wales, for example, genetics laboratories have been funded by Health Department and Area Health Service allocations under a consortium model where each laboratory ‘specialised’ in a small number of genetic disorders (Department of Health (NSW)2000b, para 1). In Victoria, the Victorian Clinical Genetics Service (within the Murdoch Institute), a centralised, State-funded service, provides an over-arching, coordinating role in the provision of clinical genetics services to all hospitals, clinics and primary care providers employing clinical geneticists, genetic counsellors and scientists.
68.
The Human Genetics Society of Australasia maintains a database of those genetic tests currently being offered in Australia, and by which organisation within each State: http://www.hgsa.com.au/ (refer to ‘DNA Testing Laboratories’).
More specifically, the Department states that: ‘Evidence based pathways should be developed which provide rigorous and robust criteria for offering tests. Issues to be considered include testing capabilities, criteria for test availability, sensitivity and specificity of tests, costs and benefits, risk categories for access, numbers in the community for whom testing is appropriate, pretest genetic counselling requirements, quality control measures in laboratories and recommended throughput, and whether it is appropriate to offer a particular test from one or more laboratories’ (Department of Health (NSW)2000b, para 4.6).
71.
The following discussion draws on verified data from an interview the author conducted with Professor David Danks, former Director, Victorian Clinical Genetics Service and Murdoch Institute, Royal Children's Hospital, Melbourne, 27 June 1994.
72.
Newborn screening using ‘Guthrie spots’ has long been carried out by States and Territories (‘ALRC and AHEC’2001, pp.258–260). The NSW Newborn Screening Program, based at the New Children's Hospital, Westmead, Sydney, screens newborns for phenylketonuria, primary congenital hypothyroidism, cystic fibrosis, galactosaemia, and more than 20 rarer metabolic disorders. Of the 87,000 babies born each year in NSW, around 90 are diagnosed with one of these genetic conditions (Department of Health (NSW)2001).
73.
In New South Wales, for example, genetic neonatal cystic fibrosis screening occurs under the Public Health Act. The current screen tests for the 12–15 commonest mutations causing CF. The Delta F508 mutations account for about 85% of cases.
74.
See Duncan v Medical Disciplinary Committee [1986] 1 NZLR 513, at 521; Slater v Bissett (1986) 69 ACTR 25, at 28–29; Brown v Brooks, unreported, Supreme Court of New South Wales, 18 August 1988, McLellandJ, (duty of consulting clinical nurse).
75.
Most but not all of these provisions apply to public sector-held health information. See Health Administration Act1982 (NSW) s 22; Public Health Act 1991 (NSW) s 75; Mental Health Act 1990 (NSW) s 289; Health Services Act 1988 (Vic) s 141 (also applies to private hospitals); Mental Health Act 1986 (Vic) s 120A; Health Services Act 1991 (Qld) s 63; Health Act 1937 (Qld) ss 100E, 100FO, 100I; Public and Environmental Health Act 1987 (SA) s 42; South Australian Health Commission Act 1976 (SA) s 64.
76.
See Public Health Act1991 (NSW) s 17; Health Act 1958 (Vic) s 128; HIV/AIDS Preventive Measures Act 1993 (Tas) ss 17–19. For a more detailed review, see Magnusson 1996, pp 399–402.
77.
Privacy Act1988 (Cth) s 14.
78.
Privacy Act1988 (Cth) Schedule 3 (the ‘National Privacy Principles’, introduced by the Privacy Amendment (Private Sector) Act 2000 (Cth)).
79.
Privacy and Personal Information Protection Act1998 (NSW); Health Records Act 2001 (Vic).
80.
Information Privacy Act2000 (Vic).
81.
Health Records (Privacy and Access) Act1997 (ACT); Health Records Act 2001 (Vic).
A recent information sheet, ‘Towards a National Health Information Privacy Framework’, states that this legislation may determine ‘how consumer consent should operate in HealthConnect (including consent of what information is transferred, to whom, and for what purposes), the responsibilities and obligations of providers, the purpose for which the information can be used, and governance arrangements’.
84.
To quote NSW Privacy Commissioner Chris Puplic, speaking to the First National Privacy Conference, Melbourne, 26 November 2001.
85.
Other examples include Kaiser Permanente, a managed care organisation in the United States, which provides online services to members, which mistakenly sent 838 e-mail messages to the wrong recipients, some of which contained sensitive information (GoldmanHudson2000, p.141).
86.
This is perhaps the most serious risk within on-line health information systems. Recent examples include the case of an employee of the Health Insurance Commission detected browsing the records of women who had had IVF treatment, and Asian women: See ‘Health, Privacy and the New Technology’, The Law Report, ABC Radio, 27 February 2001; Lodkowski v Comcare, unreported, Federal Court of Australia, Goldberg J, 5 March 1998 (disclosure by an employee of the Health Insurance Commission that the applicant had had a termination of pregnancy prior to marriage).
87.
Leung (2000) presents a case study featuring a man with a recently diagnosed autosomal recessive inheritance, treatable in the presymptomatic stage, who refused permission to disclose his diagnosis to his siblings.
