New Frontiers Old Cowboys: A Consumer Perspective on ehealth Initiatives
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- Harriet Caldwell
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1 New Frontiers Old Cowboys: A Consumer Perspective on ehealth Initiatives Nicola Ballenden The move to an efficient, patient-focused health system as outlined by John Dwyer and the Australian Health Reform Alliance (Dwyer 2004) could be greatly assisted by an integrated electronic health record. However, examination of the recent uses of technology within the health system has raised concern. This article focuses on two areas of concern, eprescribing and the patenting of health software, and the sorts of protections that need to be instituted to ensure that any new system of electronic record keeping serves the needs of the health system and consumers. Ideally, an electronic health record would include details of diagnosis, treatments and contacts with the health system. The consumer, within a strict privacy framework, would determine access to the record and what gets included on it. Such a record could help to prevent unnecessary or inappropriate treatment, improving the quality of care and improving the use of precious resources within the health system. This, at least, is the promise of an integrated health record. The commercialisation of electronic prescribing and the use of patents in health software are two examples of threats to the potential that an electronic health record offers to consumers and the health system. In coming years both state and federal governments intend to roll out a range of ehealth initiatives including: 1. Healthonline An overarching plan for ehealth defining the key building blocks, including the provision of consumer information (HealthInsite) and electronic decision support. 2. Healthconnect This program plans to develop a national cradle-to-grave electronic health record for all Australians. The federal government intends to start implementing this record from 2005 at the cost of $430 million over 10 years. 3. Mediconnect This program aims to share summary medication records of consumers between doctors and pharmacists. The federal government has announced that this initiative will not be pursued and will be integrated into Healthconnect. eprescribing More than 90% of doctors use eprescribing software to write the majority of their prescriptions (Harvey 2004). Governments have stimulated this development through a series of grants designed to encourage doctors to purchase computers and software, and use the technology to keep patient records and to prescribe drugs. Some of the perceived benefits of eprescribing include: improved legibility of prescriptions; allergy and drug-drug interactions easier to check; and improved quality and safety though better access to objective, best practice information in a timely and appropriate way. Successes and Failures The legibility of prescriptions written with eprescribing software has definitely improved a clear benefit for consumers. However, some of the other benefits of eprescribing have so far failed to eventuate. In part, this is due to the how doctors are using the software, and to some design issues within the software. Another important factor is that the development of the Medical Director software, which is used by most general Health Issues, 2005, Number 42, pp
2 practitioners, has been driven by commercial concerns and the government has failed to regulate this area. As with most technology, the user has huge influence over its usefulness. If doctors use their computer as an electronic typewriter and fail to enter details such as the patient s allergy history then any mechanisms designed to pick up drug allergy problems is of limited use. They may even lull the doctor into a false sense of security because the doctor assumes that interactions will be picked up. Problems can also arise where doctors fail to close one patient s record before seeing the next, and end up prescribing medication for the wrong patient. In addition, no performance standards were set for eprescribing software in terms of picking up drug/drug interactions. The National Prescribing Service recently tested four general practitioner software packages and found huge variability in the efficacy of various packages. Some produced a range of trivial alerts that caused some general practitioners to turn off all alerts within their software. Other packages missed serious drug-drug interactions (Ahearn 2003). The integration of best practice information into software has been somewhat disappointing. Often best practice content is not free; software developers have to pay for it. Then there is the expense of adapting the information into the operating environment so that it is available within the software in a useful form. These development costs will lead to a higher price for the software, which could put the company at a competitive disadvantage. Again there is a lack of standards nothing prescribed in terms of the type, quality and accessibility of information that should be included so it is all too easy not to do anything at all. Fortunately, there are some positives on this front. The National Prescribing Service has developed independent information on medicines that have a new or changed listing on the Pharmaceutical Benefits Scheme (PBS). This information, known as Rational Assessment of Drugs and Research or RADAR, has been integrated into prescribing software. It is worth noting that the federal government funded both the development of the information and its integration into software packages. This sort of activity is rightly one that should be supported by government funding and needs to be extended to incorporate other independent sources of information (Harvey 2004). Problems with a Commercial Focus Software makers have found they can make their products cheaper for users by building a range of other income streams such as advertising and data harvesting into the software. By and large these extra features appear to be designed to assist the pharmaceutical industry promote its products to doctors. Advertising Medical Director is the most popular prescribing software, and it flashes up advertisements when the doctor uses the electronic prescribing feature. Despite the fact that this sort of advertising was prohibited on paper script pads there are no regulations that prohibit it within an electronic environment. Clearly, this sort of activity is not in the interests of consumers, who want their doctor to use objective information, not advertising, to make decisions particularly this sort of subliminal advertising where the contraindications and side effects of the medication are not listed. The advertisements would also appear to be in breach of the Medicines Australia Code of Conduct, Section that states: All advertisements must be displayed for a sufficient period to allow for viewer comprehension and the ability to access references. Neither is this sort of information in the interests of the government-subsidised PBS as cheaper generic and older drugs are less likely to be advertised. Health Issues, 2005, Number 42, pp
3 Until recently the prescribing feature would default to ticking the No generic substitution box on the script. The federal government recently disallowed this; however, some problems remain. For example, the software appears to default to the maximum number of repeats allowed, and unless the doctor changes this, consumers may be using more of the drug than is necessary, especially with antibiotics, where a short course is usually all that is required. Data Harvesting The other income stream included in the software is that of data harvesting. A general practitioner recently contacted the Australian Consumers Association (ACA) saying that a software company had offered them payments if they turned on on a feature that would enable de-identified patient prescribing data to be collected and sold. Presumably this would be sold to pharmaceutical companies although in press reports the software company s director helpfully volunteered that the data was available to anyone who wanted to pay for it not just pharmaceutical companies. ACA was concerned about this on a number of levels; firstly, at what point was the data being de-identified and what guarantees did the doctor have that patient/doctor confidentiality was not being breached? Even if the data is in a de-identified form, this sort of activity still has the capacity to make people feel extremely uncomfortable. It is also arguably not in the interests of consumers or the PBS if the pharmaceutical industry now has at its disposal such a powerful market research tool, which can be used to shape drug promotion strategies. When people go to the doctor, they are giving information on the basis that it will be used only in their clinical care. They do not expect that third parties will be trawling through their health records, even it is in a de-identified form. In this sense, third party access to data, without the consumers knowledge is something of a breach of trust. For example, many people are unaware that the Health Insurance Commission looks at medical records in order to regulate doctors, pharmacists and consumers who may be misusing either the PBS or the Medical Benefits Scheme (MBS). A recent study commissioned by the Office of the Federal Privacy Commissioner found that two-thirds of the 1,500 people they surveyed said a person s permission should be sought before de-identified data about them was used for research purposes (Office of Federal Privacy Commissioner 2004). Neither is it realistic to assume that only data in a de-identified form is of interest. In the USA, a consumer advocacy group, the Privacy Rights Clearinghouse, has filed lawsuits against a pharmacy chain for allegedly selling identified patient records to pharmaceutical companies (Frosh 2004). The patients were then getting phone calls and addressed mail at home telling them of newly released drugs and advising them to ask their doctors about these drugs. The information was targeted to particular consumers with a history of particular illnesses; for example, someone with a history of depression would be told about a new anti-depressant. The breach in privacy involved in this sort of activity is bad enough, but what if the letters had been delivered to the wrong address. Who would want their neighbour knowing all about their medical conditions? The practice is not new in the USA. In 2002, a pharmacy chain paid US$1 million in legal fines for using its customer s medical information for marketing purposes, including sending free samples of medication through the mail. Like Australia, the USA has strict privacy rules, although in these cases, consumers have not been protected. This sort of activity undermines the trust people have in health professionals and their faith in any system of electronic record keeping. For such a system to work it must have the trust of the community. Trust depends on a very strict privacy regime and heavy penalties for breaches. What Needs to Change? There are some specific changes required to prescribing software to ensure that doctors and consumers are getting the best use from the technology. These include: Health Issues, 2005, Number 42, pp
4 1. Agreed standards for picking up allergy drug interactions and drug/drug interaction. 2. Agreed standards on the inclusion of best practice information in prescribing software. 3. Government leadership in funding the adaptation of best practice information to prescribing software. 4. Advertising to be removed from prescribing software. 5. No default option for repeat prescriptions. 6. No uploading of data for commercial purposes. There are also more general principles needed to ensure that any new system of electronic record keeping, such as Healthconnect (see box), has the trust of consumers and that their privacy is protected. These include: 1. Strong privacy protections with serious penalties for any breaches. 2. The choice to opt in or out of any record keeping system. 3. The right to determine who has access to their medical record and which parts of the record they have access to. 4. The right to access their own medical record, and make additions and corrections. 5. Non-participation in any system of electronic health record keeping must not limit the availability of any health service to the consumer. The latest version of the Healthconnect Business Architecture (Commonwealth Department of Health & Ageing 2004) recognises a number of these rights, which is a positive first step; however, it is important they are also recognised in legislation. People also have the right to know if their records are being used for any other purpose, even in a de-identified form. This would include any activities that may be undertaken by the Health Insurance Commission for the purposes of monitoring Medicare and the PBS. Patenting Software in Health In recent years there has been much public debate concerning what should be patented and what should be located in the public domain, with the patenting of DNA being the best known example. Patents grant their holder monopolies. It has been argued that some things should belong to all humanity not just one individual or organisation. Others contend that patents allow those who put resources into research and development to recoup their costs, and prevent others from profiting from their hard work. For example, concern was raised recently when the Pharmacy Guild lodged an application to patent an electronic record keeping system. The application to the patent office states the following: The invention provides a method and system for a health care provider to obtain personal health data relating to a consumer. The system comprises a secure repository for the storage of a consumer's personal health data, and further comprises a template or the like enabling the consumer to select items of personal health data that are to be shared with a health care provider. The template also enables the consumer to identify the health care provider, or class of health care providers, to whom access will be provided for those selected items of personal health data. The system authenticates the identity of health care providers and provides access to the selected items of personal health data of the consumer for which the authenticated health care provider has been identified as having permission to access. The system further allows the health care provider to record details of the consultation in the consumer's secure repository of health data (Dibben et al 2004). The exact terms of this patent are unclear; however, if this monopoly is granted to the Guild, would other aspects of ehealth be able to function without somebody having to Health Issues, 2005, Number 42, pp
5 pay a licence fee to the Pharmacy Guild for using their patent? If this is the case, it is highly likely that either taxpayers or consumers would be the ones meeting the cost. Allowing these sorts of patents, to some extent, means the public interest can always be trumped by a single commercial interest. Allowing a patent for health software that is used to interconnect and access electronic health records systems would appear to be a major threat to the Healthconnect vision. The ACA believes there is a need to be much, much more wary of granting patents for health software. In particular, ACA believes that, if public money has been used to develop software in the health area, this should be nonpatented, from an open source and freely available in the public domain. If government is committed to building an affordable and accessible electronic record keeping system then it must object to any patent applications that may threaten this aim, especially as intervening is an expensive exercise for individuals and not-for-profit organisations. As with many other areas in health, the needs of commercial interests need to be balanced very carefully against those of patients and taxpayers. It is not that commercial interests have nothing to contribute in the development of software in ehealth, it is just that the most profitable way to develop certain health software may not be the way that is best for the health system and consumers. The public interest must be paramount in any new system of electronic health record keeping. Prescribing software must be more carefully regulated and so must any new form of electronic record keeping. Only in this way can Australia have a system that works for everybody. Building a system in consultation with all stakeholders is going to be slower, but it is more likely to be a system that people will trust. Nicola Ballenden, at the time of writing, was a Senior Health Policy Officer with the Australian Consumers' Association. Acknowledgements The author would like to thank Dr Ralph Faggotter and Dr Ken Harvey for their assistance in preparing some of the material in this article. References Ahearn, M. D. & Kerr, S. J. 2003, General practitioners perceptions of the pharmaceutical decision support tool in the prescribing software, Medical Journal of Australia, Vol. 179, No. 1, pp Commonwealth Department of Health &Ageing 2004, HealthConnect Business Architecture Version 1.9, Commonwealth Government, Canberra. Dibben, P., Demirian,V., Sinclair T., Pharmacy Guild (patent applicants) 2004, Method and System for Sharing Personal Health Data, European Patent Office. Retrieved from Dwyer, John 2004, Moving from a provider- to a patient-focused health care system: The health reform imperative, Health Issues, No. 81, pp Harvey, K. 2004, Impact of eprescribing on Antibiotic Use in Australia, presented at the 44 th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, USA. Office of Federal Privacy Commissioner 2004, Community Attitudes Towards Privacy. Retrieved from Frosch, D. 2004, Drug Store Cowboys. Retrieved from Health Issues, 2005, Number 42, pp
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