The purpose of this document is to emphasise the need for an ethical framework for the global adoption of the Electronic Healthcare Record. This paper sets out to argue the case, and propose the development of a framework.
The ISO/TC215 committee has a brief to deliver a working standard for global interoperability in Health Care within a defined time span. Interoperability is an urgent need for healthcare systems. The proliferation and provenance of information technology in Health Care cannot realise its full potential without it. Furthermore the new technologies developing around the World Wide Web are delivering an entirely new environment for electronic data exchange of all sorts. The ISO process in its founding assumptions looks for international standards separate from de facto proprietary standards.
There is a great diversity of views and practices surrounding ownership and access to electronic records. This diversity manifests between Nations, and even within Nations (eg in Japan, Takeda, personal communication). There are many spheres of relevance to this argument.
The concept of 'Ownership' itself can be deconstructed into Rights and their reciprocal Obligations. Similarly the concept of 'Access' to the Electronic Healthcare Record (EHCR) has a reciprocal, denial of access or Privacy. The concepts of Rights, Obligations, Access and Privacy are an interrelated set which define each other, and must be considered together both theoretically and practically.
For those who would wish this argument to be located within contemporary discourses on social responsibility and distributive justice, we would point out the diversity of views in the area of rights and obligations, definitions of the self, and relationships between the individual and society. These matters are not trivial for individuals. As Claude Levi-Strauss points out in his discussion of Sorcery (Levi-Strauss, 'the Sorcerer and his Magic', 1968) physical integrity cannot withstand the dissolution of the social personality. However, the definition of it can vary markedly between cultures. Authors such as Rawls, who presupposes an account of individual autonomy that places care of others in the context of enlightened self interest, or his communitarian critics such as Walzer who sees the 'self' concept as socially constituted, between them articulate the contested dimensions of the debate (see 'Liberals and Communitarians', Mulhall and Swift, Blackwell, 1996 for a pertinent discussion).
The Standard should support diverse definitions of self and society. The search for universal criteria on which to found definitions of self, society, rights and obligations is a universal, but the solutions are plural. The 'standard' must therefore be a framework, which permits diverse solutions to these age-old questions. It should facilitate exchange of Healthcare entities between systems with different 'set up' configurations in the networks of rights, obligations, access, and privacy considerations which surround records.
Medical data can also be considered as 'goods', which are distributed. The definition of any 'good' is social, as Walzer (ibid) points out, and that definition implies how it should be distributed. He gives the example of 'medical goods' which are usually defined as being distributable where need exists. This common cultural definition has given to the moral dilemma involved in rationing medical goods, because there is an unresolved conflict between the social definition of medical goods and those from other spheres of value.
The CEN group has elaborated 'distribution rules' to govern distribution and access to 'medical goods', which can be customised for user groups (CEN/TC 251/N98-120). They apply to units defined by the CEN architecture ( CEN/TC 251/N98-119), and they are complex, but they identify requirements that must be met to specify access to records. At WG1 in Berlin, the US delegation head explicitly disavowed architectural considerations as a Work Item. Some authorities suggest that despite elaborate modelling exercises, the definition of some boundaries might end up being decided in the courts.
A related field is that of 'intellectual property' rights, and these have a large legal literature. There is overlap and identity between rights in intellectual property, and rights in medical data, and both might be validly argued to be part of any global EHCR structure.
However, it appears that there is already a global standard in evolution for the management of intellectual property electronically. Such a standard is the 'Indecs' project (Interoperability of data in e-commerce systems generic meta data model; see www.indecs.org/). This has as one of its aims to provide a standardised semantic framework for an XML-based infrastructure for integrating diverse metadata in the web environment. The very existence of such a product for electronic commerce will influence our attempts to gain global consensus (or alignment) for the EHCR. The concept has architectural features. The generic concepts of 'People', 'Stuff', and 'Deals' and the relationships between them could also be made to apply to the Electronic Healthcare Record. To quote from the 'Indecs' document: "Not only can 'meta data' (data about data) be precise and all-embracing, but in the distributed digital environment now dominating the future of intellectual property management, it has to be."
The generic model will be expressed as a technical data model using the W3C standard RDF (Resource Description Framework) based in XML (Extensible Mark Up Language). This is intended to integrate a variety of web-based metadata activities. It has an ability to specify 'privacy practice descriptions' which can mediate between the privacy practices in different web sites, to come to an agreement about the release of information.
The remarkable reality is that there are a number of global standards developing at the same time, based around Internet technology and the new XML markup language. We have from ISO/ TC 215 the accord between CEN and HL7. There is a classic quote on the W3.org site under 'What the Future Holds: this section will be updated shortly'!
What emerges is the concept of an 'n' dimensional labyrinth of options and possibilities through which a record has made a 'track' in time. Every system becomes connected to every other system, and the implications of this are literally unimaginable.
In Attachment B of the draft minutes of the WG1 meeting in Berlin (Terms of Reference), the penultimate item reads: 'not be limited to application within computerised systems or highly developed record environments.'
Whatever design for the global EHCR standard that emerges should be accessible to clinical practice at all levels of technological sophistication and complexity. The ISO process could be used to facilitate the 'business plan' for global healthcare that Peter Tresseder mentioned in his first address to the inaugural TC/215 meeting in Orlando, August 1998. It would greatly facilitate this if the distribution rules and security processes surrounding record objects could be packaged or 'wrapped' so that they are invisible to the naive user. In some pioneering clinical contexts, national or institutional guidelines and definitions of clinical goods might not be in place, yet useable medical objects such as simple free text sheets with identifiers might still be freely downloaded from accredited international sources. Such channels could also be the source of verified decision support. In such circumstances, the configurations of rights and obligations surrounding such items could be taken from 'default' international positions and the 'Universal Declaration of Human Rights' might be the appropriate reference document.
Access to the global EHCR should be a right for all suitably credentialled people, and the Standard itself should not be 'owned', unless by an accredited international body such as ISO or the UN. The 'open source' concept in software is rapidly gaining momentum, and many initiatives recognise it, including the CEN initiative, and the latest GEHR 'kernel' proposals still under development from www.gehr.org.
Summary
There is a great diversity of issues and considerations surrounding concepts of ownership and access to Electronic Healthcare Records, and this draft document has tried to outline some of the spheres of relevance. Of crucial importance is the relationship that these concepts have in the final working standard to Work Group 4 recommendations on security processes. The ISOTC/215 committee has a brief to produce a working global standard within a defined time span. We should now approach Working Group 4 to consider the joint development of a discussion document for review at the London meeting of WG1 in September, with a view to developing a technical report to progress this issue.