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The objective of this report is to provide a structured overview of key ICT standards in the health sector and to understand related needs of ICT producing and using industries. Standardisation processes as well as economic impacts are analysed and policy implications are derived thereof. The report pays particular attention to standards for electronic health records. Since the field of ICT standards in the health sector is very wide and difficult to overview, it focuses on key standards, key trends in standardisation, and important implications. The report is based on literature evaluation, expert interviews, and results of an international online survey of e-health experts.
This report takes an industry perspective so that “ICT standards in the health sector” is an appropriate term. However, it is often abbreviated to “e-health standards” in this report.
Standards are defined here in a general, functional sense as “technical specifications”. From an institutional perspective one can distinguish four types of standards: official standards which are mandatory to use, voluntary standards, proprietary standards defined by industry, and open standards. Standards are of enormous economic importance: By determining both the requirements producers have to fulfil and the expectations of the customer, standards reduce problems of risk, transaction costs and issues of interoperability (section 2.1).
For the European Commission (EC), standardisation remains a voluntary, consensus-based, market driven activity. The EC promotes standardisation because it considers standardisation as a priority issue for the competitiveness of a number of industries in Europe, including ICT manufacturing.
The current situation of e-health standards may be summarised as follows (section 2.2.1):
Conflicting standards, versions and implementations: There is a lack of standards that are widely used, implying that standards often conflict and interoperability problems often occur. Many of the conflicting standards are proprietary. There may also be different or flawed implementations of the same standard that are not interoperable. In some cases even different versions of the same standard may conflict.
Lack of “right” standards: There is also a lack of the “right” e-health standards, i.e. well-developed standards for particular applications and concrete use cases.
For health service providers, this situation may imply that computerised systems remain stand-alone and unable to exchange data with each other in-house or externally. Health service providers may have to invest considerable funds to make systems that operate with different standards interoperable.
Reasons for the currently problematic situation in e-health standards can be broken down by stakeholders: governments, SDOs, industry, and ICT users (section 2.2.2):
Political barriers: On the one hand, there are many different national and also regional health systems with different standardisation approaches and standards implemented across Europe. On the other hand, there is also low governmental support for developing prominent e-health standards and the level of incentives to communicate electronically – which may spur the use of standards – is low.
SDO barriers: There is a large number of SDOs developing e-health standards. The main reason why they do not simply agree on common standards or harmonise their standards is that standards development is an expensive investment, and SDOs wish to realise positive returns.
Company barriers: Just like SDOs, ICT firms seek to realise the returns from their standardisation efforts. Furthermore, manufacturers may not be willing to adopt commonly used standards because these are very complex and thus expensive to implement. Finally, a situation of many conflicting standards may be favourable for companies that sell middleware or services to make systems interoperable.
ICT user barriers: On the part of health service providers such as general practitioners, community care centres, and hospitals, barriers to adopt widely used e-health standards are mainly related to costs: Search costs for systems with the most suitable standards, costs of converting existing data to new standards, and costs of software upgrades which may be necessary before adopting standards.
Currently there is now powerful process to harmonise existing standards. However, recently there has been a major advance in such activities. In August 2007, a collaborative e-health standards harmonisation group was formed between the European Standardisation Committee (CEN), the International Standardisation Organisation (ISO), and Health Level 7 (HL7). This initiative may potentially be very influential in the future.
All in all, the stakeholders involved in e-health standardisation are increasingly becoming aware of a need to develop the market for standards, and they are more and more active in this respect. The Member States’ e-health large-scale pilot planned to start in 2008, being funded by the ICT Policy Support Programme (PSP), is expected to become a further catalyst in this respect (section 2.2.3).
Introducing electronic health record (EHR) systems and defining related standards is an important topic on the agenda of many European countries and the EC. In July 2008 the EC issued a Recommendation on cross-border interoperability of electronic health record systems. EHR applications are available for an increasing number of institutions. However, solutions are often isolated without data exchange and interoperability, and they have implemented early and limited EHR versions. Contributing to the delay of more sophisticated EHR implementations is a lack of EU-wide standards for the collection, coding, classification and exchange of clinical and administrative data (section 2.2.4).
Five principal standardisation organisations, a promising open source initiative and a major interoperability initiative have been selected for detailed analysis in this report as they can be expected to play a leading role in further e-health standards development:
ISO, the International Organisation for Standardisation, as the largest developer of world-wide standards,
CEN, the European Committee for Standardisation as the principal SDO in Europe,
IHTSDO, the International Health Terminology SDO, as the developer of the fairly widely adopted SNOMED-CT terminology standard,
HL7, Health Level 7, as the developer of the most widely used standards for electronic messages in healthcare,
DICOM, Digital Imaging and Communications in Medicine, as a de facto standard for electronic medical imaging,
OpenEHR as a promising open source activity for electronic health records,
IHE, Integrating the Healthcare Enterprise, as a major e-health systems interoperability initiative.
Understanding the objectives, rationales and constraints of these organisations may help to form viable alliances for harmonising and consolidating standards.
In November 2007, empirica conducted an online survey of e-health experts from ICT industry, user organisations, public authorities, university and research, SDOs, and consultants. 94 experts responded. The principal results were the following (chapter 3):
Future importance of standards development SDOs: The majority of respondents agreed that all seven e-health SDOs mentioned (ISO, CEN, IHTSDO, HL7, IHE, DICOM, openEHR) should be important in the future.
Current situation in e-health standards: Nearly all interviewees agreed that there is a lack of widely used e-health standards. There was also agreement that there is a lack of sufficiently developed e-health standards, a lack of e-health standards harmonisation activities, and that there are too many conflicting e-health standards.
Impacts of current situation: Nearly three quarters of the respondents indicated that within a single health service provider the overall situation is supportive, but the majority found the situation unsupportive for cross-border care provision.
Current situation in e-health standardisation processes: The respondents favoured a stronger involvement in e-health standardisation processes from many different organisations, including above all ICT user organisations and national governments, but also national competence centres, the EC and ICT industry.
Barriers to adopt common e-health standards in hospitals: Hospital IT managers may first of all find internal process functionality more important than commonly used standards. The respondents also agreed that the managers miss financial incentives to electronically exchange information.
Business analysts assess the market for health information systems in Europe as being huge and largely untapped. However, interoperability problems may be one reason for hospitals and other health service providers to hold off investments in ICT. Consequently, growth in companies supplying ICT for the health sector is smaller than it could be. Furthermore, economic growth related to standardisation may accrue predominantly in the country or part of the world where a standard has been developed (section 4.1).
Further economic implications of a lack of commonly used e-health standards are lost opportunities for cost reduction and compromised quality of healthcare. As regards costs, due to a lack of commonly used standards, opportunities for streamlining health service processes and for delivering activity data for more effective accounting and controlling are lost. As regards health care quality, a lack of information systems integration may prolong physicians’ and nurses’ access to patient data (section 4.1).
In January 2008, the US Department of Health and Human Services recognised certain interoperability standards for health ICT which federal agencies have to include in procurement specifications for certain fields of health. This could be a step towards mandatory use of a confined number of standards for principal e-health applications. Such a regulation by the US government could have considerable impacts in the EU. In order to prevent unfavourable developments, the EC and the Member States may be well advised to develop a common strategy and roadmap for e-health standards development.
A solution for the interoperability challenge in e-health may be the common use of a more confined and harmonised number of well-developed standards. Related efforts by the EC and national governments should involve the following objectives (section 4.2.1):
Promote an EU-wide agreement on priority standards. Promote an increased uptake of prominent standards, for example those developed by ISO, CEN and HL7, and thereby increase the network benefits of standards use.
Promote the development of standards in applications areas in which there is currently a lack of well-defined standards.
Promoting the harmonisation of key standards that conflict with each other.
In order to achieve these objectives, the following means may be used (section 4.2.2):
The collaboration initiative of ISO, CEN and HL7 should be strengthened.
Stronger involvement of industry and user groups in the standardisation process by ensuring that the outcome of the standardisation efforts are highly relevant for them.
Member States and their national Competent Authorities should become more committed to international e-health standardisation.
The EC and Member States should implement a roadmap for further development of e-health standards (section 4.2.3). The large-scale pilots for patient summaries and e-prescribing planned to take place in Member States should be stepwise extended to other key applications. In parallel it will be mandatory to also develop standards for a European e-health infrastructure.