Ebook: Transatlantic Cooperation Surrounding Health Related Information and Communication Technology

On December 17, 2010, in Washington DC, Neelie Kroes, Vice-President of the Euro-pean Commission and Kathleen Sebelius, United States Secretary of Health and Human Services signed a Memorandum of Understanding on Cooperation Surrounding Health Related Information and Communication Technologies (ICT). This high level partnership between the EU and the US sent a strong signal to all stakeholders that a more global approach was needed to foster a mutual understanding of the opportunities and challenges ahead, and reinforced that advancing the effective use of Health ICT will benefit patients, health systems and the eHealth market.

In this book, we introduce the Policy Briefs which have resulted from the ARGOS project. We trust that this provides a good example of a transatlantic cooperation jointly coordinated by the EuroRec Institute and by the American Medical Informatics Association (AMIA). The ARGOS project was funded by the European Union within the framework of the Pilot Project on Transatlantic Methods for Handling Global Challenges in the European Union and the United States. The general objective of the Pilot Project, created through a European Parliament initiative, was to promote mutual understanding and learning among EU and US policy researchers and policymakers relevant to a number of challenges having a global dimension.

More specifically, the goal of the ARGOS project was to help address and meet global health policy challenges using ICT-enabled solutions, as well as to develop and promote common methods for responding to global eHealth challenges in the EU and the US.

The ARGOS Policy Briefs address key health informatics topics (many of which require interoperability and standardization) and cover the following four areas:

1. Semantic interoperability was the first priority identified by the ARGOS Transatlantic Observatory. This topic represents a globally recognised challenge that must be addressed if electronic health records are to be shared among heterogeneous systems, and the information in them exploited to the maximum benefit of patients, professionals, health services, research, and industry. Progress in this multi-faceted challenge has been gradual, valuable lessons have been learnt, and approaches discovered in Europe and in the US that can be shared and combined. In particular, interoperability between systems requires widespread and dependable access to published and well maintained collections of coherent and quality-assured semantic resources, including models such as archetypes and templates that would (1) provide clinical context, (2) be mapped to interoperability standards for EHR data, (3) be linked to well specified multi-lingual terminology value sets, and (4) be derived from high quality ontologies. Wide-scale engagement and commitment from professional bodies is needed at a global level to develop such clinical information standards.

2. Modelling and simulation of human physiology and diseases is a longer term endeavour also addressed by ARGOS. Life is the result of an intricate systemic interaction between many processes occurring at radically different spatial and temporal scales. Every day, worldwide biomedical research and clinical practice produce a huge amount of information on such processes. However, because this information is highly fragmented, its integration is largely left to the human actors who find this task increasingly demanding in a context where the information available continues to increase exponentially. Investments in the Virtual Physiological Human (VPH) research are largely motivated by the need for integration in healthcare. As all health information becomes digital, the complexity of health care will continue to evolve, translating into an ever increasing pressure which will result from a growing demand in parallel to limited budgets. Hence, the best way to achieve the dream of personalised, preventive, and participative medicine at sustainable costs will be through the integration of all available data, information and knowledge.

3. A common approach towards measuring the adoption, usage and benefits of eHealth was the third area covered by ARGOS. Health policy-makers and administrators are increasingly challenged by insufficient human and capital capacity. As the demand for health care services continues to grow, so do the related costs, which must be strictly managed against fixed budgets. Demographic changes, the rising incidence of chronic disease among young and old, and significant unmet medical needs call for more personalised care. Such evolving needs also call for the design of a new, better, smarter and high-performance healthcare model. For eHealth to deliver the expected benefits, it requires policies to foster and facilitate the actual deployment of different eHealth applications and programs (including investments, improvement of interoperability, reducing legal and other barriers) on the one hand and the deployment of measures that evaluate the effectiveness of current versus future take-up on the other. Micro- and macro- socio-economic evaluations of eHealth systems and solutions can offer significant benefits to health policy decision-makers to assist resource allocation decisions. In particular, these evaluations include evidence-based information to help eHealth decision-makers to identify the type and scope of services to deploy, the related costs and the expected overall benefits to patients, carers, health care professionals, health care systems and other organisations and stakeholders to consider when making decisions to invest in eHealth, including society as a whole. A rigorous evaluation program framework for identifying and measuring the benefits, costs and cost-effectiveness of eHealth programs is needed.

4. Certification of Electronic Health Records in the US and Europe. Health IT has the potential to make a significant contribution to the better management of healthcare provision. This cannot be achieved without the availability of trustworthy Electronic Health Record systems (EHRs) that meet all the necessary clinical information requirements, enabling the timely sharing of up-to-date patients' medical data to support “high quality care” and the “continuity of care”. Given the increasing complexity of EHR systems requirements, and the risk of system deficiencies or failure to meet expectations, there is a need for an assessment process to assure the quality of EHRs on the market and to ensure their interoperability with other systems. Without an agreed set of functional criteria to support the introduction of robust and sustainable EHRs, major ICT investments are potentially at risk. Certification, licensing and accreditation endeavours are now well established and accepted as being essential to quality assurance and continuous improvement. With increasing investments in eHealth and the central and expanding role and dependence on ICT in health, particularly in the core areas of patient diagnosis, treatment and care, there is a growing recognition of the need to ensure the quality of the content, capacities, capabilities and performance of related systems. EHR systems must be suitably developed and sufficiently comprehensive and robust to achieve the benefits. EHR procurers and end-users frequently claim that EHR systems and related product quality, data portability and interoperability are difficult to judge. Certification eliminates this concern for procurers and users.

Three other articles have also been included in this book as they address another topic that has now become a high priority challenge: Strategies for the development of a skilled health IT workforce. There is an increasing demand for human resources specialised in eHealth as a result of the major eHealth developments aimed at supporting more effective healthcare services in many countries. However, there are challenges to ensuring that the eHealth informatics staff involved in the production and operation of such eHealth systems are ‘fit to practice’ professionals. Levels of understanding, qualification, quantification and definition of the existing and projected work-force requirements across Europe and in the US currently differ.

Given these many opportunities and challenges, we hope that you will enjoy reading this book and its different practical recommendations, including an article on a vision for the future. We trust that this work will contribute to many more exciting developments to come in this highly specialised and fascinating field for the benefits of the patients, health care providers and society.

Georges De Moor, University of Ghent, Belgium

Dipak Kalra, University College London, UK

With our special thanks to Pascal Coorevits (EuroRec), Geert Thienpont and Gunther Ruyssinck (RAMIT) and their teams assisting in producing this book.

Semantic interoperability is one of the priority themes of the ARGOS Trans-Atlantic Observatory. This topic represents a globally recognised challenge that must be addressed if electronic health records are to be shared among heterogeneous systems, and the information in them exploited to the maximum benefit of patients, professionals, health services, research, and industry. Progress in this multi-faceted challenge has been piecemeal, and valuable lessons have been learned, and approaches discovered, in Europe and in the US that can be shared and combined.

Experts from both continents have met at three ARGOS workshops during 2010 and 2011 to share understanding of these issues and how they might be tackled collectively from both sides of the Atlantic. This policy brief summarises the problems and the reasons why they are important to tackle, and also why they are so difficult. It outlines the major areas of semantic innovation that exist and that are available to help address this challenge. It proposes a series of next steps that need to be championed on both sides of the Atlantic if further progress is to be made in sharing and analysing electronic health records meaningfully.

Semantic interoperability requires the use of standards, not only for EHR data to be transferred and structurally mapped into a receiving repository, but also for the clinical content of the EHR to be interpreted in conformity with the original meanings intended by its authors. Wide-scale engagement with professional bodies, globally, is needed to develop these clinical information standards. Accurate and complete clinical documentation, faithful to the patient's situation, and interoperability between systems, require widespread and dependable access to published and maintained collections of coherent and quality-assured semantic resources, including models such as archetypes and templates that would (1) provide clinical context, (2) be mapped to interoperability standards for EHR data, (3) be linked to well specified multi-lingual terminology value sets, and (4) be derived from high quality ontologies.

There is need to gain greater experience in how semantic resources should be defined, validated, and disseminated, how users (who increasingly will include patients) should be educated to improve the quality and consistency of EHR documentation and to make full use of it. There are urgent needs to scale up the authorship, acceptance, and adoption of clinical information standards, to leverage and harmonise the islands of standardisation optimally, to assure the quality of the artefacts produced, and to organise end-to-end governance of the development and adoption of solutions.

The European Union (EU) sponsored ARGOS project analysed current eHealth policy thinking in both the EU and the USA, compared strategic challenges and outcomes in selected fields, and drafted roadmaps towards developing advanced global approaches for these issues. This policy brief focuses on better understanding the benefits and costs of eHealth investments, assessing their overall socio-economic impact, identifying challenges and success factors, as well as measuring and globally benchmarking the concrete usage of eHealth solutions. These are by now key policy priorities not only of national governments and the European Commission, but also of international institutions like WHO or OECD. There is a strong felt transatlantic need for stocktaking, identifying lessons learned, sharing of experience, and working together to advance these issues for the benefit of health systems. A growing number of national and international activities can be taken advantage of. Recommendations on how to proceed with such transatlantic activities are proposed.

Life is the result of an intricate systemic interaction between many processes occurring at radically different spatial and temporal scales. Every day, worldwide biomedical research and clinical practice produce a huge amount of information on such processes. However, this information being highly fragmented, its integration is largely left to the human actors who find this task increasingly and ever more demanding in a context where the information available continues to increase exponentially. Investments in the Virtual Physiological Human (VPH) research are largely motivated by the need for integration in healthcare. As all health information becomes digital, the complexity of health care will continue to evolve, translating into an ever increasing pressure which will result from a growing demand in parallel to limited budgets. Hence, the best way to achieve the dream of personalised, preventive, and participative medicine at sustainable costs will be through the integration of all available data, information and knowledge.

If Electronic Health Record systems are to provide an effective contribution to healthcare, a set of benchmarks need to be set to ensure quality control and interoperability of systems. This paper outlines the prevailing status of EHR certification in the US and the EU, compares and contrasts established schemes and poses opportunities for convergence of activity in the domain designed to advance certification endeavours generally.

Several EU Member States have in the past proceeded with EHR systems quality labeling and/or certification, but these differ in scope, in legal framework under which they operate, in policies (legislation and financial incentives), in organization, and perhaps most importantly in the quality criteria used for benchmarking. Harmonization, therefore, became a must. Now, through EuroRec (with approaches ranging from self-assessment to third party certification depending on the level of confidence needed) and its Seals, the possibility to achieve this for EHR systems has started in the whole of Europe.

The US HITECH Act also attempts to create incentives for all hospitals and eligible providers to adopt and use electronic information. A centerpiece of the Act is to put in place strong financial incentives to adopt and meaningfully use EHRs. The HHS/EHR Certification Programme makes use of ISO/IEC 170XX standards for accreditation, testing and certification. The approved test method addresses the functional and the interoperability requirements defined in the Final Rule criteria and standards. To date six Authorized Testing and Certification Bodies (ATCBs) are testing and certifying products in the US.

In 2010 the ARGOS project was funded by the EC (DG RELEX) to contribute to the establishement of a “Transatlantic Observatory for meeting Global Health Policy Challenges through Information and Communication Technology-enabled solutions” to develop and promote common methods for responding to global eHealth challenges in the EU and the US. The European Institute for Health Records (EuroRec) was coordinating the project. The vision is that the Transatlantic Observatory will act as an international platform for dialogue and collaboration on health policy issues and will 1. build international consensus about how to improve the access, efficiency and quality of health services through ICT, 2. promote the importance of interoperability in eHealth, 3. help to define approaches to ensure that health data are easily available where it is needed, 4. identify optimal development paths.

Supported by stronger and more coordinated US federal funding and policies, driven by goals to deliver care more efficiently, and motivated to provide high quality care for an aging and more diverse population, public-private-sector organisations are redoubling efforts to implement information systems. Thus, there is a critical need to increase and broaden the pool of workers who can help organizations maximise the effectiveness of their investments in technology. There are in the US various current health informatics education and training initiatives and ongoing efforts to accelerate Health IT workforce development.

There is an increasing demand for informatics human resources from major ehealth developments aimed at supporting more effective healthcare in many countries. Focus to date has been on the standards required to describe ehealth applications and solutions; with sporadic attention to the workforce necessary to deliver them. There are challenges to ensuring that the ehealth informatics staff involved in production and operation of such ehealth systems are ‘fit to practice’ professionals and their competences can be clearly defined. There are currently different levels of understanding, quantification and definition of the existing and projected workforce requirements across Europe and in the USA. This paper highlights some of the issues to be considered across Europe in moving towards a situation where the limitations to appropriately skilled staff being deployed wherever necessary are reduced and free mobility of the workforce can be enabled.

In addition to technology services required to leverage information technology, qualified knowledge workers familiar with information management acquisition, storage and use and destruction are required to transform the healthcare industry to “next generation” status and capabilities. Sound information management principles for health information content enables less costly, yet more effective results.