Report on the eStandards Final Conference (June 26 -27, 2017 – Brussels)

Standards and profiles in action for large-scale eHealth deployment in Europe and beyond

The eStandards Project

The eStandards project funded by the European Commission 2015-2017, a partnership of HL7 Europe with CEN/TC 251, the European Standardization Institute, IHE Europe, and eHealth competence centres in Europe, aims to advance eHealth interoperability and global alignment of standards. Bringing together actors involved in standards and specifications in Europe and globally, eStandards compiled a roadmap to accelerate knowledge sharing and promote collaborative standards development and alignment for sustainable eHealth deployment.

Guided by the vision of a global eHealth ecosystem, where navigation tools guide people to safe and informed health care and where interoperability assets fuel creativity, entrepreneurship, and innovation in sustainable health systems, we envision a new generation of ‘live’ standards, called eStandards. eStandards are able to drive large-scale eHealth deployment and support the digital transformation of how we manage our health and deliver health care.

eStandards presents its Roadmap for collaborative and sustainable development of standards  in its final conference.

Final eStandards Conference

beStandards is a collaborative project funded by the European Union under the Horizon 2020 programme. Its outcome supports the European Commission's policy work on the Digital Single Market and specifically on eHealth.

eStandards presents its Roadmap for collaborative and sustainable development of standards  in its final conference.

On 26-27 of June 2017, the eStandards project held its final conference, which was hosted at the CEN/TC 251 premises in Brussels.

The final eStandards conference comprised two days packed with workshop sessions for discussion and debate among a multi-stakeholder audience including standards developers, health ministry eHealth experts, health professional organisations, patient and public representative organisations, ICT vendor associations and clinical academics. The conference addressed how digital health standards should evolve, building on current best practices to support large-scale eHealth deployment in Europe and globally.

The eStandards roadmap blossomed out of the evidence of best practices in the implementation of eHealth projects, broad international collaboration exemplified in the joint work of CEN and HL7 on the international patient summary project, guidance on clinical content development and quality management in interoperability testing, and an analysis of socioeconomic factors affecting successful cooperation of users with vendors.

 

The eStandards Roadmap: co-Creation, Governance, Alignment

The eStandards roadmap provides an agile process framework, which links the needs for a trusted flow of data from the perspectives of the health system, the citizen, the workforce, and the market, to standardised artefacts and interlocked actions in co-creation, governance, and alignment (CGA). This roadmap is atypical and dynamic, in the sense that it does not dictate or assign actions that are specific, measurable, actionable, realistic, and timed.

aSpecific roadmaps will need to be taken up by digital health initiatives that actively engage the actors that strive for tangible improvements in health and healthcare, engaging the people and organizations that “can make it happen”. While policy makers and standardization bodies belong to this group of stakeholders, the efforts should be driven in a way that secures trust and flow of health data in the daily practice of health management and healthcare delivery. The objective to realise value for the health of individuals and society will then guide the further development and use of eStandards.

In explaining Co-creation, Petra Wilson of Health Partners Connect and former CEO of the International Diabetes Federation, who is Task 3.5 eStandards Roadmap Leader for CEN/TC 251, explains: “Co-creation is a collaborative process where players from across different sectors – such as companies, social sector organizations, financial institutions and government bodies – come together to co-design and co-implement new or improved products and services that address essential needs of underserved populations. While the process is co-creation – peers working across sectors hand in hand to design and implement solutions based on a shared vision – the result is addressing society’s challenges at scale, while achieving economic gains. Co-creation represents a fundamental shift in interaction between the business, social, and public sectors to create shared value.

True co-creation across sectors will result in important transformations within the entities involved. Partners begin to capitalize on one another’s complementary assets and experiences, and as values begin to cross-pollinate, internal leadership styles and organizational structures evolve. Co-creation therefore becomes a powerful force for internal culture change for all entities within the partnership.“

cPetra provided examples of co-creation: In the “You Design It, We Make It” programme: LEGO invites customers to join its innovation community and propose designs. Also, the Specialisterne Foundation works with employers to adopt hybrid value systems, in order to create one million jobs globally for people with autism who often have valuable skills for the labour market, such as an outstanding memory or a remarkable eye for details. Finally, she reminded us the story of the Ferarri team that was brought in to share the experience of rapid and co-ordinated pit-stop management and apply this to the redesign and optimise processes and performance in Great Ormond Street Hospital's surgical and intensive care units.

Governance describes how regions and organizations ensure they run efficiently and effectively. That includes maintaining the strategic direction of policy development and implementation; detecting and correcting undesirable trends and distortions; articulating the case for health in national development; regulating the behaviour of actors from healthcare financiers to healthcare providers; and establishing transparent and effective accountability mechanisms. The instruments of governance range from international and European law, all the way down to procedures and protocols in the smallest units of organizations. They cover aspects such as certification of professionals, product and workplace safety requirements, as well as standards and specifications for digital health interoperability. Governance actions seek to develop and review the necessary measures to ensure that eStandards will be deployed at scale, because they are supported and, when needed, required by regulations and practice guidelines.

Alignment has historically been discussed in business literature and tends to focus on the integration of business strategy and delivery systems (including IT systems). We also refer to alignment as fit, integration, harmony, linkage, and fusion. “Alignment drives the iterative aspect of co-creation and  serves as the ‘reality check’ aspect of governance” explains Petra. It ensures the sustained usability and use of eStandards across their lifecycle.

Focus on medication identification, patient summaries, chronic diseases and reference networks

Four focus areas of specific interest were selected for further analysis, due to their special relevance to healthcare within the European policy setting:

  1. Identification of medicinal products (IDMP) undertaken as an implementation initiative involving the European Medicines Agency (EMA), serves the goals of good pharmacovigilance practices across Europe: making sure that medications don’t harm patients.  Meanwhile proper identification of medicinal products also plays an important role in the delivery of care, the safe prescription of medication, and for measuring costs and outcomes at healthcare system level at Member States level and the level of cross-border healthcare provision.
  2. Patient Summary for unplanned and emergency care, together with cross border ePrescription, has been a top priority for the European eHealth Network in setting up the eHealth Digital Services Infrastructure and connecting Member states to safely deliver cross border care.
  3. Chronic Disease Management is top concern for practitioners and policy makers across the world, and the Joint Action on Chronic Disease Management (JA-CHRODIS) underlined this importance. Making sure advances in prevention and population health are shared and adopted quickly requires new ways of looking at empowering patients and their care providers.
  4. European Reference Networks (ERNs) for rare diseases are already a main topic in the 2011 European Directive on the application of patients’ rights in cross-border healthcare. Patients within Europe should have access to the sparse knowledge on rare diseases and be diagnosed and treated quickly.  The knowledge should travel, rather than the patient.

dIn explaining Co-creation, Petra Wilson of Health Partners Connect and former CEO of the International Diabetes Federation, who is Task 3.5 eStandards Roadmap Leader for CEN/TC 251, explains: “Co-creation is a collaborative process where players from across different sectors – such as companies, social sector organizations, financial institutions and government bodies – come together to co-design and co-implement new or improved products and services that address essential needs of underserved populations. While the process is co-creation – peers working across sectors hand in hand to design and implement solutions based on a shared vision – the result is addressing society’s challenges at scale, while achieving economic gains. Co-creation represents a fundamental shift in interaction between the business, social, and public sectors to create shared value.In sessions dedicated to each of these focus areas, after a short introduction, invited experts for each of the focus areas delivered lightning ninety second/one slide interventions on their sense of co-creation, governance, and alignment as applied to the topic at hand. The Co-creation-Governance-Alignment (CGA) framework was very well received and conference participants provided important examples and insights.

Elena Petelos, public health specialist and regulatory expert at the UoC notes “I am glad to be part of an effort, where [we] have the unique opportunity and obligation to define the parameters for interdisciplinary work; part of this work is involving, educating and mobilising all stakeholders, particularly citizens, for bottom-up policy-making.”

Giorgio Cangioli, co-facilitator of the HL7 International Patient Summary (IPS) project and member of the CEN IPS team, in its speech highlighted how “the IPS (International Patient Summary) project is a good example of pre-adoption of the CGA methodology considering the governance role played by the policy level (EC and EU Member States) and the co-creation and the alignment actions accomplished by the SDOs. New actions should be however expected to facilitate the synchronization of the eStandards and the deployment lifecycles, starting from the IPS and the eHDSI projects. Furthermore, since many are the aspects that concur to the IPS lifecycle, and not all of them could be covered by a single organization, a coordination among all the activities covering those aspects should have envisioned, to assure traceability and consistency of all the products that will be produced.”

Camilla Torlasco, a cardiologist with the health apps working group of the European Society of Hypertension, expressed her commitment and that of the society: “We are ready to work with you and identify specific needs and actions in co-creation, governance, alignment” within the focus area of Chronic Disease Management.

Estelle Huchet of the AGE platform shared: “Looking at eStandards, I was not sure what the contribution of AGE might be, but being here I feel the AGE platform can and should contribute a lot.”

The lively discussions showed the value of the eStandards Roadmap as a process framework. As Robert Stegwee, chair of CEN/TC 251 and leader of the roadmap development effort, summarized: “You have shown us that the roadmap invites collaboration on the necessary actions, each from your own perspective.  It is that trust in collaboration that will support large scale deployment of digital health solutions, based on sustainable eStandards.” 

The dedication of the roadmap to Henk Bakker, an ambassador of the Personal Health Record program in the Netherlands, who unfortunately did not live to see his dream of connected health become a reality, deeply moved the participants.

For a video interview with Henk Bakker,
please see: https://www.youtube.com/

Marcel Heldoorn of the Dutch Patient Federation, who accepted the dedication on behalf of the family of Henk Bakker said: “Patients become digital citizens faster than hospitals are embracing digital transformation. The patient perspective is a formidable and indispensable driver of change in the digital age, when connected in a safe and meaningful way to the health and wellness professionals. The Patients federation of the Netherlands has taken the initiative for a personal digital health environment for which Henk Bakker was one of the early ambassadors. We still share Henk’s experiences and ideas to convince people of the importance of digital health tools for patients almost every day. Making a personal health environment meaningful for patients requires standards for information exchange and a clear regulatory framework to drive trust and adoption. Most standards and regulatory frameworks are the result of co-creation with all parties concerned including patients, health professionals, health care providers, their organizations, and the health IT industry. In our shared vision, the connected personal health environment serves as a solid foundation for all kinds of innovative applications ranging from health management for chronic conditions to research into treatment of rare diseases and complex and ill understood conditions. The availability of extensive patient data fuels innovation. Putting patients in charge of what can and cannot be done with their personal health data is key to instilling trust in these innovations. I want to underline and recognize the dedication of your roadmap to Henk Bakker, as one of  the ambassadors of the Patient Federation for personal health record adoption.”

In the end, if we start thinking of “Standards as infrastructure for innovation”, as Catherine Chronaki from HL7 Foundation and scientific lead of the eStandards project mentioned, “standards organisations need to work with digital health stakeholders and leverage different speeds of development, dynamic governance, and active alignment.

At the closing of the two day program, Prof. Dipak Kalra, President of EuroRec, noted “What I have found truly remarkable about this conference is that all of the standards bodies represented here have emphasised the centrality of patients and the importance of engaging patients and citizens in the future development of standards, so that they can access and use their own health data, to become empowered players in their own wellness and prevention, health and healthcare.”