Giorgio Cangioli (HL7 foundation) presented on Tools for the formal Standards lifecycle. Giorgio pointed out that deployment of services compliant to standards requires an architectural approach based on a portfolio of standards artefacts. The use of tools that enable consistent adoption and cooperative use of the selected standards has strong impact on the effectiveness and efficiency of the resulting services in cycle that interlaces the formal standards lifecycle (see figure below), supporting the parties involved. With the digital evolution, Giorgio argued, “standards are changing from text-based (paper, excel, pdf) to computable artefacts exemplified by HL7 FHIR®.” Information on standards needs to be adapted to the recipient: “Each type of human or non-human user needs different types of information and artefacts in a format that is understandable and fit for the purpose of use. Tools are essential to assure the consistency between the reference standards’ and/or profiles’ specifications and the published human readable (html, pdf, etc.) and computable artefacts ” shared Giorgio. He stressed that “SDOs should promote tools that are designed to facilitate the adoption of portfolios of standards by users (not only for standards developers!), work seamlessly within and across the different phases of the standards´ lifecycle and rely on open widely adopted standard formats.” Finally, Giorgio announced that convinced that use of tools should be monitored, HL7 Europe is working on a registry for tools and a first version is available for comments at: http://wiki.hl7.eu/index.php?title=Tools.
Then, Kai Heitmann presented ART-DECOR as an example tool that offers computable specifications, its validation capabilities has been integrated with IHE Gazelle ObjectsChecker and has been already used to support connectathons. Kai indicated that ART-DECOR is an open source tool and a methodology to facilitate health care information exchange among multiple stakeholders by supporting comprehensive collaboration of team members within and between governance groups. The tool allows separation of concerns and different views on one single formalized documentation for different domain experts. It supports creation and maintenance of HL7 templates (STU), value sets, data sets and scenarios and a formalized documentation of the artefacts as HTML, PDF etc. ART-DECOR repositories with collection of templates (building bocks for clinical document definitions) and Value Sets (code lists) have been established in several countries i.e. Germany, Austria, Netherlands, Poland, and Switzerland, and sharing of templates and value sets is now common practice.
Marcelo Melgara (Region of Lombardy) presented the European public procurement directive 2014/24 and advocated educating procurers, noting that still the language of standardization and procurement are very far and apart. Marcello started with an overview of the legal and regulatory requirements in Europe, the EU ICT standardization policy, the Data Protection Regulation, and Medical Device Directive and their national interpretation. Marcello presented the terms mentioned in the directive: (1) National standards transposing European standards, (2) European Technical Assessments, (3) Common technical specifications, (4) International standards, (5) other technical reference systems established by the European standardization bodies, Then, he called upon the SDOs to work together, establish a common language with procurers, and help them reduce the cost and increase the effectiveness of the procurement processes. On conformance testing, Marcello referred to article 44 of the public procurement directive, noting that procurers should learn to request evidence in the form of Test Reports and Conformance Reports on compliance to IHE profiles as demonstrated in Connect-a-thons since the 27 IHE profiles identified by the MSP to be eligible for reference in public procurement (Decision 2015/1302, 28/7/2015).
Next, Robert Stegwee moderated the industry panel comprising Horst Merkle, Director of Diabetes Management at Roche Diagnostics, Chair of Personal Connected Health Alliance, Nicole Denjoy, Secretary General of COCIR, Jaime Gamboa, Philips Health Informatics Solutions, and Alexander IhIis Telecom Healthcare Solutions. The questions addressed to the panel were as follows:
On the role of standards on the diabetes care market, Horst Merkle noted that the market is consumerized and rapidly commoditizing. Without good standardization the market will spiral down very fast. Thus, it is a matter of survival to establish good communication with the customers (patients) and “rich” standard datasets are needed. Consumer electronics is a fast moving market, and time is the main opponent. So, the answer is: yes. We have spent too much time putting data into silos. For example it would be good to complement our bonus calculator with data from a step tracker, but the data is not available. The typical deviation of trackers is up to 48%, making them next to useless for clinical use. On the question of where standards should contribute, Horst highlights education: “We already have a good set of standards for personal health and healthcare IT. Deployment and adoption is a problem, and guidance for users on which standards are there or needed is a challenge. We have an education task at hands.” “Test tools are important for implementers and for users.” Horst adds. We need to re-think our wording Horst urges: Don´t talk about “implementing an interoperability framework”. We need to say that “we want to help you to make your data flow freely from here to there”. “Interoperability is infrastructure for innovation and standards give consumers freedom of choice.” Horst Merkle, inspired us.
Nicole Denjoy underlined that with respect to standards Industry is always very pragmatic. For us it is important to have standards with market relevance. “Large-scale deployment is happening albeit slowly. Despite standards and activity at the national level, the eHealth market is still very fragmented… we need to raise awareness for the importance of standards. We have many standards and just need to use them smartly. As technology moves forward, we need to expand standards, but not continuously invent new ones. And we don´t need to standardize everything.” “We all would be happy if interoperability in the healthcare sector would be as good as in banking.” Nicole adds “However, the situation in healthcare is more complex, with many stakeholders such as patient, doctors, social care, insurance, policymakers, etc. Also the question who owns the data: there are very different positions in the different EU countries.”Nicole also highlights the need to invest in infrastructure. The ministries of health would have to discuss with their neighbors (ministry of industry, ministry of communication) because the money for infrastructure should not come from the healthcare budget.
Jaime Gamboa highlighted two trends of interest to Philips: (a) personalization of care that produces more data, big data, too much data, perhaps and (b) industrialization of care and optimization of care processes. Standards are key in identifying what is relevant data. Jaime shared the views that education on standards is important. Otherwise users will drown in data sooner or later. Jamie also notes that data is becoming a value, an asset to be shared and that raises questions on the potential business model. Healthy living and prevention are areas where governments need to invest according to Jamie, if they want to limit healthcare costs. Policymakers need to create incentives and provide guidance for vendors to provide interoperability. It is important that SDOs understand the market needs, identify gaps, and coordinate to avoid unnecessary overlaps. Young people are empowered, but there is still education to be done on the benefits of standards and interoperability even for the healthy, i.e. to make sure data is available at the point of care as needed. Jamie stressed that once EU member states and healthcare providers should look into their roadmaps and determine where they want to go, the industry would be happy to support them.
Alexander Ihlis, Vendor co-chair of IHE Germany, observes that today it is difficult to combine data from a fitness tracker with data from medical devices, There is due to lack of standards and inadequate precision of the fitness trackers. However, activity trackers have a life cycle of less than 12 months. Customers that change their tracker wish to compare data from different trackers and that is not possible when data is stored on a proprietary vendor portal. Alexander shares their commitment to standards: “At Telekom, we have intensive discussions with vendors and try to convince them to implement standards into their products so as to add value to our customers though these devices.” Alexander firmly supports that infrastructure should be financed by the government “Everyone agrees that regional or national patient records are a good thing. However: who pays for that? I personally believe that infrastructure must be financed, not by the insurance companies, but by the nation, by taxes. Medical IT infrastructure should be provided such as streets and water pipes. On top of that, there can be reimbursement models for healthcare service provision.” On government-mandated standards, Alexander pointed to examples from EU countries that are publishing regulatory guidelines on standards required or strongly recommended such as the IHE XDS based ELGA in Austria and vital parameter devices supporting Continua in Denmark. Alexander concluded “I agree that some business models are not based on standards, but the world is changing.”
Stephen Kay, Vice Chair of CEN/ TC 251 , presented current initiatives related to the International Patient Summary Standards. Stephen started with the notion of a patient summary considered as part of the healthcare fabric, commonplace, and even mundane with so many different variants (e.g. discharge summaries, handovers), and numerous regional or national implementations. Although, Stephen argues, one might assume that with many implementations standardization would be easy, this clearly is not the case. Making the Patient Summary Structure & Content available for global use, independent of whether the demand is for cross-border or within a national state, or locally across organizations is tricky and Stephen cited several reasons for that (a) “The value of data lies in their use.” (b) “Data have no value or meaning in isolation” (c) “Data can be assets or liabilities or both.” (d) “The information necessary to interpret data is specific to the problem”. Stephen moved on to report on several initiatives related to patient summaries including the EU patient summary guidelines, specific EU projects like Trillium Bridge dealing with patient summaries, the HL7 InterPAS project on clinical summaries, ISO TC 215 Reference Standards Portfolios (Bundles) on Clinical Imaging, and the JIC Standards Sets addressing Patient Summaries for unplanned/emergency Care.
Michiel Sprenger, Strategy adviser at Nictiz, the National Competence Center of the Netherlands (NCC-NL), moderated the panel of the European eHealth SDO platform, Michiel Sprenger recognized three geographic layers: Global, Europe as themain focus of the discussion, and national. He recognized the partners to the discussion as SDOs and Profiling Organisations that develop base standards on international scale and assisting localisation on national level, National Competence Centres (NCCs) that localize and combine standards to new national specifications and/or standards, and policy makers, namely Ministries of Health in the Member states, the eHealth Network, and JAseHN the joint action to support it. He then introduced the panelists: Christof Gessner, German NCC, HL7 Germany, European HL7 Strategic Advisory Board, Pim Volkert, Dutch NCC, SNOMED terminology release center, Manne Andersson Swedish NCC and JAseHN, Karima Bourquard, IHE-Europe, Catherine Chronaki, European HL7 Foundation, and Robert Stegwee, Chair CEN-TC251.
The main questions addressed to the panelists were:
Christof Gessner, reflected on collaboration between SDOs in Europe and felt it is already pretty good. In Germany, he notes, there is a good collaboration between IHE, HL7 and DIN, bvitg, and the German NCC (Gematik). One challenge that all SDOs are facing is that clinical experts are not involved in standardization. The engagement of Gematik might offer the chance of mediating between standardization efforts and stakeholders in the health area. In Germany, an “interoperability forum” is a two-day open SDO meeting organized organized 4 times per year, where all the experts meet, discuss their standardization projects and their problems. Agenda and minutes are posted in the HL7.de wiki. The results are taken back at the Technical Committees of the SDOs. Christof felt that this is a very constructive way of bringing people together, motivating them, and involving clinical experts and could be one of the models that could work for Europe as well.
Pim Volkert works on terminology on national level, at the Dutch SNOMED-CT release center. He sees Europe as a geographical area where people can exchange experiences between SDOs. In the end, however, Pim felt standards need to be implemented on national level in the healthcare system. Sharing experience of how standards are implemented and localized in the different products on the market, will no doubt help users, and also vendors.
Manne Anderssen from the Swedish eHealth Agency, active in JAseHN, the joint action supporting the eHealth network, notes that it is hard for a hospital or small care provider to take into consideration the European policies when they define requirements for procurement. Manne feels that projects usually have tight deadlines and detailed requirements analysis is typically overlooked. Someone needs to analyze policies and break these down into requirements -including interoperability and standards related requirements- that hospitals can use in procurement. Who is that to be?
Karima Bourquard notes that IHE as a profiling organization needs to work with users (such as NCCs) on one hand, and SDOs on the other hand. Karima feels that this collaboration is happen already now on national, European and global level. However, according to Karima, there is indeed need for procurement guidelines. In France, where Karima serves as User co-chair of IHE-France, such a guideline exists, it is very useful and is used by hospitals, but on a European level, this is more difficult of course. Karima agreed that developing and implementing standards is not so easy and needs expertise. Training is part of change management and should be further developed in order to increase the consistent adoption of standards and profiles in eHealth projects.
Catherine Chronaki, reported that HL7 has national affiliates in 19 European countries, which by definition have to take clinicians, industry, consultants etc. on board. There is a lot of collaboration between SDOs already, Catherine feels because it is frequently the same people in different roles, and that provides opportunities to learn from each other. She felt however, that there important issues to be tackled by SDOs working together: For example, how can we use EIDAS to help hospitals improve identification? Also Catherine said “we need to rethink whether paper standards are enough for the digital age – I believe no. The Digital age needs digital artefacts, also in standards.” She also felt surprised about the gap between standards and procurement, which seem to speak “different languages” and felt that SDO should work together to bridge that gap with education.
Robert Stegwee said that “CEN TC/251 has done a lot of “soul searching” in the last years and has changed their focus from being a “standards development organization” to a “standards delivery organization” that also thinks about educating people how to use our standards.” He thought that the challenge of all SDOs is to focus on their clients, the value they bring to the standard users, and not on the rules of how standardization works. We need to work based on use-cases, but also coordinate across use-cases. In the question of Catherine Chronaki, what do the different SDOs bring to the table, Robert responded that CEN can offer its recognized processes, and invites SDOs to get together in CEN workshop agreement and collaborate to deliver specifications that procurement people can reference in their RFPs and concluded that “SDOs need to solve the real problems of the users, and for that we need to understand each other.”
The discussion picked up and several people commented. Morten Bruun-Rasmussen felt that learning from others is always beneficial and his experience suggests that standards are usually more complex than the implementer expects. “We have a problem with the way standards are written. Too few practical examples, too many pages, very hard to read.“ Morten concludes.
Stephen Kay responded that “technical writing can be difficult.” SDOs can improve the way they write standards, but there are other issues why clinicians are not involved. We need more ways of interacting with a specification. However, I am worry that the pressure put on the SDOs to “dumb down” specifications may be inappropriate. Not each specification can be understandable to the layman. Especially when it comes to safety critical aspect, you need to be very formal to the degree of using mathematical concepts.
Giorgio Cangioli joined the debate underlining that “specifications should formal, precise and technical when developing standards.” Relaxed specification are error prone. A good help with DICOM has been the availability of open source tools like CTN or DCMTK. Such implementations tools do not necessarily have to be provided by the SDOs.
Marco Eichelberg felt that we need tools (testing, reference implementation etc.) for the implementers, but also guidance for end users on the benefit of a standard, and the way it can be requested in procurement. Standards need marketing!
Michiel Sprenger in closing the debate felt that the discussion was a lot about Education and Knowledge and the question “How can we educate users about using and deploying standards.“ However, anyone who wants to use standards actually needs more than one standard to solve his specific problem, which again would be a topic for SDOs. Michiel concluded that “ SDOs and NCCs need more communication, with users and with policy people.” In the fields of knowledge and communication the SDOs should work together to improve awareness and diffusion of standards.
Robert Stegwee in his summary reported that eStandards will consolidate the feedback received and the first draft version of the Roadmap will be published in May. He welcomed submissions to the questionnaire and any further input, since eStandards has another year to finalize its roadmap for collaborative standards development.
In his talk Steve Kay, presented a picture of the day break, hoping that indeed this work is the sunrise for high standards.