Henrique Martins, Associate Professor in Health Management and Leadership at FCS-UBI, ISCTE-IUL, ISCSP-ULisboa
Introduction to eHealth in the context of national and EU challenges
To better understand current trends and directions of eHealth in the European Union (EU) there are three fundamental referential and what are three more specific, yet very relevant, tendencies or lines of work being explored right now. The three fundamental referential documents are:
- Digital Single Market (DSM) Strategy
- eHealth Network multi-annual workplan form 2018-2021 (MWP 18-21)
- Communication on Digital Transformation of Health and Care (DTHC 2018)
Although different the lines of focus that these document outline, they obviously intersect with each other in more than one way. They also have relevant differences namely regarding proponents, commitments, and target audiences. All of them, currently condition lines of work in EU funding for research and developments, for interoperability and harmonization efforts, as well as eHealth implementation projects more broadly.
Such conditioning is not just at EU level, like for example cross-border eHealth Digital Services like country-to-country exchange of ePrescriptions, but actually and increasingly, at national level. This is very important trend to analyze as, in the EU, health is a prerogative of member states, ie. it is not part of the treaties that establish the EU. However, thought the fact that there are cross-border movement of goods, services and citizens, there is not just a growing need for harmonization and interoperability, but actually since the publication of the, so called, Cross-border care directive (DIRECTIVE 2011/24/EU), there are also legal imperatives for cooperation.
The Digital Single Market (DSM) also acts as a powerful enabler as communications and digital markets are regulated at EU level and via that way influence and cooperation is needed and justified increasingly in the areas of eHealth and Digital Transformation. Regarding the Digital Single Market Strategy, it is built on three pillars. These have influenced many calls and ongoing support actions. With regards to eHealth it has meant an important energy in standardization work as one of the challenges is the lack of interoperability in the many existing technologies and applications, which limits the “single” digital market, dividing it into language or country markets. The downside of this is larger costs for healthcare providers as they face low competition, severe vendor lock-in and difficulties in switching systems if they so desire. The MWP 2018-2021, and its support Joint Action (eHAction) have four areas of work of which “overcoming implementation challenges” included efforts related to interoperability, e-skills for professionals, data protection and data security and evaluation, which are highly relevant.
Finally, in 25th April 2018, following a mid-term review of the DSM strategy, the European Commission felt a need to focus some of the aspects and principles of the DSM, into the specificities of modern health and future health and care in the Union. The Communication highlights the importance of advancing the Digital Transformation of Health and Care (DTHC), laying out three priorities to be followed in the coming years. This is very useful document for eHealth and Digital Health strategic planning and its three outlined priorities, to some extents relate directly to the three pillars of the DSM. Of higher relevance to this paper is pilar 1: “Citizens’ secure access to electronic health records (EHRs) and the possibility to share their records across borders, and the use of e-prescriptions”. In sequence we saw the publication of the Recommendation on the European Eletronic Health Record exchange format (EHRxF), based on which the eHealth Network approved important recommendations on the Interoperability ecosystem and funding criteria linking for the first time funding of projects and structural funds to interoperability solutions and harmonization efforts and setting the grounds for conditioning EU funding in the future Multi-Annual Financial Framework (MFF 2021-2027). The three recent tendencies of focus from the European Commission that trigger action in EU Member States, and which deserve special attention by health leaders are:
- Artificial Intelligence (AI)
- European (Health) Data Space
These are not isolated items, but rather new focus of attention within the scope of the strategies presented before. These trends are somehow future looking, necessary research and development efforts, but link to interoperability of systems and information in health as they all have two things in common: i) need for large volumes of interoperable datasets, and ii) high quality of the data, with regards to its semantic interoperability and its capacity to be a true capture of health reality.
LOST Interoperability framework, LOST-IIS, and healthcare guide for interoperability
Many years ago, the EU has adopted the famous European Interoperability Framework, which has been further refined and adapted to health into 6 layers, but the famous four, Legal, Organisational, Semantic and Technical (LOST) interoperability layers are still the best way to explain interoperability to non-technical people.
- Legal dimension includes not just law (hard law) such as GDPR or CyberSecurity legislation but also soft-law: clinical guidelines, technical guidelines and other national and EU regulators soft-law inputs. Of relevance in 2021, will be the new Medical Device Regulation and its remit and scope regarding software-as-a-medical device. A new area of complexity as many existing and future digital systems and tools will inevitably fall into this category raising the level of requirements, concerns, investment and organizational follow-up.
- When we talk about Organizational Interoperability, we talk about the capacity of two or more organizations work collaboratively on a similar or same clinical pathway, organizational flow or any other form of value-chain. Such work needs to seamlessly articulate inputs and outputs and for such organizational interoperability to exist in healthcare that requires significant level of alignment particularly at the level of human resource management and operations management.
- Semantic interoperability relates to the capacity of health data to move, between IT systems without loosing clinical and contextual meaning. A record of “severe allergy” needs to retain “severeness” at the same level when “migrated” or read on the display of a different clinical application within and between different healthcare organizations, as a simple example. For this sets of international standard terminologies such as SNOMED CT, LOINC, and clinical data models are key enablers. Training of clinical staff is paramount.
- Technical interoperability is perhaps the most familiar to most, even top managers as they have learnt to pay the price of costly non-interoperable ecosystems, yet often fail to appreciate the value of investing in open, interoperable solutions. Much more details on this are available from the Healthcare Interoperability Online guide I launched in the eHAction Joint Action.
Finally, however, I have argued that the famous LOST interoperability framework should be enhanced with two final ‘I’s’ and an ‘S’, which would stand for:
- International – or global interoperability, as more organizations need to link cross-borders
- Intelligent – advancing AI global standards for its better use in health
- Security – health information cybersecurity that presents particular challenges and requires foresight positioning and response.
A LOST-IIS approach to digital health is needed at all levels: from Global to National, and from National to local and institutional. Through a holistic global and sustained approach to digital health worldwide, I believe we will see digital health as the only way forward for Universal Health Coverage, for fair and balanced healthcare transformation. Such transformation starts in healthcare organizations but also extends to digital solutions providers who benefit from participating in forums such as, per example, HL7 Chapter Portugal or its equivalents in other countries.
Interoperability challenges and (re)Emerging Technologies
At present, the main ehealth interoperability challenges are:
- Standardization and common digital identification of professionals, and recognition of both professional categories and their respective roles and system permissions.
- Standards associated with mHealth APPs and tele-health.
- Standards adoption the area of wearables and devices, and how these link – send and receive data – to EHRs be them local, regional or national in nature.
- Detailed definition of the initial five domains of the EU EHRxF, and the rollout on the ground, namely hospitals. More details on this are to come out from X-eHealth project.
- Identification of interoperability standards associated with of cybersecurity platforms, genomic data exchange, and transfers of bulk or large volumes of health data.
- Wide adoption of Semantic Interoperability standards, namely common terminologies such as SNOMED CT, LOINC, and hybrid solutions like SNOMED-FHIR aggregates or SNOMED-LOINC mapping tables; or semantic standards for imaging reports (for example, LOINC-RadLex). This is especially important for the 3 new domains under the EHRxF.
- AI associated interoperability standard and platforms form multiple-AI based solutions.
Interoperability is much more than technical interoperability; the organizational dimensions are perhaps the least appreciated and ill-managed by healthcare organizations. Multidisciplinary boundary-spanning capacities are needed to consult and help healthcare organizations excel in how they integrate with others and integrate their services, value circles and, at the end of the day, deliver or foster better health and care.
 The DSM Strategy is available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52015DC0192; it was revised in 2017 but in essence the pillars are the same.
 The MWP 2018-2021 of the eHealth Network, follows is available at: https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20171128_co01_en.pdf
 The Communication on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society is available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2018%3A233%3AFIN
[4 ]The Joint Action to support the eHealth Network, is running from June 2018 to June 2021, coordinated by SPMS, Portugal and is named eHAction, more info at: http://ehaction.eu/
 COM(2017) 228 final, Mid-Term Review on the implementation of the Digital Single Market Strategy. A Connected Digital Single Market for All; https://eur-lex.europa.eu/content/news/digital_market.html
 Commission Recommendation on a European Electronic Health Record exchange format (C(2019)800) of 6 February 2019, https://ec.europa.eu/digital-single-market/en/news/recommendation-european-electronic-health-record-exchange-format
 eHealth Network Guidelines on an interoperable eco-system for digital health and investment programmes for a new/updated generation of digital infrastructure in Europe, https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20190611_co922_en.pdf
 For access to the Healthcare Interoperability guide please use: http://ehaction.eu/interoperability-guide/
 Henrique Martins (2020) Digital Health Diplomacy in Chained Globalised Health Context. From https://healthmanagement.org/c/healthmanagement/issuearticle/digital-health-diplomacy-in-chained-globalised-health-context
 For more information on HL7 Portugal Chapter please visit: https://www.hl7.pt/
 X-eHealth Project website: https://www.x-ehealth.eu/
 On role of interoperability technical standards, in particular FLAT FHIR, please refer to my article on HL7 Europe Newsletter 10, available from: http://www.hl7.eu/