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Bridging Semantic Interoperability and Trustworthy AI: Towards a Common Framework for High-Risk AI Medical Devices under the EU AI Act and ISO Standards

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A critical topic for future discussion is the convergence between clinical information interoperability standards—such as ISO 13606, ISO 13940, and HL7 FHIR—and emerging standards for artificial intelligence under development within ISO/TC 215 Task Force 5 and ISO/IEC JTC 1/SC 42. This alignment is essential for operationalising the EU Artificial Intelligence Act in synergy with the Medical Device Regulation (MDR), particularly for high-risk AI systems deployed as medical technologies. The harmonisation of health information models with AI-related terminologies, ethical frameworks, and interoperability requirements offers a path towards technically robust and regulation-ready AI systems. By encoding patient context, consent, clinical reasoning, and system constraints using established semantic models, these standards can provide the traceability, accountability, and transparency demanded by European regulatory frameworks. Beyond compliance, such convergence would foster greater trust and adoption of AI in clinical settings, reinforcing the safe and meaningful integration of AI into the fabric of health systems.

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Synergies Among Health Data Projects with Cancer Use Cases based on Health Standards

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Synergies Among Health Data Projects with Cancer Use Cases based on Health Standards. Stud Health Technol Inform. Gyrard A, Gribbon P, Hussein R, Abedian S, Bonmati LM, Cabornero GL, et al. Accepted (Full-paper). In: Medical Informatics Europe 2024 (MIE 2024). In press.

Amelie Gyrard, Philip Gribbon, Rada Hussein, Somayeh Abedian, Luis Marti Bonmati, Gibi Luisa Cabornero, George Manias, Gabriel Danciu, Stefano Dalmiani, Serge Autexier, Rick van Nuland, Mario Jendrossek, Ioannis Avramidis, Eva Garcia Alvarez

We are creating a synergy among European Health Data Space projects (e.g., IDERHA, EUCAIM, ASCAPE, iHELP, Bigpicture, and HealthData@EU pilot project) via health standards usage thanks to the HSBOOSTER EU Project since they are involved or using standards, and/or designing health ontologies. We compare health-standardized models/ontologies/terminologies such as HL7 FHIR, DICOM, OMOP, ISO TC 215 Health Informatics, W3C DCAT, etc. used in those projects.

https://ebooks.iospress.nl/doi/10.3233/SHTI240649

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What is eHEALTH?

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I am often asked, “What is eHEALTH?”  

Suno Wood, Chair, ETSI TC eHEALTH

eHEALTH is not a single entity. It is a merging of many information and communication technologies and their attendant standards that work together to provide and constantly improve the provision of health services. eHEALTH equipment is essentially contextual in healthcare. Wellness and fitness data form an integral part of our information stream from before the cradle to beyond the grave as we add genetics to the diagnostic mix.

We view the Green Deal as an important development. Clean air and water are the building blocks of health and today’s ICT standards contribute to their availability. We expect medical devices to be enhanced with greater connectivity. eHEALTH will envelope IoT, wearables, and the use of AI without making them specifically, “medical.” We will encourage sustainability, and a better understanding of environmental waste versus contamination.

There are many areas in which standards could be developed to support the Green Deal and the new industrial policies in Europe. However, there are also challenges to be faced which we aim to tackle in our technical group. For example, emphasis in the Green Deal is placed on the reuse of equipment and clothing. Whilst many have criticised the over abundant use of single use medical instruments and PPE, few would dispute that strict adherence to single use practice has slowed the spread of the recent pandemic and continues to protect the most vulnerable members of our society. There can be no compromise in health safety but new ways of reducing the burdens of single use need to be found if we are not to turn the clock back and discard the practice. This includes record keeping, storage and transport, areas where IoT has a clear role to play.

Technology in health services requires constant updating and improvement to provide ever-better care for the patient. In order for this to be effective, technical standards must aid the process. This, for example will support new methods of diagnosis, particularly as AI is implemented, in areas such as cancer diagnosis, pharmaceuticals, monitoring and control. Examples are too many to enumerate which is why our group has studied, with the support of StandICT, a range of generic issues, such as Use Cases and Data Sharing which are important to the eHEALTH community and to European society in a wider context.

Finally, I would add that TC eHEALTH discussions on standards always include an awareness of the European respect for Human Rights issues which may arise as a result of new technologies to be employed in the health environment.

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Challenges and limitations for transforming ISO13606-3 clinical reference information structures (CRIS) based on ISO13606-1 archetypes and CONTSYS concepts into HL7 FHIR schemas.

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Working we are developing in ISO TC 215 WG1 - AWI TR 24305 "Health informatics - Guidelines for implementation of HL7/FHIR based on ISO 13940 and ISO 13606", and specifically in mapping FHIR resources with ISO13606-3 Clinical Reference Information Structures (CRIS) based on ISO13606-1 archetypes and CONTSYS concepts, we have identified a certain number of challenges and limitations and expect from the community contributions to address the challenges. For example: 
Should we map FHIR profiles or FHIR resources?
Perhaps mapping FHIR profiles with the generation of reference archetypes should be the objective because it would mean an absolute harmonization when mapping dynamic processes. Still, to discover these similarities, we must do it by abstraction after the practical and direct work of mapping FHIR resources with their attributes, reference archetypes, and elements, which should reveal the limitations and restrictions of each attribute/information element in each case.

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eHEALTH and AI

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eHEALTH issues are often high on the list of potential applications of AI - but these are difficult to quantify and narrow down to the clear focus required for a standardization Work Item. We are looking for a way to address this. eHEALTH concerns include Human Rights and support for health living for the elderly, but most AI applications are for a much wider audience. Can you recommend an eHEALTH application for AI which needs a new standard to be written? or do we wait for other groups to pick up the baton?

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Knowledge Engineering Framework for IoT Robotics Applied to Smart Healthcare and Emotional Well-Being

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  • Knowledge Engineering Framework for IoT Robotics Applied to Smart Healthcare and Emotional Well-Being. Amelie Gyrard, Kasia Tabeau, Laura Fiorini, Antonio Kung, Eloise Senges, Marleen De Mul, Francesco Giuliani, Delphine Lefebvre, Hiroshi Hoshino, Isabelle Fabbricotti, Daniele Sancarlo, Grazia D’Onofrio, Filippo Cavallo, Denis Guiot, Estibaliz Arzoz-Fernandez, Yasuo Okabe, Masahiko Tsukamoto. International Journal of Social Robotics 2021. Springer Nature.
  • URL: https://link.springer.com/article/10.1007/s12369-021-00821-6
  • Abstract: Social companion robots are getting more attention to assist elderly people to stay independent at home and to decrease their social isolation. When developing solutions, one remaining challenge is to design the right applications that are usable by elderly people. For this purpose, co-creation methodologies involving multiple stakeholders and a multidisciplinary researcher team (e.g., elderly people, medical professionals, and computer scientists such as roboticists or IoT engineers) are designed within the ACCRA (Agile Co-Creation of Robots for Ageing) project. This paper will address this research question: How can Internet of Robotic Things (IoRT) technology and co-creation methodologies help to design emotional-based robotic applications? This is supported by the ACCRA project that develops advanced social robots to support active and healthy ageing, co-created by various stakeholders such as ageing people and physicians. We demonstra this with three robots, Buddy, ASTRO, and RoboHon, used for daily life, mobility, and conversation. The three robots understand and convey emotions in real-time using the Internet of Things and Artificial Intelligence technologies (e.g., knowledge-based reasoning).

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Call for experts to work on ISO 13606-3 and FHIR R4 mapping with Covid19 use case on ISO/AWI TR 24305 Health informatics - Guidelines for implementation of HL7/FHIR based on ISO 13940 and ISO 13606

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Dear experts.

In the scope of work of ISO/AWI TR 24305 Health informatics - Guidelines for implementation of HL7/FHIR based on ISO 13940 and ISO 13606 is currently developing a proposal for mapping HL7 FHIR R4 resources with: ISO 13606-1 (archetypes), ISO 13940 (continuity of care concepts) and with ISO 13606-3 CRIS (Clinical Reference Information Structures).
This activity has been organized in 3 WPs. Each of them is working on mapping FHIR resources with each of the ISO standards.
In WP 2, in which I am chair, we are working on FHIR mapping with reference archetypes.
Moving forward, we are working with a set of archetypes on patient healthcare from Covid19.
Next December 17 at 11 30 we will have a work package meeting. I encourage those interested in participating to contact me.

My email is carlos.parra.sspa@juntadeandalucia.es

Thanks for your interest.

Carlos.

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Healthcare Data Management and Blockchain: Use Cases

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Health data is personal data and thus falls under the EU’s General Data Protection Regulation (GDPR). Hence data security and privacy preservation should be addressed in every step of the data processing flow.

The privacy preserving approaches of two EU Horizon 2020 projects in healthcare data management deserve special attention. These projects applying blockchain technology are MyHealthMyData (MHMD) and PharmaLedger. These could serve as blueprints for the development of data flow standards for blockchain use cases.

Detailed information on the two projects is available under:

https://pharmaledger.eu/

http://www.myhealthmydata.eu/

Date: November 11, 2021

Author: Galia Kondova

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