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Burden, H. & Stenberg, S. (2025). An intermediate governance model for EU regulatory sandboxes. RISE Research Institutes of Sweden
Open this publication in new window or tab >>An intermediate governance model for EU regulatory sandboxes
2025 (English)Report (Other academic)
Abstract [en]

The purpose of this document is to present a first attempt to define what to consider when establishing an EU regulatory sandbox from a perspective of management. We do this by summarising and synthesizing both the principles laid out in the relevant EU regulations, our own case-based research and by including other sources we found relevant to governing regulatory sandboxes.

In short, we present an intermediate governance model for regulatory sandboxes. By intermediate we mean both as a step between the current situation and the future when best practice for conducting regulatory sandboxes is established, as well as to show shared aspects of governance across the different kinds of regulatory sandboxes. Our primary audience are the authorities that will establish or be involved in the operations of the regulatory sandboxes. The outlined model may of course be adapted by other organisations, as well as to the specific contexts of the case at hand.

This report is a deliverable from the pre-study Forsa (Förstudie om regulatoriska sandlådors roll för AI-baserad innovation, Vinnova dnr. 2024-01668), which is a research project funded by the Swedish innovation agency and conducted by Theo Andersson, Mats Snäll and Jeanna Åkerman at the Swedish Agency for Digital Government and Håkan Burden and Susanne Stenberg at RISE Research Institutes of Sweden. The ambition with Forsa was to explore the role of and cooperation among public authorities in relation to AI-based innovation in regulatory sandboxes.

Place, publisher, year, edition, pages
RISE Research Institutes of Sweden, 2025. p. 21
Series
RISE Rapport ; 2025:82
Keywords
Artificial Intelligence, Cyber Resilience, European Health Data Space, Interoperable Europe, Medicine for Human Consumption, Net-Zero Industry, Quality Management System
National Category
Law
Identifiers
urn:nbn:se:ri:diva-78781 (URN)978-91-90036-70-9 (ISBN)
Available from: 2025-09-05 Created: 2025-09-05 Last updated: 2025-09-23Bibliographically approved
Burden, H. & Stenberg, S. (2025). EU regulatory sandboxes - An opportunity for coordinating AI Innovation. RISE Research Institutes of Sweden
Open this publication in new window or tab >>EU regulatory sandboxes - An opportunity for coordinating AI Innovation
2025 (English)Report (Other academic)
Abstract [en]

The aim of the report is to make the synergies between the EU’s different regulatory sandboxes explicit. A specific focus is on the role of and coordination among public authorities in respect to AI-driven innovation, with the aim to prevent silo management by giving concrete examples of how the initiatives interact and complement each other. We provide insights in how regulatory sandboxes, and similar initiatives, can be explored together, even if some will not come into force until 2029.

In short, our analysis is that regulatory sandboxes shall support innovation by clarifying how to apply certain rules to innovative systems and technologies. This is done with the involvement of relevant authorities and under contextual constraints.

The similarities across EU’s regulatory sandboxes, and the overlap in scope, opens for a governance structure that focuses on regulatory guidance for innovative and complex products, instead of establishing silo management based on individual regulations.

The AI Act establishes regulatory sandboxes for AI-driven innovation. From our study we propose to start now, through the regulatory sandboxes established by the Interoperable Europe Act and the Net-Zero Industry Act, and transfer the understanding of how to establish and govern regulatory sandboxes to AI regulatory sandboxes and related initiatives, such as the Cyber Resilience Act and the European Health Data Space.

This report is a deliverable from the pre-study Forsa, which is a research project funded by the Swedish innovation agency and conducted by Theo Andersson, Mats Snäll and Jeanna Åkerman at the Swedish Agency for Digital Government and Håkan Burden and Susanne Stenberg at RISE Research Institutes of Sweden.

Place, publisher, year, edition, pages
RISE Research Institutes of Sweden, 2025. p. 25
Series
RISE Rapport ; 2025:81
Keywords
Artificial Intelligence, Cyber Resilience, European Health Data Space, Interoperable Europe, Medicine for Human Consumption, Net-Zero Industry
National Category
Law
Identifiers
urn:nbn:se:ri:diva-78780 (URN)978-91-90036-69-3 (ISBN)
Available from: 2025-09-05 Created: 2025-09-05 Last updated: 2025-09-23Bibliographically approved
Burden, H., Stenberg, S. & Bronson, J. (2025). Grid stability and market disruption – a policy analysis from the perspective of bi-directional charging: Deliverable 5.3.. SCALE Smart Charging Alignment for Europe
Open this publication in new window or tab >>Grid stability and market disruption – a policy analysis from the perspective of bi-directional charging: Deliverable 5.3.
2025 (English)Report (Other academic)
Abstract [en]

SCALE (Smart Charging Alignment for Europe) is a three-year Horizon Europe project that aims at preparing EU cities for mass deployment of electric vehicles and the accompanying smart charging infrastructure.

Place, publisher, year, edition, pages
SCALE Smart Charging Alignment for Europe, 2025. p. 18
National Category
Electrical Engineering, Electronic Engineering, Information Engineering
Identifiers
urn:nbn:se:ri:diva-78759 (URN)
Note

SCALE is funded by the European Union’s Horizon Europe Research and Innovation programme under Grant Agreement No 101056874.

Available from: 2025-08-21 Created: 2025-08-21 Last updated: 2025-09-23Bibliographically approved
Fahria, K., Mowla, N. & Stenberg, S. (2025). Human-Centric Ground Truth Evaluation and Acceptance (Hu-GTVA): An Oversight by Design process for RAG-LLM evaluation. Borås: RISE Research Institutes of Sweden
Open this publication in new window or tab >>Human-Centric Ground Truth Evaluation and Acceptance (Hu-GTVA): An Oversight by Design process for RAG-LLM evaluation
2025 (English)Report (Other academic)
Abstract [en]

We present Hu-GTVA, a framework for human-grounded test case generation, validation, and acceptance designed to create contextual ground truths for the evaluation of retrieval-augmented generation (RAG) systems in high-stakes public-sector contexts. The framework addresses the challenge of aligning RAG system evaluations with expert-grounded domain knowledge by combining automated test case generation, structured expert annotation, and dual-review protocols. We demonstrate its application in collaboration with the Swedish National Financial Management Authority (ESV), where it supports the evaluation of Konsekvenshjälpen, a RAG-LLM system for regulatory impact assessment assistance. Hu-GTVA takes conceptual motivation from both the principle of Oversight by Design and the regulatory requirement of Human Oversight under Article 14 of the EU AI Act. Oversight by Design emphasizes integrating oversight considerations already during the design phase, while Human Oversight defines who, when, and what must be governed to ensure accountable AI use. Drawing from both, Hu-GTVA introduces structured expert review, acceptance criteria, and quantitative agreement metrics to bring human judgment into the evaluation process before deployment. Designed for modularity and domain adaptability, the framework can be extended to other high-risk settings such as healthcare or critical infrastructure. Hu-GTVA offers a reproducible and human-centered pre-hoc RAG-LLM evaluation pipeline.

Place, publisher, year, edition, pages
Borås: RISE Research Institutes of Sweden, 2025. p. 30
Series
RISE Rapport
Keywords
Human oversight, oversight by design, ground truth, RAG, RAG LLM, RAG evaluation, RAGChecker, RAGAS, TruLens
National Category
Computer Sciences
Identifiers
urn:nbn:se:ri:diva-80077 (URN)978-91-90109-25-0 (ISBN)
Available from: 2025-12-22 Created: 2025-12-22 Last updated: 2025-12-22Bibliographically approved
Lundahl, J., Benmayor, A., Linåker, J., Östling, A., Nordell, E., Wernicke, P., . . . Stenberg, S. (2025). Report on existing regulatory frameworks and governance mechanisms for mobility data sharing. deployEMDS Consortium
Open this publication in new window or tab >>Report on existing regulatory frameworks and governance mechanisms for mobility data sharing
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2025 (English)Report (Other academic)
Abstract [en]

This report provides an overview of regulatory frameworks and governance mechanisms for mobility data sharing in Europe. It analyses governance principles, organisational, legal, and technical challenges, and reviews local implementation sites using Ostrom’s principles. The report also examines EU legislation relevant to mobility data spaces, including GDPR, Data Act, Data Governance Act, AI Act, and ITS Directive, highlighting their implications for interoperability, data access, and compliance. Recommendations focus on embedding governance and legal considerations into the design of European Mobility Data Space (EMDS) to ensure trust, transparency, and sustainability.

Place, publisher, year, edition, pages
deployEMDS Consortium, 2025. p. 131
Keywords
Mobility data, data sharing, data governance, data space, policy and regulation, legal landscape
National Category
Other Legal Research
Identifiers
urn:nbn:se:ri:diva-80080 (URN)
Note

Deliverable: D3.1; Grant Agreement: 101123520; Project: deployEMDS

Available from: 2025-12-30 Created: 2025-12-30 Last updated: 2025-12-30Bibliographically approved
Burden, H., Stenberg, S., Nilsson, E. & Petersson, C. (2025). Slutrapport Policy Lab Urban Zjöfart. RISE Research Institutes of Sweden
Open this publication in new window or tab >>Slutrapport Policy Lab Urban Zjöfart
2025 (Swedish)Report (Other academic)
Abstract [en]

Urban waterways can play an important role in making cities and communities more attractive with a positive effect on congestion. Electrified mobility solutions utilising waterways can also offer climate-smarter alternatives than new construction of bridges and roads. An example is smaller ships that enable pedestrians and cyclists to move swiftly between areas within a city. Smart and electrified ferries thus offer new perspectives for urban planning and citizen mobility in relation to sustainable development. Unlike for road traffic, where various trials with autonomous vehicles are already taking place, there is a lack of trials of smart ships on Swedish waters. One of the reasons is that there is uncertainty about what can and cannot be done, as well as how to know when smart ships are reasonably safe for the intended usage. That uncertainty has been addressed through two trials with the smart ship MS Estelle in Stockholm, Sweden. The trials have been carried out in relation to the Swedish Transport Agency's guidelines for tests with smart ships, including a safety argumentation for each trial.

The project has thus resulted in: 1. An analysis of how responsibilities and roles change when tasks that traditionally are carried out onboard the ship are instead performed remotely from shore 2. The world's first notification of trials with smart ships in Swedish waters 3. A safety argument for trialling remote monitoring of MS Estelle while completing a crossing of Riddarfjärden, Stockholm, in autonomous mode

The project took place between February 2023 and February 2025. The active partners were Torghatten AB, Zeabuz, RISE Research Institutes of Sweden AB, Ports of Stockholm, DNV AB and Vattenbussen AB with funding by the Swedish Transport Administration’s grant number 2022/108255. Vattenbussen took part in the project until January 2024.

Place, publisher, year, edition, pages
RISE Research Institutes of Sweden, 2025
Keywords
Remote operations, ROC, fjärrövervakning, säkerhetsargumentation, smarta fartyg, anmälan om test.
National Category
Transport Systems and Logistics
Identifiers
urn:nbn:se:ri:diva-78256 (URN)978-91-89821-87-3 (ISBN)
Available from: 2025-03-10 Created: 2025-03-10 Last updated: 2025-09-23Bibliographically approved
Nordström, E., Lööf, J., Forsman, F., Carlgren, L., Vega, M., Tidholm, S., . . . Malmström, B. (2025). SOCIAL HÅLLBARHET TILL SJÖSS.
Open this publication in new window or tab >>SOCIAL HÅLLBARHET TILL SJÖSS
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2025 (Swedish)Report (Other academic)
Abstract [sv]

För att branschen ska klara framtida kompetensförsörjning behöver sjöfart vara ett attraktivt yrkesval för fler än idag. När vi säger att sjöfart är för alla behöver det också upplevas på det sättet och med det följer ett aktivt arbete för en inkluderande arbetsplatskultur. Denna rapport beskriver hur Redo2 har arbetat fram verktyg och metoder för att i praktiken stötta rederier, befäl och medarbetare i denna riktning.

Vi har valt att arbeta med de tre hörnstenarna trygghet, inkludering och motivation som bidrag till en bra social arbetsmiljö. Målet är att skapa en bransch där alla, oavsett kön eller bakgrund, känner sig trygga och inkluderade.

Att utveckla den sociala arbetsmiljön är en del av social hållbarhet och arbetsmiljöarbetet och bör därför ha förebyggande åtgärder på alla nivåer. Arbetsplatskultur måste vara en del av det ordinarie arbetsmiljöarbetet och bäras av både ledare och medarbetare. För att åstadkomma en hållbar förändring behöver vi arbeta med både strukturer och relationer ombord.

De huvudsakliga leveranserna består av verktyg och metoder för att främja en inkluderande arbetsplats. Ledarskapsutbildning för sjöbefäl på Chalmers bygger nu på principerna för psykologisk trygghet och en kurs för yrkesverksamma med samma tema har utvecklats. Trygga rum för samtal och Årshjulet är två omfattande workshopserier med förebyggande insatser att använda på arbetsplatsträffar ombord. I samma anda har vi undersökt möjligheter och utmaningar med spelifiering av metodmaterial i Challenge Archipelago. Dessutom har nu WISTA Sweden ett mentorprogram för kvinnliga sistaårselever på sjöbefäls- och logistikprogram och på Sjöfartsverket är ett nätverk för kvinnor inom operativ verksamhet igång. Projektet har också ägnat uppmärksamhet åt livspusslet för ombordanställda föräldrar, slagit hål på en del myter och lyfter fram rekommendationer för framtiden.

Rapporten beskriver sammanfattat projektets resultat. De fem annexen beskriver hur dessa resultat har arbetats fram tillsammans med samarbetspartners och rederier. Metodmaterialen finns med som bilagor till annex 2-4.

National Category
Production Engineering, Human Work Science and Ergonomics
Identifiers
urn:nbn:se:ri:diva-78000 (URN)
Note

REDO2 är ett projekt finansierat av Trafikverkets sjöfartsportfölj som pågått2022-2024 under ledning av RISE.

Annex 1. PSYKOLOGISK TRYGGHET av Fredrik Forsman (Chalmers), Cajsa Jersler Fransson (Sjöfartsverket), Jill Jarnsäter (Sjöfartsverket) och Lisa Carlgren (RISE).

Annex 2.  TRYGGA RUMFÖR SAMTAL OMBORD av Marco Vega (MÄN), Eva Nordström (Sjöfartsverket) och Viktoria Sjöholm.

Annex 3.  ÅRSHJULET WHEEL OF INCLUSION av Sara Fallahi (RISE), Amanda Sundström (RISE), Erik Einebrant (RISE), Carolina Kihlström (Svensk sjöfart), Madeleine Säll (Svensk sjöfart), Cajsa Jersler Fransson (Sjöfartsverket), Jill Jarnsäter (Sjöfartsverket) och Eva Nordström (Sjöfartsverket).

Annex 4. STÖDJANDE STRUKTURER FÖR KVINNOR TILL SJÖSS av Cajsa Jersler Fransson (Sjöfartsverket), Eva Nordström (Sjöfartsverket) och Jill Jarnsäter (Sjöfartsverket).

Annex 5.  POLICYLABB LIVSPUSSLET FÖR OMBORDANSTÄLLDA FÖRÄLDRAR av Lisa Carlgren (RISE), Susanne Stenberg (RISE), Håkan Burden (RISE) och Benjamin Malmström (Sjöfartsverket).

Available from: 2025-03-03 Created: 2025-03-03 Last updated: 2025-09-23Bibliographically approved
Lundahl, J., Månsson, A. & Stenberg, S. (2024). D3.2 Lokalt delad el – juridiska utmaningar och möjligheter.
Open this publication in new window or tab >>D3.2 Lokalt delad el – juridiska utmaningar och möjligheter
2024 (Swedish)Report (Other academic)
Publisher
p. 41
National Category
Law
Identifiers
urn:nbn:se:ri:diva-76337 (URN)
Note

”Systemförändring med lokalt delad energi – en samhällsekonomiskt lönsam modell” är ett forskningsprojekt finansierat av Energimyndigheten inom programmet Pilot och demo.

Available from: 2025-01-02 Created: 2025-01-02 Last updated: 2025-09-23Bibliographically approved
Burden, H. & Stenberg, S. (2024). Fit for purpose – Data quality for Artificial Intelligence. RISE Research Institutes of Sweden
Open this publication in new window or tab >>Fit for purpose – Data quality for Artificial Intelligence
2024 (English)Report (Other academic)
Abstract [en]

The rise of Artificial Intelligence has put data and data quality at the core of digitalisation. At the same time there seems to be a need to better understand what is meant by data quality and how to ensure it is at hand. Our first attempt to start the discussion was made at the Data Space Symposium in Darmstadt in March 2024. In terms of contribution this report is an increment to the slideshow by giving further examples of how data quality is defined and put into use at the same time as highlighting the contextual properties of data quality and the need for human judgement. We do this from a policy perspective, i.e. grounding our analysis in regulations and standards. Our analysis starts with the legal reasonings on data quality found in the AI Act and the European Health Data Space regulation. Our ambition is not to be exhaustive, there are more EU regulations and directives to consider in relation to data quality than the ones we cover here – such as the directive on Copyright in the Digital Single Market that introduces the concept of text and data mining; the Data and Data Governance Acts that enable standardised formats for making data interoperable across services; and the Digital Service and Market Acts that define responsibilities in terms of making data and information available. Among others. The same goes for standards on data quality which span across specific domains and disciplines. Coming back to our ambition, we believe it is important to raise the question to what extent data quality can be automatically assessed, as this is an ambition floated at various events and foras within the data community. While we think this can be achieved for specific and narrow contexts, we argue that data quality is a topic that still requires judgement and the competence to make assessments on a case-by-case basis.

Place, publisher, year, edition, pages
RISE Research Institutes of Sweden, 2024. p. 15
Series
RISE Rapport ; 2024:57
Keywords
Policy labs, Regulatory development, AI Act, Standards, Public sector, Innovation, Research
National Category
Computer and Information Sciences
Identifiers
urn:nbn:se:ri:diva-74929 (URN)978-91-89971-17-2 (ISBN)
Available from: 2024-08-19 Created: 2024-08-19 Last updated: 2025-09-23Bibliographically approved
Sjöblom, T., Olsson, R., Petersson, C., Pramanik, R., Sanfridson, M., Olsson, F., . . . Burden, H. (2024). Virtual wires as a safety-enhancing concept.
Open this publication in new window or tab >>Virtual wires as a safety-enhancing concept
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2024 (English)Report (Other academic)
Alternative title[sv]
Virtuella vajrar som säkerhetshöjande koncept för inrikes sjöfart
Abstract [en]

This research project investigates the feasibility and potential benefits of implementing virtual guide wires as a safety enhancement measure for Swedish national waters, inspired by the Finnish Virtual Wire system developed by Finferries. The study focuses on cable ferry operations and functionalities, highlighting the variations in cable ferry and guide wire designs that are often influenced by specific route requirements.

A novel concept of a virtual wire system is proposed, mirroring the safety features of cable-driven ferries, guide wire ferries, and the Finnish virtual wire system, while incorporating an advanced safety features from automation system designed for self-driving ferries. Traditional guide wires, while aiding the own ships navigation, present challenges for others, such as obstructing maritime traffic, disturbing bottom sediments, limited use in ice conditions, and is restricted to routes with straight paths.

The project aims to enhance the safety and operational efficiency of both guide wire ferries and ferries. A significant driver for this research is the industry's difficulty in hiring qualified ferry operators, a trend expected to intensify in the future.

The Finnish virtual wire system, which is a digital navigation aid that provides real-time positional and directional information, was investigated. It utilizes GNSS data with RTK correction for accuracy and offers visual and audible feedback similar to a traditional guide wire. Cabel driven ferries operate very predictable and on a very limited geographical area. Advance automation system including auto docking, departure and position keeping along with traffic collision avoidance aid. A combination of listed functionalities are brought into the novel concept of a virtual wire system is proposed.

To assess the virtual wire's system, various risk assessment methods were challenging as the system influence the whole ferry operation and systems onboard and ashore. Following risk assessment methods was explored including RBAT, HAZID, Mitigation Analysis, D-FMEA, Fault Tree - Event Tree - Bow Tie Diagram, and What-if Analysis.

The project concludes that while virtual wire systems hold promise, comprehensive real-life testing and evaluation in the Swedish context are necessary. Factors such as operator training, system maintenance, regulatory framework, infrastructure integration, and public perception must be carefully considered for successful implementation.

Abstract [sv]

Forskningsstudien har undersökt möjligheterna och fördelar med införande av virtuella vajrar som ett säkerhetshöjande koncept för svensk inrikes sjöfart, inspirerad av det finska virtuella vajersystemet utvecklat av Finferries. Studien fokuserar på linfärjor med styrvajer, och belyser skillnaderna olika typer av linfärjor som ofta påverkas av specifika ruttkrav. Ett nytt koncept av ett virtuellt vajersystem föreslås, som speglar säkerhetsfunktionerna hos kabeldrivna färjor, linfärjor och det finska virtuella vajersystemet, samtidigt som det använder avancerade säkerhetsfunktioner från automationssystem designade för självgående färjor. Traditionella styrlinor, medan de hjälper den egna fartygets navigering, medför utmaningar, såsom att hinder för passerande sjötrafik, rör upp bottensediment, begränsad användning i isförhållanden och är inskränkta till rutter med raka vägar. Projektet syftade till att förbättra säkerheten och driftseffektiviteten för både linfärjor och färjor. En stor drivkraft för denna studie är svårigheten att anställa kvalificerade färjepersonal, en trend som förväntas förvärras framöver. Det finska virtuella vajersystemet som varit inspirationen för studien är ett digitalt navigationshjälpmedel som tillhandahåller realtidspositionerings- och riktningsinformation. Det använder GNSS-data med RTK-korrigering för noggrann positionering och erbjuder audiovisuell feedback liknande en traditionell linfärjeled. Vajerdrivna färjor opererar mycket förutsägbart och på ett mycket begränsat geografiskt område. Avancerade automationssystem inkluderar automatisk dockning, avgång och positionshållning tillsammans med beslutsstöd för att hantera trafiksituationer. En kombination av listade funktioner införs i det nya konceptet av ett virtuellt vajersystem. För att bedöma riskerna med ett nytt system har en kombination av olika riskbedömningsmetoder så som RBAT, HAZID, Mitigation Analysis, D-FMEA, Fault Tree - Event Tree - Bow Tie Diagram och What-if Analysis nyttjats. Utöver riskanalyser har RISE policylabb studerat de legala aspekterna och frågor lyfts med relevanta aktörer på workshops. Praktiska försök i Sverige och Finland med olika sensorer och tekniska lösningar har resulterat i ett förslag på koncept som behåller det enkla och rättframma med en traditionell linfärja, men med digitala stöd istället för fysisk vajer. Tillsammans med Zeabuz genomfördes en lyckad demonstration av konceptet på Riddarfjärden med färjan Estelle. Virtuella vajrar i större skala har potential att öka effektiviteten, minska energiåtgången, underlätta rekrytering och kan sänka tröskeln i from av investeringar i infrastruktur för nya färjelinjer på platser som inte tidigare varit aktuella för linfärjor. Projektet drar slutsatsen att även om virtuella systemsystem har potential, är omfattande tester och utvärdering i svensk kontext nödvändiga. Faktorer som operatörsutbildning, systemunderhåll, regelverk, infrastrukturintegration och allmänhetens uppfattning måste övervägas om implementeringen skall bli framgångsrik.

Publisher
p. 63
Keywords
Virtual wires, Cable-driven ferries, Maritime safety, Navigation aid, Maritime regulations
National Category
Vehicle and Aerospace Engineering
Identifiers
urn:nbn:se:ri:diva-78254 (URN)
Funder
Swedish Transport Administration, 2022/108225
Note

RISE Report : P117285 Virtuella vajrar som säkerhetshöjande koncept. Trafikverket projektnummer: TRV 2022/108225

Available from: 2025-03-07 Created: 2025-03-07 Last updated: 2025-09-23Bibliographically approved
Organisations
Identifiers
ORCID iD: ORCID iD iconorcid.org/0000-0001-9215-3896

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