Publications
Scientific journal:
Finnish Journal of eHealth and eWelfare (FinJeHeW), https://www.finjehew.fi
FinJeHeW is a scientific journal published jointly by the Finnish Society for Telemedicine and eHealth and the Finnish Association for Social and Health Care Informatics since 2009. The journal belongs to publication platform category 1. The ISSN of the journal is 1798-0798.
FinJeHeW welcomes scientific articles and other material related to information technology in social and healthcare services, telemedicine, and eHealth. Author guidelines are available on the journal’s website. The journal is published mainly in Finnish, but it also includes articles, abstracts, and other material in English. Manuscripts are evaluated using a double-referee peer review process. The journal publishes at least four issues per year as an online publication in PDF format. Each issue is freely available online. www.finjehew.fi.
Lääkintälaitteiden valmistajien valmistautuminen uuteen lääkintälaiteasetukseen (MDR) fi
Medical device manufacturers preparation for the new Medical Device Regulation (MDR) en
Huusko, Juhamatti; Kinnunen, Ulla-Mari; Saranto, Kaija
Tiivistelmä
Markkinoilla on enenevässä määrin lääkintälaitteita, joita käytetään potilaiden hoidossa ja potilaan itsensä suorittamassa omahoidossa. Tämä vaatii lainsäätäjiltä lainsäädännön ajantasaistamista. Lainsäädännön yksi keskeisin tarkoitus on potilasturvallisuuden varmistaminen.
Vuonna 2017 Euroopan parlamentti ja neuvosto antoivat asetuksen (2017/745) lääkintälaitteista (engl. Medical Device Regulation, MDR), joka astui voimaan toukokuussa 2017. Sen siirtymäaikaa on vuoden 2020 toukokuuhun asti, ja se korvaa aikaisemmin voimassa olleen lääkintälaitedirektiivin (93/42/ETY).
Tämän tutkimuksen tarkoituksena oli kartoittaa, minkälaista tietoa Suomessa toimivien lääkintälaitteiden valmistajilla on uudesta lääkintälaiteasetuksesta (2017/745) ja kuinka ne hankkivat lisää tietoa ennen siirtymäajan loppua. Tutkimusaineisto kerättiin kyselylomakkeella Suomessa toimivilta lääkintälaitteiden valmistajilta vuoden 2019 huhtikuussa. Kyselylomake muodostettiin Webropol-ohjelmistolla ja vastaanottajille (N=287) lähetettiin linkki kyselylomakkeeseen. Tämän lisäksi vastauslinkkiä jaettiin sosiaalisessa mediassa. Kyselyyn vastasi lääkintälaitteiden valmistajien edustajia (n=60) ympäri Suomea.
Tämä tutkimus osoitti, että tieto uuteen lääkintälaiteasetukseen (2017/745) liittyen on pirstaloitunutta ja yritykset joutuvat hakemaan tietoa useasta eri lähteestä. Yritysten mielestä tietoa on kuitenkin saatavana ja osaamisen taso on hyvää yritysten keskuudessa. Yritykset hankkivat huomattavassa määrin osaamista itsenäisesti opiskellen, mutta myös kouluttautuvat osallistumalla muun muassa Healthtech Finlandin ja regulaatiopalveluita tarjoavien asiantuntijayritysten järjestämiin koulutuksiin. Suuremmat yritykset ovat pienempiä yrityksiä paremmin valmistautuneita ja tietoisia uudesta lääkintälaiteasetuksesta (2017/745). Tämän tutkimuksen perusteella voidaan todeta, että uuden lääkintälaiteasetuksen (2017/745) alkuperäinen aikataulu oli haastava. Tähän tutkimukseen osallistuneista yrityksistä neljäsosalla oli rekisteröity lääkintälaitteita Iso-Britanniaan.
Abstract (English)
There is an increasing number of medical devices on the market that help health care providers to diagnose and treat patients. In addition, patients can use medical devices for self-care purposes. This requires legislators to update legislation. One of the main purposes of the legislation is to ensure patient safety.
In 2017, the European Parliament and the Council adopted the Regulation (2017/745) on Medical Device Regulation (MDR), which entered into force in May 2017. It has a transitional period until May 2020, and it replaces the former Medical Devices Directive (93/42/EEC).
The purpose of this study was to find out what kind of information the medical device manufacturers in Finland have about the new Medical Device Regulation (2017/745) and how they obtain information. The sample data was collected by a questionnaire in April 2019. The questionnaire was created with Webropol software and sent directly to the recipients (N=287). In addition, the questionnaire was shared in social media. In total, 60 participants responded to the questionnaire.
This study showed that information on the new Medical Device Regulation (2017/745) is fragmented and companies need to find information from multiple sources. However, companies state that the information is available and the level of knowledge among companies is good. Companies acquire a significant amount of knowledge through self-study, but they also receive more information by attending training organized by Healthtech Finland and expert companies, which provide regulatory services. Larger companies are better prepared for the regulation than the smaller companies. Based on these results, the original timetable for the new Medical Device Regulation (2017/745) was challenging. Quarter of the companies involved in this study had medical devices registered in the UK.
Avainsanat
Kanoninen lähde ja PDF: journal.fi. Tätä artikkelia ei ole kopioitu tälle palvelimelle.
Lisenssi: http://creativecommons.org/licenses/by-nc-nd/4.0
The society's 30-year history (available only in Finnish)
30 VUOTTA KEHITYKSEN KÄRJESSÄ – Suomen telelääketieteen ja e-Health seura 1995-2025, 2025,
ISBN 978-952-65791-1-5 (PDF)
The Society’s 30-Year History
30 Years at the Forefront – The Finnish Society of Telemedicine and eHealth 1995-2025, 2025.
ISBN: 978-952-65791-5-3 (pdf)
Podcasts
eHealth & Telemedicine Today – by STeHS
What’s happening in digital healthcare right now? In this podcast, STeHS brings you conversations on telemedicine, eHealth, and the evolving healthcare landscape—featuring voices from Finland and beyond.
Innovaatiot ja yrittäjyys suomalaisessa eHealthissa
This episode was recorded live at the eHealth2025 Conference, part of the 30th anniversary of the Finnish Society of Telemedicine and eHealth (STeHS). Hosts of this podcast are Titta Venho and Anna Saranlinna.In this discussion, Kalevi Virta, CEO of eWell Oy, and Arto Holopainen, Innovation Director at the City of Kuopio, share their perspectives on the development of the Finnish eHealth ecosystem, with a particular focus on innovation, entrepreneurship, and collaboration.The conversation explores how digital health has evolved in Finland over the past decades, highlighting key milestones such as mobile technologies, national digital health services, and international collaboration. The speakers reflect on the opportunities and challenges faced by startups and innovators in the health technology sector, including funding, regulation, and access to real-world testing environments.The episode also discusses the role of cities, ecosystems, and collaborative networks in supporting innovation, as well as the importance of early user engagement and cross-sector partnerships. Looking ahead, the discussion touches on future trends such as artificial intelligence, data-driven services, and the increasing demand for sustainable and scalable digital health solutions.Finally, the guests share practical advice for entrepreneurs and emphasize the need for stronger strategic leadership, long-term investment, and continued cooperation between public and private sectors to drive meaningful impact in healthcare.Note: This episode is in Finnish.Full transcript is available in https://www.telemedicine.fi/julkaisut/
Vaikuttavuus digitaalisissa terveyspalveluissa
This episode was recorded live at the eHealth2025 Conference, part of the 30th anniversary of the Finnish Society of Telemedicine and eHealth (STeHS). Hosts of this podcast are Titta Venho and Anna Saranlinna.In this discussion, Mika Perttu, Director of Digital Transformation at the City of Helsinki’s Social, Health and Rescue Division, and Minna Saranpää, Customer Manager and Social and Healthcare Specialist at Vivago Oy, explore the topic of impact and effectiveness in digital health and care services.As digitalisation continues to reshape how healthcare services are delivered, used, and evaluated, the conversation focuses on how to ensure that digital solutions truly create value for patients, professionals, and society. The speakers discuss how effectiveness can be defined, measured, and integrated into service development and decision-making.The episode highlights practical examples from both public and private sectors, addressing challenges such as fragmented systems, limited resources, and the need for better data-driven leadership. It also explores the future role of digital tools, including artificial intelligence and remote care, in improving outcomes and enabling more proactive and personalised healthcare services.Note: This episode is in Finnish.Full transcript is available: https://www.telemedicine.fi/julkaisut/
Women around the world in health care digitalisation
This episode was recorded live at the eHealth2025 Conference, part of the 30th anniversary of the Finnish Society of Telemedicine and eHealth (STeHS). Hosts of this podcast are Titta Venho and Anna Saranlinna.In this discussion, Dr Michelle Griffith, President of ISfTeH, a physician specializing in internal, lifestyle, and integrative medicine with over 30 years of clinical experience, and Professor Pirkko Kouri, Vice President of ISfTeH and a Finnish expert in health informatics and digital health education, explore the theme Women Around the World in Healthcare Digitalisation.Together, they reflect on how gender shapes the development, leadership, and use of digital health services across different cultural and global contexts. The conversation highlights both the challenges women face in technology-driven environments and the critical role they play in designing more inclusive, holistic healthcare solutions.The episode also offers insights into international collaboration, leadership experiences, and practical advice for women aiming to make an impact in the rapidly evolving field of telemedicine and eHealth.Full transcript will be available in: https://www.telemedicine.fi/julkaisut/
Jaksot päivittyvät tälle sivulle automaattisesti. Kaikki jaksot myös Spotifyssa.
Conference publications:
- XXXI Kansallinen ja kansainvälinen Telelääketieteen ja eHealth konferenssi, #eHealth2026: Effective digital solutions in health care and social welfare services, 2026, ISBN 978-952-65791-4-6 (PDF)
- XXX Kansallinen telelääketieteen ja eHealth seminaari, #eHealth2025: Strengthening Interoperability and Equality in Digital Health with Nordic Innovations, 2025, ISBN 978-952-65791-3-9 (PDF)
- XXIX National Seminar on Telemedicine and eHealth, #eHealth2024: From Research to Impact on Digital Health and Welfare Services, 2024, ISBN 978-952-69224-9-2 (PDF)
- XXVIII National Telemedicine and eHealth Seminar, #eHealth2023: Human oriented approach in eHealth and digital services, 2023, ISBN 978-952-69224-8-5 (pdf)
- XXVII National Telemedicine and eHealth Seminar, #eHealth2022: Digital Health – from Research to Applied Solutions, 2022, ISBN 978-952-69224-6-1 (PDF)
- XXVI National Telemedicine and eHealth Seminar, #eHealth2021: eHealth in a Lifecycle, 2021, ISBN: 978-952-69224-4-7 (pdf)
- XXV National Telemedicine and eHealth Seminar, eHealth2020: From Dream to Reality, 2020, ISBN: 978-952-69224-2-3 (pdf)
- XXIV National Telemedicine and eHealth Seminar, eHealth2019: Data-Driven Health, 2019, ISBN: 978-952-68112-9-1 (pdf)
- XXII National Telemedicine and eHealth Seminar, eHealth2018: Health communities facing cyber transformation, 2018, ISBN: 978-952-68112-8-4 (pdf)
- XXII National Telemedicine and eHealth Seminar, Win-Win-Win, for citizens, professionals and society, 2017, ISBN: 978-952-68112-6-0 (pdf)
- XXI National Telemedicine and eHealth Seminar, Nordic eHealth2016 Culture of experimentation and digitalisation, 2016, ISBN: 978-952-68112-4-6 (pdf)
- XX National Telemedicine and eHealth Seminar, eHealth, an engine for change, 2015, ISBN: 978-952-68112-2-2 (pdf)
- XIX National Telemedicine and eHealth Seminar, Towards effective eHealth, 2014, ISBN: 978-952-67213-9-2 (pdf)
- XVIII Kansallinen telelääketieteen ja eHealth seminaari: Teknologiatalkoilla parempiin hoitotuloksiin, 2013, ISBN: 978-952-67213-8-5 (pdf)
- XVII Kansallinen telelääketieteen ja eHealth seminaari: Tietoa tarpeeseen, 2012, ISBN: 978-952-67213-6-1 (pdf)
- XVI Kansallinen telelääketieteen ja eHealth seminaari: Maalta maailmalle – Aluemalli terveyspalveluiden kehittämisessä, 2011, ISBN: 978-952-67213-4-7 (pdf)
- XV Kansallinen telelääketieteen ja eHealth seminaari: Katse yli rajojen, 2010, ISBN: 978-952-67213-2-3 (pdf)
- XIV Kansallinen telelääketieteen ja eHealth seminaari: Terveyttä verkosta ja verkostosta, 2009, ISBN: 978-952-67213-0-9 (pdf)
- XIII Kansallinen telelääketieteen ja eHealth seminaari: e-Health kansalaisen palveluksessa, 2008 (pdf)
