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The European Parliament has approved new legislation, the Digital Services Act (DSA) and Digital Markets Act (DMA) to improve the functioning of the internal market of intermediary services in the European Union (EU) where there is a risk that the major so-called gatekeeper companies can exercise unfair control of core platform services. The purpose of this study was to investigate, what health information systems could be in the scopes of these acts and what requirements the acts may have for the production, the sale and the use of health information systems. The act texts were examined bearing in mind what types of health information systems exist and what their user bases are. Those health information systems that can belong or do not belong to the groups of systems regulated by the DMA and DSA were identified. The most relevant requirements for these systems were also identified from these acts. The result of the study is that these acts have only minor consequences for the healthcare information systems sector as they are not often intermediary (hosting) services in the meaning of the DSA or gatekeepers in the meaning of the DMA. The emerging digital healthcare platforms are most affected by the new DSA and secondly such peer support patient portals where patients can supply content for others to see. Apparently, no digital healthcare platform has yet reached such a size or a dominant role within the EU that it would fall under the scope of the DMA. The two above mentioned healthcare related intermediary services have due diligence obligations to remove illegal contents from their services and to treat their business and consumer customers fairly. The obligations include clear and fair terms and conditions, the provision of a single point of contact for users and authorities, content moderation, complaint handling, marking advertising clearly, annual reporting, and responding to the contacts from the authorities. The obligations increase when the size of the enterprise increases. It is still too early to produce healthcare information systems specific guidance to support the implementation of these two acts as the acts themselves and potential upcoming general guidance documents can serve the health information systems community sufficiently well. publishedVersion

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Artificial intelligence (AI) can have a significant positive impact on health and healthcare. AI can be used to improve the quality, efficiency and equity of health care. However, AI has the potential to have significant negative impacts. Therefore, AI medical applications should be designed and deployed in accordance with established guidelines and legislation. There may be gaps or questions in the current regulatory framework related to the interpretation and application of the existing regulatory framework to healthcare applications that include artificial intelligence solutions. Global standardization maintains a consistent approach and can reduce the burden on stakeholders when it comes to establishing regulatory frameworks, interpreting and complying with regulatory requirements. While AI is far from new, it has only recently become mainstream. This chapter outlines the research of the authors who are members of the Hoc Group on Application of AI Technologies in Health Informatics (ISO AHG2 TC215), which was formed by ISO Technical Committee 215 to define goals and directions for standardization in the field of AI in health care. acceptedVersion

Ever since the first publication of the standard communication protocol for computerassisted electrocardiography (SCP-ECG), prENV 1064, in 1993, by the European Committee for Standardization (CEN), SCP-ECG has become a leading example in health informatics, enabling open, secure, and well-documented digital data exchange at a low cost, for quick and efficient cardiovascular disease detection and management. Based on the experiences gained, since the 1970s, in computerized electrocardiology, and on the results achieved by the pioneering, international cooperative research on common standards for quantitative electrocardiography (CSE), SCP-ECG was designed, from the beginning, to empower personalized medicine, thanks to serial ECG analysis. The fundamental concept behind SCP-ECG is to convey the necessary information for ECG re-analysis, serial comparison, and interpretation, and to structure the ECG data and metadata in sections that are mostly optional in order to fit all use cases. SCP-ECG is open to the storage of the ECG signal and ECG measurement data, whatever the ECG recording modality or computation method, and can store the over-reading trails and ECG annotations, as well as any computerized or medical interpretation reports. Only the encoding syntax and the semantics of the ECG descriptors and of the diagnosis codes are standardized. We present all of the landmarks in the development and publication of SCP-ECG, from the early 1990s to the 2009 International Organization for Standardization (ISO) SCP-ECG standards, including the latest version published by CEN in 2020, which now encompasses rest and stress ECGs, Holter recordings, and protocol-based trials. publishedVersion

Physical activity is a vital part of cardiac rehabilitation (CR). However, heart-healthy physical activity levels in people with cardiovascular disease drop significantly after CR. This exploratory study employs qualitative and survey methods within a co-creation approach. The aim is to understand the mechanisms of healthy behavior and habit formation in order to create a novel evidence-based (post-)rehabilitation approach that employs digital means to sustain long-term physical activity levels in people with cardiovascular disease.

Finland is a world leader in the use of public electronic services. Continuous improvement to competencies is a prerequisite for the success of digitalisation in the service development sector. The increasing use of information technology in health and social care needs to be taken into account in the education of the health and social care sector work force. The mandate of the national SotePeda 24/7 project is to identify and define the informatics competencies required for multidisciplinary education of this sector in Finland. The project has adapted international recommendations for use in the national context. The national recommendation covers 12 areas of competency and related content. In addition to defining competencies, the project has produced a toolbox of materials for use by educators of these topics in universities that cover applied sciences and lifelong learning. The results of the project are expected to significantly improve the preparedness of graduating health and social care and related engineering and business sector students to make full use information technology, all of which benefits the national health and social welfare system. publishedVersion

The quality of software is high in medical devices due to the strict regulatory requirements and their implementation in the software development processes through the use of the IEC 62304 standard. The goal of this standard revision project was to extend the scope of the standard to all health software and also to bring the requirements of the 12 year old standard back to the state-of-the-art including provisions for cybersecurity. The joint IEC/SC62A and ISO/TC215 project team revised the standard and adapted its risk management, usability, and security requirements to serve both the medical device industry and the overall health software industry. The resulting second version of the standard has gone through a multistage global voting process to achieve a consensus of the requirements to serve both these communities. The resulting standard has potential to have a major impact on the quality of software used in health care globally publishedVersion

Pirkanmaan sairaanhoitopiirin lääkintätekniikka on osa tietohallinnon ja teknologian vastuualuetta TAYS palvelukeskuksessa. Tietohallinto vastaa perustietotekniikan palveluiden lisäksi tietohallinnon palveluista, potilastietopalveluista ja tietohallinnon muutostöiden suunnittelusta. Lääkintätekniikka vastaa strategisista palveluista, kun taas operatiivisista palveluista vastaa Istekki Oy. Lääkintälaitteiden lainsäädäntö vaatii laitteiden laadun, turvallisuuden ja toiminnan mittaamista kvantitatiivisesti, minkä prosessinäkökulma mahdollistaa. Yhteiset toimintatavat kaikille tietoteknisille laitteille sairaanhoitopiirissä mahdollistavat tehokkaan ja turvallisen hoitoympäristön.Lääkintätekniikan ja tietohallinnon prosesseissa on paljon yhteisiä rajapintoja, sillä useat lääkintälaitteet ovat verkotettuja ja yhteydessä muihin laitteisiin. Verkotettujen lääkintälaitteiden elinkaaren aikainen ylläpito vaatii erikoisosaamista sekä tietotekniikasta että laitteen toiminnasta ja lainsäädännöstä. Lääkintätekniikan yhä enemmän digitalisoituessa tulisi huolehtia siitä, että prosesseja uudistetaan ja toimintatavoista pidetään kiinni yhteistyössä prosesseissa toimivien asiantuntijoiden kanssa. Lääkintälaitteiden elinkaaren hallinnalle on eduksi, jos palvelujen tuottaminen keskittyy sairaanhoitopiirissä samalle toimijalle.The Medical Technical Department of Pirkanmaa Hospital District is part of the Information Management Unit of the Hospital Service Center. Medical Technology is responsible of the strategic services, whereas Istekki Oy is responsible of the operative services of medical devices. Information Management Unit is responsible of the computer services, information management, patient information services and changes of information management. Medical devices are strictly regulated and the legislation requires quantitative measurements of quality, safety and functionality. This is possible by using a process approach of medical device management. Common policies for all interactive devices in the hospital district enables efficient and safe environment for healthcare.Medical technology and information management processes have common interfaces, since most of the current medical devices are in a network and connected to other devices. Medical devices connected to a network require maintenance with special competences from both computer sciences and medical devices functionalities, as well as legislation of medical devices. As digitalization makes progress also in medical technology, the organization should ensure that processes are being renewed and the policies are kept in cooperation with the medical technology professionals. Medical technology life cycle control benefits if the services are focused on one actor.

Henkilökohtaisen terveyden seuranta kasvattaa nopeasti suosiotaan. Laitteiden yhteentoimivuus on merkittävässä roolissa henkilökohtaisen terveyden seurannassa. Laiteliitynnät muodostavat perustan yhteentoimivuudelle. Standardoidut laiteliitynnät pyrkivät vähintään syntaktiseen yhteentoimivuuteen. Tässä artikkelissa selvitetään henkilökohtaisen terveyden seurantaan liittyviä laiteliityntästandardeja ja niiden käyttöä edistäviä organisaatioita. ISO/IEEE 11073 on merkittävin terveystekniikan laiteliityntästandardi joka on saanut taakseen kolmen merkittävän yleiskäyttöisen liityntästandardin, Bluetooth, USB, ja Zigbee, tuen. Sen merkittävin haastaja on IP‐tekniikan yleistyminen ja IP:n päälle kehitetyt yhteentoimivuusstandardit. Artikkelissa käydään lisäksi läpi standardeja kehittäviä organisaatioita ja pohditaan laiteliitynnän standardoinnin kehityssuuntia.