Suchergebnisse

The European Union Medical Device Directive 2007/47/EC1 defines software with a medical purpose as a medical device. The implementation of health information technology suffers from patient safety problems that require effective post-market surveillance. The purpose of this study was to review, classify and discuss the incident data submitted to a nationwide database of the Finnish National Competent Authority with other forms of data. We analysed incident reports submitted to the authority database by users of electronic health records from 2010 to 2015. We identified 138 valid reports. Adverse events associated with electronic health record vulnerabilities, clustered around certain error types, cause serious harm and occur in all types of healthcare settings. The low rate of reported incidents raises questions about not only the challenges associated with medical software oversight but also the obstacles for reporting. ; Peer reviewed

The impact of digitalization of health services has been profound and is expected to be even more profound in the future. It is important to evaluate whether digital health services contribute to health system goals in an optimal way. This should be done at the level of the service, not the 'digital transformation'. Decisions to adopt new digital health services, at different levels of the health care system, are ideally based on evidence regarding their performance in light of health system goals. In order to evaluate this, a broad perspective should be taken in evaluations of digital health services. Attainment of the broad health system goals, including quality, efficiency and equity, are objectives against which to judge new digital health services. These goals in a broad sense are unaltered by the process of digitalization. Governance should be designed and tailored in such a way to capture all relevant changes in an adequate way. When evaluating digital health services many specific aspects need to be considered. Like for other innovations and (new) technologies, such promises may or may not materialize and potential benefits may also be accompanied by unintended and/or negative (side) effects in the short or long term. Hence, the introduction, implementation, use and funding of digital health technologies should be carefully evaluated and monitored. Governments should play a more active role in the further optimization both of the process of decision making (both at the central and decentral level) and the related outcomes. They need to find a balance between centralized and decentralized activity. Moreover, the broader preparation of the health care system to be able to deal with digitalization, from education, through financial and regulatory preconditions, to implementation of monitoring systems to monitor its effects on health system performance remains important. ; Peer reviewed

The impact of digitalization of health services has been profound and is expected to be even more profound in the future. It is important to evaluate whether digital health services contribute to health system goals in an optimal way. This should be done at the level of the service, not the 'digital transformation'. Decisions to adopt new digital health services, at different levels of the health care system, are ideally based on evidence regarding their performance in light of health system goals. In order to evaluate this, a broad perspective should be taken in evaluations of digital health services. Attainment of the broad health system goals, including quality, efficiency and equity, are objectives against which to judge new digital health services. These goals in a broad sense are unaltered by the process of digitalization. Governance should be designed and tailored in such a way to capture all relevant changes in an adequate way. When evaluating digital health services many specific aspects need to be considered. Like for other innovations and (new) technologies, such promises may or may not materialize and potential benefits may also be accompanied by unintended and/or negative (side) effects in the short or long term. Hence, the introduction, implementation, use and funding of digital health technologies should be carefully evaluated and monitored. Governments should play a more active role in the further optimization both of the process of decision making (both at the central and decentral level) and the related outcomes. They need to find a balance between centralized and decentralized activity. Moreover, the broader preparation of the health care system to be able to deal with digitalization, from education, through financial and regulatory preconditions, to implementation of monitoring systems to monitor its effects on health system performance remains important. ; other ; published

The impact of digitalization of health services has been profound and is expected to be even more profound in the future. It is important to evaluate whether digital health services contribute to health system goals in an optimal way. This should be done at the level of the service, not the 'digital transformation'. Decisions to adopt new digital health services, at different levels of the health care system, are ideally based on evidence regarding their performance in light of health system goals. In order to evaluate this, a broad perspective should be taken in evaluations of digital health services. Attainment of the broad health system goals, including quality, efficiency and equity, are objectives against which to judge new digital health services. These goals in a broad sense are unaltered by the process of digitalization. Governance should be designed and tailored in such a way to capture all relevant changes in an adequate way. When evaluating digital health services many specific aspects need to be considered. Like for other innovations and (new) technologies, such promises may or may not materialize and potential benefits may also be accompanied by unintended and/or negative (side) effects in the short or long term. Hence, the introduction, implementation, use and funding of digital health technologies should be carefully evaluated and monitored. Governments should play a more active role in the further optimization both of the process of decision making (both at the central and decentral level) and the related outcomes. They need to find a balance between centralized and decentralized activity. Moreover, the broader preparation of the health care system to be able to deal with digitalization, from education, through financial and regulatory preconditions, to implementation of monitoring systems to monitor its effects on health system performance remains important.

The impact of digitalization of health services has been profound and is expected to be even more profound in the future. It is important to evaluate whether digital health services contribute to health system goals in an optimal way. This should be done at the level of the service, not the 'digital transformation'. Decisions to adopt new digital health services, at different levels of the health care system, are ideally based on evidence regarding their performance in light of health system goals. In order to evaluate this, a broad perspective should be taken in evaluations of digital health services. Attainment of the broad health system goals, including quality, efficiency and equity, are objectives against which to judge new digital health services. These goals in a broad sense are unaltered by the process of digitalization. Governance should be designed and tailored in such a way to capture all relevant changes in an adequate way. When evaluating digital health services many specific aspects need to be considered. Like for other innovations and (new) technologies, such promises may or may not materialize and potential benefits may also be accompanied by unintended and/or negative (side) effects in the short or long term. Hence, the introduction, implementation, use and funding of digital health technologies should be carefully evaluated and monitored. Governments should play a more active role in the further optimization both of the process of decision making (both at the central and decentral level) and the related outcomes. They need to find a balance between centralized and decentralized activity. Moreover, the broader preparation of the health care system to be able to deal with digitalization, from education, through financial and regulatory preconditions, to implementation of monitoring systems to monitor its effects on health system performance remains important.