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  1. Article ; Online: The need for action by evaluators and decision makers in Europe to ensure safe use of medical software.

    Kyhlstedt, Mattias

    Frontiers in medical technology

    2022  Volume 4, Page(s) 1063622

    Abstract: Digital Health Solutions (DHS) approved under the Medical Device Directive (MDD) in the European Union may be used until May 27, 2025. The regulation provides appropriate requirements for the products but lack the evaluation by an external independent ... ...

    Abstract Digital Health Solutions (DHS) approved under the Medical Device Directive (MDD) in the European Union may be used until May 27, 2025. The regulation provides appropriate requirements for the products but lack the evaluation by an external independent organization. For many DHS, the company can make a self-certification that the requirements have been fulfilled. As demonstrated in the evaluation of smartphone-based apps for skin cancer risk assessment such products may expose the public to undue risks. The new Medical Device Regulation provides adequate control of DHS through evaluation of independent organization prior to allowing the product on the market. HTA-evaluators and those who make decisions regarding the use of DHS need to understand the associated risks with the use of products approved according to the MDD and ensure appropriate risk mitigations to ensure that the public is not exposed to undue risk. This perspective aims to inform decisionmakers about the risks associated with the delayed requirement to transition to the new MDR regulation. There is a gap in the current guidance regarding the evolving use of machine learning and artificial intelligence. With the evolving use of DHS, it is important that industry, regulators and HTA evaluators work jointly to establish the safe and effective use of DHS.
    Language English
    Publishing date 2022-11-29
    Publishing country Switzerland
    Document type Journal Article
    ISSN 2673-3129
    ISSN (online) 2673-3129
    DOI 10.3389/fmedt.2022.1063622
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Diagnostic and digital solutions to address the COVID-19 pandemic: The need for international collaboration to close the gap.

    Kyhlstedt, Mattias / Andersson, Sarah Wamala

    Health policy and technology

    2020  Volume 9, Issue 2, Page(s) 126–128

    Keywords covid19
    Language English
    Publishing date 2020-04-25
    Publishing country Netherlands
    Document type Editorial
    ISSN 2211-8837
    ISSN 2211-8837
    DOI 10.1016/j.hlpt.2020.04.010
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Standardising policy and technology responses in the immediate aftermath of a pandemic: a comparative and conceptual framework.

    Moy, Naomi / Antonini, Marcello / Kyhlstedt, Mattias / Fiorentini, Gianluca / Paolucci, Francesco

    Health research policy and systems

    2023  Volume 21, Issue 1, Page(s) 10

    Abstract: Background: The initial policy response to the COVID-19 pandemic has differed widely across countries. Such variability in government interventions has made it difficult for policymakers and health research systems to compare what has happened and the ... ...

    Abstract Background: The initial policy response to the COVID-19 pandemic has differed widely across countries. Such variability in government interventions has made it difficult for policymakers and health research systems to compare what has happened and the effectiveness of interventions across nations. Timely information and analysis are crucial to addressing the lag between the pandemic and government responses to implement targeted interventions to alleviate the impact of the pandemic.
    Methods: To examine the effect government interventions and technological responses have on epidemiological and economic outcomes, this policy paper proposes a conceptual framework that provides a qualitative taxonomy of government policy directives implemented in the immediate aftermath of a pandemic announcement and before vaccines are implementable. This framework assigns a gradient indicating the intensity and extent of the policy measures and applies the gradient to four countries that share similar institutional features but different COVID-19 experiences: Italy, New Zealand, the United Kingdom and the United States of America.
    Results: Using the categorisation framework allows qualitative information to be presented, and more specifically the gradient can show the dynamic impact of policy interventions on specific outcomes. We have observed that the policy categorisation described here can be used by decision-makers to examine the impacts of major viral outbreaks such as SARS-CoV-2 on health and economic outcomes over time. The framework allows for a visualisation of the frequency and comparison of dominant policies and provides a conceptual tool to assess how dominant interventions (and innovations) affect different sets of health and non-health related outcomes during the response phase to the pandemic.
    Conclusions: Policymakers and health researchers should converge toward an optimal set of policy interventions to minimize the costs of the pandemic (i.e., health and economic), and facilitate coordination across governance levels before effective vaccines are produced. The proposed framework provides a useful tool to direct health research system resources and build a policy benchmark for future viral outbreaks where vaccines are not readily available.
    MeSH term(s) Humans ; COVID-19/epidemiology ; SARS-CoV-2 ; Pandemics/prevention & control ; Policy ; Disease Outbreaks
    Language English
    Publishing date 2023-01-25
    Publishing country England
    Document type Journal Article
    ZDB-ID 2101196-5
    ISSN 1478-4505 ; 1478-4505
    ISSN (online) 1478-4505
    ISSN 1478-4505
    DOI 10.1186/s12961-022-00951-x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Reply to a commentary on Swedish policy analysis for Covid-19.

    Kavaliunas, Andrius / Lindfeldt, Isis / Kyhlstedt, Mattias

    Health policy and technology

    2021  Volume 10, Issue 3, Page(s) 100550

    Language English
    Publishing date 2021-07-16
    Publishing country Netherlands
    Document type Journal Article
    ISSN 2211-8837
    ISSN 2211-8837
    DOI 10.1016/j.hlpt.2021.100550
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Standardising policy and technology responses in the immediate aftermath of a pandemic

    Naomi Moy / Marcello Antonini / Mattias Kyhlstedt / Gianluca Fiorentini / Francesco Paolucci

    Health Research Policy and Systems, Vol 21, Iss 1, Pp 1-

    a comparative and conceptual framework

    2023  Volume 20

    Abstract: Abstract Background The initial policy response to the COVID-19 pandemic has differed widely across countries. Such variability in government interventions has made it difficult for policymakers and health research systems to compare what has happened ... ...

    Abstract Abstract Background The initial policy response to the COVID-19 pandemic has differed widely across countries. Such variability in government interventions has made it difficult for policymakers and health research systems to compare what has happened and the effectiveness of interventions across nations. Timely information and analysis are crucial to addressing the lag between the pandemic and government responses to implement targeted interventions to alleviate the impact of the pandemic. Methods To examine the effect government interventions and technological responses have on epidemiological and economic outcomes, this policy paper proposes a conceptual framework that provides a qualitative taxonomy of government policy directives implemented in the immediate aftermath of a pandemic announcement and before vaccines are implementable. This framework assigns a gradient indicating the intensity and extent of the policy measures and applies the gradient to four countries that share similar institutional features but different COVID-19 experiences: Italy, New Zealand, the United Kingdom and the United States of America. Results Using the categorisation framework allows qualitative information to be presented, and more specifically the gradient can show the dynamic impact of policy interventions on specific outcomes. We have observed that the policy categorisation described here can be used by decision-makers to examine the impacts of major viral outbreaks such as SARS-CoV-2 on health and economic outcomes over time. The framework allows for a visualisation of the frequency and comparison of dominant policies and provides a conceptual tool to assess how dominant interventions (and innovations) affect different sets of health and non-health related outcomes during the response phase to the pandemic. Conclusions Policymakers and health researchers should converge toward an optimal set of policy interventions to minimize the costs of the pandemic (i.e., health and economic), and facilitate coordination across ...
    Keywords COVID-19 ; Health research systems ; Policy categorisation ; Public health crisis ; Policy gradient ; Policy interventions ; Public aspects of medicine ; RA1-1270
    Subject code 360
    Language English
    Publishing date 2023-01-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: Diagnostic and digital solutions to address the COVID-19 pandemic

    Kyhlstedt, Mattias / Andersson, Sarah Wamala

    Health Policy and Technology

    The need for international collaboration to close the gap

    2020  Volume 9, Issue 2, Page(s) 126–128

    Keywords Health Policy ; Biomedical Engineering ; covid19
    Language English
    Publisher Elsevier BV
    Publishing country us
    Document type Article ; Online
    ISSN 2211-8837
    DOI 10.1016/j.hlpt.2020.04.010
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  8. Article ; Online: Deriving more value from RWE to ensure timely access of medicines by patients.

    Andersson, Sarah Wamala / Kyhlstedt, Mattias

    Journal of comparative effectiveness research

    2017  Volume 6, Issue 5, Page(s) 391–395

    MeSH term(s) Data Accuracy ; Data Collection/methods ; Data Interpretation, Statistical ; Evidence-Based Medicine ; Humans ; Public-Private Sector Partnerships ; Research Design
    Language English
    Publishing date 2017-07-12
    Publishing country England
    Document type Editorial
    ISSN 2042-6313
    ISSN (online) 2042-6313
    DOI 10.2217/cer-2017-0030
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Swedish policy analysis for Covid-19.

    Kavaliunas, Andrius / Ocaya, Pauline / Mumper, Jim / Lindfeldt, Isis / Kyhlstedt, Mattias

    Health policy and technology

    2020  Volume 9, Issue 4, Page(s) 598–612

    Abstract: Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has challenged health care systems and put societies to the test in the world beyond expectations.: Objective: Our aim is to describe and analyze the Swedish approach in ... ...

    Abstract Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has challenged health care systems and put societies to the test in the world beyond expectations.
    Objective: Our aim is to describe and analyze the Swedish approach in combating the pandemic.
    Methods: We present and discuss data collated from various sources - published scientific studies, pre-print material, agency reports, media communication, public surveys, etc. - with specific focus on the approach itself, Covid-19 trends, healthcare system response, policy and measures overview, and implications.
    Results: The main intervention to manage the curve has been the general recommendations to adhere to good hand hygiene, beware of physical distance to others, to refrain from large gatherings and restrain from non-essential travel. Persons with suspected Covid-19 infection were recommended to stay at home and avoid social contacts. Additionally, visits to the elderly care homes and meetings with more than 50 people were forbidden. As a result, the healthcare system in the country has so far, never been overwhelmed. However, the relatively high mortality among the elderly, together with the vulnerability of some migrants, points out the drawbacks.
    Conclusions: Many countries have both marvelled and criticized the Swedish strategy that is formed in a close partnership between the government and the society based on a mutual trust giving the responsibility to individuals. It already highlights how much can be achieved with voluntary measures (recommendations) - something that was noticed and proposed as a future model by the World Health Organization.
    Keywords covid19
    Language English
    Publishing date 2020-08-29
    Publishing country Netherlands
    Document type Journal Article
    ISSN 2211-8837
    ISSN 2211-8837
    DOI 10.1016/j.hlpt.2020.08.009
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Swedish Policy Analysis for COVID-19

    Kavaliunas, Andrius / Ocaya, Pauline / Mumper, Jim / Lindfeldt, Isis / Kyhlstedt, Mattias

    SSRN Electronic Journal ; ISSN 1556-5068

    2020  

    Keywords covid19
    Language English
    Publisher Elsevier BV
    Publishing country us
    Document type Article ; Online
    DOI 10.2139/ssrn.3656245
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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