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

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.

The need for action by evaluators and decision makers in Europe to ensure safe use of medical software.

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.

Advancing digital health applications: priorities for innovation in real-world evidence generation.

In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a "Fast-Track" regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can present evidence for new digital products, including the use of real-world data and real-world evidence. Against this backdrop, the Digital Medicine Society and the Health Innovation Hub of the German Federal Ministry of Health convened a set of roundtable discussions to bring together international experts in evidence generation for digital medicine products. This Viewpoint highlights findings from these discussions with the aims of (1) accelerating and stimulating innovative approaches to digital medical product evaluation, and (2) promoting international harmonisation of best evidentiary practices. Advancing these topics and fostering international agreement on evaluation approaches will be vital to the safe, effective, and evidence-based deployment and acceptance of digital health applications globally.

Swedish policy analysis for Covid-19.

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.

Utilisation of real-world data from heart failure registries in OECD countries - A systematic review.

BACKGROUND: Heart failure represents a major public health issue that impacts 26 million people globally. Currently, real-world data represents a key instrument for providing the verification of both internal and external validity, yet there is still a lack of understanding regarding its scope in complementing evidence of treatments for heart failure. This study aims to increase understanding of the utilisation of real-word data from heart failure registries in Organisation for Economic Co-operation and Development (OECD) countries. METHOD: This was a systematic review of existing observational studies from heart failure registries in 35 OECD member countries. Studies from 2000 to March 2017 were identified through electronic databases (MEDLINE (Ovid), EMBASE, Web of Science Core Collection, CINAHL (Ebsco), Cochrane CENTRAL) and appraised according to eligibility criteria. RESULTS: Two-hundred and two studies met the inclusion criteria, in which the majority were published from 2013 to 2016. All 202 studies were observational, among which 98% were cohort studies (198). The median sample size of all studies was 5152 (2417 to 32,890) and median study period 55 months (33.0 to 72.0). Swedish heart failure registry had the most publications (24, 12%). CONCLUSION: Since 2000 there has been an upward trend in the number of published observational studies on heart failure registries in OECD countries with increasingly diverse outcomes and advanced statistical methods to improve their validity and reliability. This indicates that the utilisation of real-world data has experienced a significant upsurge in complementing the findings of clinical trials for improved research of heart failure treatments.