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Note From the Editors The pace of impact through digital health in 2021 is off to a rapid start be it the number of transactions, the numerous legislative proposals and actions, or the focused attention of enforcement bodies. Given the accelerated pace of tech-enabled methods, such as telehealth or product development through streamlined digital tools and decentralized clinical trials, not to mention AI and big data s impact on diagnostic and research capacity, the policy and regulatory spotlight on digital health will no doubt be bright throughout this year. In the Industry Insights contribution for this issue, several of our digital health experts briefly summarize the focused attention of U.S. enforcement agencies on telehealth given significantly increased reimbursement trends in the area. ....
Note From the Editors The pace of impact through digital health in 2021 is off to a rapid start be it the number of transactions, the numerous legislative proposals and actions, or the focused attention of enforcement bodies. Given the accelerated pace of tech-enabled methods, such as telehealth or product development through streamlined digital tools and decentralized clinical trials, not to mention AI and big data s impact on diagnostic and research capacity, the policy and regulatory spotlight on digital health will no doubt be bright throughout this year. In the Industry Insights contribution for this issue, several of our digital health experts briefly summarize the focused attention of U.S. ....
The Quint has found that that the same Bhopal hospital that had earlier been reported as having committed ethical breaches during COVID-19 vaccine trials has also violated the protocols set down by Bharat Biotech for phase 3 trials of its Covaxin candidate vaccine. In addition to already reported violations of the New Drug and Clinical Trial Rules 2019 (NDCT 2019), the People’s Hospital also violated these protocols to a degree that renders data from this section of trials “untrustworthy,” notes Pulla. The hospital is one among 26 trial sites for Covaxin and had signed on more than 1,700 participants. The protocol violation also jeopardises Bharat Biotech’s understanding of the efficacy and safety of its COVID-19 vaccine. ....
Economic impact of the first wave of the COVID-19 pandemic on acute care hospitals in Japan Roles Conceptualization, Investigation, Validation, Writing – review & editing Affiliations Department of Healthcare Economics and Quality Management, Graduate School of Medicine, Kyoto University, Kyoto, Japan, Department of Pharmacy, National Center for Child Health and Development Hospital, Tokyo, Japan ⨯ Emi Teraoka, Roles Conceptualization, Investigation, Validation, Writing – review & editing Affiliation Department of Healthcare Economics and Quality Management, Graduate School of Medicine, Kyoto University, Kyoto, Japan ⨯ Takuya Okuno, Roles Conceptualization, Investigation, Validation, Writing – review & editing Affiliation Department of Healthcare Economics and Quality Management, Gradu ....