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Vital Signs: Digital Health Law Update Spring 2021 | Jones Day


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. ....

United States , France General , West Virginia , New Jersey , South Dakota , Becky Martin , Dan Cody , Kristen Mcdonald , Christi Grimm , Xavier Becerra , Norris Cochran , Laura Laemmle Weidenfeld , Dakota Legislation Goes Technology , Office Of Inspector , Health Resources , Ministry Of Health , Health Insurance Portability , Service Administrative Company , Reimbursement For Telehealth Services , Department Of Health , Clinical Research , Digital Europe Programme , Office For Civil Rights , Evidence Based Telehealth Network Program , Florida Senate , Gene Research Analysis ,

Vital Signs: Digital Health Law Update Spring 2021 - Food, Drugs, Healthcare, Life Sciences


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. ....

United States , France General , West Virginia , New Jersey , South Dakota , Becky Martin , Dan Cody , Kristen Mcdonald , Kimberly Rockwell , Laura Laemmle Weidenfeld , Cristiana Spontoni , Xavier Becerra , Christi Grimm , Ann Hollenbeck , Mary Waller , Chicago Bar Association , Dakota Legislation Goes Technology , Ministry Of Health , Digital Health , Actions Signal Expansion Of Agency Regulation , Office For Civil Rights , Evidence Based Telehealth Network Program , Centers For Disease , Florida Senate , European Parliament , European Union Agency For Cybersecurity ,

Bharat Biotech and ICMR Announce Interim Results from Phase 3 trials of COVAXIN®; Demonstrates overall Interim Clinical Efficacy of 78% and 100% efficacy against Severe COVID-19 disease


Apr 21, 2021
Safety and Efficacy results from the final analysis will be available in June, and the final report will be submitted to a peer-reviewed publication. Based on the achievement of the success criteria, placebo recipients have now become eligible to receive two doses of COVAXIN®.
The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 10% over the age of 60, with analysis conducted 14 days post 2
nd dose. COVAXIN® was developed with seed strains received from the National Institute of Virology, and the phase 3 clinical trial was co-funded by the Indian Council of Medical Research, making it a true public, private partnership towards public health. ....

West Bengal , Andhra Pradesh , Krishna Ella , Balram Bhargava , Suchitra Ella , National Institute Of Virology , Global Public Health , Indian Council Of Medical Research , Health Research , Research Development , Bharat Biotech , National Institute , Indian Council , Medical Research , Managing Director , Director General , Emergency Use Authorization , Joint Managing Director , Principal Investigators , Use Authorizations , மேற்கு பெங்கல் , ஆந்திரா பிரதேஷ் , கிருஷ்ணா எல்லா , பால்ராம் பார்கவா , சூச்சித்ர எல்லா , தேசிய நிறுவனம் ஆஃப் வைராலஜி ,

Pfizer-BioNTech study shows COVID-19 vaccine continues to be more than 90% effective for at least 6 months


Pfizer COVID-19 vaccine is 90% effective for at least 6 months and protects against South Africa variant, study shows
Karen Weintraub, USA TODAY
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Six months after getting a second dose of the Pfizer-BioNTech vaccine as part of a 46,000-person clinical trial, volunteers remained more than 90% protected against symptomatic COVID-19 and even better protected against severe disease, a new company study found.
© Rick Bowmer, AP
Allison Oler, 17, receives her Pfizer vaccination, Wednesday, March 24, 2021, in Sandy, Utah. All adults in Utah aged 16 and older became eligible to receive COVID-19 vaccinations Wednesday. (AP Photo/Rick Bowmer)
Out of 927 trial participants who fell ill with COVID-19 more than a week after their second dose, only 77 had received the active vaccine, compared with 850 who got a placebo.  ....

United States , South Africa , Allison Oler , Luciana Borio , Albert Bourla , Edith Arangoitia , Rick Bowmer , Jacob Sherkow , Biontech Covid , Ugur Sahin , Centers For Disease , University Of Illinois College Law , Drug Administration , Oxford University , Emergency Use Authorizations , Biologics License Application , Illinois College , Biologics License , Use Authorizations , Getty Images Edith Arangoitia , Disease Control , ஒன்றுபட்டது மாநிலங்களில் , லூசியானா போரியோ , ரிக் பவுமர் , மையங்கள் க்கு நோய் , பல்கலைக்கழகம் ஆஃப் இல்லினாய்ஸ் கல்லூரி சட்டம் ,