Telehealth Can Lower Employer Health Costs, CEO Says

Employers can benefit financially by investing in making telemedicine options available to their workers, the CEO of a software development company involved in the digital health industry wrote. Nicholas Domnisch, CEO of EE Solutions and a member of the Forbes Technology Council, emphasized the positive impact digital health usage can have on employers’ finances in a recent article in Forbes . Domnisch cited a study showing that digital health programs allowing employees to access telemedicine primary care led to a...
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Bill By Sens. Rosen And Young Directs FDA To Regularly Update Medical Device Cyber Guidance

Regulators would be required to review and update guidance on medical device cybersecurity every two years under a bill by Sens. Jacky Rosen (D-NV) and Todd Young (R-IN) that also calls for a GAO study of software and other cyber challenges related to the devices. “The bipartisan Strengthening Cybersecurity for Medical Devices Act would require the FDA, in consultation with the Cybersecurity and Infrastructure Security Agency, to review guidance for industry and FDA staff regarding medical device cybersecurity and...
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Bill By Sens. Rosen And Young Directs FDA To Regularly Update Medical Device Cyber Guidance

Regulators would be required to review and update guidance on medical device cybersecurity every two years under a bill by Sens. Jacky Rosen (D-NV) and Todd Young (R-IN) that also calls for a GAO study of software and other cyber challenges related to the devices. “The bipartisan Strengthening Cybersecurity for Medical Devices Act would require the FDA, in consultation with the Cybersecurity and Infrastructure Security Agency, to review guidance for industry and FDA staff regarding medical device cybersecurity and...
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FDA Issue: 
FDA Week - 06/10/2022
FDA Volume: 
Vol. 28, No. 23
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Novavax Rejects FDA Concerns COVID Shot Linked To Myocarditis

FDA is concerned that Novavax’s COVID-19 vaccine candidate may be directly linked to cases of heart inflammation in people who received the shot in clinical trials, but Novavax says there’s not enough evidence to establish a direct link. The company says it will continue to monitor all adverse events, including myocarditis and pericarditis, associated with its shot should it be authorized. FDA highlighted its concerns in a briefing document posted online Friday (June 3) . The agency’s Vaccines and Related...
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COVID-19 Vaccine News
FDA Issue: 
FDA Week - 06/10/2022
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Vol. 28, No. 23
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HRSA Creates New Provider Relief Reporting Period

It’s not clear if a new provider relief reporting period for relief spanning Jan. 1 through June 30 means HHS will finish distributing remaining phase 4 funds by June 30, and hospitals are still fighting the administration on several provider relief issues, like speeding up distributions and giving providers more than one year to spend their COVID-19 relief. The new fifth reporting period applies to recipients who received relief Jan. 1 through June 30, 2022 and gives them until June...
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CMS Issue: 
Inside CMS - 06/09/2022
CMS Volume: 
Vol. 25, No. 23


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