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Telemedicine COVID-19 Briefing: March 16

Government, media and industry have all pointed to the potential for telemedicine to assist in combating the COVID-19 pandemic. In addition, steps have been taken by the government to ease the burdens associated with the use of telemedicine during this crisis. Unfortunately, the complexity of the regulatory infrastructure has left a fair amount of confusion with respect to the extent to which rules have been, and may be, liberalized. At a time when our healthcare infrastructure is engaging with a health crisis that will get worse before it gets better, confusion about the requirements for care delivery needs to be reduced to a minimum. Please join us on Monday, March 16 from 1 - 2pm ET for an update on: Loosened Medicare reimbursement requirements State emergency efforts Related issues associated with the delivery of telemedicine services during the COVID-19 pandemic CLICK HERE TO REGISTER

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FDA Outlines the New Digital Health Innovation Action Plan and Software Precertification Pilot Program

Last Tuesday afternoon, the US Food and Drug Administration (FDA) held a webinar to outline a recently-published Digital Health Innovation Action Plan (Plan). In the Plan, the agency recognized that the traditional regulatory approach toward moderate and high risk medical devices is not well suited for the fast-paced, iterative design, development and type of validation used for digital health software products today. Going forward, the agency plans to explore an innovative approach to regulating these types of products. The approach contains three primary prongs: (1) the issuance of new guidance, (2) the Digital Health Software Precertification Program and (3) an internal expansion of FDA’s digital health capabilities. The webinar was presented by Bakul Patel, Associate Director for Digital Health at FDA. At least 905 attendees logged in to the webinar. Below are a few important takeaways. The presentation provided a high-level overview of the digital health...

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