Reimbursement A Top Goal For New Digital Health Lobbying Center
As digital health becomes more ubiquitous in the medical device space, industry advocacy group AdvaMed has launched a Center for Digital Health to aggregate its resources and coordinate efforts to lobby the government on behalf of digital-health companies.
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For health-care providers and medtech manufacturers alike, the decade ahead will require a coming to terms with digital technologies and integrating new methods of payment. Quality of service delivery remains the market-entry criterion, but companies will have to adapt to evolving health-care models. The stakes are high. Will manufacturers be able to capitalize on the changes in a market that is more competitive and unpredictable than ever?
There's A Lot On FDA’s 2020 Guidance Priorities Lists – But The Software Pre-Cert Program Isn't One Of Them
The US FDA's device center has released its annual proposed guidance document lists for fiscal year 2020. Industry experts pointed out that the lists don't address the agency's software precertification program that it has been working on so hard. That may just mean the issue has fallen off of the FDA's radar or the agency needs congressional authority to move ahead with issuing guidances on the topic, an industry expert says. Also notable is a lack of an artificial intelligence guidance.
Following his recent talk at the National Press Club on reimbursement issues, former US FDA Commissioner Scott Gottlieb told Medtech Insight a new breakthrough device rule proposed by the Medicare agency CMS is good but will still be economically unfeasible for many hospitals. Instead, he says new frameworks need to be developed for the new kinds of technologies coming to market.