Originally published on medgadget.com
Welcome back for a summary of Day 2 of HxRefactored which featured keynotes and breakout sessions around the design of healthcare processes, systems, and technologies. Matthew Holt, Chairman of Health 2.0, returned to the stage to kick things off with a keynote on the current changes taking place in Washington, D.C. and the potential impact those changes will have on healthcare systems and policies. A key takeaway of his discussion was the claim that under the AHCA, as a result of tax cuts to the rich and reduced subsidies for Medicaid recipients, those making less than $50,000 per year may end up paying disproportionately more for their healthcare.
Matthew was followed by Robin Farmanfarmaian, author of The Patient as CEO and a familiar face from the Exponential Medicine stage, and Bakul Patel, Associate Director of Digital Health at the FDA. Robin spoke about how technology is raising the bar on interactions between patients and physicians and gave examples of how new technologies, like virtual and augmented reality, are shaping the future of patient education and therapy. One specific example is how VR is currently being used to help patients struggling to cope with phobias. Bakul followed with a short history lesson and review of the FDA’s current position on digital health technologies.
In summary, there are three tiers to how the FDA looks at mobile apps: (1) mobile apps that are not considered medical devices , (2) lower risk mobile apps that meet the definition of a medical device but are not considered mobile medical applications (MMA) and are not regulated, and (3) mobile apps that are considered MMA and are therefore regulated. Bakul summarized that the approach was designed to be pragmatic and focus on higher risk functionalities and that would cause concern if the product in question did not work as planned. He also revealed that the FDA is currently reimagining a new paradigm for digital health regulation that better aligns with the timelines of technology development, the methods of development, and global healthcare trends. This reimagining is in part coming from a new unit at the FDA that is currently focusing purely on digital health and has been taking a stronger look at software. We’ll keep a look out for updates to current regulations that Bakul mentioned that should be expected in the coming months.
Before pausing for the first of two rounds of breakout sessions, Matthew and Amy Cueva of Mad*Pow returned to the stage to announce Health Payment Systems as the winner of the third annual Design for Health Award. Motivated by the idea that patients shouldn’t need to be CFOs to understand their health bills, Health Payment Systems eliminates healthcare billing confusion by consolidating a consumer’s healthcare bills and explanation of benefits into a single statement.
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