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Download now - Digital Medicine 2018 Report: Part 1

As with all things in life, the only consistency is that there will be change. This is no truer in any organization than it is in the U.S. Food and Drug Administration (FDA) as it grapples with the accelerating pace of technology. Both policy and politics have shifted drastically within the past two years, and the agency has done a commendable job at keeping its eye on supporting innovation and innovators while protecting patient safety. Most notably, 2018 has seen the implementation of new policies to speed up approval for digitaltechnologies. Hopefully, the regulatory changes on the horizon live up to the current hype.

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A shifting regulatory environment
The FDA is forging into new territory, folding digital medicine into the regulatory process. Recognizing that digital health encompasses a broad range of technologies and capabilities, such as mobile health, health information technology, wearable devices, telehealth, telemedicine and personalized medicine, pilot programs are moving forward to help new and existing devices to communicate with one another. The objective is to increase the quality of medicine by reducing inefficiencies, improving access, reducing costs and delivering on the promise of personalized medicine.

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Nicole Fisher is the founder and CEO of HHR Strategies, a healthcare- and human-rights focused advising firm. She is also a senior policy advisor on Capitol Hill and expert on health economics, technology, and reform, specifically as they impact vulnerable populations. Fisher runs a Health Innovation and Policy page at Forbes, highlighting ideas and advising companies and people that are changing the health landscape, and she curates a monthly international dinner series, “A Seat at the Table,” bringing together thought leaders for an off-the-record discussion focused on moving health policy and planning forward. She also runs the nonprofit Global Brain Health Coalition and is pursuing a doctoral degree in health policy at the University of North Carolina.

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