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Malinda Peeples Feature

FDA’s Pre-Certification Public Workshop: Top Line Take Aways from a Digital Health Clinician Researcher

In mid-2017, the U.S. Food and Drug Administration (FDA) published the Digital Health Innovation Action Plan. At the same time FDA’s current Commissioner, Scott Gottleib, MD, launched the Software Precertification Pilot Program, simply called Pre-Certification or Pre-Cert program. Uniqueness’s of Digital Health Technologies This program, developed under FDA’s Center for Center for Devices and Radiological Health […]

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FDA’s Pre-Certification Public Workshop: Top Line Take Aways from a Digital Health Innovator

In mid-2017, the U.S. Food and Drug Administration (FDA) published the Digital Health Innovation Action Plan. At the same time FDA’s current Commissioner, Scott Gottleib, MD, launched the Software Precertification Pilot Program, simply called Pre-Certification or Pre-Cert program. Uniqueness’s of Digital Health Technologies This program, developed under FDA’s Center for Center for Devices and Radiological Health

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Older woman working out with weights, headphones, and checking her smartphone

Diabetes Care Standards Encourage Optimization of Self-care with Digital Health Solutions

For many years, the American Diabetes Association (ADA) has annually updated their Standards of Medicare Care in Diabetes and for years these standards have included the recommendation that all people receive Diabetes Self-Management Education and Support (DSMES),1 a service covered by Medicare and other health plans. Yet several reports show that despite evidence of its effectiveness, the rate

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Taking Diabetes Self-Management to the Next Level