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Medical Devices › Digital Health › Data Collection

Jones Day

Medicare's Innovation Center Charts New Direction: Part 3 – Drugs, Devices, and Data

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The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more

Butler Snow LLP

The Wearable Revolution: How to Use Personal Health Device Data in Litigation

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Wearable technology compiles extensive information on our bodily systems—including activity levels, menstruation and fertility, exercise activity and attainment, food consumption, weight, sleep, noise exposure, heart rate,...more

Goodwin

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. ​​​​​​​ Companies that once only developed hardware-based solutions for...more

King & Spalding

A Pandemic Silver Lining: FDA’s New Guidance on Using Digital Health Technologies for Clinical Investigations

King & Spalding on

With spring timidly approaching, it’s hard not to dwell on the fact that we are almost two full years into the COVID-19 pandemic. The pandemic has placed into clear relief many of the access issues faced by patients and...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Guidance for Digital Health Tech Used in Clinical Investigations

Sheppard Mullin Richter & Hampton LLP on

n December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from...more

Womble Bond Dickinson

Wellness Wearables and Big Data

Womble Bond Dickinson on

Nearly half of Americans have tried wellness wearables or another digital health product. In a global pandemic, can we use the information tracked by wellness wearables to help prevent further spread and infection?...more

Troutman Pepper Locke

Exploring Digitization of Health and Medical Data and Records Part One

Troutman Pepper Locke on

The Digital Planning Podcast is designed to educate individuals about all things digital in connection with estate planning, business planning and estate administration. Your hosts, Jennifer Zegel, Ross Bruch and Justin...more

Cooley LLP

Alert: FDA Finalizes Guidance on Devices that Store and Transfer Data

Cooley LLP on

The Food and Drug Administration (FDA) on February 6th, finalized guidance on certain medical devices that store and transfer data, opting for a very light regulatory touch. In its guidance, the FDA states that it doesn't...more

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