Medical Devices and Wearables


Study to Use Apple Watch Data
March 21, 2019 | Eric D. Fader | Electronic Health Records | Medical Devices and Wearables
A new three-year study at the University of Michigan’s medical center will examine whether data collected on Apple Watch, along with other health information, can be useful in analyzing patients’ health. The MIPACT (Michigan Predictive Activity and Clinical Trajectories) Study has already begun with 1,000 participants, and thousands more patients are expected to enroll over the …
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Fitbit, Solera Health Expand Diabetes Efforts
March 12, 2019 | Eric D. Fader | Electronic Health Records | Medical Devices and Wearables | Private Insurers
Fitbit and Solera Health announced on March 6 that they have expanded their partnership that seeks to reduce the prevalence of type 2 diabetes. Solera, an integrated benefit network, will make Fitbit devices available to all Solera patients who participate in the National Diabetes Prevention Program (DPP). In a study, Solera found that its patients …
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FDA Issues Warning Letter on Unapproved Breast Implant Device
February 19, 2019 | Steven Shapiro | Litigation | Medical Devices and Wearables
Last week, the U.S. Food and Drug Administration (FDA) announced that it issued a warning letter to Mark Berman, M.D., a Beverly Hills, Calif., cosmetic surgeon, for illegally marketing an unapproved implantable device. Dr. Berman claims that the “Pocket Protector” can prevent and treat capsular contracture (tightening of scar tissue), a complication of breast implants. …
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New Medicare App to Explain Coverage
February 6, 2019 | Cassandra Rivais | Hospitals | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Private Insurers
On January 28, the Centers for Medicare & Medicaid Services (CMS) announced the launch of a new mobile app called “What’s Covered” to help consumers understand which items and services are covered by Medicare. The app is part of the eMedicare Initiative, launched in October 2018 to modernize the delivery of information about the program. …
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The False Claims Act: A Powerful Tool Against Federal Health Care Program Fraud
January 7, 2019 | Rivkin Rounds Staff | False Claims Act | Fraud and Abuse | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals
Evan Krinick authored an article, “The False Claims Act: A Powerful Tool Against Federal Health Care Program Fraud,” that was published in the New York Law Journal.  The article discusses recent actions taken by U.S. Attorneys in New York against health care providers under the FCA. …
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Kaiser to Present on PLI Panel on Enforcement Trends
November 5, 2018 | Eric D. Fader | False Claims Act | Fraud and Abuse | Medical Devices and Wearables | Pharmaceuticals
On November 16, 2018, Geoffrey R. Kaiser will join the faculty of the Practising Law Institute’s Life Sciences 2018: Navigating Legal Challenges in the Drug and Device Industries. Jeff will participate on a panel entitled, “Enforcement Trends Impacting the Drug and Device Industries.” Topics covered will include the False Claims Act, the Anti-Kickback Statute, off-label …
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Garmin, Fitabase to Collaborate on Analysis of Wearables Data
October 25, 2018 | Eric D. Fader | Electronic Health Records | Medical Devices and Wearables | Telehealth
Garmin International, best known in the U.S. for its GPS navigation units, has announced a collaboration with Fitabase to analyze digital health data from Garmin’s wearable devices, including activity trackers and smartwatches. The alliance puts Garmin in direct competition with Apple and Fitbit, both of which use data from their devices in healthcare research. Fitabase, …
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