Medical Devices and Wearables


Amazon Enters Health Wearables Market
September 11, 2020 | Eric D. Fader | Electronic Health Records | Home Health | Medical Devices and Wearables | Private Insurers | Telehealth
Amazon recently introduced the Halo fitness tracker, its first entry into the health wearables market currently dominated by Fitbit and the Apple Watch. Amazon’s previous efforts to move into the healthcare industry have included the acquisition of online pharmacy PillPack in 2018, the mysterious Haven initiative with Berkshire Hathaway and JPMorgan Chase, and various other …
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Fitbit Study: Devices Can Identify COVID-19 Early
August 20, 2020 | Rivkin Rounds Staff | Medical Devices and Wearables
An August 19 blog post on Fitbit’s website discussed preliminary results of the company’s COVID-19 study suggesting that Fitbit devices can detect signs of the disease before symptoms are noticed. The 100,000-person study found more than 1,100 positive cases of COVID-19, of which nearly 50% were detected at least one day before participants reported symptoms. …
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HHS, DOJ Release Fraud and Abuse Report
July 23, 2020 | Eric D. Fader | Electronic Health Records | False Claims Act | Fraud and Abuse | Home Health | Hospitals | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Telehealth
The U.S. Department of Health and Human Services (HHS) and Department of Justice (DOJ) have released the 2019 annual report for their Health Care Fraud and Abuse Control Program. The government recovered almost $3.6 billion, of which about $2.5 billion was returned to the Medicare trust fund. The recoveries included judgments and settlements from fraud …
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Rivkin Health Attorneys Write the Book on Federal AKS and Safe Harbors
July 10, 2020 | Rivkin Rounds Staff | Electronic Health Records | Employer/Employee | False Claims Act | Fraud and Abuse | Hospitals | Legislation and Public Policy | Litigation | Medical Devices and Wearables | Pharmaceuticals | Private Insurers
Eric Fader, Jeff Kaiser, Chris Kutner, Ada Kozicz and Ben Malerba are authors of the newly released book, “The Federal Anti-Kickback Statute and Safe Harbors: A Practical Guide.” Published by the American Bar Association, the book covers all safe harbors currently in place, as well as the interplay between the Anti-Kickback Statute (AKS) and other …
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Wearables Brands Fight for Healthcare Space
June 23, 2020 | Eric D. Fader | Electronic Health Records | Employer/Employee | Legislation and Public Policy | Medical Devices and Wearables | Telehealth
Manufacturers of activity trackers and smartwatches have been fighting over the “serious” healthcare market for several years. Companies such as Apple (previously discussed here), Fitbit (previously discussed here), and Garmin (previously discussed here) have all announced research partnerships with academic and clinical institutions to expand their businesses from the “exercise and fitness” market into healthcare …
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CISA Guidance Clarifies “Essential Industry” for Healthcare
March 31, 2020 | Marc S. Ullman | Behavioral Health | Home Health | Hospitals | Legislation and Public Policy | Medical Devices and Wearables | Nursing Homes | Pharmaceuticals
On March 28, the U.S. Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (CISA) issued a much-needed update clarifying what constitutes “essential industry” during the national COVID-19 response. This updated Guidance is especially important as many of the individual state declarations of emergency refer to “essential industry” without any enumeration, or specifically reference DHS-CISA agency …
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CMS and ONC Release New Interoperability Rules
March 12, 2020 | Ada (Kozicz) Janocinska | Electronic Health Records | HIPAA | Hospitals | Legislation and Public Policy | Medical Devices and Wearables | Medicare and Medicaid | Private Insurers | Telehealth
The Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) have finalized two highly anticipated rules that are intended to give patients “unprecedented safe, secure access to their health data.” ONC will establish a certification process for application programming interfaces (APIs) that will meet certain interoperability …
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Medical Equipment Co. to Pay $37.5M to Settle Kickback Claims
January 17, 2020 | Eric D. Fader | False Claims Act | Fraud and Abuse | Litigation | Medical Devices and Wearables | Medicare and Medicaid
The U. S. Department of Justice (DOJ) announced on January 15 that ResMed Corp., a San Diego-based manufacturer of durable medical equipment, will pay $37.5 million to the federal government to settle five qui tam (whistleblower) cases under the False Claims Act (FCA) alleging that ResMed paid kickbacks to DME suppliers, sleep labs and other …
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DOJ Reports $3 Billion in 2019 False Claims Act Recoveries
January 14, 2020 | Eric D. Fader | False Claims Act | Fraud and Abuse | Hospitals | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals
The U.S. Department of Justice (DOJ) announced last week that in the fiscal year ended September 30, 2019, it obtained more than $3 billion in total recoveries from civil cases brought under the False Claims Act (FCA). The total, a slight increase from the $2.9 billion recovered in the prior fiscal year, included both settlements …
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The Broad Reach of the Medicare Fraud Strike Forces
January 3, 2020 | Rivkin Rounds Staff | False Claims Act | Fraud and Abuse | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Telehealth
Rivkin Radler’s Evan Krinick authored an article for the New York Law Journal, “The Broad Reach of the Medicare Fraud Strike Forces.” The article discusses recent strike force actions in New York and New Jersey that targeted a variety of healthcare fraud schemes.   …
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