Medical Devices and Wearables


OIG Issues Special Fraud Alert on Speaker Programs
November 20, 2020 | Eric D. Fader | Fraud and Abuse | Legislation and Public Policy | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals
The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert on November 16, warning that speaker programs organized by pharmaceutical and medical device companies pose inherent fraud and abuse risks. OIG is “skeptical about the educational value of such programs” and cautioned that remuneration to referring practitioners …
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Medtronic Settles Kickback and Open Payments Violations for $9.2M
November 13, 2020 | Eric D. Fader | Affordable Care Act | False Claims Act | Fraud and Abuse | Litigation | Medical Devices and Wearables | Medicare and Medicaid
The U.S. Department of Justice (DOJ) announced on October 29 that Medtronic USA Inc. agreed to pay $8.1 million to settle allegations that it violated the False Claims Act (FCA) and federal Anti-Kickback Statute by paying kickbacks to a South Dakota neurosurgeon to use Medtronic’s medical devices. Medtronic will pay an additional $1.11 million for …
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FDA Announces Digital Health Center of Excellence
October 7, 2020 | Cassandra Rivais DiNova | Electronic Health Records | FDA | Home Health | Legislation and Public Policy | Medical Devices and Wearables | Telehealth
On September 22, the U.S. Food and Drug Administration (FDA) announced the launch of its Digital Health Center of Excellence within the Center for Devices and Radiological Health. The FDA called this an important step toward its goal of advancing digital health technology, including mobile health (mHealth), health information technology, wearable devices, telehealth, and personalized …
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OCR Updates Mobile Health App Resources
September 25, 2020 | Eric D. Fader | Cybersecurity | Electronic Health Records | HIPAA | Legislation and Public Policy | Medical Devices and Wearables | Telehealth
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently unveiled a new website with updated guidance and resources for mobile health app developers regarding the HIPAA Privacy, Security, and Breach Notification Rules. The new Resources for Mobile Health Apps Developers site replaces OCR’s prior Health App Developer Portal. The new site’s Health …
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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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