Medical Devices and Wearables


Smart Speakers Can Monitor Heartbeats
March 11, 2021 | Eric D. Fader | Home Health | Medical Devices and Wearables
Researchers from the University of Washington have developed a system that uses smart speakers and machine learning algorithms to monitor heartbeats without the need for physical contact. The system was described in a study published in Communications Biology. When a person sits within two feet of a smart speaker, the system sends out inaudible sounds from the …
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False Claims Act Cases Poised to Jump Now and for Years to Come
March 4, 2021 | Rivkin Rounds Staff | Behavioral Health | False Claims Act | Fraud and Abuse | Hospitals | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals
Rivkin Radler’s Evan H. Krinick wrote an article entitled “False Claims Act Cases Poised to Jump Now and for Years to Come” that was published in the March 5, 2021 issue of the New York Law Journal. The article discusses health insurance fraud cases in 2020 that involved kickbacks, provision of medically unnecessary services, and …
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Flo Health Settles with FTC Over Privacy Violations
February 17, 2021 | Eric D. Fader | Cybersecurity | Electronic Health Records | Litigation | Medical Devices and Wearables | Telehealth
Flo Health, Inc., which markets a menstrual and ovulation tracking app, recently entered into a settlement with the Federal Trade Commission (FTC) to dispose of charges that Flo improperly shared consumer data with third parties, including Facebook and Google. The disclosure of the data, which included pregnancy status and sexual history of more than 100 million …
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CMS Clarifies RPM Reimbursement
January 28, 2021 | Eric D. Fader | Home Health | Legislation and Public Policy | Medical Devices and Wearables | Medicare and Medicaid | Telehealth
The Centers for Medicare & Medicaid Services (CMS) recently released corrections to its 2021 Physician Fee Schedule final rule that was published on December 28. Some of the corrections clarify reimbursement requirements for remote patient monitoring (RPM), which entails gathering and interpreting physiologic data from patients at home. The December 28 final rule had stated …
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New AKS Safe Harbors Finalized
December 3, 2020 | Geoffrey R. Kaiser | Electronic Health Records | Fraud and Abuse | Hospitals | Legislation and Public Policy | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Telehealth
The Office of Inspector General, Department of Health and Human Services (OIG) has finalized new safe harbors and modifications of existing safe harbors under the federal Anti-Kickback Statute (AKS) to reflect a policy priority favoring a value-based health care system that “pays for health and outcomes” and that will “remove potential barriers to more effective …
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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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