Medical Devices and Wearables

In a recent Advisory Opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined that an arrangement involving certain physicians who have an ownership interest in a medical device company that manufactures products that may be ordered by the physician owners (the “Company”) was not considered a suspect physician-owned

Rivkin Radler’s Shari Claire Lewis wrote an article, “FTC Appears Ready to Begin Enforcing Its Health Breach Notification Rule,” that was published in the New York Law Journal on April 18. The article discusses the Federal Trade Commission’s rule that requires manufacturers of connected medical devices, fitness trackers and other wearables, and health

The Federal Trade Commission (FTC) recently issued a policy statement confirming that vendors of apps and other connected devices that collect personal health information, such as glucose levels, heart rate, or fertility or sleep data, are subject to the FTC’s Health Breach Notification Rule. The rule, issued in 2009, requires vendors to notify consumers

The proposed 2022 Medicare Physician Fee Schedule released on July 13 by the Centers for Medicare & Medicaid Services (CMS) includes a new category of CPT codes for “remote therapeutic monitoring” (RTM). The new codes are in addition to the set of codes introduced in 2019 for remote physiological monitoring, usually called remote patient monitoring

On June 23, the Department of Health and Human Services Office of Inspector General (OIG) posted on its website an Issue Brief entitled “Medicare Lacks Consistent Oversight of Cybersecurity for Networked Medical Devices in Hospitals.” According to the OIG, the Centers for Medicare & Medicaid Services should amend interpretative guidelines or other nonbinding guidelines, or

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

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

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

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