Medical Devices and Wearables

Tech Giants Continue Healthcare Advances
September 11, 2019 | Eric D. Fader | Electronic Health Records | Hospitals | Medical Devices and Wearables | Telehealth

Mayo Clinic announced a 10-year strategic partnership with Google that aims to “accelerate the pace of health care innovation through digital technologies.” Mayo Clinic intends to use advanced cloud computing, data analytics, machine learning and artificial intelligence (AI) to improve its delivery of care, including, for example, using AI-enabled digital diagnostics to advance virtual care.

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Fader to Speak at IONM Conference
August 29, 2019 | Rivkin Rounds Staff | Hospitals | Medical Devices and Wearables

Rivkin Radler’s Eric Fader will be speaking at the American Society of Neurophysiological Monitoring’s Fall Symposium in Boston, September 14-15. The Symposium’s theme is “Improving the Quality of Neuromonitoring Practice” and Eric’s presentation will be entitled “Current Legal Issues in IONM: Minimizing Risks.” Eric is one of the few healthcare attorneys in the U.S. with

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Kickback Charges Lead to False Claims Act Case
August 27, 2019 | Eric D. Fader | Affordable Care Act | False Claims Act | Fraud and Abuse | Litigation | Medical Devices and Wearables | Medicare and Medicaid

The Manhattan U.S. Attorney’s Office recently announced that the U.S. Department of Justice has intervened in a whistleblower suit against Life Spine Inc., an Illinois-based manufacturer of spinal implants, devices and equipment. The lawsuit, which seeks damages and civil penalties under the False Claims Act (FCA), claims that Life Spine paid millions of dollars in

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LabCorp Offers Self-Directed Blood Testing (but not in NY/NJ)
July 24, 2019 | Eric D. Fader | Home Health | Medical Devices and Wearables

LabCorp announced on July 22 that it is now offering blood tests directly to consumers online. The clinical lab giant’s “Pixel by LabCorp” platform previously offered self-directed test kits for colorectal cancer and diabetes screening, as well as lipid panels. The service is not currently offered in New York, New Jersey, Maryland or Rhode Island.

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CVS Announces Home Dialysis Machine Trials
July 22, 2019 | Eric D. Fader | FDA | Home Health | Medical Devices and Wearables | Pharmaceuticals | Private Insurers

On July 17, CVS Health Corp. announced the beginning of human trials of a new home dialysis machine called the HemoCare Hemodialysis System. The company’s CVS Kidney Care unit hopes to shift some of the $35 billion market for end-stage kidney care from outpatient dialysis clinics to patients’ homes.

The HemoCare device was designed by

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OCR Issues HIPAA FAQs on Software Apps
May 6, 2019 | Eric D. Fader | Cybersecurity | Electronic Health Records | HIPAA | Medical Devices and Wearables

The U.S. Department of Health & Human Services’ Office for Civil Rights (OCR) recently issued five new FAQs pertaining to software applications that obtain individuals’ electronic protected health information (ePHI). The FAQs describe various scenarios in which HIPAA covered entities may transmit ePHI to apps, including fitness trackers and other wearables.

In short, a covered entity

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WHO Issues Guidance on Digital Health Tools
April 25, 2019 | Electronic Health Records | Legislation and Public Policy | Medical Devices and Wearables | Telehealth

The World Health Organization (WHO) recently issued its first-ever recommendations on how digital health interventions may be used to improve health systems and patient care. Digital communication technologies covered by the report include apps, SMS text messages, and interactive voice response, and may involve the use of mobile devices, tablets, and desktop computers.

The guidance

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FDA Plans New Review Framework for AI-Based Medical Devices
April 24, 2019 | Eric D. Fader | FDA | Legislation and Public Policy | Medical Devices and Wearables

An April 2 Statement from Scott Gottlieb, M.D., Commissioner of the U.S. Food and Drug Administration (FDA), announced that the FDA is considering creating a new review framework to promote development of medical devices that use artificial intelligence (AI) algorithms. The FDA also released a Discussion Paper and Request for Feedback on the proposed regulatory

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Amazon’s Alexa Now HIPAA-Compliant
April 18, 2019 | Eric D. Fader | Cybersecurity | Electronic Health Records | HIPAA | Home Health | Hospitals | Medical Devices and Wearables | Private Insurers | Telehealth

Amazon announced in a blog post on April 4 that its Alexa voice assistant’s operating environment now complies with HIPAA. Companies that build functions, or skills, for Alexa will now be able to create skills that involve the transmission of users’ protected health information.

The initial group of six participants in an invitation-only program includes

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Medtronic Warns of Defibrillator Hacking Vulnerability
March 27, 2019 | Eric D. Fader | Cybersecurity | Electronic Health Records | FDA | Legislation and Public Policy | Medical Devices and Wearables | Telehealth

Medtronic PLC self-disclosed last week to the U.S. Food and Drug Administration (FDA) that an unspecified problem in the wireless technology of 19 models of the company’s defibrillators makes them vulnerable to being hacked. The company said it is not aware of any cyberattacks, privacy breaches, or patient harm related to the 750,000 vulnerable devices.

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