Medical Devices and Wearables


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 | Cassandra Rivais DiNova | 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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Study to Use Apple Watch Data
March 21, 2019 | Eric D. Fader | Electronic Health Records | Medical Devices and Wearables
A new three-year study at the University of Michigan’s medical center will examine whether data collected on Apple Watch, along with other health information, can be useful in analyzing patients’ health. The MIPACT (Michigan Predictive Activity and Clinical Trajectories) Study has already begun with 1,000 participants, and thousands more patients are expected to enroll over the …
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Fitbit, Solera Health Expand Diabetes Efforts
March 12, 2019 | Eric D. Fader | Electronic Health Records | Medical Devices and Wearables | Private Insurers
Fitbit and Solera Health announced on March 6 that they have expanded their partnership that seeks to reduce the prevalence of type 2 diabetes. Solera, an integrated benefit network, will make Fitbit devices available to all Solera patients who participate in the National Diabetes Prevention Program (DPP). In a study, Solera found that its patients …
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FDA Issues Warning Letter on Unapproved Breast Implant Device
February 19, 2019 | Steven Shapiro | FDA | Litigation | Medical Devices and Wearables
Last week, the U.S. Food and Drug Administration (FDA) announced that it issued a warning letter to Mark Berman, M.D., a Beverly Hills, Calif., cosmetic surgeon, for illegally marketing an unapproved implantable device. Dr. Berman claims that the “Pocket Protector” can prevent and treat capsular contracture (tightening of scar tissue), a complication of breast implants. …
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New Medicare App to Explain Coverage
February 6, 2019 | Cassandra Rivais DiNova | Hospitals | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Private Insurers
On January 28, the Centers for Medicare & Medicaid Services (CMS) announced the launch of a new mobile app called “What’s Covered” to help consumers understand which items and services are covered by Medicare. The app is part of the eMedicare Initiative, launched in October 2018 to modernize the delivery of information about the program. …
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The False Claims Act: A Powerful Tool Against Federal Health Care Program Fraud
January 7, 2019 | Rivkin Rounds Staff | False Claims Act | Fraud and Abuse | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals
Evan Krinick authored an article, “The False Claims Act: A Powerful Tool Against Federal Health Care Program Fraud,” that was published in the New York Law Journal.  The article discusses recent actions taken by U.S. Attorneys in New York against health care providers under the FCA. …
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