RECENT HEALTH LAW NEWS


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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Stem-Cell Clinics Under Fire
April 11, 2019 | Cassandra Rivais DiNova | FDA | Fraud and Abuse | Litigation
On April 3, the U.S. Food and Drug Administration (FDA) sent warning letters to about 20 stem-cell clinics notifying them that their activities appear to require FDA approval. The letters, similar in form to this one, cited guidance materials that clinics can use as resources in becoming compliant with FDA requirements. Stem-cell therapy involves removing …
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New Plan Designs for Medicare Parts C and D are Coming
April 9, 2019 | Christopher J. Kutner | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals | Private Insurers
On April 5, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (CMS-4185-F) that updates the Medicare Advantage (MA or Part C) and Medicare Prescription Drug Benefit (Part D) programs by promoting innovative plan designs, improved quality, and choices for patients. The final rule will increase MA plan choices for the 2019 …
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Rivkin Attorneys to Speak on CBD
April 8, 2019 | Marc S. Ullman | Steven Shapiro | FDA | Legislation and Public Policy | Pharmaceuticals
Rivkin Radler’s Marc Ullman and Steven Shapiro will be addressing the question “What Is the Regulatory Current State of Play With CBD?” on Wednesday, April 10, at the SupplySide East trade show in Secaucus, NJ.  Marc’s article “Regulations Remain Hazy Around CBD Use in Supplements” was recently published in the Spring/Summer 2019 issue of USLAW …
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FDA and FTC Warn CBD Marketers
April 8, 2019 | Marc S. Ullman | FDA | Legislation and Public Policy | Pharmaceuticals
On March 28, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) sent joint Warning Letters to three marketers of products represented as cannabidiol (popularly known as CBD) dietary supplements. According to the letters, the products are being marketed with questionable claims indicating that they can be used to treat a variety …
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Imaging Equipment Vulnerable to Cyberattacks
April 4, 2019 | Eric D. Fader | Cybersecurity | Electronic Health Records | Hospitals | Telehealth
Researchers at the Ben-Gurion University Cyber Security Research Center in Israel have created malware that could exploit vulnerabilities in MRI and CT scanning equipment to alter patients’ images. The Washington Post discussed the research project in an April 3 article. In theory, by adding fabricated cancerous nodules to a MRI or CT scan, an attacker …
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New York State Budget Includes ACA-Type Protections
April 3, 2019 | Eric D. Fader | Affordable Care Act | Home Health | Hospitals | Legislation and Public Policy | Medicare and Medicaid | Private Insurers
New York’s state budget for the 2019-2020 fiscal year, approved by the State Legislature on March 31, included provisions that codify into state law the primary consumer protections of the federal Affordable Care Act. In a public announcement, Gov. Andrew Cuomo said, “We have codified many of the protections of Obamacare, so regardless of what …
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CMS Accepting Applications for AI Contest
March 28, 2019 | Cassandra Rivais DiNova | Electronic Health Records | Hospitals | Legislation and Public Policy | Medicare and Medicaid
On March 27, the Innovation Center at the Centers for Medicare & Medicaid Services (CMS) announced an artificial intelligence contest. The CMS Artificial Intelligence (AI) Health Outcomes Challenge, in collaboration with the American Academy of Family Physicians and the Laura and John Arnold Foundation, is looking for innovative technology and strategies to predict health outcomes, …
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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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New Jersey to Set Up State Health Insurance Exchange
March 26, 2019 | Eric D. Fader | Affordable Care Act | Legislation and Public Policy | Private Insurers
New Jersey Governor Phil Murphy announced on March 22 that the state will create its own health insurance exchange for plan year 2021, replacing the federally run healthcare.gov marketplace. Gov. Murphy also gave notice of the change by sending a Declaration of Intent Letter to the federal government’s Center for Consumer Information and Insurance Oversight. …
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