HHS Reduces Potential HIPAA Penalties
April 30, 2019 | Eric D. Fader | Cybersecurity | Electronic Health Records | HIPAA
The U.S. Department of Health and Human Services (HHS) has revised the potential monetary penalties that may be imposed on healthcare providers, health plans and business associates for HIPAA violations. HHS’s notice of enforcement discretion, issued on April 26, reduces the maximum annual penalty for less-severe violations from $1.5 million to as low as $25,000. The …
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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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HHS Announces New Primary Care Pay Models
April 23, 2019 | Eric D. Fader | Hospitals | Legislation and Public Policy | Medicare and Medicaid | Private Insurers
On April 22, U.S. Department of Health and Human Services (HHS) officials announced the introduction of five optional value-based care models for large and small primary care physician practices. The new payment models will incorporate incentives for keeping Medicare patients healthy, as alternatives to traditional fee-for-service payment structures. Alex Azar, HHS Secretary, and Seema Verma, …
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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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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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