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Publications
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03.31.2020Healthcare Industry Implications of the CARES ActUpdatesThe Coronavirus Aid, Relief, and Economic Security Act, known as the “CARES Act,” became law on March 27, 2020. The CARES Act implements wide-ranging changes to law and funding designed to ameliorate the coronavirus pandemic’s impact on the American economy and its workers.
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06.05.2017Life Sciences: Product Regulation And Liability In The USAArticles
Lexology
The Food and Drug Administration recently revised its regulations governing submission and approval of new drug applications and abbreviated new drug applications. In the patent space, the America Invents Act provides a streamlined administrative process for challenging the validity of pharmaceutical (and other) patents. Congress also created an abbreviated pathway for biosimilar products, including a regulatory scheme for handling related patent disputes. -
05.18.2017Potential HIPAA Pitfalls for Developers of Healthcare AppsUpdatesAs federal and state governments struggle to address future healthcare regulation, demand for healthcare that is cheaper, better and faster continues to surge.
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05.11.2017The American Health Care Act: What Has Changed and What Is NextUpdatesOn May 4, 2017, the U.S. House of Representatives approved the American Health Care Act (AHCA) by a vote of 217 to 213 (with 20 Republicans voting against the bill), sending the AHCA to the Senate.
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05.03.2017Another HIPAA Settlement: Stolen Laptop Costs $2.5 Million Plus Encryption RequirementUpdatesThe U.S. Department of Health and Human Services recently announced yet another HIPAA privacy and security settlement involving Protected Health Information on a stolen laptop.
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04.27.2017Employer Shared Responsibility: Have Penalties Been—or Will Penalties Ever Be—Assessed?Updates
Are you an Applicable Large Employer (ALE) that has received rejected Forms 1095-C from the IRS? If so, you are not alone.
This update was also published by Employee Benefit Advisor on 05.04.2017, "Views Assessing Employer Shared Responsibility Penalties," and by Society for Human Resource Management on 05.05.2017, "Employer Shared Responsibility: Have Penalties Been—or Will Penalties Ever Be—Assessed?" -
04.19.2017The Fate of the ACA’s Cost-Sharing Reduction SubsidiesUpdatesAs deliberations over a replacement of the Affordable Care Act (ACA) continue in the U.S. House of Representatives, the fate of the ACA’s Cost-Sharing Reduction subsidies may be at stake.
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04.12.2017House Amends the American Health Care Act: Where Will It Lead?UpdatesOn the last day before the U.S. Congress began its spring recess, the U.S. House of Representatives amended the now consolidated bill H.R. 1628, known as the American Health Care Act.
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01.28.2013New HIPAA Omnibus Rule Implementing Provisions of the HITECH Act: An Overview of ChangesUpdatesFinal implementing regulations for many provisions of the HITECH Act (Health Insurance Technology for Economic and Clinical Health Act) were issued by the Department of Health and Human Services recently, and will appear in the Federal Register on January 25, 2013. Informally referred to as the Omnibus Rule, the regulations address a number of changes to the HIPAA Privacy Rule, HIPAA Security Rule, HIPAA breach notification rule, HIPAA privacy and security enforcement provisions, Business Associate definition and agreement requirements, and the interaction between HIPAA and the Genetic Information Nondiscrimination Act.
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04.19.2012HIPAA Enforcement Comes to Small Providers: $100,000 and Heightened Compliance ObligationsUpdatesA small cardiac surgery practice (two owners; currently five physicians) is the latest covered entity to enter into a settlement agreement and Corrective Action Plan (CAP) with the U.S. Department of Health and Human Services, Office for Civil Rights (OCR), to resolve alleged violations of the HIPAA privacy and security regulations. In announcing the $100,000 settlement OCR Director Leon Rodriguez stated, "OCR expects full compliance no matter the size of a covered entity."
Presentations
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2016Value Based Purchasing: New Ways Challenge Old Law and HabitsSpeaking EngagementsWashington State Society of Healthcare Attorneys
