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Orthopedic Clinic Settles with HHS OCR for $1.5 Million over Claims of Systemic HIPAA Noncompliance

September 25, 2020

The US Department of Health and Human Services’ Office for Civil Rights (“OCR”) recently announced a settlement with Georgia-based Athens Orthopedic Clinic PA (the “Clinic”) to resolve multiple alleged violations of the Privacy and Security Rules under the Health Insurance Portability and Accountability Act (“HIPAA”). Under the terms of the settlement, the Clinic agreed to pay $1.5 million to OCR and to adopt a corrective action plan to settle potential violations of the Privacy and…

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Department of Labor Issues Updated Families First Coronavirus Response Act Regulations, But Does Little To Resolve Employer Uncertainty (US)

By Laura Lawless

September 15, 2020

The Families First Coronavirus Response Act (FFCRA) was enacted on March 18, 2020. The sweeping federal legislation provides emergency paid sick leave (EPSL) and expanded paid Family and Medical Leave (EFML) to certain covered workers impacted by the COVID-19 pandemic. On April 1, 2020, the U.S. Department of Labor (DOL) issued regulations implementing the FFCRA and answering, at least in part, some questions related to coverage, eligibility, use, and job restoration. You can read our…

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UK End of Transition – Moves to Provide Clarity for Industry

By Adrian Spooner

September 14, 2020

The work of UK health and regulatory authorities has mainly been targeted on COVID-19 work over recent months but there has been an increasing focus on End of Transition work in recent week’s and given that the Brexit transition period ends at 11pm on 31st December 2020 (GMT). As part of this work, UK MHRA has started to issue multiple separate pieces of guidance for the UK Life Science industry that covers many areas including…

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HHS Eases Federal Substance Use Disorder Confidentiality Rules

By Elliot Golding & Kristin Bryan

August 27, 2020

Last month the Substance Abuse and Mental Health Services Administration (“SAMHSA”) finalized amendments to the federal Confidentiality of Substance Use Disorder Patient Records regulation, 42 C.F.R. Part 2 (“Part 2”). The changes purport to better facilitate substance use disorder (“SUD”) care coordination and treatment by loosening technical consent requirements, clarifying permissible disclosures, and providing other guidance. Notably, these changes do not address changes required under the COVID-19-related CARES Act, which will require aligning Part 2’s…

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Kamala Harris – Where the Vice Presidential Nominee Stands on Key Healthcare Issues

By Meg Gilley, Callan Smith, David LesStrang & John Wyand

August 17, 2020

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On Tuesday, August 11, 2020, presumptive Democratic presidential nominee Joe Biden announced Sen. Kamala Harris (D-CA) as his vice presidential running mate. Since joining Congress in 2017, Sen. Harris has largely served as a bridge between progressive and moderate Democratic positions and policies. She has made immigration, equal pay and reproductive health rights core planks of her policy proposals. Her current congressional committee assignments include Senate Judiciary, Homeland Security and Governmental Affairs, Intelligence and Budget.…

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Public Records Show Agencies Are Vigorously Enforcing New COVID-19 Requirements Against Healthcare Providers

By William Kishman

August 14, 2020

Since the COVID-19 outbreak began, healthcare providers have faced a slew of new regulatory requirements. As many healthcare providers know, enforcement agencies have taken starkly different approaches in terms of how often, and how vigorously, they enforce these requirements. Recent reports show, however, that agencies are closely enforcing workplace safety requirements relating to COVID-19, especially as they pertain to healthcare providers. Within the past month, the U.S. Occupational Safety and Health Administration (OSHA) and its state…

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Supreme Court Ruling Limits Insurer and Employer Contraceptive Obligations

By Stacey Grundman, Doug Anderson & Meghna Rao

July 29, 2020

Earlier this month the Supreme Court of the United States upheld a regulation adopted under the Trump administration significantly cutting back the requirement that insurers and group health plans provide coverage for contraceptives without cost sharing under the Affordable Care Act (ACA). Because of the ruling in Little Sisters of the Poor v. Pennsylvania, employers, including publicly traded companies, with religious or moral objections are not required to provide contraceptive coverage under the health plans…

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For Your Eyes Only: Anticompetitive Collusion at a UK Hospital

By Erling Estellon, Martin Rees & Diarmuid Ryan

July 22, 2020

Last week the UK Competition and Markets Authority (CMA) published its decision to fine Spire and 7 consultants ophthalmologists operating in its Macclesfield hospital for fixing “the level of the initial consultation fees charged by the Ophthalmologists at the Hospital” (para 3.34). This is a classic ‘price-fixing’ decision against ophthalmologists who agreed to charge the same fee (£200) for an initial consultation. However, and more importantly, this decision comes as a stark reminder to Hospitals…

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Senators Announce Bipartisan Bill Requiring Pharmaceutical Supply Chain Report

By John Wyand & Callan Smith

July 21, 2020

U.S. Senators Marco Rubio (R-FL) and Elizabeth Warren (D-MA) recently announced plans to cosponsor S. 4191, the United States Pharmaceutical Supply Chain Review Act. According to bill text released by Senator Warren’s office, the bill directs the Federal Trade Commission (FTC) and the Secretary of the Treasury, in consultation with the Secretary of the Treasury, and acting through the Committee on Foreign Investment in the United States, to study the U.S. pharmaceutical supply chain. Specifically,…

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Recent Supreme Court Decision Creates Basis For Challenge To HHS’s Rescission Of Anti-Discrimination Protections

By William Kishman

June 24, 2020

Most readers are likely familiar with the landmark decision issued by the U.S. Supreme Court last week, in which the Court held that Title VII prohibits discrimination on the basis of sexual orientation and transgender status. (Read more about this decision here.) That decision not only provided important clarification to the scope of protections for the LGBT community, but it may also create a basis for challenges to a recent rule by the Trump…

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Blog Authors

Orthopedic Clinic Settles with HHS OCR for $1.5 Million over Claims of Systemic HIPAA Noncompliance

Department of Labor Issues Updated Families First Coronavirus Response Act Regulations, But Does Little To Resolve Employer Uncertainty (US)

UK End of Transition – Moves to Provide Clarity for Industry

HHS Eases Federal Substance Use Disorder Confidentiality Rules

Kamala Harris – Where the Vice Presidential Nominee Stands on Key Healthcare Issues

Public Records Show Agencies Are Vigorously Enforcing New COVID-19 Requirements Against Healthcare Providers

Supreme Court Ruling Limits Insurer and Employer Contraceptive Obligations

For Your Eyes Only: Anticompetitive Collusion at a UK Hospital

Senators Announce Bipartisan Bill Requiring Pharmaceutical Supply Chain Report

Recent Supreme Court Decision Creates Basis For Challenge To HHS’s Rescission Of Anti-Discrimination Protections

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