Health Care Counsel

Arent Fox's health care law blog offers news, analysis, and insights for the health care industry.

Health Care Counsel
HIPAA / Health Privacy & Security
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Regulation from Across the Pond: GDPR’s Implications for United States Health Care Organizations

What’s New?

In May 2018 - merely 14 months from now - the European Union’s (EU) General Data Protection Regulation (GDPR) will go into effect. Organizations established in the European Economic Area (EEA) are subject to the GDPR and must abide by its rules with respect to the collection, processing, and transfer of personal data. And as we explained last year, health care and other organizations not established in the EEA that collect or process European personal data (by offering goods or services to individuals in the EEA or monitoring their behavior) are also subject to the GDPR - a controversial extraterritorial reach.

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Compliance Program Development & Counseling, Department of Justice Developments
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What the Department of Justice Expects in a Compliance Program

In early February, the Department of Justice’s Criminal Division, Fraud Section, published a document titled, Evaluation of Corporate Compliance Programs. A must-read for any person responsible for a compliance program, regardless of industry, the document identifies common questions that DOJ may ask when making individualized determinations about a compliance program’s effectiveness. Although DOJ points out that the publication is “neither a checklist nor a formula,” the document provides practical guidance to corporations (and their attorneys) about where DOJ will focus its compliance program inquiries. And although the publication applies only to the criminal division, it may be instructive in civil fraud matters as well.

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Cannabis Industry Standards: ASTM Considers Filling the Void
Responding to requests from the cannabis industry, ASTM International, one of the world’s largest voluntary standards-developing organizations, recently announced that it may develop industry standards that would apply to “the full life cycle of cannabis” and consumable cannabis products. The standards could cover cannabis cultivation, sampling, testing, quality management systems, processing, handling, and labeling. 
 

Lack of Uniform Standards May Impact Consumer and Environmental Health

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Compliance Program Development & Counseling, HIPAA / Health Privacy & Security, Hospitals and Acute Care
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Substance Abuse Medical Record Privacy Rules Updated For The First Time in Nearly 30 Years

For the first time in nearly three decades, the Substance Abuse and Mental Health Services Administration (SAMHSA) has updated the regulations on the confidentiality of substance abuse treatment records found in 42 C.F.R. Part 2 (the Part 2 Regulations).

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Office of Inspector General Developments, Prescription Drug Pricing & Government Price Reporting
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New OIG Drug Pricing and Reimbursement Portfolio Now Online

Have you been wondering what OIG has done regarding drug pricing and reimbursement since 2010? Today, OIG has made it easier to find out, posting a Drug Pricing and Reimbursement Web portfolio on its website. According to an OIG announcement, the portfolio “pulls together the HHS OIG’s body of work since 2010 as well as other relevant items that relate to drug pricing and reimbursement in HHS programs. The portfolio features planned work, completed reports, industry guidance, and enforcement actions.”  

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Medical Staff Leaders and the Law Conference 2017: San Francisco

Please join Arent Fox on Friday, March 10 from 8:00 AM - 1:00 PM Pacific for our annual half-day Medical Staff Leaders and the Law Conference being held at the Olympic Club in San Francisco.

About this Arent Fox Conference

This unique conference is dedicated to equipping your medical staff team with the most current skills, tools, and information to navigate challenging issues and provide effective leadership. This year’s conference will address recent legal and regulatory updates, and explore significant new laws and court decisions impacting medical staffs. We will also cover recent trends in medical staff litigation and explore the post-election impact of the new president and congress on the health care industry.

Planned Sessions Include:

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False Claims Act
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Recent Drug Company Settlement Highlights Unique Theory of False Claims Act Liability: Failure to Follow Current Good Manufacturing Practices

Last month, Baxter International Inc. and Baxter Healthcare Corporation (collectively “Baxter”) settled a qui tam False Claims Act (FCA) case with the Department of Justice (DOJ) for $18 million. The settlement is not monumental in terms of the amount, but does highlight the unique theory of FCA liability. The government alleged that Baxter submitted false claims for a drug sold to the Department of Veterans Affairs and Department of Defense, as well as reimbursed by the Medicare and Medicaid programs, because the drug was “adulterated,” given Baxter’s alleged violations of the Federal Food, Drug, and Cosmetic Act’s (FDCA) current good manufacturing practice (cGMP) requirements – but not because of any impact on the drug itself.

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HIPAA / Health Privacy & Security
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Your Money or Your Patients: Using IT Contracts to Protect Against Ransomware Attacks

An Austrian hotel was a recent victim of a “ransomware” computer attack that disabled its electronic room key system and locked up its own computers, and this follows ransomware attacks on hospitals. These attacks demonstrate that hospital administrators should be sure that IT agreements adequately address the risks of cyberattacks. Moreover, this important lesson applies to health care institutions as ransomware causes great harm because it locks up and makes patient and other records unavailable at the very time they are required for ongoing medical care. New IT agreements should cover the risks, and existing agreements should be reviewed to determine whether they still provide the necessary protection.

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Home Health Care, Hospices and Palliative Care, Hospitals and Acute Care
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What You Need to Know: New CALOSHA Workplace Violence Rules for Health Care Facilities

Please join us for a free webinar (noon-1:00 pm PT/3:00-4:00 pm ET) designed to help health care facilities prepare for the new CALOSHA regulation that addresses the threat of workplace violence.

As you might know, the California Division of Occupational Safety & Health Standards Board recently approved a new safety standard designed to provide comprehensive regulatory protections for workers exposed to workplace violence in health care settings. The standard, which was sponsored by several labor unions, will require covered health care providers to develop workplace violence prevention plans, training programs, conduct safety and security assessments, and recordkeeping procedures to track certain incidents of workplace violence.

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Home Health Care, Hospices and Palliative Care, Hospitals and Acute Care, Litigation & Alternative Dispute Resolution, Long Term Care
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Top Health Care Advisor Rachel Hold-Weiss Returns to Arent Fox

Arent Fox LLP is pleased to announce the return of health care regulatory attorney Rachel Hold-Weiss as a partner in the firm’s New York office. Ms. Hold-Weiss is re-joining Arent Fox after serving as the Associate General Counsel and Corporate Compliance Officer for the Personal-Touch Home Care companies. A welcome addition to the firm’s nationally recognized Health Care practice, Ms. Hold-Weiss will focus on regulatory, transactional, and litigation matters for health care providers, primarily hospices, home health agencies, skilled nursing facilities, and assisted living facilities.

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ABOUT ARENT FOX LLP

Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.