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Keeping you afloat amidst the rising sea of regulations

Future of Biotech: National Academies Committee Report Scans the Horizon

In a report released on March 9, 2017, a National Academies of Sciences, Engineering, and Medicine committee concluded that the bioeconomy is growing rapidly and the US regulatory system needs to provide a balanced approach to the many competing interests that will arise in the face of the expansion.

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.

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.

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. 

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).

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

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.

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.

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.

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.