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Keeping you afloat amidst the rising sea of regulations

From the Source: Senior Advisor Provides Valuable Insight Into Office For Civil Rights’ Plans

On March 27, 2017, Rachel Yount attended the Health Care Compliance Association’s Compliance Institute 2017, where Illiana Peters, a senior advisor at Health and Human Services, Office for Civil Rights (“OCR”), provided an “OCR Enforcement Update.”

The Fourth Circuit Holds That The Mere Threat of Future Harm Is Insufficient to Confer Standing On Victims of a Data Breach

A recent decision from the Fourth Circuit Court of Appeals in Beck v. McDonald, 848 F.3d 262 (4th Cir. 2017), adds to the list of circuit courts of appeal that have held that that the mere threat of future harm resulting from a data breach, without more, is insufficient to satisfy the injury-in-fact requirement for Article III standing.

Implementation and Enforcement of 340B Final Rule Delayed

In a Federal Register notice scheduled to be published on March 20, 2017, the Health Resources and Services Administration (HRSA) announced that it will delay the effective date of the January 5, 2017 final rule (the Final Rule) that provided guidance on the calculation of drug ceiling prices and the imposition of civil monetary penalties on certain drug manufacturers participating in the 340B Drug

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).

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.

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