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HTMLChina's NHFPC Publishes Approvals for 23 Food Packaging Materials
David J. Ettinger, Mark Thompson; Keller and Heckman LLP;
Legal Alert/Article
June 30, 2016, previously published on June 15, 2016
On June 8, 2016, China's National Health and Family Planning Commission (NHFPC) announced online that 23 food packaging materials had passed the safety evaluation review by the NHFPC expert panel.

 

HTMLThe California Rigid Plastic Packaging Container Law
Mitzi Ng Clark, Natalie E. Rainer; Keller and Heckman LLP;
Legal Alert/Article
June 30, 2016, previously published on May 31, 2016
The California Rigid Plastic Packaging Container (RPPC) Act of 1991 and its regulations are intended to facilitate the reuse and recycling of rigid plastic packaging containers, with provisions that are geared towards increasing the use of postconsumer recycled plastic and reducing the use of...

 

HTMLSummaries of Final Rules on Revisions to Nutrition and Supplement Facts Labeling and Serving Sizes
Melvin S. Drozen, Evangelia C. Pelonis, Natalie E. Rainer, Laura D. Venker; Keller and Heckman LLP;
Legal Alert/Article
June 30, 2016, previously published on June 2, 2016
We have reviewed and analyzed FDA's recently-issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations. The final rules were published in the Federal Register on May 27, 2016. See Food Labeling: Revision of the Nutrition and Supplement...

 

HTMLSupreme Court Decides Validity of Implied False Certification Theory in Universal Health Services v. Escobar
J. Andrew (Andy) Jackson, Laura F. Laemmle-Weidenfeld, Brian J. Murray, Kenton James Skarin, Stephen G. (Steve) Sozio; Jones Day;
Legal Alert/Article
June 26, 2016, previously published on June 2016
On June 16, 2016, the U.S. Supreme Court decided Universal Health Services v. United States ex rel. Escobar, a widely anticipated decision with implications for health care provider and government contractor liability under the False Claims Act ("FCA"). The case addressed whether the...

 

HTMLImportant Amendments to the Personal Health Information Protection Act, 2004 Now in Force
Roberto Ghignone; Borden Ladner Gervais LLP;
Legal Alert/Article
June 23, 2016, previously published on June 10, 2016
At the start of June 2016, a number of significant amendments to the Personal Health Information Act, 2004 ("PHIPA") were proclaimed in force. The most significant changes relate to the duties and responsibilities of health information custodians with respect to notification in the event...

 

Adobe PDFPhase 2 HIPAA Audits
Howard E. Bogard, Richard J. Brockman, Kelli Carpenter Fleming, James A. Hoover, Chester "Chet" J. Hosch; Burr & Forman LLP;
Legal Alert/Article
June 21, 2016, previously published on June 2016
In an effort to review and examine compliance with the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations ("HIPAA"), the Department of Health and Human Services Office for Civil Rights ("OCR") is conducting Phase 2 HIPAA audits for both...

 

HTMLCyberattacks--Health Care is Vulnerable
John F. Queenan; Iseman, Cunningham, Riester & Hyde LLP;
Legal Alert/Article
June 21, 2016, previously published on May 17, 2016
Health care is a prime target for cybersecurity incidents.

 

HTMLMSHA Issues New Workplace Exam Proposed Rule
William K. Doran, Gwendolyn K. Nightengale; Ogletree, Deakins, Nash, Smoak & Stewart, P.C.;
Legal Alert/Article
June 20, 2016, previously published on June 7, 2016
The Mine Safety and Health Administration (MSHA) announced today that it was issuing a notice of proposed rulemaking that will amend the Workplace Examination regulation at 30 C.F.R. § 56.18002 (Surface) and § 57.18002 (Underground). The amended regulation, “Examinations of Working...

 

HTMLNot Again .... Yet Another Health Care Data Breach
Ryan J. Cuthbertson, Cynthia J. Larose; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
June 17, 2016, previously published on March 17, 2016
21st Century Oncology Holdings, a company that operates a chain of 181 cancer treatment centers in the US and Latin America, announced on Friday March 4 that it was latest victim of a cyber-attack affecting 2.2 million individuals. When did the attack occur? Months ago. Read on for the gory...

 

HTMLFDA Releases Draft Guidance for 3D Printed Medical Devices
Jordan T. Cohen, Joanne S. Hawana; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 17, 2016, previously published on May 17, 2016
On May 10, 2016, FDA released its first draft guidance for medical device manufacturers who are using additive manufacturing (AM), commonly referred to as 3D printing. The draft guidance, entitled “Technical Considerations for Additive Manufactured Devices,” was informed by a public...

 


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