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|China's NHFPC Publishes Approvals for 23 Food Packaging Materials|
David J. Ettinger, Mark Thompson; Keller and Heckman LLP;
June 30, 2016, previously published on June 15, 2016On 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.
|The California Rigid Plastic Packaging Container Law|
Mitzi Ng Clark, Natalie E. Rainer; Keller and Heckman LLP;
June 30, 2016, previously published on May 31, 2016The 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...
|Summaries 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;
June 30, 2016, previously published on June 2, 2016We 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...
|Supreme 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;
June 26, 2016, previously published on June 2016On 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...
|Important Amendments to the Personal Health Information Protection Act, 2004 Now in Force|
Roberto Ghignone; Borden Ladner Gervais LLP;
June 23, 2016, previously published on June 10, 2016At 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...
|Phase 2 HIPAA Audits|
Howard E. Bogard, Richard J. Brockman, Kelli Carpenter Fleming, James A. Hoover, Chester "Chet" J. Hosch; Burr & Forman LLP;
June 21, 2016, previously published on June 2016In 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...
|Cyberattacks--Health Care is Vulnerable|
John F. Queenan; Iseman, Cunningham, Riester
& Hyde LLP;
June 21, 2016, previously published on May 17, 2016Health care is a prime target for cybersecurity incidents.
|MSHA Issues New Workplace Exam Proposed Rule|
William K. Doran, Gwendolyn K. Nightengale; Ogletree, Deakins, Nash, Smoak & Stewart, P.C.;
June 20, 2016, previously published on June 7, 2016The 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...
|Not Again .... Yet Another Health Care Data Breach|
Ryan J. Cuthbertson, Cynthia J. Larose; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
June 17, 2016, previously published on March 17, 201621st 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...
|FDA Releases Draft Guidance for 3D Printed Medical Devices|
Jordan T. Cohen, Joanne S. Hawana; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
June 17, 2016, previously published on May 17, 2016On 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...