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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.
|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...
|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...
|FDA Releases Draft Guidance for 3D Printed Medical Devices|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June 17, 2016, previously published on May 17, 2016On May 10, 2016, FDA released its first draft guidance for medical device manufacturers who are using additive manufacturing (AM), commonly referred to as 3D printing.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...
|Check Your Inbox: OCR Continues to Verify Entity Contact Information for Phase 2 HIPAA Audits|
Kate F. Stewart; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
June 17, 2016, previously published on May 23, 2016Covered Entities need to continue to check their inboxes for emails from the HHS Office for Civil Rights (“OCR”) requesting verification of contact information in connection with Phase 2 of the HIPAA Audit Program. OCR previously indicated that Covered Entities would begin to receive...
|Phase 2 HIPAA Audits Coming to You: Check Your Spam Filter!|
Dianne J. Bourque, Jordan T. Cohen, Cynthia J. Larose, Kate F. Stewart; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
June 17, 2016, previously published on March 23, 2016The HHS Office for Civil Rights (“OCR”) officially launched the long-awaited (and dreaded) Phase 2 of the HIPAA Audits Program on March 21st. Covered Entities and Business Associates need to be prepared for these audits and be on the lookout for emails (check your spam filter!) from OCR...
|FTC Wins Stay of Pennsylvania Hospital Merger Pending Appeal in Third Circuit|
Dionne C. Lomax, Farrah Short; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
June 17, 2016, previously published on May 26, 2016The Third Circuit granted on Tuesday the Federal Trade Commission’s (“FTC”) request for an injunction pending appeal of the proposed merger between Penn State Hershey Medical Center and Pinnacle Health System. The injunction comes just before the temporary restraining order...
|Don’t Neglect Your Business Associate Agreements!|
Dianne J. Bourque, Kate F. Stewart; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
June 17, 2016, previously published on March 17, 2016As we have repeatedly emphasized on this blog, HIPAA Covered Entities must ensure that they have compliant business associate agreements (“BAAs”) in place with all of their business associates and must ensure that they have performed a comprehensive risk assessment. A $1.55 million...