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K&L Gates Triage: HIPAA Enforcement Discretion, Disputes, and Data

USA - May 9 2019 The U.S. Department of Health and Human Services recently released a notice of enforcement discretion announcing changes in how the agency will…

Rebecca M. Schaefer.

Physicians Convicted of Criminal HIPAA Violations but Avoid Jail: Lessons Learned?

USA - February 25 2019 A pediatric cardiologist recently sentenced to six months’ probation is serving as the latest reminder that violations of the Health Insurance…

Patricia C. Shea.

HHS Issues Proposed Rule to Remove Safe Harbor for Drug Rebates

USA - February 11 2019 On January 31, 2019, the U.S. Department of Health & Human Services (“HHS”) issued a long-awaited proposed rule (the “Proposed Rule”) which, if…

Michael H. Hinckle, Richard P. Church, Ryan J. Severson.

OCR Wants YOU! (To Comment on Whether HIPAA Regulations Impede Coordination of Care)

USA - January 15 2019 Health care providers and others who have had difficulty navigating HIPAA’s [1] regulations in order to coordinate care are in luck because on…

Patricia C. Shea.

340B update: Hospital groups file (...and refile) 340B Program litigation

USA - September 19 2018 Regulation and reimbursement of drugs, particularly those purchased through the 340B Drug Discount Program (the "340B Program" or "340B"), continue…

Macy L. Flinchum, Richard P. Church, Ryan J. Severson.