Jennifer Mitchell

Jennifer Mitchell

Dinsmore & Shohl LLP

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FDA Issues Guidance on “Patient Counseling Information”

The Food and Drug Administration (FDA) has released new Guidance to assist in developing the “Patient Counseling Information” section of labeling required under § 201.57(c)(18) of the “Physician Labeling Rule.” See 21 C.F.R....more

12/15/2014 - FDA Healthcare New Guidance Prescription Drugs

OIG Offers Greater Protections for Health Care Providers in New Proposed Rule

On October 3, 2014, the U.S. Department of Health and Human Services of the Office of Inspector General (OIG) issued a Proposed Rule amending both the safe harbors to the anti-kickback statute and the civil monetary penalty...more

10/6/2014 - Affordable Care Act Anti-Kickback Statute Civil Monetary Penalty Gainsharing Health Care Providers Healthcare Hospitals Medicare OIG Prescription Drugs Proposed Regulation Safe Harbors

HHS Announces $800,000 HIPAA Settlement in Medical Records “Dumping” Case

On June 23, 2014, The Department of Health and Human Services (HHS) entered into an $800,000 settlement with Parkview Health System, Inc. (“Parkview”), a nonprofit community health system servicing northeastern Indiana and...more

6/25/2014 - Healthcare HHS HIPAA Hospitals Medical Records OCR Settlement

Health Plan Fined for HIPAA Breach Relating to Information Stored on Photocopiers

On Wednesday, August 14, 2013, the U.S. Department of Health and Human Services (HHS), announced that it had reached a $1,215,780 settlement with Affinity Health Plan, Inc., a not-for-profit managed care plan serving the New...more

8/19/2013 - Compliance Data Breach Healthcare HIPAA PHI Privacy Policy

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