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HHS Issues Proposed Rule Modernizing HIPAA Privacy Rule

USA - December 15 2020 On December 10, 2020, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) released a proposed rule (the Proposed…

Colleen Theresa Brown, Elizabeth Hardcastle, Meenakshi Datta, Megan Svedman.

Drug Price Reporting Implications of FDA’s Pathways for Importation

USA - September 29 2020 On September 25, 2020, the U.S. Centers for Medicare and Medicaid Services (CMS) issued guidance that addresses the treatment of certain imported…

Meenakshi Datta, Trevor L. Wear, William A. Sarraille.

OCR 2020 Settlements Target HIPAA Security Rule Non-Compliance

USA - August 27 2020 In almost the first three quarters of 2020, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) has settled three cases…

Colleen Theresa Brown, Meenakshi Datta, Megan Svedman.

President Trump Signs Four Executive Orders Intended to Lower Drug Prices

USA - July 28 2020 President Trump announced four Executive Orders on July 24 that direct the Secretary of Health and Human Services (HHS) to implement sweeping policy…

Corbin T. Santo, Jaclyn G. Fonteyne, Meenakshi Datta, Rebecca K. Wood, Stephanie P. Hales, Trevor L. Wear, William A. Sarraille.

OCR Reduces HIPAA Penalties and Clarifies Liability for Transferring ePHI to Third-Party Health Apps

USA - April 30 2019 New Annual HIPAA Penalty Tiers Six months after imposing the largest ever HIPAA fine ($16 million) following a HIPAA data breach, the U.S. Department…

Britney Alexandrea Garr, Kate Heinzelman, Meenakshi Datta.