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Department of Health and Human Services (HHS) Protected Health Information Food and Drug Administration (FDA)

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Health Care Compliance Association (HCCA)

Privacy Briefs: June 2023

Privacy Briefs: June 2023 - Long-term care pharmacy network PharMerica disclosed a breach involving more than 5.8 million patients, making it the largest breach reported to the HHS Office for Civil Rights (OCR) in the last...more

Sheppard Mullin Richter & Hampton LLP

HHS Releases Cybersecurity Guide

The US Department of Health and Human Services recently updated its guide to help the private and public healthcare sectors develop cybersecurity protocols that address NIST’s Framework for Improving Critical Infrastructure...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Holland & Knight LLP

Impact of the New Health Industry Cybersecurity Practices: 2019 Outlook

Holland & Knight LLP on

• The U.S. Department of Health and Human Services on Dec. 28, 2018, announced the release of the "Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients" that provides a "Call to Action" to make...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - June 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Baker Donelson

Significant Changes to Health Information Technology Found in 21st Century Cures Act

Baker Donelson on

On December 13, 2016, President Obama signed the 21st Century Cures Act ("Cures Act"), H.R. 34, into law. It enjoyed bipartisan support and was overwhelmingly approved by the House and Senate in recent weeks. The expansive...more

Manatt, Phelps & Phillips, LLP

Health Update - July 2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more

Cooley LLP

Blog: FDA Cybersecurity Workshop for Healthcare

Cooley LLP on

On October 21-22 the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Departments of Health and Human Services and Homeland Security, conducted a public workshop entitled “Collaborative Approaches for...more

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