News & Analysis as of

Medical Research 21st Century Cures Act

Health Care Compliance Association (HCCA)

[Event] Healthcare Privacy Compliance Academy - February 26th - 29th, Phoenix, AZ

Ideal for professionals with some compliance knowledge and experience, HCCA’s Healthcare Privacy Compliance Academy offers practitioners a deeper understanding of effective compliance management in a healthcare setting. The...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Health Care Compliance Association (HCCA)

[Virtual Event] Hawaii Regional Healthcare Compliance Conference - October 7th, 7:55 am - 4:00 pm HST

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Research Compliance Conference - June 14th - 16th, 9:00 am - 5:00 pm CDT

Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more

McDermott Will & Emery

HHS Releases Draft Federal Health IT Strategic Plan for 2020-2025

The Department of Health and Human Services released its draft 2020-2025 Federal Health IT Strategic Plan for public comment. This article outlines the goals of the plan, as well as challenges in healthcare that ONC hopes the...more

McDermott Will & Emery

Modernizing FDA’s New Drugs Regulatory Program – Reviewing the Guidance Ecosystem and Implications for Life Sciences Companies

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In 2016, Congress passed the 21st Century Cures Act (Cures Act), which contained provisions to help accelerate medical product innovation while reducing regulatory burden, as well as to increase efforts for critical research...more

Verrill

Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

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Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for...more

K&L Gates LLP

OCR Clarifies Confusion Related to Authorizations for Ongoing and Future Research Purposes

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As mandated by the 21st Century Cures Act of 2016 (the “Cures Act”), in June 2018 the Office for Civil Rights (“OCR”) issued guidance clarifying how individual authorizations under the Privacy Rule of the Health Insurance...more

Bricker Graydon LLP

New guidance from OCR regarding protected health information

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The U.S. Department of Health and Human Services Office of Civil Rights (OCR) has issued new guidance on HIPAA and individual authorization of uses and disclosures of protected health information (PHI) for research, as called...more

Holland & Knight LLP

Developments in Regenerative Medicine: FDA Announces Plans to Clarify Its Oversight of Cellular Therapy Products and Approves...

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FDA Commissioner Scott Gottlieb, on Aug. 28, 2017, announced steps the agency is taking to begin rolling out policies and guidance documents to clarify its oversight over regenerative medicine products. Dr. Gottlieb...more

Butler Snow LLP

Pro Te: Solutio - Vol. 10 No. 2 – Spring 2017

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It’s Spring! In this issue of Pro Te, we do a little a “spring cleaning” to brush the dust off some familiar topics that we consider in day-to-day pharmaceutical litigation. In The Forgotten Element? Warnings Proximate...more

Foley & Lardner LLP

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

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Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

Baker Donelson

The 21st Century Cures Act

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Signed into law by President Obama on December 13, 2016, the 21st Century Cures Act (Act) was overwhelmingly supported in both houses of Congress and comprises a dizzying array of provisions aimed to improve and modernize...more

Foley & Lardner LLP

21st Century Cures Act Provides Some Welcome Relief

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The 21st Century Cures Act (the “Cures Act”) (Pub. L. No. 114-255), which was signed into law by President Obama on December 13, 2016, includes a number of important health care provisions, and several address the...more

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