News & Analysis as of

Medical Research Health Insurance Portability and Accountability Act (HIPAA)

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - September 9th - 12th, Las Vegas, NV

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program with a focus on the topics and issues that affect research compliance professionals. Our faculty of experienced...more

Health Care Compliance Association (HCCA)

As AI-Assisted Research Advances, Experts Share Worries, Oversight Strategies; Collaboration Urged

At Cornell University, institutional review board (IRB) members meet with the chief information security officer and a liaison to the general counsel’s office. Their regular attendance has been “really critical,” said IRB...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - March 11th - 14th, Nashville, TN

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program with a focus on the topics and issues that affect research compliance professionals. Our faculty of experienced...more

Health Care Compliance Association (HCCA)

[Webinar] HIPAA and Access: The Intersection of OCR Enforcement Trends and Clinical Research - January 18th, 12:00 pm - 1:30 pm CT

Learning Objectives - Brief primer on what qualifies as “access” under HIPAA for both routine healthcare and clinical trial operations - Review of OCR enforcement and issues related to access via recent audits and...more

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

Nelson Mullins Riley & Scarborough LLP

Clinical Research and Patient Data Protection are at a Complicated Intersection

The privacy landscape in the United States and much of the world is quickly evolving around the framework of the General Data Protection Regulation (GDPR) within the European Economic Alliance (EEA). Clinical trials involve...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - March 6th - 9th, Phoenix, AZ

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program designed to help attendees increase their ability to manage effective compliance programs. Our faculty of experts provides...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - December 5th - 8th, Anaheim, CA

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day intensive training program designed to help attendees increase their ability to manage effective research compliance programs. Our faculty of experts...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - April 25th - 28th, Chicago, IL

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day intensive training program designed to help attendees increase their ability to manage effective research compliance programs. Our faculty of experts...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] Clinical Practice Compliance Conference - October 12th - 13th, 8:50 am - 6:00 pm CDT

Get the latest updates on government initiatives related to physicians and clinics - HCCA’s Clinical Practice Compliance Conference provides insights, updates, and strategies that are pertinent to developing and managing...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - December 13th - 16th, Las Vegas, NV

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day intensive training program designed to help attendees increase their ability to manage effective research compliance programs. Our faculty of experts...more

K&L Gates LLP

Health Care Triage: When Regulatory Review is Necessary: Clinical Research vs. Quality Initiatives

K&L Gates LLP on

In this week’s episode, Richard Church interviews Rebecca Schaefer about the intersection and blurred line between clinical research and quality initiatives. The presenters discuss what factors to consider when defining...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

Bradley Arant Boult Cummings LLP

Governor Approves CCPA Amendment to Further Except Healthcare and Research Information

Gov. Gavin Newsom recently approved A.B. 713, a bill that creates further CCPA exceptions for healthcare and research information. The bill is especially potent in the COVID-19 era where the need for medical research is...more

Sheppard Mullin Richter & Hampton LLP

CCPA Amendment Adds Needed Clarity for Medical & Research Community

An amendment to the CCPA recently passed through the legislature, adding some much needed clarity to HIPAA-regulated entities, research institutions and other life science and medical device companies. CCPA in its current...more

Health Care Compliance Association (HCCA)

[Event] March Research Compliance Academy - March 9th - 12th, San Diego, CA

HCCA's Health Care Research Compliance Academy is a three-and-a-half-day intensive training program focuses on compliance issues related solely to research. Its faculty is made up of experts in the field. With a wide range of...more

McDermott Will & Emery

California Bill Proposes CCPA Exceptions for HIPAA De-identified Information, Other Health Data

McDermott Will & Emery on

On January 6, 2020, the California State Senate’s Health Committee unanimously approved California AB 713, a bill that would amend the California Consumer Privacy Act (CCPA) to except from CCPA requirements additional...more

Verrill

More Proposed Changes to CCPA Geared to Health Care and Life Sciences Industries

Verrill on

The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to establish...more

Bradley Arant Boult Cummings LLP

Lawmakers Propose CCPA Amendment to Further Except Healthcare and Research Information - Cybersecurity and Privacy Alert

A little more than a week after California’s groundbreaking California Consumer Protection and Privacy Act (CCPA) went into effect on January 1, the Senate Health Committee unanimously approved A.B. 713, introduced by...more

Health Care Compliance Association (HCCA)

As MD Anderson Keeps Up Its Legal Fight, U. Rochester Pays OCR $3M

Report on Research Compliance 17, no. 1 (January 2020) - Ah, those pesky residents. If you’re a teaching hospital, you can’t live without them, right? But sometimes living with them is mighty costly, as the University of...more

K&L Gates LLP

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

K&L Gates LLP on

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

Bricker Graydon LLP on

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

Epstein Becker & Green

Six Key Changes to the Common Rule

Epstein Becker & Green on

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

King & Spalding

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

King & Spalding on

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

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