News & Analysis as of

Clinical Trials Exemptions

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

Faegre Drinker Biddle & Reath LLP

Some Clinical Trial Calls Now Eligible for the FCC’s Revised TCPA Exemption

The TRACED Act’s December 30, 2020 deadline was not the end of the FCC’s recent series of actions to bring more clarity to certain forms of TCPA exemptions. Most recently, on January 15, 2021, the FCC issued a Declaratory...more

Troutman Pepper

CCPA Amendment Further Harmonizes with HIPAA and Provides Additional Exemptions

Troutman Pepper on

On September 28, California Governor Gavin Newsom signed AB-713 into law, which relaxes some of the California Consumer Privacy Act (CCPA) compliance challenges faced by the health care and life science industries — more...more

Polsinelli

California Privacy Rights Act: Latest Update, Impact and Next Steps

Polsinelli on

The California Privacy Rights Act (CPRA) is a ballot initiative that, if passed in November, will significantly amend the California Consumer Privacy Act (CCPA)....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

Hogan Lovells

California Consumer Privacy Act: The Challenge Ahead – Four Key Considerations For Health And Life Sciences Companies

Hogan Lovells on

This is the sixth installment in Hogan Lovells’ series on the California Consumer Privacy Act. The California Consumer Privacy Act of 2018 (CCPA) adds another set of privacy requirements for health and life sciences...more

Cooley LLP

Alert: China Food and Drug Administration Offers Guidance on Clinical Trial Exemptions for Medical Devices

Cooley LLP on

The "Administrative Measures for the Registration of Medical Device" (Registration Measures) was issued by the China Food and Drug Administration (CFDA) and became effective on October 1, 2014. According to the Registration...more

McDermott Will & Emery

HHS Releases Highly Anticipated Proposal to Modernize U.S. Human Subjects Research Protections

In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more

Mintz - Health Care Viewpoints

Drastic Changes Proposed for Clinical Research Rules

The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common...more

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