News & Analysis as of

Clinical Trials Protected Health Information

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more

Holland & Knight LLP

Holland & Knight Health Dose: February 27, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Health Care Compliance Association (HCCA)

Understanding the requirements for waiving or altering HIPAA authorization for research

The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...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

McDermott Will & Emery

Five Key Considerations for Study Pre-Screening and Recruitment Initiatives in the Digital Age

McDermott Will & Emery on

Key players across the healthcare industry—including sponsors, contract research organizations (CROs), research sites, regulators and patient advocates—are well aware of the challenges associated with the prompt and effective...more

Nelson Mullins Riley & Scarborough LLP

EMA Finalizes Guidance on Safeguarding PPD and CCI in Clinical Trial Filings in the European Economic Area (EEA)

The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...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

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

Shook, Hardy & Bacon L.L.P.

COVID-19 Client Primer

Cybersecurity and Health Information Privacy During the COVID-19 Pandemic - In following CDC guidelines to effectively navigate the spread of COVID-19, many employers are closing their doors for a period of time and...more

McDermott Will & Emery

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

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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

Dickinson Wright

Healthcare Legal News: Volume 7, Number 2

Dickinson Wright on

Where is your PHI Data Traveling Today? With most vendors offering and pushing cloud computing solutions and offsite data backup, or guaranteeing offsite backup of data they process for you, many HIPAA covered entities and...more

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