News & Analysis as of

Medical Research Data-Sharing

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - November 12th, 8:00 am - 5:00 pm CT

Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more

Wilson Sonsini Goodrich & Rosati

FDA Finalizes Guidance for Using Real-World EHRs and Medical Claims Data to Support Regulatory Decisions for Drug Products

As part of the Real-World Evidence Program, the U.S. Food and Drug Administration (FDA) has released the final guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory...more

Society of Corporate Compliance and Ethics...

[Event] Higher Education & Healthcare Research Compliance Conference - June 10th - 12th, New Orleans, LA

Don’t miss our annual conference devoted to higher education and research compliance - Attend the Higher Education & Healthcare Research Compliance Conference June 10–12, 2024 and hear from experienced professionals on a...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] 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)

Report on Research Compliance Volume 18, Number 8. In This Month’s E-News: August 2021

Report on Research Compliance 18, no. 8 (August, 2021) - “As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that when data and biospecimens are shared, that it is done ethically and...more

K&L Gates LLP

Research Community Alert – NIH Finalizes Updated Data Sharing Policy

K&L Gates LLP on

On 29 October 2020, the National Institutes of Health (NIH) issued its final NIH Policy for Data Management and Sharing (the DMS Policy), which updates and replaces the 2003 NIH Data Sharing Policy. Although the DMS Policy...more

White & Case LLP

Using Data to Combat COVID-19

White & Case LLP on

Data plays a central role in the global efforts to combat the COVID-19 pandemic through virus detection, mitigation of spread, treatments, and vaccines. Public policy responses and private sector initiatives are equally...more

K&L Gates LLP

K&L Gates Triage: ONC Signals Federal Health IT Priorities with 2020-2025 Strategic Plan

K&L Gates LLP on

In this week’s episode, Ryan Severson discusses the Federal Health IT Strategic Plan, which was recently released by the Office of the National Coordinator for Health Information Technology (“ONC”). Mr. Severson discusses...more

Burns & Levinson LLP

The Importance of Context with Genetic Privacy

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As consumers, when we think of privacy, one of the first adjectives that springs to mind should be “inconsistent.” Consumers claim to want their personal information used only for the purposes they originally provided it, and...more

Morgan Lewis

Clinical Trial Data: The New Regime

Morgan Lewis on

The European Medicines Agency moves to increase EU clinical trial transparency. The last five years have seen a sea change in the attitude of EU authorities regarding the disclosure of clinical trial results, moving from...more

McDermott Will & Emery

White House Releases Draft Privacy Principles for the Precision Medicine Initiative

McDermott Will & Emery on

Six months after the Precision Medicine Initiative’s (Initiative’s) debut, the White House has released a working draft of proposed privacy and trust principles (the Principles) to govern future design and development efforts...more

Knobbe Martens

Medical Device Clinical Trial Data from Johnson & Johnson To Be Made Available

Knobbe Martens on

According to MedicalXpress, expansive data from a company’s medical device clinical trials will soon be made broadly available to medical device researchers for the first time.  The Yale University Open Data Access (“YODA”)...more

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