News & Analysis as of

Medical Research Data Collection

Manatt, Phelps & Phillips, LLP

[Webinar] State Health Data Organizations: Engines of Market Transparency and Insight - April 12th, 1:00 pm - 2:00 pm ET

Across the country, states are investing in organizations and cross-departmental offices responsible for collecting, managing, integrating and analyzing health system data to provide policymakers, regulators, researchers and...more

Butler Snow LLP

International Privacy Laws and Clinical Trials

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Recent developments in international privacy laws have complicated the conduct of clinical trials outside of the United States. Since the privacy law of the European Union – the General Data Protection Regulation or “GDPR” –...more

McDermott Will & Emery

[Webinar] Around the Corner: Evolving Opportunities and Challenges for Real-World Evidence and Data-Powered Solutions - August...

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Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more

Foley & Lardner LLP

All of Us Research Workbench Open for User Feedback

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The National Institutes of Health recently opened its data platform for user feedback of its “All of Us Researcher Workbench.”  Researchers are now able to use the initial datasets obtained from nearly 350,000 participants in...more

White & Case LLP

Using Data to Combat COVID-19

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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

Faegre Drinker Biddle & Reath LLP

FDA Funding Opportunity Announcement: “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory...

The U.S. Food & Drug Administration (FDA) has released a Funding Opportunity Announcement (FOA) titled “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials...more

Morgan Lewis

Back to the Future but Still in Flux: Court Finds Law Requires ClinicalTrials.gov Posting of Ten Additional Years of Additional...

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The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more

K&L Gates LLP

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

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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

Hogan Lovells

The importance of conscientious health data collection in European clinical trials

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Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more

Robins Kaplan LLP

Financial Daily Dose 11.15.2019 | Top Story: New Jersey Targets Uber Over “Independent Contractor” Worker Classification

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Sending a shot across the bow of the gig economy, New Jersey is seeking nearly $650 million from Uber for “years of unpaid employment taxes for its drivers, arguing that the ride-hailing company has misclassified the workers...more

Burns & Levinson LLP

Medicinal Cannabis and the Need for Data

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Discoveries advance on a regular basis as to how cannabidiol and related therapeutics can heal or at least relieve the pain associated with health conditions. From cancer and opioid addiction to chronic pain and glaucoma,...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

Bricker Graydon LLP

FDA issues guidance on use of EHR data in clinical research

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Many hospitals and health systems conduct sponsored clinical research at their facilities, and clinical trial agreements typically require that sponsors and clinical investigators have access to certain data regarding the...more

Hogan Lovells

Clinical trials: Digital technology for recruitment, consent, and data capture

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The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is...more

Knobbe Martens

Apple’s ResearchKit Turns iPhones into Medical Devices

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Apple recently released ResearchKit, an open-source software platform that allows scientists to gather medical data using an individual’s own iPhone. According to The Asian Age, the new platform allows iPhone users to easily...more

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